[Federal Register Volume 79, Number 20 (Thursday, January 30, 2014)]
[Notices]
[Pages 4913-4935]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01847]



[[Page 4913]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 034

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a 
publication containing modifications the Agency is making to the list 
of standards FDA recognizes for use in premarket reviews (FDA 
recognized consensus standards). This publication, entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 034'' (Recognition List Number: 034), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES: Submit written or electronic comments concerning this document 
at any time. See section VII for the effective date of the recognition 
of standards announced in this document.

ADDRESSES: Submit written requests for single copies of ``Modifications 
to the List of Recognized Standards, Recognition List Number: 034'' to 
the Division of Small Manufacturers, International and Consumer 
Assistance, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 
20993. Send two self-addressed adhesive labels to assist that office in 
processing your requests, or fax your request to 301-847-8149. Submit 
written comments concerning this document, or recommendations for 
additional standards for recognition, to the contact person (see FOR 
FURTHER INFORMATION CONTACT). Submit electronic comments by email: 
standards@cdrh.fda.gov. This document may also be accessed on FDA's 
Internet site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI for 
electronic access to the searchable database for the current list of 
FDA recognized consensus standards, including Recognition List Number: 
034 modifications and other standards related information.

FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796-
6287.

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended 
section 514 allows FDA to recognize consensus standards developed by 
international and national organizations for use in satisfying portions 
of device premarket review submissions or other requirements.
    In a notice published in the Federal Register of February 25, 1998 
(63 FR 9561), FDA announced the availability of a guidance entitled 
``Recognition and Use of Consensus Standards.'' The notice described 
how FDA would implement its standard recognition program and provided 
the initial list of recognized standards.
    Modifications to the initial list of recognized standards, as 
published in the Federal Register, can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
    These notices describe the addition, withdrawal, and revision of 
certain standards recognized by FDA. The Agency maintains hypertext 
markup language (HTML) and portable document format (PDF) versions of 
the list of FDA Recognized Consensus Standards. Both versions are 
publicly accessible at the Agency's Internet site. See section VI for 
electronic access information. Interested persons should review the 
supplementary information sheet for the standard to understand fully 
the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 034

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the Agency will recognize for 
use in premarket submissions and other requirements for devices. FDA 
will incorporate these modifications in the list of FDA Recognized 
Consensus Standards in the Agency's searchable database. FDA will use 
the term ``Recognition List Number: 034'' to identify these current 
modifications.
    In table 1 of this document, FDA describes the following 
modifications: (1) The withdrawal of standards and their replacement by 
others, if applicable; (2) the correction of errors made by FDA in 
listing previously recognized standards; and (3) the changes to the 
supplementary information sheets of recognized standards that describe 
revisions to the applicability of the standards.
    In section III of this document, FDA lists modifications the Agency 
is making that involve the initial addition of standards not previously 
recognized by FDA.

                           Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
    Old recognition  No.      Replacement recognition  No.      Title of standard \1\             Change
----------------------------------------------------------------------------------------------------------------
                                                  A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-15........................  ............................  ISO 5361-4:1987, Tracheal     Withdrawn. See 1-93.
                                                             tubes--Part 4: Cole type.
1-18........................  1-94........................  ISO 8359 Second edition 1996- Withdrawn and replaced
                                                             12-15, Oxygen concentrators   with newer version
                                                             for medical use--Safety       including amendment.
                                                             requirements [Including:
                                                             AMENDMENT 1 2012-07-01].
1-36........................  1-95........................  ISO 5366-3 Second edition     Withdrawn and replaced
                                                             2001-08-15, Anaesthetic and   with newer version
                                                             respiratory equipment--       including technical
                                                             Tracheostomy tubes--Part 3:   corrigendum.
                                                             Pediatric tracheostomy
                                                             tubes [Including: TECHNICAL
                                                             CORRIGENDUM 1 Published
                                                             2003-01-15].
1-44........................  ............................  ISO 5366-1 Fourth edition     Extent of recognition.
                                                             2000-12-15, Anaesthetic and
                                                             respiratory equipment--
                                                             Tracheostomy tubes--Part 1:
                                                             Tubes and connectors for
                                                             use in adults.

[[Page 4914]]

 
1-46........................  ............................  ISO 5367 Fourth edition 2000- Extent of recognition.
                                                             06-01 Breathing tubes
                                                             intended for use with
                                                             anaesthetic apparatus and
                                                             ventilators.
1-47........................  ............................  AS 4259-1995 Ancillary        Extent of recognition.
                                                             devices for expired air
                                                             resuscitation.
1-56........................  1-97........................  CGA V-7.1:2011 Standard       Withdrawn and replaced
                                                             Method of Determining         with newer version.
                                                             Cylinder Valve Outlet
                                                             Connections for Medical
                                                             Gases.
1-57........................  ............................  ASTM F1101-90 (Reapproved     Extent of recognition.
                                                             2003) [egr]1, Standard
                                                             Specification for
                                                             Ventilators Intended for
                                                             Use During Anesthesia.
1-58........................  ............................  ASTM G175-03 (Reapproved      Extent of recognition.
                                                             2011), Standard Test Method
                                                             for Evaluating the Ignition
                                                             Sensitivity and Fault
                                                             Tolerance of Oxygen
                                                             Regulators Used for Medical
                                                             and Emergency Applications.
1-65........................  ............................  ISO 21647:2004 Medical        Withdrawn. See 1-96.
                                                             electrical equipment--
                                                             Particular requirements for
                                                             the basic safety and
                                                             essential performance of
                                                             respiratory gas monitors.
1-69........................  ............................  ASTM F1464-93 (Reapproved     Extent of recognition.
                                                             2005) Standard
                                                             Specification for Oxygen
                                                             Concentrators for
                                                             Domiciliary Use.
1-70........................  ............................  ASTM F1246-91 (Reapproved     Extent of recognition.
                                                             2005) Standard
                                                             Specification for
                                                             Electrically Powered Home
                                                             Care Ventilators, Part 1--
                                                             Positive-Pressure
                                                             Ventilators and Ventilator
                                                             Circuits.
1-78........................  ............................  ASME PVHO-1-2007 Safety       Extent of recognition.
                                                             Standard for Pressure
                                                             Vessels for Human Occupancy.
1-81........................  ............................  CGA V-5:2008 (Reaffirmed      Reaffirmation.
                                                             2013), Diameter-Index
                                                             Safety System
                                                             (Noninterchangeable Low
                                                             Pressure Connections for
                                                             Medical Gas Applications).
1-83........................  ............................  ISO 21647:2004 TECHNICAL      Withdrawn. See 1-96.
                                                             CORRIGENDUM 1, Medical
                                                             electrical equipment--
                                                             Particular requirements for
                                                             the basic safety and
                                                             essential performance of
                                                             respiratory gas monitors.
1-84........................  ............................  ISO 5366-3:2001 Anaesthetic   Withdrawn. See 1-95.
                                                             and Respiratory Equipment--
                                                             Tracheostomy Tubes--Part 3:
                                                             Pediatric Tracheostomy
                                                             Tubes TECHNICAL CORRIGENDUM
                                                             1.
1-86........................  ............................  ISO 8185 Third edition 2007-  Extent of recognition.
                                                             07-01 Corrected versions
                                                             2008-06-15 Respiratory
                                                             tract humidifiers for
                                                             medical use--Particular
                                                             requirements for
                                                             respiratory humidification
                                                             systems.
1-88........................  1-98........................  ISO 80601-2-12 First edition  Withdrawn and replaced
                                                             2011-04-15 Medical            with newer version
                                                             electrical equipment--Part    including technical
                                                             2-12: Particular              corrigendum.
                                                             requirements for the safety
                                                             of lung ventilators--
                                                             Critical care ventilators
                                                             [Including: TECHNICAL
                                                             CORRIGENDUM 1 Published
                                                             2011-10-15].
1-89........................  ............................  ISO 80601-2-12 TECHNICAL      Withdrawn. See 1-98.
                                                             CORRIGENDUM 1 Medical
                                                             electrical equipment Part 2-
                                                             12: Particular requirements
                                                             for basic safety and
                                                             essential performance of
                                                             critical care ventilators.
1-90........................  ............................  ISO 8359 Second edition 1996- Withdrawn. See 1-94.
                                                             12-15 AMENDMENT 1 2012-07-
                                                             01 Oxygen concentrators for
                                                             medical use--Safety
                                                             requirements.
1-92........................  ............................  ISO 17510-2 Second Edition    Extent of recognition.
                                                             2007-10-01, Sleep apnoea
                                                             breathing therapy--Part 2:
                                                             Masks and application
                                                             accessories.
1-93........................   ISO 5361...................  Second edition 2012-10-01     Extent of recognition.
                                                             Anaesthetic and respiratory
                                                             equipment--Tracheal tubes
                                                             and connectors.
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-123.......................  2-204.......................  ASTM F720-13 Standard         Withdrawn and replaced
                                                             Practice for Testing Guinea   with newer version.
                                                             Pigs for Contact Allergens:
                                                             Guinea Pig Maximization
                                                             Test.
2-182.......................  2-205.......................  ISO 14155 Second edition      Withdrawn and replaced
                                                             2011-02-01 Clinical           with newer version
                                                             investigations of medical     including technical
                                                             devices for human subjects--  corrigendum.
                                                             Good clinical practices
                                                             [Including TECHNICAL
                                                             CORRIGENDUM 1:2011].
2-183.......................  ............................  ISO 14155:2011 and TECHNICAL  Withdrawn. See 2-205.
                                                             CORRIGENDUM 1 Published
                                                             2011-07-15 Clinical
                                                             investigation of medical
                                                             devices for human subjects--
                                                             Good clinical practice.
2-93........................  ............................  ASTM F763-04 (Reapproved      Extent of recognition.
                                                             2010), Standard Practice
                                                             for Short-Term Screening of
                                                             Implant Materials.
2-94........................  ............................  ASTM F981-04 (Reapproved      Extent of recognition.
                                                             2010) Standard Practice for
                                                             Assessment of Compatibility
                                                             of Biomaterials for
                                                             Surgical Implants with
                                                             Respect to Effect of
                                                             Materials on Muscle and
                                                             Bone.
2-114.......................  ............................  ASTM F1877-05 (Reapproved     Extent of recognition.
                                                             2010) Standard Practice for
                                                             Characterization of
                                                             Particles.
2-118.......................  ............................  ANSI/AAMI/ISO 10993-11:2006/  Extent of recognition.
                                                             (R) 2010 Biological
                                                             evaluation of medical
                                                             devices--Part 11: Tests for
                                                             systemic toxicity.
2-120.......................  ............................  ANSI/AAMI/ISO 10993-6:2007/   Extent of recognition.
                                                             (R) 2010 Biological
                                                             evaluation of medical
                                                             devices--Part 06: Tests for
                                                             local effects after
                                                             implantation.
2-126.......................  ............................  ASTM F748-06 (Reapproved      Extent of recognition.
                                                             2010) Standard Practice for
                                                             Selecting Generic
                                                             Biological Test Methods for
                                                             Materials and Devices.

[[Page 4915]]

 
2-133.......................  ............................  ASTM F1408-97 (Reapproved     Extent of recognition.
                                                             2008) Standard Practice for
                                                             Subcutaneous Screening Test
                                                             for Implant Materials.
2-134.......................  ............................  ASTM F2065-00 (Reapproved     Extent of recognition.
                                                             2010) Standard Practice for
                                                             Testing for Alternative
                                                             Pathway Complement
                                                             Activation in Serum by
                                                             Solid Materials.
2-136.......................  ............................  ASTM E1262-88 (Reapproved     Extent of recognition.
                                                             2008) Standard Guide for
                                                             Performance of the Chinese
                                                             Hamster Ovary Cell/
                                                             Hypoxanthine Guanine
                                                             Phosphoribosyl Transferase
                                                             Gene Mutation Assay.
2-137.......................  ............................  ASTM E1263-97 (Reapproved     Withdrawn.
                                                             2008) Standard Guide for
                                                             Conduct of Micronucleus
                                                             Assays in Mammalian Bone
                                                             Marrow Erythrocytes.
2-138.......................  ............................  ASTM E1280-97 (Reapproved     Withdrawn.
                                                             2008) Standard Guide for
                                                             Performing the Mouse
                                                             Lymphoma Assay for
                                                             Mammalian Cell Mutagenicity.
2-139.......................  ............................  ASTM E1397-91 (Reapproved     Withdrawn.
                                                             2008) Standard Practice for
                                                             the In Vitro Rat Hepatocyte
                                                             DNA Repair Assay.
2-140.......................  ............................  ASTM E1398-91 (Reapproved     Withdrawn.
                                                             2008) Standard Practice for
                                                             the In Vivo Rat Hepatocyte
                                                             DNA Repair Assay.
2-141.......................  ............................  ASTM F1984-99 (Reapproved     Extent of recognition.
                                                             2008) Standard Practice for
                                                             Testing for Whole
                                                             Complement Activation in
                                                             Serum by Solid Materials.
2-142.......................  ............................  ASTM F1983-99 (Reapproved     Extent of recognition.
                                                             2008) Standard Practice for
                                                             Assessment of Compatibility
                                                             of Absorbable/Resorbable
                                                             Biomaterials for Implant
                                                             Application.
2-143.......................  ............................  ASTM F1904-98 (Reapproved     Extent of recognition.
                                                             2008) Standard Practice for
                                                             Testing the Biological
                                                             Responses to Particles in
                                                             vivo.
2-144.......................  ............................  ASTMF619-03 (Reapproved       Extent of recognition.
                                                             2008) Standard Practice for
                                                             Extraction of Medical
                                                             Plastics.
2-145.......................  ............................  ASTM F1439-03 (Reapproved     Extent of recognition.
                                                             2008) Standard Guide for
                                                             Performance of Lifetime
                                                             Bioassay for the
                                                             Tumorigenic Potential of
                                                             Implant Materials.
2-153.......................  ............................  ANSI/AAMI/ISO 10993-5:2009,   Extent of recognition.
                                                             Biological evaluation of
                                                             medical devices--Part 5:
                                                             Tests for In Vitro
                                                             cytotoxicity.
2-154.......................  ............................  ASTM F756-08 Standard         Extent of recognition.
                                                             Practice for Assessment of
                                                             Hemolytic Properties of
                                                             Materials.
2-155.......................  ............................  ASTM F2147-01 (Reapproved     Extent of recognition.
                                                             2010) Standard Practice for
                                                             Guinea Pig: Split Adjuvant
                                                             and Closed Patch Testing
                                                             for Contact Allergens.
2-156.......................  ............................  ANSI/AAMI/ISO 10993-1:2009    Extent of recognition.
                                                             Biological evaluation of
                                                             medical devices--Part 1:
                                                             Evaluation and testing
                                                             within a risk management.
2-162.......................  ............................  ASTM F1903-10 Standard        Extent of recognition.
                                                             Practice for Testing for
                                                             Biological Responses to
                                                             Particles in vitro.
2-163.......................  ............................  ANSI/AAMI/ISO 10993-9:2009    Extent of recognition.
                                                             Biological evaluation of
                                                             medical devices--Part 9:
                                                             Framework for
                                                             identification and
                                                             quantification of potential
                                                             degradation products.
2-165.......................  ............................  ANSI/AAMI/ISO 10993-14:2001/  Extent of recognition.
                                                             (R) 2011 Biological
                                                             evaluation of medical
                                                             devices--Part 14:
                                                             Identification and
                                                             quantification of
                                                             degradation products from
                                                             ceramics.
2-167.......................  ............................  ISO/TS 10993-19 First         Extent of recognition.
                                                             edition 2006-06-01
                                                             Biological evaluation of
                                                             medical devices--Part 19:
                                                             Physico-chemical,
                                                             morphological, and
                                                             topographical
                                                             characterization of
                                                             materials.
2-168.......................  ............................  ISO 10993-9 Second edition    Extent of recognition.
                                                             2009-12-15 Biological
                                                             evaluation of medical
                                                             devices--Part 9: Framework
                                                             for identification and
                                                             quantification of potential
                                                             degradation products.
2-169.......................  ............................  ISO 10993-13 Second edition   Extent of recognition.
                                                             2010-06-15 Biological
                                                             evaluation of medical
                                                             devices--Part 13:
                                                             Identification and
                                                             quantification of
                                                             degradation products from
                                                             polymeric medical devices.
2-170.......................  ............................  ISO 10993-14 First edition    Extent of recognition.
                                                             2001-11-15 Biological
                                                             evaluation of medical
                                                             devices--Part 14:
                                                             Identification and
                                                             quantification of
                                                             degradation products from
                                                             ceramics.
2-171.......................  ............................  ISO 10993-16 Second edition   Extent of recognition.
                                                             2010-02-15 Biological
                                                             evaluation of medical
                                                             devices--Part 16:
                                                             Toxicokinetic study design
                                                             for degradation products
                                                             and leachables.
2-172.......................  ............................  ANSI/AAMI/ISO TIR 10993-      Extent of recognition.
                                                             19:2006 Biological
                                                             evaluation of medical
                                                             devices--Part 19:
                                                             Physicochemical,
                                                             morphological, and
                                                             topographical
                                                             characterization of
                                                             materials.
2-173.......................  ............................  ANSI/AAMI/ISO 10993-10:2010   Extent of recognition.
                                                             Biological evaluation of
                                                             medical devices--Part 10:
                                                             Tests for irritation and
                                                             skin sensitization.
2-174.......................  ............................  ISO 10993-10:2010 Biological  Extent of recognition.
                                                             evaluation of medical
                                                             devices--Part 10: Tests for
                                                             irritation and skin
                                                             sensitization.
2-175.......................  ............................  ISO 10993-3 Second edition    Extent of recognition.
                                                             2003-10-15 Biological
                                                             evaluation of medical
                                                             devices Part 3: Tests for
                                                             genotoxicity,
                                                             carcinogenicity and
                                                             reproductive toxicity.

[[Page 4916]]

 
2-176.......................  ............................  ISO 10993-11 Second edition   Extent of recognition.
                                                             2006-08-15 Biological
                                                             evaluation of medical
                                                             devices--Part 11: Tests for
                                                             systemic toxicity.
2-177.......................  ............................  ISO 10993-06 Second edition   Extent of recognition.
                                                             2007-04-15 Biological
                                                             evaluation of medical
                                                             devices--Part 6: Tests for
                                                             local effects after
                                                             implantation.
2-179.......................  ............................  ISO 10993-1 Fourth edition    Extent of recognition.
                                                             2009-10-15 Biological
                                                             evaluation of medical
                                                             devices--Part 1: Evaluation
                                                             and testing within a risk
                                                             management process.
2-181.......................  ............................  ANSI/AAMI/ISO 14155:2011,     Extent of recognition.
                                                             Clinical investigation of
                                                             medical devices for human
                                                             subjects--Good clinical
                                                             practice.
2-189.......................  ............................  ASTM F895-11, Standard Test   Extent of recognition.
                                                             Method for Agar Diffusion
                                                             Cell Culture Screening for
                                                             Cytotoxicity.
2-190.......................  ............................  ANSI/AAMI/ISO 10993-13:2010,  Extent of recognition.
                                                             Biological evaluation of
                                                             medical devices--Part 13:
                                                             Identification and
                                                             quantification of
                                                             degradation products from
                                                             polymeric medical devices.
2-191.......................  ............................  ISO 10993-12 Fourth edition   Extent of recognition.
                                                             2012-07-01, Biological
                                                             evaluation of medical
                                                             devices--Part 12: Sample
                                                             preparation and reference
                                                             materials.
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-41........................  ............................  ANSI/AAMI EC11:1991/(R)2007   Withdrawn. See 3-106.
                                                             Diagnostic
                                                             electrocardiographic
                                                             devices.
3-52........................  ............................  ANSI/AAMIEC12:2000/(R)2010    Extent of recognition.
                                                             Disposable ECG electrodes.
3-54........................  ............................  ANSI/AAMI/ISO 7198:1998/2001/ Extent of recognition.
                                                             (R)2010 Cardiovascular
                                                             implants--Tubular vascular
                                                             prostheses.
3-58........................  ............................  ANSI/AAMI/ISO 5840:2005/      Extent of recognition.
                                                             (R)2010 Cardiovascular
                                                             implants--Cardiac valve
                                                             prostheses.
3-63........................  ............................  ISO 11318 Second edition      Extent of recognition.
                                                             2002-08-01 Cardiac
                                                             Defibrillators--Connector
                                                             assembly DF-1 for
                                                             implantable defibrillators--
                                                             Dimensions and test
                                                             requirements.
3-72........................  ............................  ANSI/AAMI EC53:1995/(R) 2008  Extent of recognition.
                                                             ECG cables and leadwires.
3-73........................  3-118.......................  ANSI/AAMI EC57:2012 Testing   Withdrawn and replaced
                                                             and reporting performance     with newer version.
                                                             results of cardiac rhythm
                                                             and ST-segment measurement
                                                             algorithms.
3-75........................  ............................  ANSI/AAMI SP10:2002/(R) 2008  Withdrawn. See 3-80, 3-
                                                             & ANSI/AAMI SP10:2002/        122 and 3-123.
                                                             A1:2003, Manual, electronic
                                                             or automated
                                                             sphygmomanometers.
3-76........................  ............................  ASTM F2129-08 Standard Test   Extent of recognition.
                                                             Method for Conducting
                                                             Cyclic Potentiodynamic
                                                             Polarization Measurements
                                                             to Determine the Corrosion
                                                             Susceptibility of Small
                                                             Implant Devices.
3-78........................  ............................  ANSI/AAMI/IEC 80601-2-        Extent of recognition.
                                                             30:2009 Medical electrical
                                                             equipment--Part 2-30:
                                                             Particular requirements for
                                                             the basic safety and
                                                             essential performance of
                                                             automated noninvasive
                                                             sphygmomanometers.
3-80........................  ............................  ANSI/AAMI/ISO 81060-1:2007/   Reaffirmation.
                                                             (R) 2013 Non-invasive
                                                             sphygmomanometers--Part 1:
                                                             Requirements and test
                                                             methods for non-automated
                                                             measurement type.
3-83........................  ............................  ANSI/AAMI/ISO 14708-5:2010    Extent of recognition.
                                                             Implants for surgery--
                                                             Active implantable medical
                                                             devices--Part 5:
                                                             Circulatory support devices.
3-85........................  3-120.......................  ANSI/AAMI/ISO 25539-2:2012    Withdrawn and replaced
                                                             Cardiovascular implants--     with newer version.
                                                             Endovascular devices--Part
                                                             2: Vascular stents.
3-88........................  ............................  ASTM F2514-08 Standard Guide  Extent of recognition.
                                                             for Finite Element Analysis
                                                             (FEA) of Metallic Vascular
                                                             Stents Subjected to Uniform
                                                             Radial.
3-90........................  ............................  ISO 7198 First edition 1998-  Extent of recognition.
                                                             08-01 Cardiovascular
                                                             implants--Tubular vascular
                                                             prostheses.
3-93........................  ............................  ISO 25539-1:2003 First        Withdrawn. See 3-121.
                                                             edition 2001-11-13
                                                             AMENDMENT 1 2005-07-15
                                                             Cardiovascular implants--
                                                             Endovascular devices--Part
                                                             1: Endovascular prostheses
                                                             Amendment 1: Test methods.
3-97........................  3-122.......................  ISO 81060-2 Second edition    Withdrawn and replace
                                                             2013-05-01 Non-invasive       with newer version.
                                                             sphygmomanometers--Part 2:
                                                             Clinical validation of
                                                             automated measurement type.
3-98........................  ............................  ISO 81060-2:2009 TECHNICAL    Withdrawn. See 3-122.
                                                             CORRIGENDUM Published 2011-
                                                             02-15 Non-invasive
                                                             sphygmomanometers--Part 2:
                                                             Clinical validation of
                                                             automated measurement type.
3-100.......................  ............................  ANSI/AAMI/IEC 60601-2-        Withdrawn. See 3-101.
                                                             27:2011 Medical electrical
                                                             equipment--Part 2-27:
                                                             Particular requirements for
                                                             the basic safety and
                                                             essential performance of
                                                             electrocardiographic
                                                             monitoring equipment.
3-107.......................  3-123.......................  IEC 80601-2-30 Edition 1.1    Withdrawn and replaced
                                                             2013-07 Medical electrical    with newer version.
                                                             equipment--Part 2-30:
                                                             Particular requirements for
                                                             the basic safety and
                                                             essential performance of
                                                             automated non-invasive
                                                             sphygmomanometers.

[[Page 4917]]

 
3-108.......................  ............................  IEC 80601-2-30 (First         Withdrawn. See 3-123.
                                                             edition 2009) Medical
                                                             electrical equipment--Part
                                                             2-30: Particular
                                                             requirements for the basic
                                                             safety and essential
                                                             performance of automated
                                                             non-invasive
                                                             sphygmomanometers
                                                             CORRIGENDUM 1.
3-113.......................  3-124.......................  ISO 7199 Second edition 2009- Withdrawn and replaced
                                                             04-15 Cardiovascular          with newer version
                                                             implants and artificial       including amendment.
                                                             organs--Blood-gas
                                                             exchangers (oxygenators)
                                                             [Including: AMENDMENT 1
                                                             (2012)].
3-114.......................  3-119.......................  ISO 5841-3 Third edition      Withdrawn and replace
                                                             2013-40-15 Implants for       with newer version.
                                                             surgery--Cardiac
                                                             pacemakers--Part 3: Low-
                                                             profile connectors (IS-1)
                                                             for implantable pacemakers.
----------------------------------------------------------------------------------------------------------------
                                                  D. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-50........................  ............................  ADA Specification No.18:1992  Extent of recognition.
                                                             Alginate Impression
                                                             Materials.
4-62........................  ............................  ISO 1563 Second edition 1990- Withdrawn.
                                                             09-01 Dental alginate
                                                             impression material.
4-63........................  ............................  ISO 1564 Second edition 1995- Withdrawn.
                                                             11-01 Dental aqueous
                                                             impression materials based
                                                             on agar.
4-86........................  ............................  ANSI/ADA Specification No.    Extent of recognition.
                                                             38 2000 (Reaffirmed 2010),
                                                             Metal-Ceramic Dental
                                                             Restorative Systems.
4-89........................  ............................  ANSI/ADA Specification No.    Extent of recognition.
                                                             53: 1999 (Reaffirmed 2008)
                                                             Polymer-Based Crowns and
                                                             Bridge Materials.
4-91........................  ............................  ANSI/ADA Specification No.    Reaffirmation and
                                                             80/ISO 7491:2000              extent of
                                                             (Reaffirmed 2013) Dental      recognition.
                                                             Materials--Determination of
                                                             Color Stability.
4-92........................  ............................  ANSI/ADA Specification No.    Reaffirmation and
                                                             88:2000 (Reaffirmed 2010)     extent of
                                                             Dental Brazing Alloys.        recognition.
4-96........................  ............................  ANSI/ADA Specification No.    Reaffirmation and
                                                             30:2000 (Reaffirmed 2012)     extent of
                                                             Dental Zinc Oxide-Eugenol     recognition.
                                                             and Zinc Oxide Non-Eugenol
                                                             Cements.
4-97........................  ............................  ANSI/ADA Specification No.    Extent of recognition.
                                                             57: (Reaffirmed 2012)
                                                             Endodontic Sealing
                                                             Materials.
4-105.......................  ............................  ANSI/ADA Specification No.    Extent of recognition.
                                                             75:1997 (Reapproved 2003)
                                                             Resilient Lining Materials
                                                             for Removable Dentures--
                                                             Part 1: Short-Term
                                                             Materials.
4-109.......................  ............................  ISO 13716 First edition 1999- Withdrawn.
                                                             05-01 Dentistry--reversible-
                                                             irreversible hydrocolloid
                                                             impression material system.
4-126.......................  ............................  ISO 10477 Second edition      Extent of recognition.
                                                             2004-10-01 Dentistry--
                                                             Polymer-based crown and
                                                             bridge materials.
4-130.......................  ............................  ADA Specification No.         Extent of recognition.
                                                             17:1983 (Reaffirmed 2006)
                                                             Denture Base Temporary
                                                             Relining Resins.
4-134.......................  4-207.......................  ISO 7494-1 Second edition     Withdrawn and replaced
                                                             2011-08-15 Dentistry--        with newer version.
                                                             Dental units--Part 1:
                                                             General requirements and
                                                             test methods.
4-135.......................  4-213.......................  ISO 10139-1 Second edition    Withdrawn and replaced
                                                             2005-02-15 Dentistry--Soft    with newer version
                                                             lining materials for          including technical
                                                             removable dentures--Part 1:   corrigendum.
                                                             Materials for short-term
                                                             use [Including: TECHNICAL
                                                             CORRIGENDUM 1 (2006)].
4-137.......................  ............................  ISO 6877 Second edition 2006- Extent of recognition.
                                                             04-01 Dentistry--Root-canal
                                                             obturating points.
4-139.......................  ............................  ANSI/ADA Specification No.    Reaffirmation and
                                                             48 (Reaffirmed 2009)          extent of
                                                             Visible Light Curing Units.   recognition.
4-143.......................  4-208.......................  ANSI/ADA Specification No.    Withdrawn and replaced
                                                             96:2012 Dental-Water-Based    with newer version.
                                                             Cements.
4-144.......................  4-209.......................  ISO 24234 First edition 2004- Withdrawn and replaced
                                                             10-15 Dentistry--Mercury      with newer version
                                                             and alloys for dental         including amendment.
                                                             amalgam [Including:
                                                             AMENDMENT 1 (2011)].
4-146.......................  ............................  ISO 22674 First edition 2006- Extent of recognition.
                                                             11-15 Dentistry--Metallic
                                                             materials for fixed and
                                                             removable restorations and
                                                             appliances.
4-149.......................  ............................  ANSI/ADA Specification No.    Reaffirmation and
                                                             39/ISO 6874:2005              extent of
                                                             (Reaffirmed 2011) Pit and     recognition.
                                                             Fissure Sealants.
4-150.......................  ............................  ANSI/ADA Specification No.    Extent of recognition.
                                                             19:2004/ISO 4823:2000
                                                             Dental--Elastometric
                                                             Impression Materials.
4-151.......................  ............................  ISO 22112 First edition 2005- Extent of recognition.
                                                             11-01 Dentistry--Artificial
                                                             teeth for dental prostheses.
4-153.......................  ............................  ISO 9917-1 Second edition     Extent of recognition.
                                                             2007-10-01 Dentistry--Water-
                                                             based cements--Part 1:
                                                             Powder/liquid acid-base
                                                             cements.
4-154.......................  4-210.......................  ISO 4823 Third edition 2000-  Withdrawn and replaced
                                                             12-15 Dentistry--             with newer version
                                                             Elastometric impression       including amendment
                                                             materials [Including:         and technical
                                                             AMENDMENT 1 (2000)            corrigendum.
                                                             TECHNICAL CORRIGENDUM
                                                             1(2004)].
4-155.......................  ............................  ISO 4823: Technical           Withdrawn. See 4-210.
                                                             Corrigendum 1 Published
                                                             2004-07-15--Dentistry--Elas
                                                             tometric impression
                                                             materials--Third Edition.

[[Page 4918]]

 
4-156.......................  ............................  ISO 4823 Third edition 2000-  Withdrawn. See 4-210.
                                                             12-15 Amendment 1 2007-07-
                                                             01 Dentistry--Elastometric
                                                             impression materials--Third
                                                             Edition.
4-157.......................  ............................  ISO 3107 Third edition 2004-  Withdrawn. See 4-198.
                                                             10-01 Dentistry--Zinc oxide/
                                                             Eugenol and zinc oxide/non-
                                                             eugenol cements--Third
                                                             edition.
4-159.......................  4-211.......................  ANSI/IEEE C63.19:2007         Withdrawn and replaced
                                                             American National Standard    with newer version.
                                                             Methods of Measurement of
                                                             Compatibility between
                                                             Wireless Communications
                                                             Devices and Hearing Aids.
4-170.......................  4-212.......................  ANSI/ASA S3.36-2012 American  Withdrawn and replaced
                                                             National Standard             with newer version.
                                                             Specification for a Manikin
                                                             for Simulated in situ
                                                             Airborne Acoustic
                                                             Measurements.
4-178.......................  ............................  ISO 6872 Third edition 2008-  Extent of recognition.
                                                             09-01 Dentistry--Ceramic
                                                             materials.
4-179.......................  ............................  ISO 7405 Second edition 2008- Extent of recognition.
                                                             12-15 Dentistry--Evaluation
                                                             of biocompatibility of
                                                             medical devices used in
                                                             dentistry.
4-180.......................  ............................  ISO 9168 Third edition 2009-  Extent of recognition.
                                                             07-15 Dentistry--Hose
                                                             connectors for air driven
                                                             dental handpieces.
4-181.......................  ............................  ISO 4049 Fourth edition 2009- Extent of recognition.
                                                             10-01 Dentistry--Polymer-
                                                             based restorative materials.
4-182.......................  ............................  ISO 10139-2 Second edition    Extent of recognition.
                                                             2009-08-01 Dentistry--Soft
                                                             lining materials for
                                                             removable dentures--Part 2:
                                                             Materials for long-term use.
4-188.......................  ............................  ISO 9917-2 Second edition     Extent of recognition.
                                                             2010-04-15 Dentistry--Water-
                                                             based cements--Part 2:
                                                             Resin-modified cements.
4-189.......................  ............................  ISO 10139-1:2005 TECHNICAL    Withdrawn. See 4-213.
                                                             CORRIGENDUM 1 2006-03-01
                                                             Dentistry--Soft lining
                                                             materials for removable
                                                             dentures--Part 1: Materials
                                                             for short-term use.
4-195.......................  ............................  ISO 14801 Second edition      Extent of recognition.
                                                             2007-11-15 Dentistry--
                                                             Implants-Dynamic fatigue
                                                             test for endosseous dental
                                                             implants.
4-196.......................  ............................  ANSI/ADA Specification        Extent of recognition.
                                                             No.69:2010/ISO 6872:2008
                                                             Dental Ceramic.
4-198.......................  ............................  ISO 3107 Fourth edition 2011- Extent of recognition.
                                                             03-01 Dentistry--Zinc oxide/
                                                             eugenol and zinc oxide/non-
                                                             eugenol cements.
4-199.......................  ............................  ISO 6876 Third edition 2012-  Extent of recognition.
                                                             06-01 Dentistry--Root Canal
                                                             Sealing Materials.
4-200.......................  ............................  ISO 24234 First edition 2004- Withdrawn. See 4-209.
                                                             10-15 Dentistry--Mercury
                                                             and alloys for dental
                                                             amalgam AMENDMENT 1.
4-201.......................  ............................  ISO 9693-2012 Dentistry--     Extent of recognition.
                                                             Compatibility testing--
                                                             Metal-ceramic systems.
4-205.......................  ............................  ISO 14457 First edition 2012- Withdrawn. See 4-206.
                                                             09-15 Dentistry--Handpieces
                                                             and motors.
----------------------------------------------------------------------------------------------------------------
                                                   E. General
----------------------------------------------------------------------------------------------------------------
5-22........................  ............................  ISO 2768-1 First edition      Extent of recognition.
                                                             1989-11-15 General
                                                             tolerances--Part 1:
                                                             Tolerances for linear and
                                                             angular dimensions without
                                                             individual tolerance
                                                             indications.
5-23........................  ............................  ISO 2768-2 First edition      Extent of recognition.
                                                             1989-11-15 General
                                                             Tolerances--Part 2:
                                                             Geometrical tolerances for
                                                             features without individual
                                                             tolerance indications.
5-36........................  ............................  ISO/TR 16142 Second edition   Extent of recognition.
                                                             2006-01-15 Medical devices--
                                                             Guidance on the selection
                                                             of standards in support of
                                                             recognized essential
                                                             principles of safety and
                                                             performance of medical
                                                             devices.
5-37........................  5-81........................  ISO 2859-1 Second edition     Withdrawn and replaced
                                                             1999-11-15 Sampling           with newer version
                                                             procedures for inspection     including technical
                                                             by attributes--Part 1:        corrigendum.
                                                             Sampling schemes indexed by
                                                             acceptance quality limit
                                                             (AQL) for lot-by-lot
                                                             inspection [Including:
                                                             TECHNICAL CORRIGENDUM 1
                                                             (2001)].
5-43........................  ............................  ANSI/ESD S20.20-2007 For the  Extent of recognition.
                                                             Development of an
                                                             Electrostatic Discharge
                                                             Control Program for
                                                             Protection of Electrical
                                                             and Electronic Parts,
                                                             Assemblies and Equipment
                                                             (Excluding Electrically
                                                             Initiated Explosive
                                                             Devices).
5-45........................  5-79........................  ASTM D7386-12 Standard        Withdrawn and replaced
                                                             Practice for Performance      with new version.
                                                             Testing of Packages for
                                                             Single Parcel Delivery
                                                             Systems.
5-46........................  ............................  ISO 2859-1:1999/Cor 1:2001    Withdrawn. See 5-81.
                                                             Sampling procedures for
                                                             inspection by attributes--
                                                             Part 1: Sampling schemes
                                                             indexed by acceptance
                                                             quality limit (AQL) for lot-
                                                             by-lot inspection.
5-47........................  ............................  ISO 10012 First edition 2003- Extent of recognition.
                                                             01-15 Measurement
                                                             management systems--
                                                             Requirements for
                                                             measurement processes and
                                                             measuring equipment.
5-50........................  ............................  IEC 62366 Edition 1.0 2007-   Extent of recognition.
                                                             10 Medical devices--
                                                             Application of usability
                                                             engineering to medical
                                                             devices.

[[Page 4919]]

 
5-51........................  5-80........................  ASTM D-4332-13 Standard       Withdrawn and replaced
                                                             Practice for Conditioning     with new version.
                                                             Containers, Packages, or
                                                             Packaging Components for
                                                             Testing.
5-53........................  ............................  IEC 60601-1-2 Edition 3.0     Relevant guidance.
                                                             2007-03 Medical electrical
                                                             equipment--Part 1-2:
                                                             General requirements for
                                                             basic safety and essential
                                                             performance--Collateral
                                                             standard: Electromagnetic
                                                             compatibility--Requirements
                                                             and tests.
5-54........................  ............................  ANSI/AAMI/IEC 60601-1-2:2007/ Reaffirmation and
                                                             (R)2012 Medical electrical    relevant guidance.
                                                             equipment--Part 1-2:
                                                             General requirements for
                                                             basic safety and essential
                                                             performance--Collateral
                                                             standard: Electromagnetic
                                                             compatibility--Requirements
                                                             and tests.
5-57........................  ............................  ANSI/AAMI HE75:2009 Human     Extent of recognition.
                                                             factors engineering--Design
                                                             of medical devices.
5-58........................  5-82........................  IEC 60601-1-11 Edition        Withdrawn and replaced
                                                             1.0:2010 Medical electrical   with newer version
                                                             equipment--Part 1-11:         including technical
                                                             General requirements for      corrigendum.
                                                             basic safety and essential
                                                             performance--Collateral
                                                             Standard: Requirements for
                                                             medical electrical
                                                             equipment and medical
                                                             electrical systems used in
                                                             the home healthcare
                                                             environment [Including:
                                                             TECHNICAL CORRIGENDUM 1
                                                             (2011)].
5-62........................  ............................  ANSI/ASQ Z1.4-2008 Sampling   Extent of recognition.
                                                             Procedures and Tables for
                                                             Inspection by Attributes.
5-66........................  ............................  IEC 60601-1-10 Edition 1.0:   Extent of recognition.
                                                             2007-11 Medical electrical
                                                             equipment--Part 1-10:
                                                             General requirements for
                                                             basic safety and essential
                                                             performance--Collateral
                                                             Standard: Requirements for
                                                             the development of
                                                             physiologic closed-loop
                                                             controllers.
5-67........................  ............................  ANSI/AAMI/IEC 62366:2007/     Reaffirmation and
                                                             (R)2013 Medical devices--     extent of
                                                             Application of usability      recognition.
                                                             engineering to medical
                                                             devices.
5-69........................  ............................  IEC 60601-1-11 (First         Withdrawn. See 5-82.
                                                             edition 2010) April 2011
                                                             Medical electrical
                                                             equipment--Part 1-11:
                                                             General requirements for
                                                             basic safety and essential
                                                             performance--Collateral
                                                             Standard: Requirements for
                                                             medical electrical
                                                             equipment and medical
                                                             electrical systems used in
                                                             the home healthcare
                                                             environment CORRIGENDUM 1.
----------------------------------------------------------------------------------------------------------------
                                   F. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-13........................  ............................  ISO 595-1 First edition 1986- Withdrawn.
                                                             12-15 Reusable all-glass or
                                                             metal-and-glass syringes
                                                             for medical use--Part 1:
                                                             Dimensions.
6-14........................  ............................  ISO 595-2 First edition 1987- Withdrawn.
                                                             12-15 Reusable all-glass or
                                                             metal-and-glass syringes
                                                             for medical use--Part 2:
                                                             Design, performance
                                                             requirements and tests.
6-117.......................  ............................  ASTM F2172-02 (Reapproved     Extent of recognition.
                                                             2011) Standard
                                                             Specification for Blood/
                                                             Intravenous Fluid/
                                                             Irrigation Fluid Warmers.
6-142.......................  ............................  ANSI/AAMI II36:2004 Medical   Withdrawn. See 6-230.
                                                             electrical equipment--Part
                                                             2: Particular requirements
                                                             for safety of baby
                                                             incubators.
6-143.......................  ............................  ANSI/AAMI II51:2004 Medical   Withdrawn. See 6-231.
                                                             electrical equipment--Part
                                                             2: Particular requirements
                                                             for safety of transport
                                                             incubators.
6-150.......................  ............................  ASTM D7161-05 (Reapproved     Withdrawn.
                                                             2010) Standard Practice for
                                                             Determination of Real Time
                                                             Expiration Dating of Mature
                                                             Medical Gloves Stored Under
                                                             Typical Warehouse
                                                             Conditions.
6-161.......................  6-301.......................  ISO 10555-1 Second edition    Withdrawn and replaced
                                                             2013-06-15 Corrected          with newer version.
                                                             version 2013-07-01
                                                             Intravascular catheters--
                                                             Sterile and single-use
                                                             catheters--Part 1: General
                                                             requirements.
6-163.......................  ............................  ISO 9626 First edition 1991-  Withdrawn. See 6-302.
                                                             09-01 AMENDMENT 1 2001-06-
                                                             01 Stainless steel needle
                                                             tubing for the manufacture
                                                             of medical devices.
6-164.......................  6-303.......................  ISO 10555-5 Second edition    Withdrawn and replaced
                                                             2013-06-15 Intravascular      with newer version.
                                                             catheters--Sterile and
                                                             single-use catheters--Part
                                                             5: Over-needle peripheral
                                                             catheters.
6-170.......................  6-304.......................  ISO 7886-1 First edition      Withdrawn and replaced
                                                             1993-10-01 Sterile            with newer version
                                                             hypodermic syringes for       including technical
                                                             single use--Part 1:           corrigendum.
                                                             Syringes for manual use
                                                             [Including: TECHNICAL
                                                             CORRIGENDUM 1 Published
                                                             1995-11-01].
6-171.......................  6-305.......................  ISO 10555-3 Second edition    Withdrawn and replaced
                                                             2013-06-15 Intravascular      with newer version.
                                                             catheters--Sterile and
                                                             single-use catheters--Part
                                                             3: Central venous catheters.
6-176.......................  ............................  ASTM D7103-06 (Reapproved     Extent of recognition.
                                                             2013) Standard Guide for
                                                             Assessment of Medical
                                                             Gloves.
6-187.......................  6-306.......................  ASTM F1671/F1671M-13          Withdrawn and replaced
                                                             Standard Test Method for      with newer version.
                                                             Resistance of Materials
                                                             Used in Protective Clothing
                                                             to Penetration by Blood-
                                                             Borne Pathogens Using Phi-
                                                             X174 Bacteriophage
                                                             Penetration as a Test
                                                             System.

[[Page 4920]]

 
6-233.......................  ............................  IEC 60601-2-52 Edition 1.0    Withdrawn. See 6-321.
                                                             2009-12 Medical electrical
                                                             equipment--Part 2-52:
                                                             Particular requirements for
                                                             basic safety and essential
                                                             performance of medical beds.
6-236.......................  6-307.......................  IEC 80601-2-59 Edition 1.0    Withdrawn and replaced
                                                             2008-10 Medical Electrical    with newer version
                                                             Equipment--Part 2-59:         including technical
                                                             Particular requirements for   corrigendum.
                                                             the basic safety and
                                                             essential performance of
                                                             screening thermographs for
                                                             human febrile temperature
                                                             screening [Including:
                                                             CORRIGENDUM 1 (April 2009)].
6-237.......................  ............................  IEC 80601-2-59 (First         Withdrawn. See 6-307.
                                                             edition 2008) Medical
                                                             Electrical Equipment--Part
                                                             2-59: Particular
                                                             requirements for the basic
                                                             safety and essential
                                                             performance of screening
                                                             thermographs for human
                                                             febrile temperature
                                                             screening CORRIGENDUM 1.
6-238.......................  6-308.......................  IEC 80601-2-35 Edition 2.0    Withdrawn and replaced
                                                             2009-10 Medical electrical    with newer version
                                                             equipment--Part 2-35:         including technical
                                                             Particular requirements for   corrigendum.
                                                             the basic safety and
                                                             essential performance of
                                                             heating devices using
                                                             blankets, pads or
                                                             mattresses and intended for
                                                             heating in medical use
                                                             [Including: CORRIGENDUM 1
                                                             (March 2012)].
6-245.......................  ............................  ISO 8536-4 Fifth edition      Withdrawn. See 6-318.
                                                             2010-10-01 Infusion
                                                             equipment for medical use--
                                                             Part 4: Infusion sets for
                                                             single use, gravity feed.
6-253.......................  ............................  ISO 10535 Second edition      Extent of recognition.
                                                             2006-12-15 Hoists for the
                                                             transfer of disabled
                                                             persons--Requirements and
                                                             test methods.
6-264.......................  ............................  ISO 10555-1 First edition     Withdrawn. See 6-301.
                                                             1995-06-15 AMENDMENT 1 1999-
                                                             07-15 Sterile, single-use
                                                             intravascular catheters--
                                                             Part 1: General
                                                             requirements.
6-265.......................  ............................  ISO 10555-1 First edition     Withdrawn. See 6-301.
                                                             1995-06-5 AMENDMENT 2 2004-
                                                             05-15 Sterile, single-use
                                                             intravascular catheters--
                                                             Part 1: General
                                                             requirements.
6-266.......................  ............................  ISO 10555-5 First edition     Withdrawn. See 6-303.
                                                             1996-06-15 AMENDMENT 1
                                                             Sterile, single-use
                                                             intravascular catheters--
                                                             Part 5: Over-needle
                                                             peripheral catheters.
6-267.......................  ............................  ISO 10555-5 1996 TECHNICAL    Withdrawn. See 6-303.
                                                             CORRIGENDUM 1 Published
                                                             2002-06-15 Sterile, single-
                                                             use intravascular
                                                             catheters--Part 5: Over-
                                                             needle peripheral catheters.
6-273.......................  ............................  ISO 23908 First edition 2011- Extent of recognition.
                                                             06-11 Sharps injury
                                                             protection--Requirements
                                                             and test methods--Sharps
                                                             protection features for
                                                             single-use hypodermic
                                                             needles, introducers for
                                                             catheters and needles used
                                                             for blood sampling.
6-279.......................  ............................  IEC 60601-2-19 (Second        Withdrawn. See 6-319.
                                                             Edition 2009) Medical
                                                             electrical equipment--Part
                                                             2-19: Particular
                                                             requirements for the basic
                                                             safety and essential
                                                             performance of infant
                                                             incubators CORRIGENDUM 1.
6-280.......................  ............................  IEC 60601-2-20 (Second        Withdrawn. See 6-320.
                                                             edition 2009) Medical
                                                             electrical equipment--Part
                                                             2-20: Particular
                                                             requirements for the basic
                                                             safety and essential
                                                             performance of infant
                                                             transport incubators
                                                             CORRIGENDUM 1.
6-281.......................  ............................  IEC 80601-2-35 (Second        Withdrawn. See 6-308.
                                                             edition 2009) Medical
                                                             electrical equipment--Part
                                                             2-35: Particular
                                                             requirements for the basic
                                                             safety and essential
                                                             performance of heating
                                                             devices using blankets,
                                                             pads or mattresses and
                                                             intended for heating in
                                                             medical use CORRIGENDUM 1.
6-283.......................  6-309.......................  USP 36-NF31:2013 Sodium       Withdrawn and replaced
                                                             Chloride Irrigation.          with newer version.
6-284.......................  6-310.......................  USP 36-NF31:2013 Sodium       Withdrawn and replaced
                                                             Chloride Injection.           with newer version.
6-285.......................  6-311.......................  USP 36-NF31:2013              Withdrawn and replaced
                                                             Nonabsorbable Surgical        with newer version.
                                                             Suture.
6-286.......................  3-312.......................  USP 36-NF31:2013 <881>        Withdrawn and replaced
                                                             Tensile Strength.             with newer version.
6-287.......................  6-313.......................  USP 36-NF31:2013 <861>        Withdrawn and replaced
                                                             Sutures--Diameter.            with newer version.
6-288.......................  6-314.......................  USP 36-NF 31:2013 <871>       Withdrawn and replaced
                                                             Sutures--Needle Attachment.   with newer version.
6-289.......................  6-315.......................  USP 36-NF31:2013 Sterile      Withdrawn and replaced
                                                             Water for Irrigation.         with newer version.
6-290.......................  6-316.......................  USP 36-NF31:2013 Heparin      Withdrawn and replaced
                                                             Lock Flush Solution.          with newer version.
6-291.......................  6-317.......................  USP 36-NF31:2013 Absorbable   Withdrawn and replaced
                                                             Surgical Suture.              with newer version.
6-292.......................  ............................  ISO 7886-1:1993 TECHNICAL     Withdrawn. See 6-304.
                                                             CORRIGENDUM 1 Published
                                                             1995-11-01 Sterile
                                                             hypodermic syringes for
                                                             single-use--Part 1:
                                                             Syringes for manual use.

[[Page 4921]]

 
6-298.......................  6-319.......................  IEC 60601-2-19 Edition 2.0    Withdrawn and replaced
                                                             2009-02 Medical electrical    with newer version
                                                             equipment--Part 2-19:         including technical
                                                             Particular requirements for   corrigendum.
                                                             the basic safety and
                                                             essential performance of
                                                             infant incubators
                                                             [Including: CORRIGENDUM 1
                                                             (2012)].
6-299.......................  ............................  IEC 60601-2-20 Edition 2.0    Withdrawn. See 6-320.
                                                             2009-02 Medical electrical
                                                             equipment--Part 2-20:
                                                             Particular requirements for
                                                             the basic safety and
                                                             essential performance of
                                                             infant transport incubators.
----------------------------------------------------------------------------------------------------------------
                                             G. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-100.......................  ............................  ISO 15197 First edition 2003- Withdrawn.
                                                             05-01 In Vitro diagnostic
                                                             test systems--Requirements
                                                             for blood-glucose
                                                             monitoring systems for self-
                                                             testing in managing
                                                             diabetes mellitus.
7-137.......................  7-244.......................  CLSI NBS01-A6 Blood           Withdrawn and replaced
                                                             Collection on Filter Paper    with newer version.
                                                             for Newborn Screening
                                                             Programs; Approved
                                                             Standard--Sixth Edition.
7-239.......................  ............................  CLSI EP32-R (Formerly X05-R)  Designation number.
                                                             Metrological Traceability
                                                             and Its Implementation; A
                                                             Report.
7-226.......................  ............................  CLSI QMS01-A4 (Formerly GP26- Designation number.
                                                             A4) Quality Management
                                                             System: A Model for
                                                             Laboratory Services;
                                                             Approved Guideline--Fourth
                                                             Edition.
7-224.......................  ............................  CLSI EP28-A3c (Formerly C28-  Designation number.
                                                             A3c) Defining,
                                                             Establishing, and Verifying
                                                             Reference Intervals in the
                                                             Clinical Laboratory;
                                                             Approved Guideline--Third
                                                             Edition.
7-223.......................  ............................  CLSI QSM06-A3 (Formerly GP22- Designation number.
                                                             A3) Quality Management
                                                             System: Continual
                                                             Improvement; Approved
                                                             Guideline--Third Edition.
7-92........................  7-245.......................  CLSI EP09-A3 Measurement      Withdrawn and replaced
                                                             Procedure Comparison and      with newer version.
                                                             Bias Estimation Using
                                                             Patient Samples; Approved
                                                             Guideline--Third Edition.
7-210.......................  ............................  CLSI H26-A2 Validation,       Extent of recognition.
                                                             Verification, and Quality
                                                             Assurance of Automated
                                                             Hematology Analyzers;
                                                             Approved Standard--Second
                                                             Edition.
7-152.......................  ............................  CLSI EP12-A2 User Protocol    Extent of recognition.
                                                             for Evaluation of
                                                             Qualitative Test
                                                             Performance; Approved
                                                             Guideline--Second Edition.
7-174.......................  ............................  CLSI EP21-A Estimation of     Extent of recognition.
                                                             Total Analytical Error for
                                                             Clinical Laboratory
                                                             Methods; Approved Guideline.
7-178.......................  ............................  CLSI M22-A3 Quality Control   Extent of recognition.
                                                             for Commercially Prepared
                                                             Microbiological Culture
                                                             Media; Approved Standard--
                                                             Third Edition.
7-193.......................  ............................  CLSI EP06-A Evaluation of     Extent of recognition.
                                                             the Linearity of
                                                             Quantitative Measurement
                                                             Procedures: A Statistical
                                                             Approach; Approved
                                                             Guideline.
7-220.......................  ............................  CLSI H59-A Quantitative D-    Extent of recognition.
                                                             dimer for the Exclusion of
                                                             Venous Thromboembolic
                                                             Disease; Approved Guideline.
----------------------------------------------------------------------------------------------------------------
                                                  H. Materials
----------------------------------------------------------------------------------------------------------------
8-67........................  8-344.......................  ISO 7153-1 Second edition     Withdrawn and replaced
                                                             1991-04-01 Surgical           with newer version
                                                             instruments--Metallic         including amendment.
                                                             materials--Part 1:
                                                             Stainless steel [Including:
                                                             AMENDMENT 1(1999)].
8-138.......................  ............................  ASTM F745-07 Standard         Withdrawn.
                                                             Specification for 18
                                                             Chromium-12.5 Nickel-2.5
                                                             Molybdenum Stainless Steel
                                                             for Cast and Solution-
                                                             Annealed Surgical Implant
                                                             Applications.
8-139.......................  8-345.......................  ASTM F1314-13 Standard        Withdrawn and replaced
                                                             Specification for Wrought     with newer version.
                                                             Nitrogen Strengthened 22
                                                             Chromium-13 Nickel-5
                                                             Manganese-2.5 Molybdenum
                                                             Stainless Steel Alloy Bar
                                                             and Wire for Surgical
                                                             Implants (UNS S20910).
8-140.......................  8-346.......................  ASTM F1813-13 Standard        Withdrawn and replaced
                                                             Specification for Wrought     with newer version.
                                                             Titanium-12 Molybdenum-6
                                                             Zirconium-2 Iron Alloy for
                                                             Surgical Implant (UNS
                                                             R58120).
8-141.......................  8-347.......................  ASTM F2146-13 Standard        Withdrawn and replaced
                                                             Specification for Wrought     with newer version.
                                                             Titanium-3 Aluminum-2.5
                                                             Vanadium Alloy Seamless
                                                             Tubing for Surgical Implant
                                                             Applications (UNS R56320).
8-169.......................  8-348.......................  ASTM F138-13 Standard         Withdrawn and replaced
                                                             Specification for Wrought     with newer version.
                                                             18 Chromium-14 Nickel-2.5
                                                             Molybendum Stainless Steel
                                                             Bar and Wire for Surgical
                                                             Implants (UNS S31673).
8-176.......................  8-349.......................  ASTM F2503-13 Standard        Withdrawn and replaced
                                                             Practice for Marking          with newer version.
                                                             Medical Devices and Other
                                                             Items for Safety in the
                                                             Magnetic Resonance
                                                             Environment.
8-149.......................  8-350.......................  ISO 5832-1 Fourth edition     Withdrawn and replaced
                                                             2007-06-15 Implants for       with newer version
                                                             surgery--Metallic             including technical
                                                             materials--Part 1: Wrought    corrigendum.
                                                             stainless steel [Including:
                                                             TECHNICAL CORRIGENDUM
                                                             1(2008)].

[[Page 4922]]

 
8-196.......................  ............................  ISO 5832-1: 2007 Implants     Withdrawn. See 8-350.
                                                             for surgery--Metallic
                                                             materials--Part 1: Wrought
                                                             stainless steel TECHNICAL
                                                             CORRIGENDUM 1.
8-151.......................  8-351.......................  ISO 5832-12 Second edition    Withdrawn and replaced
                                                             2007-05-01 Implants for       with newer version
                                                             surgery--Metallic             including technical
                                                             materials--Part 12: Wrought   corrigendum.
                                                             cobalt-chromium-molybdenum
                                                             alloy [Including: TECHNICAL
                                                             CORRIGENDUM 1 2008].
8-197.......................  ............................  ISO 5832-12:2007 TECHNICAL    Withdrawn. See 8-351.
                                                             CORRIGENDUM 1 2008-09-05,
                                                             Implants for surgery--
                                                             Metallic materials--Part
                                                             12: Wrought cobalt-chromium-
                                                             molybdenum alloy TECHNICAL
                                                             CORRIGENDUM 1.
8-211.......................  8-352.......................  ISO 5834-1 Third edition      Withdrawn and replaced
                                                             2005-06-01 Implants for       with newer version
                                                             surgery--Ultra-high-          including technical
                                                             molecular-weight              corrigendum.
                                                             polyethylene--Part 1:
                                                             Powder form [Including:
                                                             TECHNICAL CORRIGENDUM 1
                                                             2007].
8-212.......................  ............................  ISO 5834-1:2005 Technical     Withdrawn. See 8-352.
                                                             Corrigendum 1 Published
                                                             2007-05-01 Implants for
                                                             surgery--Ultra-high-
                                                             molecular-weight
                                                             polyethylene--Part 1:
                                                             Powder form TECHNICAL
                                                             CORRIGENDUM 1.
8-228.......................  8-353.......................  ASTM F86-13 Standard          Withdrawn and replaced
                                                             Practice for Surface          with newer version.
                                                             Preparation and Marking of
                                                             Metallic Surgical Implants.
8-175.......................  8-354.......................  ASTM F1377-13 Standard        Withdrawn and replaced
                                                             Specification for Cobalt-28   with newer version.
                                                             Chromium-6 Molybdenum
                                                             Powder for Coating of
                                                             Orthopedic Implants (UNS
                                                             R30075).
8-163.......................  8-355.......................  ASTM F1586/F 1586M-13[egr]1   Withdrawn and replaced
                                                             Standard Specification for    with newer version.
                                                             Wrought Nitrogen
                                                             Strengthened 21 Chromium-10
                                                             Nickel-3 Manganese-2.5
                                                             Molybdenum Stainless Steel
                                                             Alloy Bar for Surgical
                                                             Implants (UNS S31675).
8-129.......................  8-356.......................  ASTM F67-13 Standard          Withdrawn and replaced
                                                             Specification for Unalloyed   with newer version.
                                                             Titanium, for Surgical
                                                             Implant Applications (UNS
                                                             R50250, UNS R50400, UNS
                                                             R50550, UNS R50700).
8-208.......................  8-357.......................  ASTM F648-13 Standard         Withdrawn and replaced
                                                             Specification for Ultra-      with newer version.
                                                             High-Molecular-Weight
                                                             Polyethylene Powder and
                                                             Fabricated Form for
                                                             Surgical Implants.
8-103.......................  ............................  ASTM F1801-97 (Reapproved     Extent of recognition.
                                                             2009) [egr]1 Standard
                                                             Practice for Corrosion
                                                             Fatigue Testing of Metallic
                                                             Implant Materials.
8-107.......................  ............................  ASTM F746-04 (Reapproved      Extent of recognition.
                                                             2009) [egr]1 Standard Test
                                                             Method for Pitting or
                                                             Crevice Corrosion of
                                                             Metallic Surgical Implant
                                                             Materials.
8-111.......................  ............................  ASTM F1160-05 (Reapproved     Extent of recognition.
                                                             2011) [egr]1 Standard Test
                                                             Method for Shear and
                                                             Bending Fatigue Testing of
                                                             Calcium Phosphate and
                                                             Metallic Medical and
                                                             Composite Calcium Phosphate/
                                                             Metallic Coatings.
8-112.......................  ............................  ASTM F1044-05 (Reapproved     Extent of recognition.
                                                             2011) [egr]1 Standard Test
                                                             Method for Shear Testing of
                                                             Calcium Phosphate Coatings
                                                             and Metallic Coatings.
8-113.......................  ............................  ASTM F1147-05 (Reapproved     Extent of recognition.
                                                             2011) Standard Test Method
                                                             for Tension Testing of
                                                             Calcium Phosphate and Metal
                                                             Coatings.
8-114.......................  ............................  ASTM F2255 (Reapproved 2010)  Extent of recognition.
                                                             Standard Test Method for
                                                             Strength Properties of
                                                             Tissue Adhesives in Lap
                                                             Shear by Tension Loading.
8-115.......................  ............................  ASTM F2256-05 (Reapproved     Extent of recognition.
                                                             2010) Standard Test Method
                                                             for Strength Properties of
                                                             Tissue Adhesives in T-Peel
                                                             by Tension Loading.
8-116.......................  ............................  ASTM F2258-05 (Reapproved     Extent of recognition.
                                                             2010) Standard Test Method
                                                             for Strength Properties of
                                                             Tissue Adhesives in Tension.
8-121.......................  ............................  ASTM F2005-05 (Reapproved     Extent of recognition.
                                                             2010) Standard Terminology
                                                             for Nickel-Titanium Shape
                                                             Memory Alloys.
8-123.......................  ............................  ISO 5832-5 Third edition      Extent of recognition.
                                                             2005-10-15 Implants for
                                                             surgery--Metallic
                                                             materials--Part 5: Wrought
                                                             cobalt-chromium-tungsten-
                                                             nickel alloy.
8-124.......................  ............................  ASTM F2052-06 [egr] Standard  Extent of recognition.
                                                             Test Method for Measurement
                                                             of Magnetically Induced
                                                             Displacement Force on
                                                             Medical Devices in the
                                                             Magnetic Resonance
                                                             Environment.
8-125.......................  ............................  ASTM F2004-05 (Reapproved     Extent of recognition.
                                                             2010) Standard Test Method
                                                             for Transformation
                                                             Temperature of Nickel-
                                                             Titanium Alloys by Thermal
                                                             Analysis.
8-126.......................  8-370.......................  ASTM F561-13 Standard         Withdrawn and replaced
                                                             Practice for Retrieval and    with newer version.
                                                             Analysis of Medical
                                                             Devices, and Associated
                                                             Tissues and Fluids.
8-128.......................  ............................  ASTM F2213-06 (Reapproved     Extent of recognition.
                                                             2011) Standard Test Method
                                                             for Measurement of
                                                             Magnetically Induced Torque
                                                             on Medical Devices in the
                                                             Magnetic Resonance
                                                             Environment.
8-132.......................  ............................  ASTM F1088-04a (Reapproved    Extent of recognition.
                                                             2010) Standard
                                                             Specification for Beta-
                                                             Tricalcium Phosphate for
                                                             Surgical Implantation.

[[Page 4923]]

 
8-134.......................  ............................  ASTM F2082-06 Standard Test   Extent of recognition.
                                                             Method for Determination of
                                                             Transformation Temperature
                                                             of Nickel-Titanium Shape
                                                             Memory Alloys by Bend and
                                                             Free Recovery.
8-135.......................  ............................  ASTM F2392-04 (Reapproved     Extent of recognition.
                                                             2010) Standard Test Method
                                                             for Burst Strength of
                                                             Surgical Sealants.
8-136.......................  ............................  ASTM F2458-05 (Reapproved     Extent of recognition.
                                                             2010) Standard Test Method
                                                             for Wound Closure Strength
                                                             of Tissue Adhesives and
                                                             Sealants.
8-150.......................  ............................  ISO 5832-9 Second edition     Extent of recognition.
                                                             2007-06-15 Implants for
                                                             surgery--Metallic
                                                             materials--Part 9: Wrought
                                                             high nitrogen stainless
                                                             steel.
8-157.......................  ............................  ISO 9583 First edition 1993-  Extent of recognition.
                                                             10-15 Implants for surgery--
                                                             Non-destructive testing--
                                                             Liquid penetrant inspection
                                                             of metallic surgical
                                                             implants.
8-159.......................  ............................  ISO 9584 First edition 1993-  Extent of recognition.
                                                             10-15 Implants for surgery--
                                                             Non-destructive testing--
                                                             Radiographic examination of
                                                             cast metallic surgical
                                                             implants.
8-165.......................  ............................  ASTM F1058-08[egr]1 Standard  Extent of recognition.
                                                             Specification for Wrought
                                                             40 Cobalt-20 Chromium-16
                                                             Iron-15 Nickel-7 Molybdenum
                                                             Alloy Wire and Strip for
                                                             Surgical Implant
                                                             Applications (UNS R30003
                                                             and UNS R30008).
8-167.......................  ............................  ASTM F1350-08 Standard        Extent of recognition.
                                                             Specification for Wrought
                                                             18 Chromium-14 Nickel-2.5
                                                             Molybdenum Stainless Steel
                                                             Surgical Fixation Wire (UNS
                                                             S31673).
8-168.......................  ............................  ASTM F1472-08[egr]1 Standard  Extent of recognition.
                                                             Specification for Wrought
                                                             Titanium-6 Aluminum-4
                                                             Vanadium Alloy for Surgical
                                                             Implant Applications (UNS
                                                             R56400).
8-170.......................  ............................  ASTM F961-08 Standard         Extent of recognition.
                                                             Specification for 35 Cobalt-
                                                             35 Nickel-20 Chromium-10
                                                             Molybdenum Alloy Forgings
                                                             for Surgical Implants (UNS
                                                             R30035).
8-171.......................  ............................  ASTM F1609-08 Standard        Extent of recognition.
                                                             Specification for Calcium
                                                             Phosphate Coatings for
                                                             Implantable Materials.
8-173.......................  ............................  ASTM F601-03 (Reapproved      Extent of recognition.
                                                             2008) Standard Practice for
                                                             Fluorescent Penetrant
                                                             Inspection of Metallic
                                                             Surgical Implants.
8-177.......................  ............................  ASTM F2129-08 Standard Test   Extent of recognition.
                                                             Method for Conducting
                                                             Cyclic Potentiodynamic
                                                             Polarization Measurements
                                                             to Determine the Corrosion
                                                             Susceptibility of Small
                                                             Implant Devices.
8-179.......................  ............................  ASTM F754-08 Standard         Extent of recognition.
                                                             Specification for
                                                             Implantable
                                                             Polytetrafluoroethylene
                                                             (PTFE) Sheet, Tube, and Rod
                                                             Shapes Fabricated from
                                                             Granular Molding Powders.
8-183.......................  ............................  ASTM F560-08 Standard         Extent of recognition.
                                                             Specification for Unalloyed
                                                             Tantalum for Surgical
                                                             Implant Applications (UNS
                                                             R05200, UNS R05400).
8-184.......................  ............................  ASTM F2516-07[egr]2 Standard  Extent of recognition.
                                                             Test Method for Tension
                                                             Testing of Nickel-Titanium
                                                             Superelastic Materials.
8-185.......................  ............................  ASTM F451-08 Standard         Extent of recognition.
                                                             Specification for Acrylic
                                                             Bone Cement.
8-187.......................  ............................  ISO 13779-1 Second edition    Extent of recognition.
                                                             2008-10-01 Implants for
                                                             surgery--Hydroxyapatite--Pa
                                                             rt 1: Ceramic
                                                             hydroxyapatite.
8-188.......................  ............................  ISO 13779-2 Second edition    Extent of recognition.
                                                             2008-10-01 Implants for
                                                             surgery--Hydroxyapatite--Pa
                                                             rt 2: Coatings of
                                                             hydroxyapatite.
8-189.......................  ............................  ASTM F 1108-04 (Reapproved    Extent of recognition.
                                                             2009) Standard
                                                             Specification for Titanium-
                                                             6 Aluminum-4 Vanadium Alloy
                                                             Castings for Surgical
                                                             Implants (UNS R56406).
8-190.......................  ............................  ASTM F 90-09 Standard         Extent of recognition.
                                                             Specification for Wrought
                                                             Cobalt-20 Chromium-15
                                                             Tungsten-10 Nickel Alloy
                                                             for Surgical Implant
                                                             Applications (UNS R30605).
8-192.......................  ............................  ASTM F1854-09 Standard Test   Extent of recognition.
                                                             Method for Stereological
                                                             Evaluation of Porous
                                                             Coatings on Medical
                                                             Implants.
8-193.......................  ............................  ASTM F2754/F 2754M-09         Extent of recognition.
                                                             Standard Test Method for
                                                             Measurement of Camber,
                                                             Cast, Helix and Direction
                                                             of Helix of Coiled Wire.
8-194.......................  ............................  ISO 6474-1 First edition      Extent of recognition.
                                                             2010-02-15 Implants for
                                                             surgery--Ceramic materials--
                                                             Part 1: Ceramic materials
                                                             based on high purity
                                                             alumina.
8-195.......................  ............................  ASTM F2024-10 Standard        Extent of recognition.
                                                             Practice for X-Ray
                                                             Diffraction Determination
                                                             of Phase Content of Plasma-
                                                             Sprayed Hydroxyapatite
                                                             Coatings.
8-199.......................  ............................  ASTM F2633-07 Standard        Extent of recognition.
                                                             Specification for Wrought
                                                             Seamless Nickel-Titanium
                                                             Shape Memory Alloy Tube for
                                                             Medical Devices and
                                                             Surgical Implants.
8-204.......................  ............................  ASTM F2118-10 Standard Test   Extent of recognition.
                                                             Method for Constant
                                                             Amplitude of Force
                                                             Controlled Fatigue Testing
                                                             of Acrylic Bone Cement
                                                             Materials.
8-205.......................  ............................  ASTM F1635-11 Standard Test   Extent of recognition.
                                                             Method for In Vitro
                                                             Degradation Testing of
                                                             Hydrolytically Degradable
                                                             Polymer Resins and
                                                             Fabricated Forms for
                                                             Surgical Implants.

[[Page 4924]]

 
8-206.......................  ............................  ASTM F688-10 Standard         Extent of recognition.
                                                             Specification for Wrought
                                                             Cobalt-35 Nickel-20
                                                             Chromium-10 Molybdenum
                                                             Alloy Plate, Sheet, and
                                                             Foil for Surgical Implants
                                                             (UNS R30035).
8-207.......................  ............................  ASTM F1926/F1926M-10          Extent of recognition.
                                                             Standard Test Method for
                                                             Evaluation of the
                                                             Environmental Stability of
                                                             Calcium Phosphate Granules,
                                                             Fabricated Forms, and
                                                             Coatings.
8-213.......................  ............................  ISO 5834-3 First edition      Extent of recognition.
                                                             2005-07-15 Implants for
                                                             surgery--Ultra-high-
                                                             molecular-weight
                                                             polyethylene--Part 3:
                                                             Accelerated ageing methods.
8-214.......................  ............................  ISO 5834-4 First edition      Extent of recognition.
                                                             2005-05-01 Implants for
                                                             surgery--Ultra-high-
                                                             molecular-weight
                                                             polyethylene--Part 4:
                                                             Oxidation index measurement
                                                             method.
8-215.......................  ............................  ISO 5834-5 First edition      Extent of recognition.
                                                             2005-06-01 Implants for
                                                             surgery--Ultra-high-
                                                             molecular-weight
                                                             polyethylene--Part 5:
                                                             Morphology assessment
                                                             method.
8-216.......................  ............................  ASTM F1295-11 Standard        Extent of recognition.
                                                             Specification for Wrought
                                                             Titanium-6 Aluminum-7
                                                             Niobium Alloy for Surgical
                                                             Implant Applications (UNS
                                                             R56700).
8-217.......................  ............................  ASTM F620-11 Standard         Extent of recognition.
                                                             Specification for Alpha
                                                             Plus Beta Titanium Alloy
                                                             Forgings for Surgical
                                                             Implants.
8-218.......................  ............................  ASTM F799-11 Standard         Extent of recognition.
                                                             Specification for Cobalt-28
                                                             Chromium-6 Molybdenum Alloy
                                                             Forgings for Surgical
                                                             Implants (UNS R31537,
                                                             R31538, R31539).
8-220.......................  ............................  ASTM F629-11 Standard         Extent of recognition.
                                                             Practice for Radiography of
                                                             Cast Metallic Surgical
                                                             Implants.
8-221.......................  ............................  ASTM F2066-11 Standard        Extent of recognition.
                                                             Specification for Wrought
                                                             Titanium-15 Molybdenum
                                                             Alloy for Surgical Implant
                                                             Applications (UNS R58150).
8-224.......................  ............................  ASTM F2102-06[egr]1 Standard  Extent of recognition.
                                                             Guide for Evaluating the
                                                             Extent of Oxidation in
                                                             Ultra-High-Molecular-Weight
                                                             Polyethylene Fabricated
                                                             Forms Intended for Surgical
                                                             Implants.
8-225.......................  ............................  ASTM F2003-02 (Reapproved     Extent of recognition.
                                                             2008) Standard Practice for
                                                             Accelerated Aging of Ultra-
                                                             High Molecular Weight
                                                             Polyethylene after Gamma
                                                             Irradiation in Air.
8-226.......................  ............................  ASTM F603-12 Standard         Extent of recognition.
                                                             Specification for High-
                                                             Purity Dense Aluminum Oxide
                                                             for Medical Application.
8-229.......................  ............................  ASTM F75-12 Standard          Extent of recognition.
                                                             Specification for Cobalt-28
                                                             Chromium-6 Molybdenum Alloy
                                                             Castings and Casting Alloy
                                                             for Surgical Implants (UNS
                                                             R30075).
8-330.......................  ............................  ASTM F1978-12 Standard Test   Extent of recognition.
                                                             Method for Measuring
                                                             Abrasion Resistance of
                                                             Metallic Thermal Spray
                                                             Coatings by Using the Taber
                                                             Abraser.
8-331.......................  ............................  ASTM F1580-12 Standard        Extent of recognition.
                                                             Specification for Titanium
                                                             and Titanium-6 Aluminum-4
                                                             Vanadium Alloy Powders for
                                                             Coatings of Surgical
                                                             Implants.
8-333.......................  ............................  ASTM F2393-12 Standard        Extent of recognition.
                                                             Specification for High-
                                                             Purity Dense Magnesia
                                                             Partially Stabilized
                                                             Zirconia (Mg-PSZ) for
                                                             Surgical Implant
                                                             Applications.
8-334.......................  ............................  ASTM F2459-12 Standard Test   Extent of recognition.
                                                             Method for Extracting
                                                             Residue from Metallic
                                                             Medical Components and
                                                             Quantifying via Gravimetric
                                                             Analysis.
----------------------------------------------------------------------------------------------------------------
                                                I. Nanotechnology
----------------------------------------------------------------------------------------------------------------
18-1........................  ............................  ASTM E2490-09 Standard Guide  Extent of recognition.
                                                             for Measurement of Particle
                                                             Size Distribution of
                                                             Nanomaterials in Suspension
                                                             by Photon Correlation
                                                             Spectroscopy (PCS).
18-2........................  ............................  ASTM E2535-07 (Reapproved     Reaffirmation and
                                                             2013) Standard Guide for      extent of
                                                             Handling Unbound Engineered   recognition.
                                                             Nanoscale Particles in
                                                             Occupational Settings.
----------------------------------------------------------------------------------------------------------------
                                                  J. Neurology
----------------------------------------------------------------------------------------------------------------
17-3........................  17-12.......................  ISO 7197 Third edition 2006-  Withdrawn and replaced
                                                             06-01 Neurosurgical           with newer version
                                                             Implants--Sterile, single-    including technical
                                                             use hydrocephalus shunts      corrigendum.
                                                             and components [Including
                                                             TECHNICAL CORRIGENDUM 1
                                                             (2007)].
17-7........................  ............................  ISO 7197: 2006 Neurosurgical  Withdrawn. See 17-12.
                                                             implants--Sterile, single-
                                                             use hydrocephalus shunts
                                                             and components TECHNICAL
                                                             CORRIGENDUM 1.
17-1........................  ............................  ANSI/AAMI NS28:1988/(R) 2010  Extent of recognition.
                                                             Intracranial pressure
                                                             monitoring devices.

[[Page 4925]]

 
17-4........................  ............................  ASTM F647-94 (Reapproved      Extent of recognition.
                                                             2006) Standard Practice for
                                                             Evaluating and Specifying
                                                             Implantable Shunt
                                                             Assemblies for
                                                             Neurosurgical Application.
17-9........................  ............................  ASTM F2129-08 Standard Test   Extent of recognition.
                                                             Method for Conducting
                                                             Cyclic Potentiodynamic
                                                             Polarization Measurements
                                                             to Determine the Corrosion
                                                             Susceptibility of Small
                                                             Implant Devices.
----------------------------------------------------------------------------------------------------------------
                                       K. OB-GYN/Gastroenterology/Urology
----------------------------------------------------------------------------------------------------------------
9-34........................  9-82........................  ISO 4074 First edition 2002-  Withdrawn and replaced
                                                             02-15 Corrected version       with newer version
                                                             2002-12-01 Natural latex      including technical
                                                             rubber condoms--              corrigendum.
                                                             Requirements and test
                                                             methods [Including
                                                             TECHNICAL CORRIGENDUM 1
                                                             (2002), TECHNICAL
                                                             CORRIGENDUM 2 (2002)].
9-57........................  ............................  ISO 4074:2002 TECHNICAL       Withdrawn. See 9-82.
                                                             CORRIGENDUM 2, Natural
                                                             latex rubber condoms--
                                                             Requirements and test
                                                             methods TECHNICAL
                                                             CORRIGENDUM 2.
9-75........................  9-84........................  ISO 8600-3 First edition      Withdrawn and replaced
                                                             1997-07-01 Optics and         with newer version
                                                             Optical instruments--         including amendment.
                                                             Medical endoscopes and
                                                             endoscopic accessories--
                                                             Part 3: Determination of
                                                             field of view and direction
                                                             of view of endoscopes with
                                                             optics [Including AMENDMENT
                                                             1 (2003)].
9-36........................  9-90........................  ISO 8009 First edition 2004-  Withdrawn and replaced
                                                             10-01 Mechanical              with newer version
                                                             contraceptives--Reusable      including amendment.
                                                             natural and silicone rubber
                                                             contraceptive diaphragms--
                                                             Requirements and tests
                                                             [Including AMENDMENT
                                                             1(2012)].
9-37........................  9-83........................  ISO 8600-1 Third edition      Withdrawn and replaced
                                                             2013-03-01 Endoscopes--       with newer version.
                                                             Medical endoscopes and
                                                             endotherapy devices--Part
                                                             1: General requirements.
9-38........................  ............................  ISO 8600-3 First edition      Withdrawn. See 9-84.
                                                             1997-07-01 AMENDMENT 1,
                                                             Optics and optical
                                                             instruments--Medical
                                                             endoscopes and endoscopic
                                                             accessories Part 3:
                                                             Determination of field of
                                                             view and direction of view
                                                             of endoscopes with optics.
9-44........................  ............................  ASTM F623-99 (Reapproved      Extent of recognition.
                                                             2006) Standard Performance
                                                             Specification for Foley
                                                             Catheter.
9-54........................  9-85........................  ASTM D6976-13 Standard        Withdrawn and replaced
                                                             Specification for Rubber      with a newer version.
                                                             Contraceptives--Vaginal
                                                             Diaphragms.
9-56........................  ............................  ASTM D3492-08 Standard        Extent of recognition.
                                                             Specification for Rubber
                                                             Contraceptives (Male
                                                             Condoms).
9-65........................  9-91........................  ANSI/AAMI/ISO 8637:2010       Withdrawn and replaced
                                                             Cardiovascular implants and   with newer version
                                                             extracorporeal systems--      including amendment.
                                                             Hemodialyzers,
                                                             hemodiafilters,
                                                             hemofilters, and
                                                             hemoconcentrators
                                                             [Including AMENDMENT 1
                                                             (2013)].
9-66........................  ............................  ANSI/AAMI/ISO 8638:2010       Extent of recognition.
                                                             Cardiovascular implants and
                                                             Extracorporeal blood
                                                             circuit for hemodialyzers,
                                                             hemodiafilters, and
                                                             hemofilters.
9-67........................  ............................  ASTM D7661-10 Standard Test   Extent of recognition.
                                                             Method for Determining
                                                             Compatibility of Personal
                                                             Lubricants with Natural
                                                             Rubber Latex Condoms.
9-68........................  ............................  ISO 23409 First edition 2011- Extent of recognition.
                                                             02-15 Male Condoms--
                                                             Requirements and test
                                                             methods for condoms made
                                                             from synthetic materials.
9-73........................  ............................  ANSI/AAMI/ISO 13958:2009      Extent of recognition.
                                                             Concentrates for
                                                             hemodialysis and related
                                                             therapies.
9-74........................  ............................  ISO 13958 Second edition      Extent of recognition.
                                                             2009-04-15 Concentrates for
                                                             haemodialysis and related
                                                             therapies.
9-79........................  ............................  ISO 26722 First edition 2009- Extent of recognition.
                                                             04-15 Water treatment
                                                             equipment for haemodialysis
                                                             applications and related
                                                             therapies.
----------------------------------------------------------------------------------------------------------------
                                                  L. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-41.......................  10-81.......................  ISO 11979-7 Second edition    Withdrawn and replaced
                                                             2006-05-01 Ophthalmic         with newer version
                                                             implants--Intraocular         including amendment.
                                                             lenses--Part 7: Clinical
                                                             investigations [Including
                                                             Amendment 1:2012].
10-75.......................  ............................  ISO 11979-7/Amendment 1:2012  Withdrawn. See 10-81.
                                                             Ophthalmic implants--
                                                             Intraocular lenses--Part 7:
                                                             Clinical investigations.
10-42.......................  10-82.......................  ISO 11979-2 First edition     Withdrawn and replaced
                                                             1999-12-15 Ophthalmic         with newer version
                                                             implants--Intraocular         including technical
                                                             lenses--Part 2: Optical       corrigendum.
                                                             properties and test methods
                                                             [Including TECHNICAL
                                                             CORRIGENDUM 1 (2003)].
10-53.......................  10-83.......................  ISO 18369-1 First edition     Withdrawn and replaced
                                                             2006-08-15 Ophthalmic         with newer version
                                                             optics--Contact lenses--      including amendment.
                                                             Part 1: Vocabulary,
                                                             classification system and
                                                             recommendations for
                                                             labeling specifications
                                                             [Including AMENDMENT 1
                                                             2009].

[[Page 4926]]

 
10-61.......................  ............................  ISO 18369-1:2006 Ophthalmic   Withdrawn. See 10-83.
                                                             optics--Contact lenses Part
                                                             1: Vocabulary,
                                                             classification system and
                                                             recommendations for
                                                             labeling specifications.
                                                             ISO 18369-1 First edition
                                                             2006-08-05 AMENDMENT 1 2009-
                                                             02-15.
10-58.......................  10-84.......................  ANSI Z80.11-2012 American     Withdrawn and replaced
                                                             National Standard for         with newer version.
                                                             Ophthalmics--Laser Systems
                                                             for Corneal Reshaping.
10-59.......................  10-85.......................  ISO 11980 Third edition 2012- Withdrawn and replaced
                                                             11-15 Corrected version       with newer version.
                                                             2013-12-01 Ophthalmic
                                                             optics--Contact lenses and
                                                             contact lens care products--
                                                             Guidance for clinical
                                                             investigations.
10-71.......................  10-86.......................  ISO 14729 First edition 2001- Withdrawn and replaced
                                                             04-15 Ophthalmic optics--     with newer version
                                                             Contact lens care products--  including amendment.
                                                             Microbiological
                                                             requirements and test
                                                             methods for products and
                                                             regimens for hygienic
                                                             management of contact
                                                             lenses [Including:
                                                             AMENDMENT 1 2010].
10-43.......................  ............................  ISO 11979-8 Second edition    Extent of recognition.
                                                             2006-07-01 Ophthalmic
                                                             implants--Intraocular
                                                             lenses--Part 8: Fundamental
                                                             requirements.
10-54.......................  ............................  ISO 18369-4 First edition     Extent of recognition.
                                                             2006-08-15 Ophthalmic
                                                             optics--contact lenses--
                                                             Part 4: Physicochemical
                                                             properties of contact lens
                                                             materials.
10-55.......................  ............................  ISO 11979-6 Second edition    Extent of recognition.
                                                             2007-07-15 Ophthalmic
                                                             implants--Intraocular
                                                             lenses--Part 6: Shelf-life
                                                             and transport stability.
10-56.......................  ............................  ANSI Z80.12-2007 (R2012)      Reaffirmation and
                                                             American National Standard    extent of
                                                             for Ophthalmics--Multifocal   recognition.
                                                             Intraocular Lenses.
10-57.......................  ............................  ANSI Z80.13-2007 (R2012)      Reaffirmation and
                                                             American National Standard    extent of
                                                             for Ophthalmics--Phakic       recognition.
                                                             Intraocular Lenses.
10-60.......................  ............................  ISO 11981 Second edition      Extent of recognition.
                                                             2009-07-01 Ophthalmic
                                                             optics--Contact lenses and
                                                             contact lens care products--
                                                             Determination of physical
                                                             compatibility of contact
                                                             lens care products with
                                                             contact lenses.
10-62.......................  ............................  ANSI Z80.10-2009 Ophthalmic   Extent of recognition.
                                                             Instruments--Tonometers.
10-64.......................  10-89.......................  ANSI Z80.7-2013 Ophthalmics-- Withdrawn and replaced
                                                             Intraocular Lenses.           with newer version.
10-68.......................  ............................  ISO 13212 Second edition      Extent of recognition.
                                                             2011-05-15 Ophthalmic
                                                             optics--Contact lens care
                                                             products--Guidelines for
                                                             determination of shelf-life.
10-69.......................  ............................  ANSI Z80.18-2010 American     Extent of recognition.
                                                             National Standard for
                                                             Ophthalmics--Contact Lens
                                                             Care Products--Vocabulary,
                                                             Performance Specifications
                                                             and Test Methodology.
10-74.......................  ............................  ISO 10940 Second edition      Extent of recognition.
                                                             2009-08-01 Ophthalmic
                                                             instruments--Fundus Cameras.
----------------------------------------------------------------------------------------------------------------
                                                  M. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-190......................  11-256......................  ISO 14243-3 First edition     Withdrawn and replaced
                                                             2004-09-15 Implants for       with newer version
                                                             surgery--Wear of total knee-  including technical
                                                             joint prostheses--Part 3:     corrigendum.
                                                             Loading and displacement
                                                             parameters for wear-testing
                                                             machines with displacement
                                                             control and corresponding
                                                             environmental conditions
                                                             for test [Including:
                                                             TECHNICAL CORRIGENDUM
                                                             1(2006)].
11-218......................  ............................  ISO 14243-3:2004 TECHNICAL    Withdrawn. See 11-256.
                                                             CORRIGENDUM 1 Implants for
                                                             surgery--Wear of total knee-
                                                             joint prostheses--Part 3:
                                                             Loading and displacement
                                                             parameters for wear-testing
                                                             machines with displacement
                                                             control and corresponding
                                                             environmental conditions
                                                             for test.
11-210......................  11-257......................  ASTM F543-13 Standard         Withdrawn and replaced
                                                             Specification and Test        with a newer version.
                                                             Methods for Metallic
                                                             Medical Bone Screws.
11-212......................  ............................  ASTM F1440-92 (Reapproved     Withdrawn.
                                                             2008) Standard Practice for
                                                             Cyclic Fatigue Testing of
                                                             Metallic Stemmed Hip
                                                             Arthroplasty Femoral
                                                             Components Without Torsion.
11-241......................  ............................  ASTM F543-07 Standard         Withdrawn duplicate.
                                                             Specification and Test       See 11-257.
                                                             Methods for Metallic
                                                             Medical Bone Screws.
11-244......................  11-258......................  ASTM F2083-12 Standard        Withdrawn and replaced
                                                             Specification for Knee        with a newer version.
                                                             Replacement Prosthesis.
11-74.......................  ............................  ISO 5838-2 First edition      Extent of recognition.
                                                             1991-01-15 Implants for
                                                             surgery--Skeletal pins and
                                                             wires--Part 2: Steinmann
                                                             skeletal pins--Dimensions.
11-75.......................  ............................  ISO 5838-3 First edition      Extent of recognition.
                                                             1993-09-15 Implants for
                                                             surgery--Skeletal pins and
                                                             wires--Part 3: Kirschner
                                                             skeletal wires.
11-80.......................  ............................  ISO 8828 First edition 1988-  Extent of recognition.
                                                             10-15 Implants for surgery--
                                                             Guidance on care and
                                                             handling of orthopaedic
                                                             implants.
11-83.......................  ............................  ISO 13402 First edition 1995- Extent of recognition.
                                                             08-01 Surgical and dental
                                                             hand instruments--
                                                             Determination of resistance
                                                             against autoclaving,
                                                             corrosion and thermal
                                                             exposure.
11-168......................  ............................  ASTM F1781-03 (Reapproved     Extent of recognition.
                                                             2009) Standard
                                                             Specification for
                                                             Elastomeric Flexible Hinge
                                                             Finger Total Joint Implants.

[[Page 4927]]

 
11-171......................  ............................  ASTM F1814-97a (Reapproved    Extent of recognition.
                                                             2009) Standard Guide for
                                                             Evaluating Modular Hip and
                                                             Knee Joint Components.
11-183......................  ............................  ASTM F1875-98 (Reapproved     Extent of recognition.
                                                             2009) Standard Practice for
                                                             Fretting Corrosion Testing
                                                             of Modular Implant
                                                             Interfaces: Hip Femoral
                                                             Head-bore and Cone Taper
                                                             Interface.
11-184......................  ............................  ISO 8827 First edition 1988-  Extent of recognition.
                                                             10-15 Implants for surgery--
                                                             Staples with parallel legs
                                                             for orthopaedic use--
                                                             General requirements.
11-185......................  ............................  ASTM F2267-04 (Reapproved     Extent of recognition.
                                                             2011) Standard Test Method
                                                             for Measuring Load Induced
                                                             Subsidence of
                                                             Intervertebral Body Fusion
                                                             Device Under Static Axial
                                                             Compression.
11-191......................  ............................  ISO 14879-1 First edition     Extent of recognition.
                                                             2000-06-01 Implants for
                                                             surgery--Total knee-joint
                                                             prostheses--Part 1:
                                                             Determination of endurance
                                                             properties of knee tibial
                                                             trays.
11-196......................  ............................  ASTM F1672-95 (Reapproved     Extent of recognition.
                                                             2011) Standard
                                                             Specification for
                                                             Resurfacing Patellar
                                                             Prosthesis.
11-197......................  ............................  ASTM F983-86 (Reapproved      Reaffirmation and
                                                             2013) Standard Practice for   extent of
                                                             Permanent Marking of          recognition.
                                                             Orthopaedic Implant
                                                             Components.
11-199......................  ............................  ASTM F565-04 (Reapproved      Reaffirmation and
                                                             2013) Standard Practice for   extent of
                                                             Care and Handling of          recognition.
                                                             Orthopedic Implants and
                                                             Instruments.
11-203......................  ............................  ASTM F1541-02 (Reapproved     Extent of recognition.
                                                             2011) 1 Standard
                                                             Specification and Test
                                                             Methods for External
                                                             Skeletal Fixation Devices.
11-207......................  ............................  ASTM F2193-02 (Reapproved     Extent of recognition.
                                                             2007) Standard
                                                             Specifications and Test
                                                             Methods for Components Used
                                                             in the Surgical Fixation of
                                                             the Spinal Skeletal System.
11-211......................  ............................  ASTM F1798-97 (Reapproved     Extent of recognition.
                                                             2008) Standard Guide for
                                                             Evaluating the Static and
                                                             Fatigue Properties of
                                                             Interconnection Mechanisms
                                                             and Subassemblies Used in
                                                             Spinal Arthrodesis Implants.
11-214......................  ............................  ASTM F382-99 (Reapproved      Extent of recognition.
                                                             2008) \1\ Standard
                                                             Specification and Test
                                                             Method for Metallic Bone
                                                             Plates.
11-216......................  ............................  ASTM F1264-03 (Reapproved     Extent of recognition.
                                                             2012) Standard
                                                             Specification and Test
                                                             Methods for Intramedullary
                                                             Fixation Devices.
11-220......................  ............................  ASTM F2068-09 Standard        Extent of recognition.
                                                             Specification for Femoral
                                                             Prostheses--Metallic
                                                             Implants.
11-222......................  ............................  ISO 14243-1 Second edition    Extent of recognition.
                                                             2009-11-15 Implants for
                                                             surgery--Wear of total knee-
                                                             joint prostheses--Part 1:
                                                             Loading and displacement
                                                             parameters for wear-testing
                                                             machines with load control
                                                             and corresponding
                                                             environmental conditions
                                                             for test.
11-223......................  ............................  ISO 14243-2 Second edition    Extent of recognition.
                                                             2009-11-15 Implants for
                                                             surgery--Wear of total knee-
                                                             joint prostheses--Part 2:
                                                             Methods of measurement.
11-224......................  ............................  ASTM F2706-08 Standard Test   Extent of recognition.
                                                             Methods for Occipital-
                                                             Cervical and Occipital-
                                                             Cervical-Thoracic Spinal
                                                             Implant Constructs in a
                                                             Vertebrectomy Model.
11-225......................  ............................  ISO 7206-4 Third edition      Extent of recognition.
                                                             2010-06-15 Implants for
                                                             surgery--Partial and total
                                                             hip-joint prostheses--Part
                                                             4: Determination of
                                                             endurance properties and
                                                             performance of stemmed
                                                             femoral components.
11-226......................  ............................  ASTM F1089-10 Standard Test   Extent of recognition.
                                                             Method for Corrosion of
                                                             Surgical Instruments.
11-227......................  ............................  ASTM F366-10 Standard         Extent of recognition.
                                                             Specification for Fixation
                                                             Pins and Wires.
11-228......................  ............................  ASTM F564-10 Standard         Extent of recognition
                                                             Specification and Test
                                                             Methods for Metallic Bone
                                                             Staples.
11-231......................  ............................  ISO 7207-2 Second edition     Extent of recognition.
                                                             2011-07-01 Implants for
                                                             surgery--Components for
                                                             partial and total knee
                                                             joint prostheses--Part 2:
                                                             Articulating surfaces made
                                                             of metal, ceramic and
                                                             plastics materials.
11-232......................  ............................  ISO 7207-1 Third edition      Extent of recognition.
                                                             2007-02-01 Implants for
                                                             surgery--Components for
                                                             partial and total knee
                                                             joint prostheses--Part 1:
                                                             Classification, definitions
                                                             and designation of
                                                             dimensions.
11-234......................  ............................  ASTM F732-00 (Reapproved      Extent of recognition.
                                                             2011) Standard Test Method
                                                             for Wear Testing of
                                                             Polymeric Materials Used in
                                                             Total Joint Prostheses.
11-235......................  ............................  ASTM F2077-11 Test Methods    Extent of recognition.
                                                             for Intervertebral Body
                                                             Fusion Devices.
11-237......................  ............................  ISO 7206-6 First edition      Extent of recognition.
                                                             1992-03-15 Implants for
                                                             surgery--Partial and total
                                                             hip joint prostheses--Part
                                                             6: Determination of
                                                             endurance properties of
                                                             head and neck region of
                                                             stemmed femoral components.
11-238......................  ............................  ASTM F2033-12 Standard        Extent of recognition.
                                                             Specification for Total Hip
                                                             Joint Prosthesis and Hip
                                                             Endoprosthesis Bearing
                                                             Surfaces Made of Metallic,
                                                             Ceramic, and Polymeric
                                                             Materials.

[[Page 4928]]

 
11-239......................  ............................  ASTM F 2345-03 (Reapproved    Extent of recognition.
                                                             2013) Standard Test Methods   Reaffirmation.
                                                             for Determination of Static
                                                             and Cyclic Fatigue Strength
                                                             of Ceramic Modular Femoral
                                                             Heads.
11-240......................  ............................  ASTM F382-99 (Reapproved      Extent of recognition.
                                                             2008) \1\ Standard
                                                             Specification and Test
                                                             Method for Metallic Bone
                                                             Plates.
11-243......................  ............................  ASTM F2346-05 (Reapproved     Extent of recognition.
                                                             2011) Standard Test Methods
                                                             for Static and Dynamic
                                                             Characterization of Spinal
                                                             Artificial Discs.
11-245......................  ............................  ASTM F384-12 Standard         Extent of recognition.
                                                             Specifications and Test
                                                             Methods for Metallic Angled
                                                             Orthopedic Fracture
                                                             Fixation Devices.
11-247......................  ............................  ASTM F2789-10 Standard Guide  Extent of recognition.
                                                             for Mechanical and
                                                             Functional Characterization
                                                             of Nucleus Devices.
11-248......................  ............................  ISO 14242-1 Second edition    Extent of recognition.
                                                             2012-01-15 Implants for
                                                             surgery--Wear of total hip-
                                                             joint prostheses--Part 1:
                                                             Loading and displacement
                                                             parameters for wear-testing
                                                             machines and corresponding
                                                             environmental conditions
                                                             for test.
11-249......................  ............................  ISO 14242-2 First edition     Extent of recognition.
                                                             2000-09-15 Implants for
                                                             surgery--Wear of total hip-
                                                             joint prostheses--Part 2:
                                                             Methods of measurement.
11-250......................  ............................  ISO 14242-3 First edition     Extent of recognition.
                                                             2009-03-15 Implants for
                                                             surgery--Wear of total hip-
                                                             joint prostheses--Part 3:
                                                             Loading and displacement
                                                             parameters for orbital
                                                             bearing type wear testing
                                                             machines and corresponding
                                                             environmental conditions
                                                             for test.
----------------------------------------------------------------------------------------------------------------
                                              N. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-25.......................  ............................  ISO 7176-13 First edition     Extent of recognition.
                                                             1989-08-01 Wheelchairs--
                                                             Part 13: Determination of
                                                             coefficient of friction of
                                                             test surfaces.
16-27.......................  ............................  ISO 7176-15 First edition     Extent of recognition.
                                                             1996-11-15 Wheelchairs--
                                                             Part 15: Requirements for
                                                             information disclosure,
                                                             documentation and labeling.
16-29.......................  ............................  ISO 7176-6 Second edition     Extent of recognition.
                                                             2001-10-01 Wheelchairs--
                                                             Part 6: Determination of
                                                             maximum speed, acceleration
                                                             and deceleration of
                                                             electric wheelchairs.
16-158......................  ............................  ISO 7176-1 Second edition     Extent of recognition.
                                                             1999-10-01 Wheelchairs--
                                                             Part 1: Determination of
                                                             static stability.
16-159......................  ............................  ISO 7176-2 Second edition     Extent of recognition.
                                                             2001-06-15 Wheelchairs--
                                                             Part 2: Determination of
                                                             dynamic stability of
                                                             electric wheelchairs.
16-162......................  ............................  ISO 7176-4 Third edition      Extent of recognition.
                                                             2008-10-01 Wheelchairs--
                                                             Part 4: Energy consumption
                                                             of electric wheelchairs and
                                                             scooters for determination
                                                             of theoretical distance
                                                             range.
16-163......................  ............................  ISO 7176-5 Second edition     Extent of recognition.
                                                             2008-06-01 Wheelchairs--
                                                             Part 5: Determination of
                                                             overall dimensions, mass
                                                             and manoeuvring space.
16-164......................  ............................  ISO 7176-10 Second edition    Extent of recognition.
                                                             2008-11-01 Wheelchairs--
                                                             Part 10: Determination of
                                                             obstacle-climbing ability
                                                             of electrically powered
                                                             wheelchairs.
16-165......................  ............................  ISO 7176-14 Second edition    Extent of recognition.
                                                             2008-02-15 Wheelchairs--
                                                             Part 14: Power and control
                                                             systems for electrically
                                                             powered wheelchairs and
                                                             scooters--Requirements and
                                                             test methods.
16-166......................  ............................  ISO 7176-21 Second edition    Extent of recognition.
                                                             2009-04-01 Wheelchairs--
                                                             Part 21: Requirements and
                                                             test methods for
                                                             electromagnetic
                                                             compatibility of
                                                             electrically powered
                                                             wheelchairs and scooters,
                                                             and battery chargers.
16-167......................  ............................  ISO 7176-9: Third edition     Extent of recognition.
                                                             2009-11-15 Wheelchairs--
                                                             Part 9: Climatic tests for
                                                             electric wheelchairs.
16-168......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 1: Determination of
                                                             static stability.
16-169......................  ............................  ANSI/RESNA WC-2:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 2:
                                                             Additional Requirements for
                                                             Wheelchairs (including
                                                             Scooters) with Electrical
                                                             Systems Section 2:
                                                             Determination of dynamic
                                                             stability of electrically
                                                             powered wheelchairs.
16-170......................  ............................  ANSI/RESNA WC-2:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 2:
                                                             Additional Requirements for
                                                             Wheelchairs (including
                                                             Scooters) with Electrical
                                                             Systems Section 3:
                                                             Determination of
                                                             effectiveness of brakes.
16-171......................  ............................  ANSI/RESNA WC-2:2009 Section  Extent of recognition.
                                                             4: Energy consumption of
                                                             electrically powered
                                                             wheelchairs and scooters
                                                             for determination of
                                                             theoretical distance range.

[[Page 4929]]

 
16-172......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 5: Determination of
                                                             dimensions, mass and
                                                             maneuvering space.
16-173......................  ............................  ANSI/RESNA WC-2:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 2:
                                                             Additional Requirements for
                                                             Wheelchairs (including
                                                             Scooters) with Electrical
                                                             Systems Section 6:
                                                             Determination of maximum
                                                             speed, acceleration and
                                                             deceleration of
                                                             electrically powered
                                                             wheelchairs.
16-174......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 7: Method of
                                                             Measurement of Seating and
                                                             Wheel Dimensions.
16-175......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 8: Requirements and
                                                             test methods for static,
                                                             impact and fatigue
                                                             strengths.
16-176......................  ............................  ANSI/RESNA WC-2:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 2:
                                                             Additional Requirements for
                                                             Wheelchairs (including
                                                             Scooters) with Electrical
                                                             Systems Section 9: Climatic
                                                             tests for electrically
                                                             powered wheelchairs.
16-177......................  ............................  ANSI/RESNA WC-2:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 2:
                                                             Additional Requirements for
                                                             Wheelchairs (including
                                                             Scooters) with Electrical
                                                             Systems Section 10:
                                                             Determination of obstacle-
                                                             climbing ability of
                                                             electrically powered
                                                             wheelchairs.
16-178......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 11: Test dummies.
16-179......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 13: Determination
                                                             of coefficient of friction
                                                             of test surfaces.
16-180......................  ............................  ANSI/RESNA WC-2:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 2:
                                                             Additional Requirements for
                                                             Wheelchairs (including
                                                             Scooters) with Electrical
                                                             Systems Section 14: Power
                                                             and control systems for
                                                             electrically powered
                                                             wheelchairs--Requirements
                                                             and test methods.
16-181......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 15: Requirements
                                                             for information disclosure,
                                                             documentation and labeling.
16-182......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 16: Resistance to
                                                             ignition of upholstered
                                                             parts--Requirements and
                                                             test methods.
16-183......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 20: Determination
                                                             of the performance of stand-
                                                             up type wheelchairs.
16-184......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 22: Set-up
                                                             procedures.
16-185......................  ............................  ANSI/RESNA WC-                Extent of recognition.
                                                             2:2009,American National
                                                             Standard for Wheelchairs--
                                                             Volume 2, Additional
                                                             Requirements for
                                                             Wheelchairs (including
                                                             Scooters) with Electrical
                                                             Systems Section 21:
                                                             Requirements and test
                                                             methods for electromagnetic
                                                             compatibility of
                                                             electrically powered
                                                             wheelchairs and motorized
                                                             scooters.
16-187......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 26: Vocabulary.
----------------------------------------------------------------------------------------------------------------
                                                  O. Radiology
----------------------------------------------------------------------------------------------------------------
12-53.......................  12-257......................  ISO 2919 Third edition 2012-  Withdrawn and replaced
                                                             02-15 Radiological            with newer version.
                                                             protection--Sealed
                                                             radioactive sources--
                                                             General requirements and
                                                             classification.
12-59.......................  ............................  IEC 61168 First edition 1993- Extent of recognition.
                                                             12 Radiotherapy simulators--
                                                             Functional performance
                                                             characteristics.
12-66.......................  ............................  AIUM MUS, Medical Ultrasound  Extent of recognition.
                                                             Safety.

[[Page 4930]]

 
12-139......................  ............................  AIUM AOMS-2004, Acoustic      Extent of recognition.
                                                             Output Measurement Standard
                                                             for Diagnostic Ultrasound
                                                             Equipment.
12-140......................  ............................  AIUM RTD2-2004 Standard for   Withdrawn. See 12-209
                                                             Real-Time Display of          and 12-258.
                                                             Thermal and Mechanical
                                                             Acoustic Output Indices on
                                                             Diagnostic Ultrasound
                                                             Equipment Revision 2.
12-145......................  12-259......................  IEC 61674 Edition 2.0 2012-   Withdrawn and replaced
                                                             11 Medical electrical         with newer version.
                                                             equipment--Dosimeters with
                                                             ionization chambers and/or
                                                             semiconductor detectors as
                                                             used in X-ray diagnostic
                                                             imaging.
12-149......................  12-260......................  IEC 60336 Fourth edition      Withdrawn and replaced
                                                             2005-04 Medical electrical    with newer version
                                                             equipment--X-ray tube         including technical
                                                             assemblies for medical        corrigendum.
                                                             diagnosis--Characteristics
                                                             of focal spots [Including:
                                                             Technical Corrigendum 1
                                                             (2006)].
12-150......................  ............................  ISO/IEC 10918-1:1994          Withdrawn. See 12-261.
                                                             TECHNICAL CORRIGENDUM
                                                             1:2005 Information
                                                             technology--Digital
                                                             compression and coding of
                                                             continuous-tone still
                                                             image--Part 1: Requirements
                                                             and guidelines.
12-156......................  ............................  ISO 11670:2003 TECHNICAL      Withdrawn. See 12-262.
                                                             CORRIGENDUM 1:2004 Lasers
                                                             and laser-related
                                                             equipment--Test methods for
                                                             laser beam parameters--Beam
                                                             positional stability.
12-157......................  ............................  ISO 13694:2000 TECHNICAL      Withdrawn. See 12-263.
                                                             CORRIGENDUM 1:2005 Optics
                                                             and optical instruments--
                                                             Lasers and laser-related
                                                             equipment--Test methods for
                                                             laser beam power (energy)
                                                             density distribution.
12-159......................  12-264......................  NEMA MS 11-2010               Withdrawn and replaced
                                                             Determination of Gradient-    with newer version.
                                                             Induced Electric Fields In
                                                             Diagnostic Magnetic
                                                             Resonance Imaging.
12-167......................  12-265......................  NEMA NU 2-2012 Performance    Withdrawn and replaced
                                                             Measurements of Positron      with newer version.
                                                             Emission Tomographs (PETs).
12-179......................  ............................  ANSI/IESNA RP-27.3-2007,      Extent of recognition.
                                                             Recommended Practice for
                                                             Photobiological Safety for
                                                             Lamps--Risk Group
                                                             Classification and Labeling.
12-180......................  12-266......................  IEC 61689 Edition 3.0 2013-   Withdrawn and replaced
                                                             02 Ultrasonic-Physiotherapy   with newer version.
                                                             systems--Field
                                                             specifications and methods
                                                             of measurement in the
                                                             frequency range 0. 5 MHz to
                                                             5 MHz.
12-190......................  12-267......................  IEC 61217 Edition 2.0 2011-   Withdrawn and replaced
                                                             12 Radiotherapy equipment--   with newer version.
                                                             Coordinates, movements and
                                                             scales.
12-194......................  ............................  ANSI/HPS N43.6-2007, Sealed   Extent of recognition.
                                                             Radioactive Sources--
                                                             Classification.
12-207......................  12-271......................  IEC 60601-2-33 Edition 3.1    Withdrawn and replaced
                                                             2013-04 Medical electrical    with newer version.
                                                             equipment--Part 2-33:
                                                             Particular requirements for
                                                             the basic safety and
                                                             essential performance of
                                                             magnetic resonance
                                                             equipment for medical
                                                             diagnosis.
12-208......................  12-268......................  IEC 60601-2-22 Edition 3.1    Withdrawn and replaced
                                                             2012-10 Medical electrical    with newer version.
                                                             equipment--Part 2-22:
                                                             Particular requirements for
                                                             basic safety and essential
                                                             performance of surgical,
                                                             cosmetic, therapeutic and
                                                             diagnostic laser equipment.
12-210......................  12-269......................  IEC 60601-1-3 Edition 2.1     Withdrawn and replaced
                                                             2013-04 Medical electrical    with newer version.
                                                             equipment--Part 1-3:
                                                             General requirements for
                                                             basic safety and essential
                                                             performance--Collateral
                                                             Standard: Radiation
                                                             protection in diagnostic X-
                                                             ray equipment.
12-219......................  ............................  IEC 60336 (2005) Medical      Withdrawn. See 12-260.
                                                             electrical equipment--X-ray
                                                             tube assemblies for medical
                                                             diagnosis--Characteristics
                                                             of focal spots.
12-222......................  12-270......................  IEC 61223-3-5 First edition   Withdrawn and replaced
                                                             2004-08 Evaluation and        with newer version
                                                             routine testing in medical    including technical
                                                             imaging departments--Part 3-  corrigendum.
                                                             5: Acceptance tests--
                                                             Imaging performance of
                                                             computed tomography X-ray
                                                             equipment [Including:
                                                             TECHNICAL CORRIGENDUM 1
                                                             (2006)].
12-223......................  ............................  IEC 61223-3-5 (First edition  Withdrawn. See 12-270.
                                                             2004) Evaluation and
                                                             routine testing in medical
                                                             imaging departments--Part 3-
                                                             5: Acceptance tests--
                                                             Imaging performance of
                                                             computed tomography X-ray
                                                             equipment CORRIGENDUM 1.
12-227......................  ............................  IEC 61391-1 First edition     Extent of recognition.
                                                             2006-07 Ultrasonics--Pulse-
                                                             echo scanners--Part 1:
                                                             Techniques for calibrating
                                                             spatial measurement systems
                                                             and measurement of system
                                                             point-spread function
                                                             response.
12-228......................  ............................  IEC 61391-2 Edition 1.0 2010- Extent of recognition.
                                                             01 Ultrasonics--Pulse-echo
                                                             scanners--Part 2:
                                                             Measurement of maximum
                                                             depth of penetration and
                                                             local dynamic range.
12-233......................  12-262......................  ISO 11670 Second edition      Withdrawn and replaced
                                                             2003-04-01 Lasers and laser-  with newer version
                                                             related equipment--Test       including technical
                                                             methods for laser beam        corrigendum.
                                                             parameters--Beam positional
                                                             stability [Including:
                                                             TECHNICAL CORRIGENDUM 1
                                                             (2004)].
12-237......................  12-258......................  IEC 62359 Edition 2.0 2010-   Withdrawn and replaced
                                                             10 Ultrasonics--Field         with newer version
                                                             characterization--Test        including technical
                                                             methods for the               corrigendum.
                                                             determination of thermal
                                                             and mechanical indices
                                                             related to medical
                                                             diagnostic ultrasonic
                                                             fields [Including TECHNICAL
                                                             CORRIGENDUM 1 (2011)].

[[Page 4931]]

 
12-243......................  12-263......................  ISO 13694 First edition 2000- Withdrawn and replaced
                                                             04-01 Optics and optical      with newer version
                                                             instruments--Lasers and       including technical
                                                             laser-related equipment--     corrigendum.
                                                             Test methods for laser beam
                                                             power [energy] density
                                                             distribution [Including:
                                                             TECHNICAL CORRIGENDUM 1
                                                             (2005)].
12-244......................  ............................  IEC 62359 (Second edition     Withdrawn. See 12-258.
                                                             2010) March 2011
                                                             Ultrasonics--Field
                                                             characterization--Test
                                                             methods for the
                                                             determination of thermal
                                                             and mechanical indices
                                                             related to medical
                                                             diagnostic ultrasonic
                                                             fields CORRIGENDUM 1.
12-247......................  ............................  ISO 11990-1 First edition     Extent of recognition.
                                                             2011-08-01, Lasers and
                                                             laser-related equipment--
                                                             Determination of laser
                                                             resistance of tracheal
                                                             tubes--Part 1: Tracheal
                                                             tube shaft.
----------------------------------------------------------------------------------------------------------------
                                             P. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-4........................  ............................  ANSI/UL 1998 Standards for    Extent of recognition.
                                                             Safety Software in
                                                             Programmable Components,
                                                             Second Edition. [This
                                                             Standard contains revisions
                                                             through and including
                                                             October 28, 2008.]
----------------------------------------------------------------------------------------------------------------
                                                  Q. Sterility
----------------------------------------------------------------------------------------------------------------
14-143......................  14-395......................  ISO 14698-2 First edition     Withdrawn and replaced
                                                             2003-09-15 Cleanrooms and     with newer version
                                                             associated controlled         including technical
                                                             environments--Biocontaminat   corrigendum.
                                                             ion control--Part 2:
                                                             Evaluation and
                                                             interpretation of
                                                             biocontamination data.
                                                             [Including: TECHNICAL
                                                             CORRIGENDUM 1 Published
                                                             2004-11-01].
14-193......................  ............................  ANSI/AAMI/ISO 11607-1:2006/   Extent of recognition
                                                             (R)2010 Packaging for         and relevant
                                                             terminally sterilized         guidance.
                                                             medical devices--Part 1:
                                                             Requirements for materials,
                                                             sterile barrier systems and
                                                             packaging systems.
14-194......................  ............................  ANSI/AAMI/ISO 11607-2:2006/   Extent of recognition
                                                             (R)2010 Packaging for         and relevant
                                                             terminally sterilized         guidance.
                                                             medical devices--Part 2:
                                                             Validation requirements for
                                                             forming, sealing and
                                                             assembly processes.
14-195......................  ............................  ANSI/AAMI/ISO 11140-          Extent of recognition.
                                                             1:2005(R)2010 Sterilization
                                                             of health care products--
                                                             Chemical indicators--Part
                                                             1: General requirements.
14-201......................  14-396......................  ANSI/AAMI ST77:2013           Withdrawn and replaced
                                                             Containment devices for       with newer version.
                                                             reusable medical device
                                                             sterilization.
14-214......................  14-397......................  AOAC 6.2.04:2013 Official     Withdrawn and replaced
                                                             Method 955.15 Testing         with newer version.
                                                             Disinfectants Against
                                                             Staphylococcus aureus, Use-
                                                             Dilution Method.
14-218......................  14-398......................  AOAC 6.3.05:2013 Official     Withdrawn and replaced
                                                             Method 966.04 Sporicidal      with newer version.
                                                             Activity of Disinfectants
                                                             Method I.
14-219......................  14-399......................  AOAC 6.3.06:2012 Official     Withdrawn and replaced
                                                             Method 965.12                 with newer version.
                                                             Tuberculocidal Activity of
                                                             Disinfectants.
14-230......................  14-400......................  ASTM F2203-13 Standard Test   Withdrawn and replaced
                                                             Method for Linear             with newer version.
                                                             Measurement Using Precision
                                                             Steel Rule.
14-231......................  14-401......................  ASTM F2217/F2217M-13          Withdrawn and replaced
                                                             Standard Practice for         with newer version.
                                                             Coating/Adhesive Weight
                                                             Determination.
14-235......................  14-402......................  ASTM F1140/F1140M-13          Withdrawn and replaced
                                                             Standard Test Methods for     with newer version.
                                                             Internal Pressurization
                                                             Failure Resistance of
                                                             Unrestrained Packages.
14-236......................  14-403......................  ASTM F2054/F2054M-13          Withdrawn and replaced
                                                             Standard Test Method for      with newer version.
                                                             Burst Testing of Flexible
                                                             Package Seals Using
                                                             Internal Air Pressurization
                                                             Within Restraining Plates.
14-241......................  14-424......................  ISO 13408-6 First edition     Withdrawn and replaced
                                                             2005-06-15 Aseptic            with newer version
                                                             processing of health care     including amendment.
                                                             products--Part 6: Isolator
                                                             systems [Including
                                                             AMENDMENT 1 (2013)].
14-258......................  14-404......................  ASTM F2250-13 Standard        Withdrawn and replaced
                                                             Practice for Evaluation of    with newer version.
                                                             Chemical Resistance of
                                                             Printed Inks and Coatings
                                                             on Flexible Packaging
                                                             Materials.
14-260......................  14-405......................  ASTM F2252/F2252M-13[egr]1    Withdrawn and replaced
                                                             Standard Practice for         with newer version.
                                                             Evaluating Ink or Coating
                                                             Adhesion to Flexible
                                                             Packaging Materials Using
                                                             Tape.
14-264......................  14-406......................  ANSI/AAMI ST8:2013 Hospital   Withdrawn and replaced
                                                             steam sterilizers.            with newer version.
14-274......................  ............................  ANSI/AAMI/ISO 15882:2008      Extent of recognition
                                                             Sterilization of health       and relevant
                                                             care products--Chemical       guidance.
                                                             indicators--Guidance for
                                                             selection, use, and
                                                             interpretation of results.
14-285......................  ............................  ANSI/AAMI/ISO 14161:2009      Extent of recognition.
                                                             Sterilization of health
                                                             care products--Biological
                                                             indicators--Guidance for
                                                             the selection, use and
                                                             interpretation of results.
14-289......................  ............................  ISO 14698-2:2003 TECHNICAL    Withdrawn. See 14-395.
                                                             CORRIGENDUM Cleanrooms and
                                                             associated controlled
                                                             environments--Biocontaminat
                                                             ion control--Part 2:
                                                             Evaluation and
                                                             interpretation of
                                                             biocontamination data.

[[Page 4932]]

 
14-296......................  ............................  ANSI/AAMI/ISO 11138-1:2006/   Relevant guidance.
                                                             (R)2010, Sterilization of
                                                             health care products--
                                                             Biological indicators--Part
                                                             1: General requirements.
14-300......................  ............................  ASTM D4169-09 Standard        Extent of recognition.
                                                             Practice for Performance
                                                             Testing of Shipping
                                                             Containers and Systems.
14-326......................  14-407......................  ISO 11737-1 Second edition    Withdrawn and replaced
                                                             2006-04-01, Sterilization     with newer version
                                                             of medical devices--          including technical
                                                             Microbiological methods--     corrigendum.
                                                             Part 1: Determination of a
                                                             population of
                                                             microorganisms on products
                                                             [Including: TECHNICAL
                                                             CORRIGENDUM 1 Published
                                                             2007-05-15].
14-328......................  14-428......................  ISO 11137-1 First edition     Withdrawn and replaced
                                                             2006-04-15 Sterilization of   with newer version
                                                             health care products--        including amendment.
                                                             Radiation--Part 1:
                                                             Requirements for
                                                             development, validation and
                                                             routine control of a
                                                             sterilization process for
                                                             medical devices [Including
                                                             AMENDMENT 1 (2013)].
14-334......................  ............................  ISO 15882 Second edition      Extent of recognition,
                                                             2008-09-01 Sterilization of   title.
                                                             health care products--
                                                             Chemical indicators--
                                                             Guidance for selection, use
                                                             and interpretation of
                                                             results.
14-335......................  14-408......................  ISO 10993-7 Second edition    Withdrawn and replaced
                                                             2008-10-15 Biological         with newer version
                                                             evaluation of medical         including technical
                                                             devices--Part 7: Ethylene     corrigendum.
                                                             oxide sterilization
                                                             residuals [Including:
                                                             TECHNICAL CORRIGENDUM 1
                                                             Published 2009-11-15].
14-336......................  ............................  ISO 14161 Second edition      Extent of recognition.
                                                             2009-09-15 Sterilization of
                                                             health care products--
                                                             Biological indicators--
                                                             Guidance for the selection,
                                                             use and interpretation of
                                                             results.
14-338......................  ............................  ISO 11138-1 Second edition    Relevant guidance.
                                                             2006-07-01, Sterilization
                                                             of health care products--
                                                             Biological indicators--Part
                                                             1: General requirements.
14-352......................  14-425......................  ANSI/AAMI/ISO 13408-6:2005    Withdrawn and replaced
                                                             Aseptic processing of         with newer version
                                                             health care products--Part    including amendment.
                                                             6: Isolator systems
                                                             [Including AMENDMENT 1
                                                             (2013)].
14-353......................  ............................  ISO 11140-1 Second edition    Extent of recognition.
                                                             2005-07-15 Sterilization of
                                                             health care products--
                                                             Chemical indicators--Part
                                                             1: General requirements.
14-355......................  ............................  ISO 11607-1 First edition     Extent of recognition
                                                             2006-04-15 Packaging for      and relevant
                                                             terminally sterilized         guidance.
                                                             medical devices--Part 1:
                                                             Requirements for materials,
                                                             sterile barrier systems and
                                                             packaging systems.
14-356......................  ............................  ISO 11607-2 First edition     Extent of recognition.
                                                             2006-04-15 Packaging for
                                                             terminally sterilized
                                                             medical devices--Part 2:
                                                             Validation requirements for
                                                             forming, sealing and
                                                             assembly processes.
14-357......................  ............................  ISO 11737-1:2006 TECHNICAL    Withdrawn. See 14-407.
                                                             CORRIGENDUM 1 Published
                                                             2007-05-15 Sterilization of
                                                             medical devices--
                                                             Microbiological methods--
                                                             Part 1: Determination of a
                                                             population of
                                                             microorganisms on products.
14-360......................  ............................  ANSI/AAMI ST72:2011,          Relevant guidance.
                                                             Bacterial endotoxins--Test
                                                             methods, routine
                                                             monitoring, and
                                                             alternatives to batch
                                                             testing.
14-362......................  14-412......................  AOAC 6.2.01:2013 Official     Withdrawn and replaced
                                                             Method 955.14, Testing        with newer version.
                                                             Disinfectants Against
                                                             Salmonella choleraesuis,
                                                             Use-Dilution Method.
14-363......................  14-413......................  AOAC 6.2.06:2013 Official     Withdrawn and replaced
                                                             Method 964.02, Testing        with newer version.
                                                             Disinfectants Against
                                                             Pseudomonas aeruginosa, Use-
                                                             Dilution Method.
14-365......................  14-409......................  ISO 11137-2 Third edition     Withdrawn and replaced
                                                             2013-06-01 Sterilization of   with newer version.
                                                             health care products--
                                                             Radiation--Part 2:
                                                             Establishing the
                                                             sterilization dose.
14-366......................  14-414......................  USP 36-NF31:2013 <61>         Withdrawn and replaced
                                                             Microbiological Examination   with newer version.
                                                             of Nonsterile Products:
                                                             Microbial Enumeration Tests.
14-367......................  14-415......................  USP 36-NF31:2013 <71>         Withdrawn and replaced
                                                             Sterility Tests.              with newer version.
14-368......................  14-416......................  USP 36-NF31:2013 <85>         Withdrawn and replaced
                                                             Bacterial Endotoxins Test.    with newer version.
14-369......................  14-417......................  USP 36-NF31:2013 <151>        Withdrawn and replaced
                                                             Pyrogen Test (USP Rabbit      with newer version.
                                                             Test).
14-370......................  14-418......................  USP 36-NF31:2013 <161>        Withdrawn and replaced
                                                             Transfusion and Infusion      with newer version.
                                                             Assemblies and Similar
                                                             Medical Devices.
14-371......................  14-419......................  USP 36-NF31:2013 Biological   Withdrawn and replaced
                                                             Indicator for Steam           with newer version.
                                                             Sterilization, Self-
                                                             Contained.
14-372......................  14-420......................  USP 36-NF31:2013 Biological   Withdrawn and replaced
                                                             Indicator for Dry-Heat        with newer version.
                                                             Sterilization, Paper
                                                             Carrier.
14-373......................  14-421......................  USP 36-NF31:2013 Biological   Withdrawn and replaced
                                                             Indicator for Ethylene        with newer version.
                                                             Oxide Sterilization, Paper
                                                             Carrier.
14-374......................  14-422......................  USP 36-NF31:2013 Biological   Withdrawn and replaced
                                                             Indicator for Steam           with newer version.
                                                             Sterilization, Paper
                                                             Carrier.
14-375......................  14-423......................  USP 36-NF31:2013 <62>         Withdrawn and replaced
                                                             Microbiological Examination   with newer version.
                                                             of Nonsterile Products:
                                                             Tests for Specified
                                                             Microorganisms.
14-380......................  14-410......................  ASTM F17-13 Standard          Withdrawn and replaced
                                                             Terminology Relating to       with newer version.
                                                             Flexible Barrier Packaging.

[[Page 4933]]

 
14-384......................  ............................  ISO 10993-7:2008 TECHNICAL    Withdrawn. See 14-408.
                                                             CORRIGENDUM 1, Published
                                                             2009-11-15 Biological
                                                             evaluation of medical
                                                             devices--Part 7: Ethylene
                                                             oxide sterilization
                                                             residuals.
14-385......................  14-426......................  ANSI/AAMI/ISO 13408-1:2008    Withdrawn and replaced
                                                             (R2011) Aseptic processing    with newer version
                                                             of health care products--     including amendment.
                                                             Part 1: General
                                                             requirements [Including
                                                             AMENDMENT 1 (2013)].
14-386......................  14-427......................  ISO 13408-1 Second edition    Withdrawn and replaced
                                                             2008-06-15 Aseptic            with newer version
                                                             processing of health care     including amendment.
                                                             products--Part 1: General
                                                             requirements [Including
                                                             AMENDMENT 1 (2013)].
14-393......................  14-411......................  ISO/ASTM 51818 Third edition  Withdrawn and replaced
                                                             2013-06-01 Practice for       with newer version.
                                                             dosimetry in an electron
                                                             beam facility for radiation
                                                             processing at energies
                                                             between 80 and 300 keV.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

    In table 2 of this document, FDA provides the listing of new 
entries and consensus standards added as modifications to the list of 
recognized standards under Recognition List Number: 034.

        Table 2.--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                      Reference No. and
     Recognition No.         Title of standard \1\           date
------------------------------------------------------------------------
                              A. Anesthesia
------------------------------------------------------------------------
1-96.....................  Medical electrical        ISO 80601-2-55
                            equipment--Part 2-55:     First edition 2011-
                            Particular requirements   12-15.
                            for the basic safety
                            and essential
                            performance of
                            respiratory gas
                            monitors.
------------------------------------------------------------------------
                            B. Cardiovascular
------------------------------------------------------------------------
3-121....................  Cardiovascular implants-- ISO 25539-1 First
                            Endovascular devices--    edition 2003-03-
                            Part 1: Endovascular      01.
                            prostheses [Including:
                            Amendment 1 (2005)].
------------------------------------------------------------------------
                               C. General
------------------------------------------------------------------------
5-83.....................  MEDICAL ELECTRICAL        ANSI/AAMI HA60601-1-
                            EQUIPMENT--Part 1-11:     1:2011.
                            General requirements
                            for basic safety and
                            essential performance--
                            Collateral Standard:
                            Requirements for
                            medical electrical
                            equipment and medical
                            electrical systems used
                            in the home healthcare
                            environment (IEC 60601-
                            1-11:2010, MOD).
5-84.....................  Design of training and    AAMI TIR49:2013.
                            instructional materials
                            for medical devices
                            used in non-clinical
                            environments.
5-85.....................  Medical electrical        IEC 60601-1-6
                            equipment--Part 1-6:      Edition 3.0 2010-
                            General requirements      01.
                            for basic safety and
                            essential performance--
                            Collateral standard:
                            Usability.
5-86.....................  Medical electrical        IEC 60601-1-8
                            equipment--Part 1-8:      Edition 2.0 2006-
                            General requirements      10.
                            for basic safety and
                            essential performance--
                            Collateral Standard:
                            General requirements,
                            tests and guidance for
                            alarm systems in
                            medical electrical
                            equipment and medical
                            electrical systems.
------------------------------------------------------------------------
               D. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-302....................  Stainless steel needle    ISO 9626 First
                            tubing for the            edition 1991-09-
                            manufacture of medical    01.
                            devices [Including:
                            AMENDMENT 1 2001-06-01].
6-318....................  Infusion equipment for    ISO 8536-4 Fifth
                            medical use--Part 4:      edition 2010-10-
                            Infusion sets for         01.
                            single use, gravity
                            feed [Including:
                            AMENDMENT 1 2013-03-01].
6-320....................  Medical electrical        IEC 60601-2-20
                            equipment--Part 2-20:     Edition 2.0 2009-
                            Particular requirements   02.
                            for the basic safety
                            and essential
                            performance of infant
                            transport incubators
                            [Including: CORRIGENDUM
                            1 (February 2012) and
                            CORRIGENDUM 2 (February
                            2013)].
6-321....................  Medical electrical        IEC 60601-2-52
                            equipment--Part 2-52:     Edition 1.0 2009-
                            Particular requirements   12.
                            for basic safety and
                            essential performance
                            of medical beds
                            [Including: CORRIGENDUM
                            1 (September 2010)].
6-322....................  Intravascular catheters-- ISO 10555-4 Second
                            Sterile and single-use    edition 2013-06-
                            catheters--Part 4:        15.
                            Balloon dilatation
                            catheters.
------------------------------------------------------------------------
                               E. Material
------------------------------------------------------------------------
8-358....................  Standard Specification    ASTM F1855-00
                            for Polyoxymethylene      (Reapproved 2011).
                            (Acetal) for Medical
                            Applications.
8-359....................  Standard Guide for        ASTM F2038-00
                            Silicone Elastomers,      (Reapproved 2011).
                            Gels, and Foams Used in
                            Medical Applications
                            Part I--Formulations
                            and Uncured Materials.

[[Page 4934]]

 
8-360....................  Standard Guide for        ASTM F2042-00
                            Silicone Elastomers,      (Reapproved 2011).
                            Gels, and Foams Used in
                            Medical Applications
                            Part II--Cross-Linking
                            and Fabrication.
8-361....................  Standard Specification    ASTM F755-99
                            for Selection of Porous   (Reapproved 2011).
                            Polyethylene for Use in
                            Surgical Implants.
8-362....................  Standard Specification    ASTM F2989-13.
                            for Metal Injection
                            Molded Unalloyed
                            Titanium Components for
                            Surgical Implant
                            Applications.
8-363....................  Standard Test Method for  ASTM D638-10.
                            Tensile Properties of
                            Plastics.
8-364....................  Standard Test Methods     ASTM D792-08.
                            for Density and
                            Specific Gravity
                            (Relative Density) of
                            Plastics by
                            Displacement.
8-365....................  Standard Test Method for  ASTM D1505-10.
                            Density of Plastics by
                            the Density-Gradient
                            Technique.
8-366....................  Ultra-high-molecular-     ISO 11542-2 First
                            weight polyethylene (PE-  edition 1998-11-
                            UHMW) moulding and        15.
                            extrusion materials--
                            Part 2: Preparation of
                            test specimens and
                            determination of
                            properties.
8-367....................  Standard Test Method for  ASTM E647-13[egr]1.
                            Measurement of Fatigue
                            Crack Growth Rates.
8-368....................  Standard Test Method for  ASTM F2625-10.
                            Measurement of Enthalpy
                            of Fusion, Percent
                            Crystallinity, and
                            Melting Point of Ultra-
                            High-Molecular Weight
                            Polyethylene by Means
                            of Differential
                            Scanning Calorimetry.
8-369....................  Standard Practice for     ASTM F2003-02
                            Accelerated Aging of      (Reapproved 2008).
                            Ultra-High Molecular
                            Weight Polyethylene
                            after Gamma Irradiation
                            in Air.
------------------------------------------------------------------------
                   F. OB-GYN/Gastroenterology/Urology
------------------------------------------------------------------------
9-86.....................  Rubber condoms for        ISO 16037 First
                            clinical trials--         Edition 2002-05-
                            Measurement of physical   15.
                            properties Including
                            [AMENDMENT 1 2011-02-
                            15)].
9-87.....................  Female condoms--          ISO 25841 First
                            Requirements and test     Edition 2011-07-
                            methods.                  15.
9-88.....................  Prophylactic dams--       ISO 29942 First
                            Requirements and test     Edition 2011-07-
                            methods.                  01.
9-89.....................  Cardiovascular implants   ISO 8638 Third
                            and extracorporeal        edition 2010-07-
                            blood circuit for         01.
                            haemodialysers,
                            haemodiafilters, and
                            haemofilters.
9-92.....................  Cardiovascular implants   ISO 8637 Third
                            and extracorporeal        edition 2010-07-
                            systems--Haemodialysers   01.
                            , haemodiafilters,
                            haemofilters and
                            haemoconcentrators
                            Including [AMENDMENT 1
                            2013-04-01)].
------------------------------------------------------------------------
                             G. Ophthalmics
------------------------------------------------------------------------
10-87....................  Standard Test Method for  ASTM D882-12.
                            Tensile Properties of
                            Thin Plastic Sheeting.
10-88....................  Standard Test Methods     ASTM D790-10.
                            for Flexural Properties
                            of Unreinforced and
                            Reinforced Plastics and
                            Electrical Insulating
                            Materials.
------------------------------------------------------------------------
                             H. Orthopedics
------------------------------------------------------------------------
11-259...................  Standard Specification    ASTM F2887-12.
                            For Total Elbow
                            Prostheses.
11-260...................  Standard Guide for        ASTM F2943-13.
                            Presentation of End
                            User Labeling
                            Information for
                            Orthopedic Implants
                            Used in Joint
                            Arthroplasty.
11-261...................  Standard Specification    ASTM F1378-12
                            for Shoulder Prostheses.
11-262...................  Standard Specification    ASTM F2091-01
                            for Acetabular            (Reapproved 2012).
                            Prostheses.
11-263...................  Standard Test Methods     ASTM F2028-08
                            for Dynamic Evaluation    (Reapproved 2012)
                            of Glenoid Loosening or   \1\.
                            Disassociation.
11-264...................  Standard Test Method for  ASTM F1820-13.
                            Determining the Forces
                            for Disassembly of
                            Modular Acetabular
                            Devices.
11-265...................  Standard Practice for     ASTM F2580-13.
                            Evaluation of Modular
                            Connection of
                            Proximally Fixed
                            Femoral Hip Prosthesis.
11-266...................  Standard Specification    ASTM F2665-09.
                            for Total Ankle
                            Replacement Prosthesis.
11-267...................  Standard Test Method for  ASTM F2009-00
                            Determining the Axial     (Reapproved 2011).
                            Disassembly Force of
                            Taper Connections of
                            Modular Prostheses.
11-268...................  Standard Test Method for  ASTM F1829-98
                            Static Evaluation of      (Reapproved 2009).
                            Glenoid Locking
                            Mechanism in Shear.
11-269...................  Standard Guide for        ASTM F2423-11.
                            Functional, Kinematic,
                            and Wear Assessment of
                            Total Disc Prostheses.
11-270...................  Standard Specification    ASTM F2502-11.
                            and Test Methods for
                            Absorbable Plates and
                            Screws for Internal
                            Fixation Implants.
11-271...................  Standard Specification    ASTM F2180-02
                            for Metallic              (Reapproved 2011).
                            Implantable Strands and
                            Cables.
11-272...................  Standard Guide for        ASTM F1714-96
                            Gravimetric Wear          (Reapproved 2013).
                            Assessment of
                            Prosthetic Hip Designs
                            in Simulator Devices.
11-273...................  Implants for surgery--    ISO 18192-1 Second
                            Wear of total             edition 2011-03-
                            intervertebral spinal     01.
                            disc prostheses--Part 1
                            Loading and
                            displacement parameters
                            for wear testing and
                            corresponding
                            environmental
                            conditions for test.
11-274...................  Implants for surgery--    ISO 18192-2 First
                            Wear of total             edition 2010-06-
                            intervertebral spinal     15.
                            disc prostheses--Part
                            2: Nucleus replacements.
11-275...................  Standard Test Method for  ASTM F2381-10.
                            Evaluating Trans-
                            Vinylene Yield in
                            Irradiated Ultra-High
                            Molecular Weight
                            Polyethylene Fabricated
                            Forms Intended for
                            Surgical Implants by
                            Infrared Spectroscopy.
------------------------------------------------------------------------

[[Page 4935]]

 
                              I. Radiology
------------------------------------------------------------------------
12-261...................  Information technology--  ISO/IEC 10918-1
                            Digital compression and   First edition 1994-
                            coding of continuous-     02-15.
                            tone still images:
                            Requirements and
                            guidelines [Including:
                            TECHNICAL CORRIGENDUM 1
                            (2005)].
------------------------------------------------------------------------
                         J. Software/Informatics
------------------------------------------------------------------------
13-63....................  Application of risk       IEC/TR 80001-2-4
                            management for IT-        Edition 1.0 2012-
                            networks incorporating    11.
                            medical devices--Part 2-
                            4: Application
                            guidance--General
                            implementation guidance
                            for healthcare delivery
                            organizations.
13-64....................  Application of risk       ANSI/AAMI/IEC
                            management for IT-        TIR80001-2-4:2012.
                            networks incorporating
                            medical devices--Part 2-
                            4: General
                            implementation guidance
                            for healthcare delivery
                            organizations.
------------------------------------------------------------------------
                              K. Sterility
------------------------------------------------------------------------
14-429...................  Practice for use of a     ISO/ASTM 51275
                            radiochromic film         Third edition 2013-
                            dosimetry system.         06-01.
14-430...................  Practice for use of an    ISO/ASTM 51607
                            alanine-EPR dosimetry     Third edition 2013-
                            system.                   06-01.
14-431...................  Guide for estimating      ISO/ASTM 51707
                            uncertainties in          Second edition
                            dosimetry for radiation   2005-05-15.
                            processing.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

IV. List of Recognized Standards

    FDA maintains the Agency's current list of FDA recognized consensus 
standards in a searchable database that may be accessed directly at 
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications 
and revisions described in this notice into the database and, upon 
publication in the Federal Register, this recognition of consensus 
standards will be effective. FDA will announce additional modifications 
and revisions to the list of recognized consensus standards, as needed, 
in the Federal Register once a year, or more often, if necessary. 
Beginning with recognition list 033, FDA no longer announces minor 
revisions to the list of recognized consensus standards such as 
technical contact person, relevant guidance, processes affected, CFR 
citations, and product codes.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for 
recognition under section 514 of the FD&C Act by submitting such 
recommendations, with reasons for the recommendation, to the contact 
person (see FOR FURTHER INFORMATION CONTACT). To be properly 
considered, such recommendations should contain, at a minimum, the 
following information: (1) The title of the standard, (2) any reference 
number and date, (3) the name and address of the national or 
international standards development organization, (4) a proposed list 
of devices for which a declaration of conformity to this standard 
should routinely apply, and (5) a brief identification of the testing 
or performance or other characteristics of the device(s) that would be 
addressed by a declaration of conformity.

VI. Electronic Access

    You may obtain a copy of ``Guidance on the Recognition and Use of 
Consensus Standards'' by using the Internet. The Center for Devices and 
Radiological Health (CDRH) maintains a site on the Internet for easy 
access to information including text, graphics, and files that you may 
download to a personal computer with access to the Internet. Updated on 
a regular basis, the CDRH home page includes the guidance as well as 
the current list of recognized standards and other standards-related 
documents. After publication in the Federal Register, this notice 
announcing ``Modification to the List of Recognized Standards, 
Recognition List Number: 034'' will be available on the CDRH home page. 
You may access the CDRH home page at http://www.fda.gov/MedicalDevices.
    You may access ``Guidance on the Recognition and Use of Consensus 
Standards,'' and the searchable database for ``FDA Recognized Consensus 
Standards'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.
    This Federal Register document on modifications in FDA's 
recognition of consensus standards is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

VII. Submission of Comments and Effective Date

    Interested persons may submit to the contact person (see FOR 
FURTHER INFORMATION CONTACT) either electronic or written comments 
regarding this document. It is only necessary to send one set of 
comments. Comments are to be identified with the docket number found in 
brackets in the heading of this document. FDA will consider any 
comments received in determining whether to amend the current listing 
of modifications to the list of recognized standards, Recognition List 
Number: 034. These modifications to the list of recognized standards 
are effective upon publication of this notice in the Federal Register.

    Dated: January 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01847 Filed 1-29-14; 8:45 am]
BILLING CODE 4160-01-P