[Federal Register Volume 73, Number 175 (Tuesday, September 9, 2008)]
[Notices]
[Pages 52358-52385]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20939]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451] (formerly FDA-2004-N-0226)


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 020

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: 020'' (Recognition List Number: 020), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES:  Effective September 9, 2008. Submit written or electronic 
comments concerning this document at any time.

ADDRESSES:  Submit written requests for single copies of 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 020'' to the Division of Small Manufacturers, International and 
Consumer Assistance, Center for Devices and Radiological Health (CDRH) 
(HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, 
MD 20850. Send two self-addressed adhesive labels to assist that office 
in processing your requests, or fax your request to 240-276-3151. 
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 to 
standards@cdrh.fda.gov. This document may also be accessed on FDA's 
Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfTopic/cdrhnew.cfm. See section VI of this document for electronic 
access to the searchable database for the current list of FDA 
recognized consensus standards, including Recognition List Number: 020 
modifications and other standards related information.

FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices 
and Radiological Health (HFZ-84), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 240-276-8714.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal 
Food, Drug, and Cosmetic Act (the 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 document 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

[[Page 52359]]

the Federal Register, are identified in table 1 of this document.

      Table 1.--Previous Publications of Standard Recognition Lists
October 16, 1998                     October 4, 2004
(63 FR 55617)                        (69 FR 59240)
 
July 12, 1999                        May 27, 2005
(64 FR 37546)                        (70 FR 30756)
 
November 15, 2000                    November 8, 2005
(65 FR 69022)                        (70 FR 67713)
 
May 7, 2001                          March 31, 2006
(66 FR 23032)                        (71 FR 16313)
 
January 14, 2002                     June 23, 2006
(67 FR 1774)                         (71 FR 36121)
 
October 2, 2002                      November 3, 2006
(67 FR 61893)                        (71 FR 64718)
 
April 28, 2003                       May 21, 2007
(68 FR 22391)                        (72 FR 28500)
 
March 8, 2004                        September 12, 2007
(69 FR 10712)                        (72 FR 52142)
 
June 18, 2004                        December 19, 2007
(69 FR 34176)                        (72 FR 71924)
------------------------------------------------------------------------

    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 of this document 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: 020

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the agency will recognize for 
use in satisfying premarket reviews and other requirements for devices. 
In addition to these changes, FDA has also established a new internal 
numbering system that assigns unique identification recognition 
numbers. FDA believes this new numbering system will facilitate the use 
of FDA Form 3654, ``Standards Data Report for 510(k)s,'' which was 
implemented in November 2007. 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: 
020'' to identify these current modifications.
    In table 2 of this document, FDA describes the following 
modifications: (1) The withdrawal of standards and their replacement by 
others, (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 2.--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
     Old       Replacement
 Recognition   Recognition           Standard                Change
     No.           No.
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
1-11          ............  IEC 60601-3-1:1996-08       Withdrawn
                             Medical Electrical
                             Equipment Part 3-1:
                             Essential Performance
                             Requirements for
                             Transcutaneous Oxygen and
                             Carbon Dioxide Partial
                             Pressure Monitoring
                             Equipment
------------------------------------------------------------------------
1-46          ............  ISO 5367:2000 Breathing     Relevant
                             Tubes Intended for Use      guidance and
                             With Anaesthetic            Extent of
                             Apparatus and Ventilators   recognition
------------------------------------------------------------------------
1-51          ............  ASTM F1101-90(1997)         Withdrawn
                             Standard Specification
                             for Ventilators Intended
                             for Use During Anesthesia
------------------------------------------------------------------------
1-62          ............  ISO 5356-1:2004             Relevant
                             Anaesthetic and             guidance
                             Respiratory Equipment--
                             Conical Connectors: Part
                             1: Cones and Sockets
------------------------------------------------------------------------
1-66          ............  ISO 9919:2005: Medical      Relevant
                             Electrical Equipment--      guidance
                             Particular Requirements
                             for the Basic Safety and
                             Essential Performance of
                             Pulse Oximeter Equipment
                             for Medical Use
------------------------------------------------------------------------
1-68          ............  CGA V-5:2005 Diameter-      Relevant
                             Index Safety System         guidance
                             (Noninterchangeable Low
                             Pressure Connections for
                             Medical Gas Applications)
------------------------------------------------------------------------
1-72          ............  ISO 10651-5:2006 Lung       Relevant
                             Ventilators for Medical     guidance, Code
                             Use--Particular             of Federal
                             Requirements for Basic      Regulations
                             Safety and Essential        (CFR) Citation
                             Performance--Part 5: Gas-   and Product
                             powered Emergency           Codes
                             Resuscitators
------------------------------------------------------------------------
1-73          ............  ISO 10651-4:2002 Lung       Relevant
                             Ventilators--Part 4:        guidance
                             Particular Requirements
                             for Operator Powered
                             Resuscitators
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-21          2-118         ANSI/AAMI/ISO 10993-11:     Withdrawn and
                             2006 Biological             replaced with
                             Evaluation of Medical       newer version
                             Devices--Part 11: Tests
                             for System Toxicity
------------------------------------------------------------------------
2-56          2-119         ASTM F813-07 Standard       Withdrawn and
                             Practice for Direct         replaced with
                             Contact Cell Culture        newer version
                             Evaluation of Materials
                             for Medical Devices
------------------------------------------------------------------------

[[Page 52360]]

 
2-63          2-120         ANSI/AAMI/ISO 10993-6:      Withdrawn and
                             2007 Biological             replaced with
                             Evaluation of Medical       newer version
                             Devices--Part 6: Tests
                             for Local Effects After
                             Implantation
------------------------------------------------------------------------
2-66          2-121         ASTM F2148-07e1 Standard    Withdrawn and
                             Practice for Evaluation     replaced with
                             of Delayed Contact          newer version
                             Hypersensitivity Using
                             the Murine Local Lymph
                             Node Assay (LLNA)
------------------------------------------------------------------------
2-68          2-122         ASTM F719-81 (2007) e1      Withdrawn and
                             Standard Practice for       replaced with
                             Testing Biomaterials in     newer version
                             Rabbits for Primary Skin
                             Irritation
------------------------------------------------------------------------
2-69          2-123         ASTM F720-81 (2007) e1      Withdrawn and
                             Standard Practice for       replaced with
                             Testing Guinea Pigs for     newer version
                             Contact Allergens: Guinea
                             Pig Maximization Test
------------------------------------------------------------------------
2-70          2-124         ASTM F750-87 (2007) e1      Withdrawn and
                             Standard Practice for       replaced with
                             Evaluating Material         newer version
                             Extracts by Systemic
                             Injection in the Mouse
------------------------------------------------------------------------
2-89          2-125         ASTM F749-98 (2007) e1      Withdrawn and
                             Standard Practice for       replaced with
                             Evaluating Material         newer version
                             Extracts by
                             Intracutaneous Injection
                             in the Rabbit
------------------------------------------------------------------------
2-92          2-126         ASTM F748-06 Standard       Withdrawn and
                             Practice for Selecting      replaced with
                             Generic Biological Test     newer version
                             Methods for Materials and
                             Devices
------------------------------------------------------------------------
2-95          ............  ASTM F1984-99(2003)         Relevant
                             Standard Practice for       guidance
                             Testing for Whole
                             Complement Activation in
                             Serum by Solid Materials
------------------------------------------------------------------------
2-109         2-128         USP 31-NF26 Biological      Withdrawn and
                             Test <87> 2008 Biological   replaced with
                             Reactivity Test, In         newer version
                             Vitro--Direct Contact
                             Test
------------------------------------------------------------------------
2-110         2-129         USP 31-NF26 Biological      Withdrawn and
                             Test <88> 2008 Biological   replaced with
                             Reactivity Test, In         newer version
                             Vitro--Elution Test
------------------------------------------------------------------------
2-111         2-130         USP 31-NF26 Biological      Withdrawn and
                             Test <88> 2008 Biological   replaced with
                             Reactivity Test, In         newer version
                             Vitro, Procedure--
                             Preparation of Sample
------------------------------------------------------------------------
2-112         2-131         USP 31-NF26 Biological      Withdrawn and
                             Test <88> 2008 Biological   replaced with
                             Reactivity Test, In         newer version
                             Vitro, Classification of
                             Plastics--Intracutaneous
                             Test
------------------------------------------------------------------------
2-113         2-132         USP 31-NF26Biological Test  Withdrawn and
                             <88> 2008 Biological        replaced with
                             Reactivity Test, In Vivo--  newer version
                             Classification of
                             Plastics--Systemic
                             Injection Test
------------------------------------------------------------------------
C. Cardiovascular/Neurology
------------------------------------------------------------------------
3-2           ............  ANSI/AAMI EC53:1995/        Reaffirmation
                             (R)2001--ECG Cables and
                             Leadwires
------------------------------------------------------------------------
3-3           ............  ANSI/AAMI NS28:1988/        Reaffirmation
                             (R)2006--Intracranial
                             Pressure Monitoring
                             Devices
------------------------------------------------------------------------
3-16          3-60          IEC 60601-2-10: Amendment   Withdrawn and
                             1: 2001-09, Medical         replaced with
                             Electrical Equipment--      newer version
                             Part 2-10: Particular
                             Requirements for the
                             Safety of Nerve and
                             Muscle Stimulators
------------------------------------------------------------------------
3-18          3-61          IEC 60601-2-27: 2005-08,    Withdrawn and
                             Second Edition, Medical     replaced with
                             Electrical Equipment--      newer version
                             Part 2-27: Particular
                             Requirements for the
                             Safety, Including
                             Essential Performance, of
                             Electrocardiographic
                             Monitoring Equipment
------------------------------------------------------------------------
3-20          3-62          IEC 60601-2-31: 2008-03,    Withdrawn and
                             Edition 2.0, Medical        replaced with
                             Electrical Equipment--      newer version
                             Part 2-31: Particular
                             Requirements for the
                             Basic Safety and
                             Essential Performance of
                             External Cardiac
                             Pacemakers with Internal
                             Power Source
------------------------------------------------------------------------
3-25          3-63          ISO 11318:2002, Second      Withdrawn and
                             Edition, Cardiac            replaced with
                             Defibrillators--Connector   newer version
                             Assembly DF-1 for
                             Implantable
                             Defibrillators--Dimension
                             s and Test Requirements
------------------------------------------------------------------------

[[Page 52361]]

 
3-40          ............  ANSI/AAMI SP9:1994, Non-    Withdrawn
                             automated
                             Sphygmomanometers
------------------------------------------------------------------------
3-41          ............  ANSI/AAMI EC11:1991/        Reaffirmation
                             (R)2007--Diagnostic
                             Electrocardiographic
                             Devices
------------------------------------------------------------------------
3-42          ............  ANSI/AAMI EC13:2002/        Reaffirmation
                             (R)2007--Cardiac
                             Monitors, Heart Rate
                             Meters, and Alarms
------------------------------------------------------------------------
3-43          3-65          ANSI/AAMI EC38:2007--       Withdrawn and
                             Medical Electrical          replaced with
                             Equipment--Part 2-47:       newer version
                             Particular Requirements
                             for the Safety, Including
                             Essential Performance, of
                             Ambulatory
                             Electrocardiographic
                             Systems
------------------------------------------------------------------------
3-44          ............  ANSI/AAMI BP22:1994/        Reaffirmation
                             (R)2006, Blood Pressure
                             Transducers
------------------------------------------------------------------------
3-45          ............  ANSI/AAMI EC57:1998/        Reaffirmation
                             (R)2003, Testing and
                             Reporting Performance
                             Results of Cardiac Rhythm
                             and ST Segment
                             Measurement Algorithms
------------------------------------------------------------------------
3-47          3-66          ASTM F2081-06, Standard     Withdrawn and
                             Guide for                   replaced with
                             Characterization and        newer version
                             Presentation of the
                             Dimensional Attributes of
                             Vascular Stents
------------------------------------------------------------------------
3-52          ............  ANSI/AAMI EC12:2000/        Reaffirmation
                             (R)2005, Disposable ECG
                             Electrodes
------------------------------------------------------------------------
3-57          3-67          ASTM F2129-06, Standard     Withdrawn and
                             Test Method for             replaced with
                             Conducting Cyclic           newer version
                             Potentiodynamic
                             Polarization Measurements
                             to Determine the
                             Corrosion Susceptibility
                             of Small Implant Devices
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat
------------------------------------------------------------------------
4-43          ............  ANSI/ADA Specification No.  Type of
                             5-Dental Casting            standard, and
                             Alloys:1997                 Relevant
                                                         guidance
------------------------------------------------------------------------
4-50          ............  ANSI/ADA Specification No.  Title and
                             18-Alginate Impression      Relevant
                             Materials:1992              guidance
------------------------------------------------------------------------
4-52          4-147         ANSI/ADA Specification No.  Withdrawn and
                             27-Resin-Based Filling      replaced with
                             Materials: 2005             newer year
------------------------------------------------------------------------
4-62          ............  ISO 1563:1990 Dental        Relevant
                             Alginate Impression         guidance and
                             Material                    Extent of
                                                         recognition
------------------------------------------------------------------------
4-63          ............  ISO 1564:1995 Dental        Relevant
                             Aqueous Impression          guidance
                             Materials Based on Agar
------------------------------------------------------------------------
4-65          4-151         ISO 3336:1993, Dentistry--  Withdrawn and
                             Synthetic Polymer Teeth     replaced with
                                                         newer version
------------------------------------------------------------------------
4-66          ............  ISO 4049:1988, Dentistry--  Withdrawn--newer
                             Resin-Based Filling         version
                             Materials                   previously
                                                         recognized
------------------------------------------------------------------------
4-67          ............  ISO 6871-1:1994, Dental     Withdrawn--newer
                             Base Metal Casting Alloys   version
                             Part 1: Cobalt-based        previously
                             Alloys--TECHNICAL           recognized
                             CORRIGENDUM 1:1998
------------------------------------------------------------------------
4-68          ............  ISO 6871-2:1994, Dental     Withdrawn--newer
                             Base Metal Casting Alloys   version
                             Part 2: Nickel-Based        previously
                             Alloys                      recognized
------------------------------------------------------------------------
4-69          ............  ISO 6872:1995/Amendment     Date of standard
                             1:1997 Dental Ceramic       and Extent of
                                                         recognition
------------------------------------------------------------------------
4-73          ............  ISO 7405:1997 Dentistry--   Extent of
                             Preclinical Evaluation of   recognition and
                             Biocompatibility of         Contact person
                             Medical Devices Used in
                             Dentistry--Test Methods
                             for Dental Materials
------------------------------------------------------------------------
4-75          ............  ISO 7785-1:1997 Dental      Relevant
                             Handpieces--Part 1: High-   guidance and
                             Speed Air Turbine           Extent of
                             Handpieces                  recognition
------------------------------------------------------------------------

[[Page 52362]]

 
4-76          ............  ISO 7785-2:1995 Dental      Relevant
                             Handpieces--Part 2:         guidance and
                             Straight and Geared Angle   Extent of
                             Handpieces                  recognition
------------------------------------------------------------------------
4-78          ............  ISO 9168:1991 Dental        Relevant
                             Handpieces--Hose            guidance and
                             Connectors                  Extent of
                                                         recognition
------------------------------------------------------------------------
4-83          ............  ISO 11498:1997 Dental       Relevant
                             Handpieces--Dental Low-     guidance and
                             Voltage Electrical Motors   Extent of
                                                         recognition
------------------------------------------------------------------------
4-84          ............  ISO 13294:1997 Dental       Relevant
                             Handpieces--Dental Air-     guidance and
                             Motors                      Extent of
                                                         recognition
------------------------------------------------------------------------
4-88          4-148         ANSI/ADA Specification No.  Withdrawn and
                             78-Endodontic Obturating    replaced with
                             Cones: 2005                 newer version
------------------------------------------------------------------------
4-89          ............  ANSI/ADA Specification No.  Reaffirmation
                             53-Polymer-Based Crowns     and Relevant
                             and Bridge Resins: 1999     guidance
                             (Reaffirmed 2005)
------------------------------------------------------------------------
4-90          ............  ANSI/ASA S3.39:1987         Reaffirmation
                             (R2007), Specifications     and Type of
                             for Instruments to          standard
                             Measure Aural Acoustic
                             Impedance and Admittance
                             (Aural Acoustic
                             Immittance)
------------------------------------------------------------------------
4-91          ............  ANSI/ADA Specification No.  Relevant
                             80-Dental Materials--       guidance
                             Determination of Color
                             Stability: 2001
------------------------------------------------------------------------
4-92          ............  ANSI/ADA Specification No.  Reaffirmation
                             88-Dental Brazing Alloys:   and Relevant
                             2000 (Reaffirmed 2006)      guidance
------------------------------------------------------------------------
4-93          4-159         IEEE ANSI C63.19:2007       Withdrawn and
                             Methods of Measurement of   replaced with
                             Compatibility Between       newer version
                             Wireless Communications
                             Devices and Hearing Aids
------------------------------------------------------------------------
4-94          ............  ANSI/ADA Specification No.  Reaffirmation,
                             14--Dental Base Metal       Date of
                             Casting Alloys: 1982        standard, Type
                             (Reaffirmed 1998)           of standard,
                                                         Offices,
                                                         Relevant
                                                         guidance
------------------------------------------------------------------------
4-95          ............  ANSI/ADA Specification      Withdrawn--newer
                             No.17:1999, Dental Base     version
                             Temporary Relining Resin    previously
                                                         recognized
------------------------------------------------------------------------
4-96          ............  ANSI/ADA Specification No.  Reaffirmation
                             30--Dental Zinc Oxide--     and Relevant
                             Eugenol and Zinc Oxide--    guidance
                             Non-Eugenol Cements: 2000
                             (Reaffirmed 2005)
------------------------------------------------------------------------
4-97          ............  ANSI/ADA Specification No.  Reaffirmation,
                             57--Endodontic Sealing      Offices and
                             Material: 2000              Type of
                             (Reaffirmed 2006)           standard
------------------------------------------------------------------------
4-98          ............  ANSI/ADA Specification No.  Withdrawn--newer
                             96:2000, Dental-Water-      version
                             Based Cements               previously
                                                         recognized
------------------------------------------------------------------------
4-99          ............  ISO 4049: 2000 Dentistry--  Relevant
                             Polymer-based Filling,      guidance, Type
                             Restorative and Luting      of standard and
                             Materials                   Extent of
                                                         recognition
------------------------------------------------------------------------
4-100         4-133         ISO 6876:2001, Dental Root  Withdrawn
                             Canal Sealing Materials     (duplicate)
------------------------------------------------------------------------
4-101         ............  ISO 8891:1998, Dental       Withdrawn--newer
                             Casting Alloys With Noble   version
                             Metal Content of At Least   previously
                             25% but Less Than 75%       recognized
------------------------------------------------------------------------
4-102         4-152         ISO 9693:1999, Metal-       Withdrawn and
                             Ceramic Dental              replaced with
                             Restorative Systems         newer version
------------------------------------------------------------------------
4-104         4-149         ANSI/ADA Specification No.  Withdrawn and
                             39--Pit and Fissure         replaced with
                             Sealants: 2006              newer version
------------------------------------------------------------------------
4-105         ............  ANSI/ADA Specification No.  Type of standard
                             75--Resilient Lining        and Relevant
                             Materials for Removable     guidance
                             Dentures--Part 1: Short-
                             Term Materials: 1997
                             (Reaffirmed 2003)
------------------------------------------------------------------------
4-107         ............  ISO 9917-2:1998 Dental      Devices
                             Water-Based Cements--Part   affected, Type
                             2: Light-Activated          of standard,
                             Cements                     Relevant
                                                         guidance and
                                                         Extent of
                                                         recognition
------------------------------------------------------------------------

[[Page 52363]]

 
4-109         ............  ISO 13716:1999 Dentistry--  Type of
                             Reversible-Irreversible     standard,
                             Hydrocolloid Impression     Relevant
                             Material Systems            guidance,
                                                         Extent of
                                                         recognition and
                                                         Code of Federal
                                                         Regulations
                                                         (CFR) citation
------------------------------------------------------------------------
4-110         ............  ANSI/ADA Specification No.  Type of standard
                             11--Agar Impression         and Relevant
                             Materials: 1997             guidance
------------------------------------------------------------------------
4-111         ............  ANSI/ADA Specification No.  Reaffirmation,
                             13--Denture Cold-Curing     Date of
                             Repair Resins: 1981         standard, Type
                             (Reaffirmed 2006)           of standard and
                                                         Relevant
                                                         guidance
------------------------------------------------------------------------
4-112         ............  ANSI/ADA Specification No.  Reaffirmation,
                             16--Dental Impression       Date of
                             Paste--Zinc Oxide-Eugenol   standard, Type
                             Type: 1961 (Reaffirmed      of standard and
                             1999)                       Relevant
                                                         guidance
------------------------------------------------------------------------
4-113         ............  ANSI/ADA Specification No.  Reaffirmation,
                             20--Dental Duplicating      Date of
                             Material: 1972              standard, Type
                             (Reaffirmed 1995)           of standard and
                                                         Relevant
                                                         guidance
------------------------------------------------------------------------
4-115         4-153         ISO 9917-1:2007 Dentistry-- Withdrawn and
                             Water-Based Cements--Part   replaced with a
                             1: Powder/Liquid Acid-      newer year
                             Base Cements
------------------------------------------------------------------------
4-117         ............  ANSI/ADA Specification No.  Type of standard
                             12--Denture Base
                             Polymers: 2002
------------------------------------------------------------------------
4-119         ............  ANSI/ADA Specification No.  Reaffirmation,
                             82--Dental Reversible/      Date of
                             Irreversible Hydrocolloid   standard, Type
                             Impression Material         of standard and
                             Systems: 1998 (Reaffirmed   Relevant
                             2003)                       guidance
------------------------------------------------------------------------
4-120         ............  ISO 10139-2:1999            Type of
                             Dentistry--Soft Lining      standard,
                             Materials for Removable     Relevant
                             Dentures--Part 2:           guidance and
                             Materials for Long-Term     Extent of
                             Use                         recognition
------------------------------------------------------------------------
4-121         ............  ISO 7494-2:2003 Dentistry-- Type of standard
                             Dental Units--Part 2:       and Extent of
                             Water and Air Supply        recognition
------------------------------------------------------------------------
4-125         ............  ISO 1562:2004, Dentistry--  Withdrawn--newer
                             Casting Gold Alloys         version
                                                         previously
                                                         recognized
------------------------------------------------------------------------
4-126         ............  ISO 10477:2004 Dentistry--  Extent of
                             Polymer-Based Crown and     recognition and
                             Bridge Materials            Relevant
                                                         guidance
------------------------------------------------------------------------
4-127         ............  ANSI/ADA Specification No.  Type of standard
                             58--Root Canal Files,       and Extent of
                             Type H (Hedstrom): 2004     recognition
------------------------------------------------------------------------
4-128         ............  ISO 4823:2000,, Dentistry-- Withdrawn
                             Elastomeric Impression
                             Materials and Technical
                             Corrigendum 1:2004
------------------------------------------------------------------------
4-129         4-150         ANSI/ADA Specification No.  Withdrawn and
                             19--Dental Elastomeric      replaced with
                             Impression Material: 2004   newer version
------------------------------------------------------------------------
4-130         ............  ANSI/ADA Specification No.  Reaffirmation,
                             17--Denture Base            Processes
                             Temporary Relining          impacted,
                             Resins: 1983 (Reaffirmed    Extent of
                             2006)                       recognition,
                                                         CFR citations
                                                         and Relevant
                                                         guidance
------------------------------------------------------------------------
4-131         ............  ISO 3107: 2004 Dentistry--  Processes
                             Zinc Oxide/Eugenol and      impacted and
                             Zinc Oxide/Non-eugenol      Relevant
                             Cements Technical           guidance
                             Corrigendum 1:2006-Third
                             Edition
------------------------------------------------------------------------
4-132         ............  ISO 6874:2005 Dentistry--   Extent of
                             Polymer-Based Pit and       recognition and
                             Fissure Sealants            Relevant
                                                         guidance
------------------------------------------------------------------------
4-133         ............  ISO 6876:2001 Dental Root   Processes
                             Canal Sealing Materials     impacted and
                                                         Extent of
                                                         recognition
------------------------------------------------------------------------
4-134         ............  ISO 7494-1:2004 Dentistry-- Extent of
                             Dental Units--Part 1:       recognition
                             General Requirements and
                             Test Methods
------------------------------------------------------------------------
4-135         ............  ISO 10139-1:2005            Relevant
                             Dentistry--Soft Lining      guidance and
                             Materials for Removable     Extent of
                             Dentures--Part 1:           recognition
                             Materials for Short-term
                             Use
------------------------------------------------------------------------

[[Page 52364]]

 
4-136         ............  ASTM F2504-05 Standard      Relevant
                             Practice for Describing     guidance
                             System Output of
                             Implantable Middle Ear
                             Hearing Devices
------------------------------------------------------------------------
4-137         ............  ISO 6877:2006 Dentistry--   Extent of
                             Root-Canal Obturating       recognition
                             Points
------------------------------------------------------------------------
4-139         ............  ANSI/ADA Specification No.  Relevant
                             48--Visible Light Curing    guidance
                             Units: 2004
------------------------------------------------------------------------
4-140         ............  ISO 6871-2:1994/Amd         Withdrawn--newer
                             1:2005, Dental Base Metal   version
                             Casting Alloys--Part 2:     previously
                             Nickel-Based Alloys         recognized
------------------------------------------------------------------------
4-141         ............  ISO 6871-1:1994, Dental     Withdrawn--newer
                             Base Metal Casting          version
                             Alloys--Part 1: Cobalt-     previously
                             Based Alloys                recognized
------------------------------------------------------------------------
4-142         ............  ISO 6871-1:1994/Amd         Withdrawn--newer
                             1:2005, Dental Base Metal   version
                             Casting Alloys--Part 1:     previously
                             Cobalt-Based Alloys         recognized
------------------------------------------------------------------------
4-143         ............  ANSI/ADA Specification      Reaffirmation,
                             No.96, Dental-Water-Based   Type of
                             Cements                     standard and
                                                         Relevant
                                                         guidance
------------------------------------------------------------------------
4-145         ............  ISO 22803:2004 Dentistry--  Relevant
                             Membrane Materials for      guidance and
                             Guided Tissue               Devices
                             Regeneration in Oral and    affected
                             Maxillofacial Surgery--
                             Contents of a Technical
                             File
------------------------------------------------------------------------
4-146         ............  ISO 22674:2006 Dentistry--  Devices affected
                             Metallic Materials for      and Processes
                             Fixed and Removable         impacted
                             Restorations and
                             Appliances
------------------------------------------------------------------------
E. General
------------------------------------------------------------------------
5-7           12-185        IEC 60601-1-3(1994-07)      Transferred
                             Medical Electrical
                             Equipment--Part 1:
                             General Requirements for
                             Safety; General
                             Requirements for
                             Radiation Protection in
                             Diagnostic X-Ray
                             Equipment
------------------------------------------------------------------------
5-8           5-41          IEC 60601-1-4:2000 Medical  Withdrawn and
                             Electrical Equipment--      replaced with
                             Part 1-4: General           newer version
                             Requirements for Safety--
                             Collateral Standard:
                             Programmable Electrical
                             Medical Systems, Edition
                             1.1
------------------------------------------------------------------------
5-16          5-42          ASTM D903-98(2004)          Withdrawn and
                             Standard Test Methods for   replaced with
                             Peel or Stripping           newer version
                             Strength of Adhesive
                             Bonds
------------------------------------------------------------------------
5-19          ............  ASTM E876/1995 Standard     Withdrawn
                             Practice for Use of
                             Statistics in the
                             Evaluation of
                             Spectrometric Data
------------------------------------------------------------------------
5-25          5-43          ANSI/ESD S20.20-2007        Withdrawn and
                             Standard for the            replaced with
                             Development of an           newer version
                             Electrostatic Discharge
                             Control Program for
                             Protection of Electrical
                             and Electronic Parts,
                             Assemblies and Equipment
                             (Excluding Electrically
                             Initiated Explosive
                             Devices)
------------------------------------------------------------------------
5-28          ............  IEC 60601-1-2, (Second      Extent of
                             Edition, 2001) Medical      recognition
                             Electrical Equipment--
                             Part 1-2: General
                             Requirements for Safety--
                             Collateral Standard:
                             Electromagnetic
                             Compatibility--Requiremen
                             ts and Tests
------------------------------------------------------------------------
5-30          ............  AAMI/ANSI/IEC 60601-1-2     Type of standard
                             Medical Electrical          and Extent of
                             Equipment--Part 1-2:        recognition
                             General Requirements for
                             Safety--Collateral
                             Standard: Electromagnetic
                             Compatibility--Requiremen
                             ts and Tests (AAMI/ANSI/
                             IEC 60601-1-2:2001 is the
                             U.S. version of IEC 60601-
                             1-2:2001 with identical
                             requirements for
                             electromagnetic
                             compatibility (EMC) of
                             medical electrical
                             equipment.)
------------------------------------------------------------------------
5-33          5-44          IEC 60601-1-8:2006 Medical  Withdrawn and
                             Electrical Equipment--      replaced with
                             Part 1-8: General           newer version
                             Requirements for Basic
                             Safety and Essential
                             Performance--Collateral
                             Standard: General
                             Requirements, Tests and
                             Guidance for Alarm
                             Systems in Medical
                             Electrical Equipment and
                             Medical Electrical
                             Systems, Second Edition
------------------------------------------------------------------------

[[Page 52365]]

 
5-34          ............  IEC 60601-1-2 Medical       Extent of
                             Electrical Equipment--      recognition
                             Part 1-2: General
                             Requirements for Safety--
                             Collateral Standard:
                             Electromagnetic
                             Compatibility--Requiremen
                             ts and Tests (Edition
                             2:2001 with Amendment
                             1:2004; Edition 2.1
                             (Edition 2:2001
                             consolidated with
                             Amendment 1:2004))
------------------------------------------------------------------------
5-35          ............  AAMI/ANSI/IEC 60601-1-2     Type of standard
                             Medical Electrical          and Extent of
                             Equipment--Part 1-2:        recognition
                             General Requirements for
                             Safety--Collateral
                             standard: Electromagnetic
                             Compatibility--Requiremen
                             ts and Tests (Edition
                             2:2001 with Amendment
                             1:2004) (AAMI/ANSI/IEC
                             60601-1-2:2001 with
                             Amendment 1:2004 is the
                             U.S. version of IEC 60601-
                             1-2:2001 with Amendment
                             1:2004, with identical
                             requirements for
                             electromagnetic
                             compatibility (EMC) of
                             medical electrical
                             equipment)
------------------------------------------------------------------------
5-36          ............  ANSI/AAMI/ISO TIR           CFR Citations,
                             16142:2006: Technical       Product codes
                             Information Report:         and Relevant
                             Medical Devices--Guidance   guidance
                             on the Selection of
                             Standards in Support of
                             Recognized Essential
                             Principles of Safety and
                             Performance of Medical
                             Devices, Second Edition
------------------------------------------------------------------------
F. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-16          ............  ISO 7886-1:1993 Sterile     Withdrawn
                             Hypodermic Syringes for
                             Single Use--Part 1:
                             Syringes for Manual Use
------------------------------------------------------------------------
6-117         ............  ASTM F2172-02: Standard     Relevant
                             Specification for Blood/    guidance
                             Intravenous Fluid/
                             Irrigation Fluid Warmers
------------------------------------------------------------------------
6-118         ............  ASTM F2196-02 Standard      Relevant
                             Specification for           guidance,
                             Circulating Liquid and      Contact person
                             Forced Air Patient
                             Temperature Management
                             Devices
------------------------------------------------------------------------
6-131         6-203         ASTM D6499-07 Standard      Withdrawn and
                             Test Method for the         replaced with
                             Immunological Measurement   newer version
                             of Antigenic Protein in
                             Natural Rubber and Its
                             Products
------------------------------------------------------------------------
6-160         6-204         ISO 8537:2007 Sterile       Withdrawn and
                             Single-Use Syringes, With   replaced with
                             or Without Needle, for      newer version
                             Insulin
------------------------------------------------------------------------
6-166         6-215         ASTM F2132-01(2008)         Withdrawn and
                             Standard Specification      replaced with
                             for Puncture Resistance     newer version
                             of Materials Used in
                             Containers for Discarded
                             Medical Needles and Other
                             Sharps
------------------------------------------------------------------------
6-167         ............  ASTM D6319-00a(2005)        Relevant
                             Standard Specification      guidance
                             for Nitrile Examination
                             Gloves for Medical
                             Application
------------------------------------------------------------------------
6-188         6-205         USP 31:2008 Nonabsorbable   Withdrawn and
                             Surgical Suture             replaced with
                                                         newer version
------------------------------------------------------------------------
6-189         6-206         USP 31<11>2008 Sterile      Withdrawn and
                             Sodium Chloride for         replaced with
                             Irrigation                  newer version
------------------------------------------------------------------------
6-190         6-207         USP 31:2008 Absorbable      Withdrawn and
                             Surgical Suture             replaced with
                                                         newer version
------------------------------------------------------------------------
6-191         6-208         USP 31<881>:2008 Tensile    Withdrawn and
                             Strength                    replaced with
                                                         newer version
------------------------------------------------------------------------
6-192         6-209         USP 31<861>:2008 Sutures--  Withdrawn and
                             Diameter                    replaced with
                                                         newer version
------------------------------------------------------------------------
6-193         6-210         USP 31<871>:2008 Sutures    Withdrawn and
                             Needle Attachment           replaced with
                                                         newer version
------------------------------------------------------------------------
6-194         6-211         USP 31<11>: 2008 Sterile    Withdrawn and
                             Water for Irrigation        replaced with
                                                         newer version
------------------------------------------------------------------------
6-195         6-212         USP 31<11>: 2008 Heparin    Withdrawn and
                             Lock Flush Solution         replaced with
                                                         newer version
------------------------------------------------------------------------

[[Page 52366]]

 
6-196         6-213         USP 31<11>: 2008 Sodium     Withdrawn and
                             Chloride Injection          replaced with
                                                         newer version
------------------------------------------------------------------------
6-198         ............  ASTM F2100-07 Standard      Relevant
                             Specification for           guidance
                             Performance of Materials
                             Used in Medical Face
                             Masks
------------------------------------------------------------------------
6-201         ............  ISO 8536-4:2007 Infusion    Relevant
                             Equipment for Medical       guidance
                             Use--Part 4: Infusion
                             Sets for Single Use,
                             Gravity Feed
------------------------------------------------------------------------
G. In Vitro Diagnostic
------------------------------------------------------------------------
7-6           7-131         CLSI ILA18-A2               Withdrawn and
                             Specifications for          replaced with
                             Immunological Testing for   newer version
                             Infectious Diseases
------------------------------------------------------------------------
7-11          7-132         CLSI MM03-A2 Molecular      Withdrawn and
                             Diagnostic Methods for      replaced with
                             Infectious Diseases         newer version
------------------------------------------------------------------------
7-12          ............  CLSI/NCCLS C12-A            Withdrawn
                             Definitions of Quantities
                             and Conventions Related
                             to Blood pH and Gas
                             Analysis; Approved
                             Standard (1994)
------------------------------------------------------------------------
7-13          ............  CLSI/NCCLS C21-A            Withdrawn
                             Performance
                             Characteristics for
                             Devices Measuring PO2 and
                             PCO2 in Blood Samples;
                             Approved Standard (1992)
------------------------------------------------------------------------
7-15          ............  CLSI/NCCLS C25-A            Withdrawn
                             Fractional Oxyhemoglobin,
                             Oxygen Content and
                             Saturation, and Related
                             Quantities in Blood:
                             Terminology, Measurement,
                             and Reporting; Approved
                             Guideline (1997)
------------------------------------------------------------------------
7-16          ............  CLSI/NCCLS C27-A Blood Gas  Withdrawn
                             Preanalytical
                             Considerations: Specimen
                             Collection, Calibration,
                             and Controls; Approved
                             Guideline (1993)
------------------------------------------------------------------------
7-18          7-133         CLSI C30-A2, Point-of Care  Withdrawn and
                             Blood Glucose Testing in    replaced with
                             Acute and Chronic Care      newer version
                             Facilities
------------------------------------------------------------------------
7-21          ............  CLSI C42-A, Erythrocyte     Contact person
                             Protoporphyrin Testing;
                             Approved Guideline (1996)
------------------------------------------------------------------------
7-22          7-134         CLSI GP20-A2 Fine-Needle    Withdrawn and
                             Aspiration Biopsy (FNAB)    replaced with
                             Techniques                  newer versions
------------------------------------------------------------------------
7-25          ............  NCCLS H8-A2 Detection of    Withdrawn
                             Abnormal Hemoglobin Using
                             Cellulose Acetate
                             Electrophoresis--Second
                             Edition; Approved
                             Standard (1994)
------------------------------------------------------------------------
7-26          ............  NCCLS H9-A Chromatographic  Withdrawn
                             (Microcolumn)
                             Determination of
                             Hemoglobin A2; Approved
                             Standard (1989)
------------------------------------------------------------------------
7-27          ............  NCCLS H10-A2 Solubility     Withdrawn
                             Test to Confirm the
                             Presence of Sickling
                             Hemoglobins--Second
                             Edition; Approved
                             Standard (1995)
------------------------------------------------------------------------
7-29          ............  NCCLS H14-A2 Devices for    Withdrawn
                             Collection of Skin
                             Puncture Blood Specimens--
                             Second Edition; Approved
                             Guideline (1990)
------------------------------------------------------------------------
7-34          7-135         CLSI H44-A2 Methods for     Withdrawn and
                             Reticulocyte Counting       replaced with
                             (Flow Cytometry and         newer version
                             Supravital Dyes)
------------------------------------------------------------------------
7-35          ............  CLSI H47-A One-Stage        Contact person
                             Prothrombin Time (PT)
                             Test and Activated
                             Partial Thromboplastin
                             Time (APTT) Test;
                             Approved Guideline (1996)
------------------------------------------------------------------------
7-36          7-136         CLSI ILA02-A2 Quality       Withdrawn and
                             Assurance of Laboratory     replaced with
                             Tests for Autoantibodies    newer version
                             to Nuclear Antigens
------------------------------------------------------------------------
7-37          ............  CLSI ILA06-A Detection and  Contact person
                             Quantitation of Rubella
                             IgG Antibody
------------------------------------------------------------------------

[[Page 52367]]

 
7-38          ............  CLSI/NCCLS I/LA10-A         Withdrawn
                             Choriogonadotropin
                             Testing: Nomenclature,
                             Reference Preparations,
                             Assay Performance, and
                             Clinical Application;
                             Approved Guideline (1996)
------------------------------------------------------------------------
7-39          ............  CLSI/NCCLS I/LA17-A         Withdrawn
                             Assessing the Quality of
                             Systems for Alpha-
                             Fetoprotein (AFP) Assays
                             Used in Prenatal
                             Screening and Diagnosis
                             of Neural Tube Defects;
                             Approved Guideline (1997)
------------------------------------------------------------------------
7-40          ............  NCCLS I/LA18-A              Withdrawn
                             Specifications for
                             Immunological Testing for
                             Infectious Diseases;
                             Approved Guideline (1994)
------------------------------------------------------------------------
7-41          ............  CLSI ILA19-A Primary        Contact person
                             Reference Preparations
                             Used to Standardize
                             Calibration of
                             Immunochemical Assays for
                             Serum Prostate Specific
                             Antigen (PSA); Approved
                             Guideline (1997)
------------------------------------------------------------------------
7-42          ............  CLSI ILA20-A Evaluation     Contact person
                             Methods and Analytical
                             Performance
                             Characteristics of
                             Immunological Assays for
                             Human Immunoglobulin E
                             (IgE) Antibodies of
                             Defined Allergen
                             Specificities; Approved
                             Guideline (1997)
------------------------------------------------------------------------
7-43          7-137         CLSI LA04-A5 Blood          Withdrawn and
                             Collection on Filter        replaced with
                             Paper for Newborn           newer version
                             Screening Programs
------------------------------------------------------------------------
7-46          7-138         CLSI M27-A2, Reference      Withdrawn and
                             Method for Broth Dilution   replaced with
                             Antifungal Susceptibility   newer version
                             Testing of Yeasts
------------------------------------------------------------------------
7-49          ............  CLSI H26-A Performance      Contact person
                             Goals for the Internal
                             Quality Control of
                             Multichannel Hematology
                             Analyzers; Approved
                             Standard
------------------------------------------------------------------------
7-50          ............  NCCLS D11-A2 Glossary and   Withdrawn
                             Guidance for
                             Immunodiagnostic
                             Procedures, Reagents, and
                             Reference Materials--
                             Second Edition, Approved
                             Guideline
------------------------------------------------------------------------
7-51          7-139         CLSI GP27-A2 Using          Withdrawn and
                             Proficiency Testing to      replaced with
                             Improve the Clinical        newer version
                             Laboratory
------------------------------------------------------------------------
7-52          ............  CLSI / NCCLS NRSCL 8-A      Withdrawn
                             Terminology and
                             Definitions for use in
                             NCCLS Documents; Approved
                             Standard
------------------------------------------------------------------------
7-53          7-140         CLSI GP22-A2 Continuous     Withdrawn and
                             Quality Improvement         replaced with
                                                         newer version
------------------------------------------------------------------------
7-55          7-141         CLSI H18-A3 Procedures for  Withdrawn and
                             the Handling and            replaced with
                             Processing of Blood         newer version
                             Specimens
------------------------------------------------------------------------
7-58          7-142         CLSI H11-A4 Procedures for  Withdrawn and
                             the Collection of           replaced with
                             Arterial Blood Specimens    newer version
------------------------------------------------------------------------
7-59          13-9          CLSI / NCCLS AUTO2-A        Transferred
                             Laboratory Automation:
                             Bar Codes for Specimen
                             Container Identification;
                             Approved Standard
------------------------------------------------------------------------
7-60          13-10         NCCLS AUTO1-A Laboratory    Transferred
                             Automation: Specimen
                             Container/Specimen
                             Carrier; Approved
                             Standard
------------------------------------------------------------------------
7-61          13-11         NCCLS AUTO3-A Laboratory    Transferred
                             Automation:
                             Communications with
                             Automated Clinical
                             Laboratory Systems,
                             Instruments, Devices, and
                             Information Systems;
                             Approved Standard
------------------------------------------------------------------------
7-62          13-12         NCCLS AUTO4-A Laboratory    Transferred
                             Automation: Systems
                             Operational Requirements,
                             Characteristics, and
                             Information Elements;
                             Approved Standard
------------------------------------------------------------------------
7-63          13-13         NCCLS AUTO5-A Laboratory    Transferred
                             Automation:
                             Electromechanical
                             Interfaces; Approved
                             Standard
------------------------------------------------------------------------
7-64          13-14         NCCLS POCT1-A Point-of-     Transferred
                             Care Connectivity;
                             Approved Standard
------------------------------------------------------------------------

[[Page 52368]]

 
7-67          7-143         CLSI EP14-A2 Evaluation of  Withdrawn and
                             Matrix Effects              replaced with
                                                         newer version
------------------------------------------------------------------------
7-68          13-15         NCCLS GP19-A2 Laboratory    Transferred
                             Instruments and Data
                             Management Systems:
                             Design of Software User
                             Interfaces and End-User
                             Software Systems
                             Validation, Operation,
                             and Monitoring; Approved
                             Guideline--Second Edition
------------------------------------------------------------------------
7-70          7-144         CLSI H4-A5 Procedures and   Withdrawn and
                             Devices for the             replaced with
                             Collection of Diagnostic    newer version
                             Blood Specimens by Skin
                             Puncture
------------------------------------------------------------------------
7-72          7-145         CLSI H42-A2 Enumeration of  Withdrawn and
                             Immunologically Defined     replaced with
                             Cell Populations by Flow    newer version
                             Cytometry
------------------------------------------------------------------------
7-74          7-146         NCCLS M6-A2 Protocols for   Withdrawn and
                             Evaluating Dehydrated       replaced with
                             Mueller-Hinton Agar         newer version
------------------------------------------------------------------------
7-77          7-147         CLSI M22-A3 Quality         Withdrawn and
                             Control for Commercially    replaced with
                             Prepared Microbiological    newer version
                             Culture Media
------------------------------------------------------------------------
7-79          7-148         CLSI M28-A2 Procedures for  Withdrawn and
                             the Recovery and            replaced with
                             Identification of           newer version
                             Parasites From the
                             Intestinal Tract
------------------------------------------------------------------------
7-80          ............  CLSI MM01-A2 Molecular      Withdrawn
                             Diagnostic Methods for
                             Genetic Diseases
------------------------------------------------------------------------
7-83          ............  NCCLS C46-A Blood Gas and   Withdrawn
                             pH Analysis and Related
                             Measurements; Approved
                             Guideline
------------------------------------------------------------------------
7-85          7-149         CLSI C24-A3 Statistical     Withdrawn and
                             Quality Control for         replaced with
                             Quantitative Measurement    newer version
                             Procedures
------------------------------------------------------------------------
7-90          7-150         CLSI H43-A2 Clinical Flow   Withdrawn and
                             Cytometric Analysis of      replaced with
                             Neoplastic Hematolymphoid   newer version
                             Cells
------------------------------------------------------------------------
7-93          ............  NCCLS EP10-A2, Preliminary  Withdrawn
                             Evaluation of
                             Quantitative Clinical
                             Laboratory Methods;
                             Approved Guideline
------------------------------------------------------------------------
7-94          7-152         CLSI EP12-A2 User Protocol  Withdrawn and
                             for Evaluation of           replaced with
                             Qualitative Test            newer version
                             Performance
------------------------------------------------------------------------
7-95          7-153         CLSI EP15-A2 User           Withdrawn and
                             Verification of             replaced with
                             Performance for Precision   newer version
                             and Trueness
------------------------------------------------------------------------
7-98          7-154         CLSI MM02-A2 Immunoglobin   Withdrawn and
                             and T-Cell Receptor Gene    replaced with
                             Rearrangement Assays        newer version
------------------------------------------------------------------------
7-99          ............  CLSI MM5-A Nucleic Acid     Contact person
                             Amplification Assays for
                             Molecular Hematopathology
------------------------------------------------------------------------
7-103         7-155         CLSI H03-A6 Procedures for  Withdrawn and
                             the Collection of           replaced with
                             Diagnostic Blood            newer version
                             Specimens by Venipunture
------------------------------------------------------------------------
7-106         7-156         CLSI M02-A9 Performance     Withdrawn and
                             Standards for               replaced with
                             Antimicrobial Disk          newer version
                             Susceptibility Tests
------------------------------------------------------------------------
7-107         7-157         CLSI M11-A7 Methods for     Withdrawn and
                             Antimicrobial               replaced with
                             Susceptibility Testing of   newer version
                             Anaerobic Bacteria
------------------------------------------------------------------------
7-108         7-158         CLSI M7-A7 Methods for      Withdrawn and
                             Antimicrobial               replaced with
                             Susceptibility Tests of     newer version
                             Anaerobic Bacteria
------------------------------------------------------------------------
7-109         ............  CLSI AUTO7-A Laboratory     Withdrawn
                             Automation: Data Content
                             for Specimen
                             Identification; Approved
                             Standard
------------------------------------------------------------------------
7-111         7-159         CLSI H21-A5 Collection,     Withdrawn and
                             Transport, and Processing   replaced with
                             of Blood Specimens for      newer version
                             Testing Plasma-Based
                             Coagulation Assays and
                             Molecular Hemostasis
                             Assays
------------------------------------------------------------------------

[[Page 52369]]

 
7-114         13-16         CLSI LIS01-A Standard       Transferred
                             Specification for Low-
                             Level Protocol to
                             Transfer Messages Between
                             Clinical Laboratory
                             Instruments and Computer
                             Systems
------------------------------------------------------------------------
7-115         13-17         CLSI LIS02-A2 Standard      Transferred
                             Specification for
                             Transferring Information
                             Between Clinical
                             Instruments and Computer
                             Systems; Approved
                             Standard-Second Edition
------------------------------------------------------------------------
7-116         13-18         CLSI LIS03-A Standard       Transferred
                             Guide for Selection of a
                             Clinical Laboratory
                             Information Management
                             System
------------------------------------------------------------------------
7-117         13-19         CLSI LIS04-A Standard       Transferred
                             Guide for Documentation
                             of Clinical Laboratory
                             Computer Systems
------------------------------------------------------------------------
7-118         13-20         CLSI LIS05-A, Standard      Transferred
                             Specification for
                             Transferring Clinical
                             Observations Between
                             Independent Computer
                             Systems
------------------------------------------------------------------------
7-119         13-21         CLSI LIS06-A Standard       Transferred
                             Practice for Reporting
                             Reliability of Clinical
                             Laboratory Information
                             Systems
------------------------------------------------------------------------
7-120         13-22         CLSI LIS07-A Standard       Transferred
                             Specification for Use of
                             Bar Codes on Specimen
                             Tubes in the Clinical
                             Laboratory
------------------------------------------------------------------------
7-121         13-23         CLSI LIS08-A Standard       Transferred
                             Guide for Functional
                             Requirements of Clinical
                             Laboratory Information
                             Management Systems
------------------------------------------------------------------------
7-122         13-24         CLSI LIS09-A Standard       Transferred
                             Guide for Coordination of
                             Clinical Laboratory
                             Services within the
                             Electronic Health Record
                             Environment and Networked
                             Architectures
------------------------------------------------------------------------
7-125         ............  CLSI/NCCLS M28-A2 Volume    Withdrawn
                             25, No. 16 Procedures for
                             the Recovery and
                             Identification of
                             Parasites From the
                             Intestinal Tract;
                             Approved Guideline
------------------------------------------------------------------------
H. Materials
------------------------------------------------------------------------
8-32          ............  ASTM F1586-02: Standard     Contact person
                             Specification for Wrought
                             Nitrogen Strengthened 21
                             Chromium-10 Nickel-3
                             Manganese-2.5 Molybdenum
                             Stainless Steel Bar for
                             Surgical Implants (UNS
                             S31675)
------------------------------------------------------------------------
8-44          ............  ASTM F0136-02a: Standard    Contact person
                             Specification for Wrought
                             Titanium-6 Aluminum-4
                             Vanadium ELI (Extra Low
                             Interstitial) Alloy for
                             Surgical Implant
                             Applications (UNS R56401)
------------------------------------------------------------------------
8-46          8-154         ASTM F0621-08: Standard     Withdrawn and
                             Specification for           replaced with
                             Stainless Steel Forgings    newer year
                             for Surgical Implants       version
------------------------------------------------------------------------
8-50          ............  ASTM F1091-02: Standard     Contact person
                             Specification for Wrought
                             Cobalt-20 Chromium-15
                             Tungsten-10 Nickel Alloy
                             Surgical Fixation Wire
                             (UNS R30605)
------------------------------------------------------------------------
8-52          ............  ASTM F1350-02: Standard     Contact person
                             Specification for Wrought
                             18 Chromium-14 Nickel-2.5
                             Molybdenum Stainless
                             Steel Surgical Fixation
                             Wire (UNS S31673)
------------------------------------------------------------------------
8-53          ............  ASTM F1472-02a: Standard    Contact person
                             Specification for Wrought
                             Titanium -6Aluminum -
                             4Vanadium Alloy for
                             Surgical Implant
                             Applications (UNS R56400)
------------------------------------------------------------------------
8-54          8-155         ASTM F1580-07 Standard      Withdrawn and
                             Specification for           replaced with
                             Titanium and Titanium-6     newer year
                             Aluminum-4 Vanadium Alloy   version
                             Powders for Coatings of
                             Surgical Implants
------------------------------------------------------------------------
8-57          ............  ISO 5832-2:1999, Implants   Contact person
                             for Surgery--Metallic
                             Materials--Part 2:
                             Unalloyed Titanium
------------------------------------------------------------------------
8-58          ............  ISO 5832-3:1996, Implants   Contact person
                             for Surgery--Metallic
                             Materials--Part 3:
                             Wrought Titanium 6-
                             Aluminium 4-Vanadium
                             Alloy
------------------------------------------------------------------------

[[Page 52370]]

 
8-59          ............  ISO 5832-4:1996, Implants   Contact person
                             for Surgery--Metallic
                             Materials--Part 4: Cobalt-
                             Chromium-Molybdenum
                             Casting Alloy
------------------------------------------------------------------------
8-61          ............  ISO 5832-6:1997, Implants   Contact person
                             for Surgery--Metallic
                             Materials--Part 6:
                             Wrought Cobalt-Nickel-
                             Chromium-Molybdenum Alloy
------------------------------------------------------------------------
8-63          ............  ISO 5832-11:1994, Implants  Contact person
                             for Surgery--Metallic
                             Materials--Part 11:
                             Wrought Titanium 6-
                             Aluminium 7-Niobium Alloy
------------------------------------------------------------------------
8-76          ............  ASTM F138-03: Standard      Contact person
                             Specification for Wrought
                             18 Chromium-14 Nickel-2.5
                             Molybdenum Stainless
                             Steel Bar and Wire for
                             Surgical Implants (UNS
                             S31673)
------------------------------------------------------------------------
8-77          8-156         ASTM F0139-08, Standard     Withdrawn and
                             Specification for Wrought   replaced with
                             18 Chromium-14 Nickel-2.5   newer year
                             Molybdenum Stainless        version
                             Steel Sheet and Strip for
                             Surgical Implants (UNS
                             S31673)
------------------------------------------------------------------------
8-79          ............  ASTM F0961-03, Standard     Contact person
                             Specification for Cobalt-
                             35 Nickel-20 Chromium-10
                             Molybdenum Alloy Forgings
                             for Surgical Implants
                             [UNS R30035]
------------------------------------------------------------------------
8-81          ............  ASTM F1609-03 Standard      Contact person
                             Specification for Calcium
                             Phosphate Coatings for
                             Implantable Materials
------------------------------------------------------------------------
11-81         8-157         ISO 9583:1993 Implants for  Transferred
                             Surgery--Non-Destructive
                             Testing--Liquid Penetrant
                             Inspection of Metallic
                             Surgical Implants
------------------------------------------------------------------------
8-82          8-158         ASTM F1713-08 Standard      Withdrawn and
                             Specification for Wrought   replaced with
                             Titanium-13 Niobium-13      newer year
                             Zirconium Alloy for         version
                             Surgical Implant
                             Applications (UNS R58130)
------------------------------------------------------------------------
11-82         8-159         ISO 9584:1993 Implants for  Transferred
                             Surgery--Non-Destructive
                             Testing--Radiographic
                             Examination of Cast
                             Metallic Surgical
                             Implants
------------------------------------------------------------------------
8-86          ............  ASTM F1926-03 Standard      Relevant
                             Test Method for             guidance
                             Evaluation of the
                             Environmental Stability
                             of Calcium Phosphate
                             Coatings
------------------------------------------------------------------------
8-88          ............  ASTM F2024-00 Standard      Relevant
                             Practice for X-Ray          guidance
                             Diffraction Determination
                             of Phase Content of
                             Plasma-Sprayed
                             Hydroxyapatite Coatings
------------------------------------------------------------------------
8-98          8-162         ASTM F451-99a(2007)e1       Withdrawn and
                             Standard Specification      replaced with
                             for Acrylic Bone Cement     newer year
                                                         version
------------------------------------------------------------------------
8-104         ............  ASTM F1108-04 Standard      Contact person
                             Specification for
                             Titanium-6Aluminum-4Vanad
                             ium Alloy Castings for
                             Surgical Implants (UNS
                             R56406)
------------------------------------------------------------------------
8-108         ............  ASTM F1295-05 Standard      Contact person
                             Specification for Wrought
                             Titanium-6 Aluminum-7
                             Niobium Alloy for
                             Surgical Implant
                             Applications (UNS R56700)
------------------------------------------------------------------------
8-110         ............  ASTM F1377-04 Standard      Contact person
                             Specification for Cobalt-
                             28 Chromium-6 Molybdenum
                             Powder for Coating of
                             Orthopedic Implants (UNS
                             R30075)
------------------------------------------------------------------------
8-112         ............  ASTM F1044-05 Standard      Relevant
                             Test Method for Shear       guidance
                             Testing of Calcium
                             Phosphate Coatings and
                             Metallic Coatings
------------------------------------------------------------------------
8-113         ............  ASTM F1147-05 Standard      Relevant
                             Test Method for Tension     guidance
                             Testing of Calcium
                             Phosphate and Metal
                             Coatings
------------------------------------------------------------------------
8-119         ............  ASTM F688-05 Standard       Contact person
                             Specification for Wrought
                             Cobalt-35 Nickel-20
                             Chromium-10 Molybdenum
                             Alloy Plate, Sheet, and
                             Foil for Surgical
                             Implants (UNS R30035)
------------------------------------------------------------------------

[[Page 52371]]

 
8-120         8-160         ASTM F0560-07 Standard      Withdrawn and
                             Specification for           replaced with
                             Unalloyed Tantalum for      newer year
                             Surgical Implant            version
                             Applications (UNS R05200,
                             UNS R05400)
------------------------------------------------------------------------
8-123         ............  ISO 5832-5:2005 Implants    Contact person
                             for Surgery--Metallic
                             Materials--Part 5:
                             Wrought Cobalt-Chromium-
                             Tungsten-Nickel Alloy
------------------------------------------------------------------------
8-127         ............  ISO 5834-2:2006 Implants    Relevant
                             for Surgery--Ultra-high-    guidance
                             molecular-weight
                             polyethylene--Part 2:
                             Moulded Forms
------------------------------------------------------------------------
8-129         ............  ASTM F67-06 Standard        Contact person
                             Specification for
                             Unalloyed Titanium for
                             Surgical Implant
                             Applications (UNS R50250,
                             UNS R50400, UNS R50550,
                             UNS R50700)
------------------------------------------------------------------------
8-130         ............  ASTM F620-06 Standard       Contact person
                             Specification for Alpha
                             Plus Beta Titanium Alloy
                             Forgings for Surgical
                             Implants
------------------------------------------------------------------------
8-131         ............  ASTM F799-06 Standard       Contact person
                             Specification for Cobalt-
                             28 Chromium-6 Molybdenum
                             Alloy Forgings for
                             Surgical Implants (UNS
                             R31537, R31538, R31539)
------------------------------------------------------------------------
8-132         ............  ASTM F1088-04ae1 Standard   Contact person
                             Specification for Beta-
                             Tricalcium Phosphate for
                             Surgical Implantation
------------------------------------------------------------------------
8-137         ............  ASTM F0075-07 Standard      Contact person
                             Specification for Cobalt-
                             28 Chromium-6 Molybdenum
                             Alloy Castings and
                             Casting Alloy for
                             Surgical Implants (UNS
                             R30075)
------------------------------------------------------------------------
8-138         ............  ASTM F0745-07 Standard      Contact person
                             Specification for 18
                             Chromium-12.5 Nickel-2.5
                             Molybdenum Stainless
                             Steel for Cast and
                             Solution-Annealed
                             Surgical Implant
                             Applications
------------------------------------------------------------------------
8-139         ............  ASTM F1314-07 Standard      Contact person
                             Specification for Wrought
                             Nitrogen Strengthened 22
                             Chromium - 13 Nickel - 5
                             Manganese - 2.5
                             Molybdenum Stainless
                             Steel Alloy Bar and Wire
                             for Surgical Implants
                             (UNS S20910)
------------------------------------------------------------------------
8-142         ............  ASTM F1978-00(2007)e2       Relevant
                             Standard Test Method for    guidance
                             Measuring Abrasion
                             Resistance of Metallic
                             Thermal Spray Coatings by
                             Using the Taber Abraser
------------------------------------------------------------------------
8-144         ............  ASTM F0754-00 Standard      Contact person
                             Specification for
                             Implantable
                             Polytetrafluoroethylene
                             (PTFE) Polymer Fabricated
                             in Sheet, Tube and Rod
                             Shapes
------------------------------------------------------------------------
8-145         ............  ASTM F0090-07 Standard      Contact person
                             Specification for Wrought
                             Cobalt-20 Chromium-15
                             Tungsten-10 Nickel Alloy
                             for Surgical Implant
                             Applications (UNS R30605)
------------------------------------------------------------------------
8-147         ............  ASTM F0562-07 Standard      Contact person
                             Specification for Wrought
                             35Cobalt-35Nickel-20Chrom
                             ium-10Molybdenum Alloy
                             for Surgical Implant
                             Applications (UNS R30035)
------------------------------------------------------------------------
8-149         ............  ISO 5832-1:2007 Implants    Contact person
                             for Surgery--Metallic
                             Materials--Part 1:
                             Wrought Stainless Steel
------------------------------------------------------------------------
8-150         ............  ISO 5832-9:2007 Implants    Contact person
                             for Surgery--Metallic
                             Materials--Part 9:
                             Wrought High Nitrogen
                             Stainless Steel
------------------------------------------------------------------------
8-151         ............  ISO 5832-12:2007 Implants   Contact person
                             for Surgery--Metallic
                             Materials--Part 12:
                             Wrought Cobalt-Chromium-
                             Molybdenum Alloy
------------------------------------------------------------------------
8-152         ............  ASTM F1537-07 Standard      Contact person
                             Specification for Wrought
                             Cobalt-28Chromium-6Molybd
                             enum Alloys for Surgical
                             Implants (UNS R31537, UNS
                             R31538, and UNS R31539)
------------------------------------------------------------------------
I. OB-GYN/Gastroenterology
------------------------------------------------------------------------

[[Page 52372]]

 
9-4           ............  IEC 60601-2-16 (1998)       Relevant
                             Medical Electrical          guidance and
                             Equipment--Part 2-16:       Contact person
                             Particular Requirements
                             for the Safety of
                             Haemodialysis,
                             Haemodiafiltration and
                             Haemofiltration Equipment
------------------------------------------------------------------------
9-6           ............  IEC 60601-2-36 (1997)       Title, Relevant
                             Medical Electrical          guidance, CFR
                             Equipment--Part 2-36:       Citation, and
                             Particular Requirements     Product Codes
                             for the Safety of
                             Equipment for
                             Extracorporeally Induced
                             Lithotripsy
------------------------------------------------------------------------
9-7           ............  IEC 61846 (1998)            Relevant
                             Ultrasonics--Pressure       guidance, CFR
                             Pulse Lithotripters--       Citation, and
                             Characteristics of Fields   Product Codes
------------------------------------------------------------------------
9-21          ............  ISO 8600-4:1997 Optics and  Relevant
                             Optical Instruments--       guidance
                             Medical Endoscopes and
                             Certain Accessories--Part
                             4: Determination of
                             Maximum Width of
                             Insertion Portion
------------------------------------------------------------------------
9-23          ............  ASTM F1518-00 Standard      Relevant
                             Practice for Cleaning and   guidance, CDRH
                             Disinfection of Flexible    Office and
                             Fiberoptic and Video        Division
                             Endoscopes Used in the      associated with
                             Examination of the Hollow   recognized
                             Viscera                     standard
------------------------------------------------------------------------
9-25          ............  AAMI / ANSI HF18:2001       Withdrawn
                             Electrosurgical Devices
------------------------------------------------------------------------
9-28          9-47          ANSI/AAMI RD16:2007         Withdrawn and
                             Cardiovascular Implants     replaced with
                             and Artificial Organs--     newer version
                             Hemodialyzers,
                             Hemodiafilters,
                             Hemofilters, and
                             Hemoconcentrators
------------------------------------------------------------------------
9-29          9-48          AAMI / ANSI RD17 :2007      Withdrawn and
                             Cardiovascular Implants     replaced with
                             and artificial organs--     newer version
                             Extracorporeal Blood
                             Circuit for
                             Hemodialyzers,
                             Hemodiafilters, and
                             Hemofilters
------------------------------------------------------------------------
9-32          ............  ASTM D3492-03 Standard      Relevant
                             Specification for Rubber    guidance
                             Contraceptives (Male
                             Condoms)
------------------------------------------------------------------------
9-34          ............  ISO 4074:2002/               Relevant
                             Cor.1:2003(E) Natural       guidance
                             Latex Rubber Condoms--
                             Requirements and Test
                             Methods, Technical
                             Corrigendum 1
------------------------------------------------------------------------
9-37          ............  ISO 8600-1:2005 Optics and  Relevant
                             Photonics--Medical          guidance
                             Endoscopes and
                             Endotherapy Devices--Part
                             1: General Requirements
                             ISO 8600-1:2005
------------------------------------------------------------------------
9-38          ............  ISO 8600-3:1997 Amendment   Relevant
                             1 2003, Optics and          guidance
                             Optical Instruments--
                             Medical Endoscopes and
                             Endoscopic Accessories
                             Part 3: Determination of
                             Field of View and
                             Direction of View of
                             Endoscopes with Optics
------------------------------------------------------------------------
9-39          ............  ISO 8600-5:2005 Optics and  Relevant
                             Photonics--Medical          guidance
                             Endoscopes and
                             Endotherapy Devices--Part
                             5: Determination of
                             Optical Resolution of
                             Rigid Endoscopes with
                             Optics
------------------------------------------------------------------------
9-40          ............  ISO 8600-6:2005 Optics and  Relevant
                             Photonics--Medical          guidance
                             Endoscopes and
                             Endotherapy Devices--Part
                             6: Vocabulary
------------------------------------------------------------------------
9-41          ............  ASTM D6324-05 Standard      Relevant
                             Test Methods for Male       guidance
                             Condoms Made from
                             Synthetic Materials
------------------------------------------------------------------------
9-42          ............  IEC 60601-2-18 (1996)       Relevant
                             Amendment 1 2000 Medical    guidance
                             electrical equipment--
                             Part 2: Particular
                             Requirements for the
                             Safety of Endoscopic
                             Equipment
------------------------------------------------------------------------
9-43          ............  ISO 16038:2005 Rubber       Relevant
                             Condoms--Guidance on the    guidance
                             Use of ISO 4074 in the
                             Quality Management of
                             Natural Rubber Latex
                             Condoms
------------------------------------------------------------------------
J. Ophthalmic
------------------------------------------------------------------------
10-21         ............  ISO 11979-2:1999            Withdrawn
                             Ophthalmic Implants--
                             Intraocular Lenses--Part
                             2: Optical Properties and
                             Test Methods
------------------------------------------------------------------------

[[Page 52373]]

 
10-23         ............  ISO 11981:1999 Ophthalmic   Withdrawn
                             Optics--Contact Lenses
                             and Contact Lens Care
                             Products--Determination
                             of Physical Compatibility
                             of Contact Lens Care
                             Products With Contact
                             Lenses
------------------------------------------------------------------------
10-42         ............  ISO 11979-2:1999/           Extent of
                             Corrigendum1:2003           recognition and
                             Ophthalmic Implants--       Process
                             Intraocular Lenses--Part    impacted
                             2: Optical Properties and
                             Test Methods
------------------------------------------------------------------------
10-44         ............  ISO 11981:1999/             Relevant
                             Corrigendum1:2005           guidance and
                             Ophthalmic Optics--         Process
                             Contact Lenses and          impacted
                             Contact Lens Car
                             Products--Determination
                             of Physical Compatibility
                             of Contact Lens Care
                             Products with Contact
                             Lenses
------------------------------------------------------------------------
K. Orthopedic
------------------------------------------------------------------------
11-73         ............  ISO 5838-1:1995 Implants    Type of standard
                             for Surgery--Skeletal       and Contact
                             Pins and Wires--Part 1:     person
                             Material and Mechanical
                             Requirements
------------------------------------------------------------------------
11-74         ............  ISO 5838-2:1991 Implants    Type of standard
                             for Surgery--Skeletal       and Contact
                             Pins and Wires--Part 2:     person
                             Steinmann Skeletal Pins--
                             Dimensions
------------------------------------------------------------------------
11-75         ............  ISO 5838-3:1993 Implants    Type of standard
                             for Surgery--Skeletal       and Contact
                             Pins and Wires--Part 3:     person
                             Kirschner Skeletal Wires
------------------------------------------------------------------------
11-79         ............  ISO 7206-8:1995 Implants    Type of
                             for Surgery--Partial and    standard, CFR
                             Total Hip Joint             Citation,
                             Prostheses--Part 8:         Product codes
                             Endurance Performance of    and Relevant
                             Stemmed Femoral             guidance
                             Components with
                             Application of Torsion
------------------------------------------------------------------------
11-80         ............  ISO 8828:1988 Implants for  Contact person
                             Surgery--Guidance on Care   Processes
                             and Handling of             Impacted
                             Orthopaedic Implants
------------------------------------------------------------------------
11-81         8-157         ISO 9583:1993 Implants for  Transferred
                             Surgery--Non-Destructive
                             Testing--Liquid Penetrant
                             Inspection of Metallic
                             Surgical Implants
------------------------------------------------------------------------
11-82         8-159         ISO 9584:1993 Implants for  Transferred
                             Surgery--Non-Destructive
                             Testing--Radiographic
                             Examination of Cast
                             Metallic Surgical
                             Implants
------------------------------------------------------------------------
11-155        ............  ISO 7207-2:1998 Implants    Type of standard
                             for Surgery--Components     and Relevant
                             for Partial and Total       guidance
                             Knee Joint Prostheses--
                             Part 2: Articulating
                             Surfaces Made of Metal,
                             Ceramic and Plastics
                             Materials
------------------------------------------------------------------------
11-164        11-203        ASTM F1541-02(2007)         Withdrawn and
                             Standard Specification      replaced with
                             and Test Methods for        newer version
                             External Skeletal
                             Fixation Devices
------------------------------------------------------------------------
11-166        11-204        ASTM F0897-02(2007)         Withdrawn and
                             Standard Test Method for    replaced with
                             Measuring Fretting          newer version
                             Corrosion of
                             Osteosynthesis Plates and
                             Screws
------------------------------------------------------------------------
11-168        ............  ASTM F1781-03 Standard      Type of standard
                             Specification for
                             Elastomeric Flexible
                             Hinge Finger Total Joint
                             Implants
------------------------------------------------------------------------
11-171        ............  ASTM F1814-97a(2003)        Type of standard
                             Standard Guide for          and Relevant
                             Evaluating Modular Hip      guidance
                             and Knee Joint Components
------------------------------------------------------------------------
11-172        ............  ASTM F1798-97(2003)         Type of standard
                             Standard Guide for          and Relevant
                             Evaluating the Static and   guidance
                             Fatigue Properties of
                             Interconnection
                             Mechanisms and
                             Subassemblies Used in
                             Spinal Arthrodesis
                             Implants
------------------------------------------------------------------------
11-175        ............  ASTM F1582-98(2003)         Type of
                             Standard Terminology        standard, CFR
                             Relating to Spinal          Citation,
                             Implants                    Product codes
                                                         and Relevant
                                                         guidance
------------------------------------------------------------------------
11-177        11-205        ASTM F1264-03(2007)         Withdrawn and
                             Standard Specification      replaced with
                             and Test Methods for        newer version
                             Intramedullary Fixation
                             Devices
------------------------------------------------------------------------

[[Page 52374]]

 
11-178        ............  ASTM F1440-92(2002)         Processes
                             Standard Practice for       impacted, Type
                             Cyclic Fatigue Testing of   of standard,
                             Metallic Stemmed Hip        CFR Citation,
                             Arthroplasty Femoral        Product codes
                             Components Without          and Relevant
                             Torsion                     guidance
------------------------------------------------------------------------
11-179        ............  ASTM F2068-03 Standard      Processes
                             Specification for Femoral   impacted, Type
                             Prostheses--Metallic        of standard,
                             Implants                    CFR Citation,
                                                         Product codes
                                                         and Relevant
                                                         guidance
------------------------------------------------------------------------
11-180        ............  ASTM F0366-04 Standard      Type of standard
                             Specification for           and Contact
                             Fixation Pins and Wires     person
------------------------------------------------------------------------
11-181        ............  ASTM F1717-04 Standard      Type of standard
                             Test Methods for Spinal     and Relevant
                             Implant Constructs in a     guidance
                             Vertebrectomy Model
------------------------------------------------------------------------
11-182        11-206        ASTM F1800-07 Standard      Withdrawn and
                             Test Method for Cyclic      replaced with
                             Fatigue Testing of Metal    newer version
                             Tibial Tray Components of
                             Total Knee Joint
                             Replacements
------------------------------------------------------------------------
11-183        ............  ASTM F1875-98(2004)         Type of
                             Standard Practice for       standard, CFR
                             Fretting Corrosion          Citations,
                             Testing of Modular          Product codes
                             Implant Interfaces: Hip     and Relevant
                             Femoral Head-Bore and       guidance
                             Cone Taper Interface
------------------------------------------------------------------------
11-184        ............  ISO 8827:1988 Implants for  Type of standard
                             surgery--Staples with       and Contact
                             Parallel Legs for           person
                             Orthopaedic Use--General
                             Requirements
------------------------------------------------------------------------
11-185        ............  ASTM F2267-04 Standard      CFR Citations,
                             Test Method for Measuring   Product codes
                             Load Induced Subsidence     and Relevant
                             of an Intervertebral Body   guidance
                             Fusion Device Under
                             Static Axial Compression
------------------------------------------------------------------------
11-186        ............  ASTM F2077-03 Test Methods  Type of
                             for Intervertebral Body     standard, CFR
                             Fusion Devices              Citations,
                                                         Product codes
                                                         and Relevant
                                                         guidance
------------------------------------------------------------------------
11-187        11-207        ASTM F2193-02(2007)         Withdrawn and
                             Standard Specifications     replaced with
                             and Test Methods for        newer version
                             Components Used in the
                             Surgical Fixation of the
                             Spinal Skeletal System
------------------------------------------------------------------------
11-188        ............  ISO 14243-1:2002 Implants   Type of
                             for Surgery--Wear of        standard, CFR
                             Total Knee-Joint            Citations and
                             Prostheses--Part 1:         Product codes
                             Loading and Displacement
                             Parameters for Wear-
                             Testing Machines With
                             Load Control and
                             Corresponding
                             Environmental Conditions
                             for Test
------------------------------------------------------------------------
11-189        ............  ISO 14243-2:2000 Implants   Type of
                             for Surgery--Wear of        standard,
                             Total Knee-Joint            Extent of
                             Prostheses--Part 2:         recognition,
                             Methods of Measurement      CFR Citations
                                                         and Product
                                                         codes
------------------------------------------------------------------------
11-190        ............  ISO 14243-3:2004 Implants   Type of
                             for Surgery--Wear of        standard, CFR
                             Total Knee-Joint            Citations and
                             Prostheses--Part 3:         Product codes
                             Loading and Displacement
                             Parameters for Wear-
                             Testing Machines With
                             Displacement Control and
                             Corresponding
                             Environmental Conditions
                             for Test
------------------------------------------------------------------------
11-191        ............  ISO 14879-1:2000 Implants   Type of standard
                             for Surgery--Total Knee-
                             Joint Prostheses--Part 1:
                             Determination of
                             Endurance Properties of
                             Knee Tibial Trays
------------------------------------------------------------------------
11-192        ............  ASTM F1223-05 Standard      Type of standard
                             Test Method for             CFR Citations
                             Determination of Total      and Product
                             Knee Replacement            codes
                             Constraint
------------------------------------------------------------------------
11-194        11-208        ISO 14630:2008 Non-Active   Withdrawn and
                             Surgical Implants--         replaced with
                             General Requirements--3d    newer version
                             Edition
------------------------------------------------------------------------
11-195        ............  ASTM F1612-95(2005)         Type of
                             Standard Practice for       standard, CFR
                             Cyclic Fatigue Testing of   Citations,
                             Metallic Stemmed Hip        Product codes
                             Arthroplasty Femoral        and Relevant
                             Components with Torsion     guidance
------------------------------------------------------------------------
11-196        ............  ASTM F1672-95(2005)         Type of standard
                             Standard Specification      and Relevant
                             for Resurfacing Patellar    guidance
                             Prosthesis
------------------------------------------------------------------------

[[Page 52375]]

 
11-197        ............  ASTM F0983-86(2005)         Contact person
                             Standard Practice for       and Processes
                             Permanent Marking of        impacted
                             Orthopaedic Implant
                             Components
------------------------------------------------------------------------
11-198        ............  ASTM F0382-99(2003)e1       Type of standard
                             Standard Specification      and Contact
                             and Test Method for         person
                             Metallic Bone Plates
------------------------------------------------------------------------
11-199        ............  ASTM F0565-04 Standard      Contact person
                             Practice for Care and       and Processes
                             Handling of Orthopedic      impacted
                             Implants and Instruments
------------------------------------------------------------------------
11-200        11-209        ASTM F2083-07 Standard      Withdrawn and
                             Specification for Total     replaced with
                             Knee Prosthesis             newer version
------------------------------------------------------------------------
11-201        ............  ASTM F0564-02(2006)         Contact person
                             Standard Specification
                             and Test Methods for
                             Metallic Bone Staples
------------------------------------------------------------------------
11-202        11-210        ASTM F0543-07 Standard      Withdrawn and
                             Specification and Test      replaced with
                             Methods for Metallic        newer version
                             Medical Bone Screws
------------------------------------------------------------------------
L. Physical Medicine
------------------------------------------------------------------------
16-19         ............  ISO 7176-4:1997             Contact person
                             Wheelchairs--Part 4:        and Type of
                             Energy Consumption of       standard
                             Electric Wheelchairs and
                             Scooters for
                             Determination of
                             Theoretical Distance
                             Range
------------------------------------------------------------------------
16-20         ............  ISO 7176-5:1986             Contact person
                             Wheelchairs--Part 5:        and Type of
                             Determination of Overall    standard
                             Dimensions, Mass and
                             Turning Space
------------------------------------------------------------------------
16-23         ............  ISO 7176-10:1988            Contact person
                             Wheelchairs--Part 10:       and Type of
                             Determination of Obstacle-  standard
                             Climbing Ability of
                             Electric Wheelchairs
------------------------------------------------------------------------
16-24         ............  ISO 7176-11:1992            Contact person
                             Wheelchairs--Part 11:       and Type of
                             Test Dummies                standard
------------------------------------------------------------------------
16-25         ............  ISO 7176-13:1989            Contact person
                             Wheelchairs--Part 13:       and Type of
                             Determination of            standard
                             Coefficient of Friction
                             of Test Surfaces
------------------------------------------------------------------------
16-26         ............  ISO 7176-14:1997            Contact person
                             Wheelchairs--Part 14:       and Type of
                             Power and Control Systems   standard
                             for Electric Wheelchairs--
                             Requirements and Test
                             Methods
------------------------------------------------------------------------
16-27         ............  ISO 7176-15:1996            Contact person
                             Wheelchairs--Part 15:       and Type of
                             Requirements for            standard
                             Information Disclosure,
                             Documentation and
                             Labeling
------------------------------------------------------------------------
16-28         ............  ISO 7176-16: 1997           Contact person
                             Wheelchairs--Part 16:       and Type of
                             Resistance to Ignition of   standard
                             Upholstered Parts--
                             Requirements and Test
                             Methods
------------------------------------------------------------------------
16-29         ............  ISO 7176-6:2001             Contact person
                             Wheelchairs--Part 6:        and Type of
                             Determination of Maximum    standard
                             Speed, Acceleration and
                             Deceleration of Electric
                             Wheelchairs
------------------------------------------------------------------------
16-30         ............  ISO 7176-9:2001             Contact person
                             Wheelchairs--Part 9:        and Type of
                             Climatic Tests for          standard
                             Electric Wheelchairs
------------------------------------------------------------------------
16-31         ............  ANSI/RESNA WC/Volume 1-     Contact person
                             1998 Section 1:             and Type of
                             Determination of Static     standard
                             Stability
------------------------------------------------------------------------
16-32         ............  ANSI/RESNA WC/Volume 2-     Contact person
                             1998 Section 2:             and Type of
                             Determination of Dynamic    standard
                             Stability of Electric
                             Wheelchairs
------------------------------------------------------------------------
16-33         ............  ANSI/RESNA WC/Volume 2-     Contact person
                             1998 Section 3: Test        and Type of
                             Methods and Requirements    standard
                             for the Effectiveness of
                             Brakes
------------------------------------------------------------------------
16-34         ............  ANSI/RESNA WC/Volume 2-     Contact person
                             1998 Section 4:             and Type of
                             Determination of Energy     standard
                             Consumption of Electric
                             Wheelchairs
------------------------------------------------------------------------
16-35         ............  ANSI/RESNA WC/Volume 1-     Contact person
                             1998 Section 5:             and Type of
                             Determination of Overall    standard
                             Dimensions, Mass, and
                             Turning Space--Wheelchair
------------------------------------------------------------------------

[[Page 52376]]

 
16-36         ............  ANSI/RESNA WC/Volume 2-     Contact person
                             1998 Section 6:             and Type of
                             Determination of Maximum    standard
                             Speed, Acceleration, and
                             Retardation of Electric
                             Wheelchairs
------------------------------------------------------------------------
16-37         ............  ANSI/RESNA WC/Volume 1-     Contact person
                             1998 Section 7:             and Type of
                             Wheelchairs -               standard
                             Determination of Seating
                             and Wheel Dimensions
------------------------------------------------------------------------
16-38         ............  ANSI/RESNA WC/Volume 1-     Contact person
                             1998 Section 8:             and Type of
                             Wheelchairs--Static,        standard
                             Impact and Fatigue
                             Strength Tests
------------------------------------------------------------------------
16-39         ............  ANSI/RESNA WC/Volume 2 -    Contact person
                             1998 Section 9: Climatic    and Type of
                             Tests for Electric          standard
                             Wheelchairs
------------------------------------------------------------------------
16-40         ............  ANSI/RESNA WC/Volume 2 -    Contact person
                             1998 Section 10:            and Type of
                             Determination of the        standard
                             Obstacle-Climbing Ability
                             of Electric Wheelchairs
------------------------------------------------------------------------
16-41         ............  ANSI/RESNA WC/Volume 1 -    Contact person
                             1998 Section 11:            and Type of
                             Wheelchairs--Test Dummies   standard
------------------------------------------------------------------------
16-42         ............  ANSI/RESNA WC/Volume 1 -    Contact person
                             1998 Section 13:            and Type of
                             Determination of            standard
                             Coefficient of Friction
                             of Test Surfaces
------------------------------------------------------------------------
16-43         ............  ANSI/RESNA WC/Volume 2 -    Contact person
                             1998 Section 14:            and Type of
                             Wheelchairs--Testing of     standard
                             Power and Control Systems
                             for Electric Wheelchairs
------------------------------------------------------------------------
16-44         ............  ANSI/RESNA WC/Volume 1 -    Contact person
                             1998 Section 15:            and Type of
                             Wheelchairs--Requirements   standard
                             for Information
                             Disclosures,
                             Documentation and
                             Labeling
------------------------------------------------------------------------
16-45         ............  ANSI/RESNA WC/Volume 1 -    Title change,
                             1998 Section 16:            Contact person
                             Wheelchairs--Determinatio   and Type of
                             n of Flammability           standard
------------------------------------------------------------------------
16-46         ............  ANSI/RESNA WC/Volume 1 -    Contact person
                             1998 Section 20:            and Type of
                             Wheelchairs--Determinatio   standard
                             n of the Performance of
                             Stand-Up Wheelchairs
------------------------------------------------------------------------
16-47         ............  ANSI/RESNA WC/Volume 1 -    Contact person
                             1998 Section 22:            and Type of
                             Wheelchairs--Set Up         standard
                             Procedures
------------------------------------------------------------------------
16-48         ............  ANSI/RESNA WC/Volume 1 -    Contact person
                             1998 Section 93: Maximum    and Type of
                             Overall Dimensions          standard
------------------------------------------------------------------------
16-49         ............  ANSI/RESNA WC/Volume 1 -    Contact person
                             1998 Section 0:             and Type of
                             Nomenclature, Terms, and    standard
                             Definitions
------------------------------------------------------------------------
16-50         ............  ISO 7176-3:2003             Contact person
                             Wheelchairs--Part 3:        and Type of
                             Determination of            standard
                             Effectiveness of Brakes
------------------------------------------------------------------------
16-158        ............  ISO 7176-1:1999             Contact person
                             Wheelchairs--Part 1:        and Type of
                             Determination of Static     standard
                             Stability
------------------------------------------------------------------------
16-159        ............  ISO 7176-2:2001             Contact person
                             Wheelchairs--Part 2:        and Type of
                             Determination of Dynamic    standard
                             Stability of Electric
                             Wheelchairs
------------------------------------------------------------------------
M. Radiology
------------------------------------------------------------------------
12-17         ............  NEMA MS 8-1993 (2000),      Relevant
                             Characterization of the     guidance and
                             Specific Absorption Rate    Contact person
                             for Magnetic Resonance
                             Imaging Systems
------------------------------------------------------------------------
12-61         12-177        UL 122 (2007): Standard     Withdrawn and
                             for Photographic            replaced with
                             Equipment--Ed. 5.0          newer version
------------------------------------------------------------------------
12-64         12-178        IEC 60601-2-45 Ed. 2.0,     Withdrawn and
                             (2006) Medical Electrical   replaced with
                             Equipment--Part 2-45:       newer version
                             Particular Requirements
                             for the Safety of
                             Mammographic X-ray
                             Equipment and
                             Mammographic Stereotactic
                             Devices
------------------------------------------------------------------------

[[Page 52377]]

 
12-69         ............  NEMA MS 6-1991 (R2000)      Relevant
                             Characterization of         guidance,
                             Special Purpose Coils for   Contact person
                             Diagnostic Magnetic         and CFR
                             Resonance Images            Citations
------------------------------------------------------------------------
12-95         ............  NEMA MS 2-2003              Relevant
                             Determination of Two-       guidance and
                             Dimensional Geometric       Contact person
                             Distortion in Diagnostic
                             Magnetic Resonance Images
------------------------------------------------------------------------
12-96         ............  NEMA MS 3-2003              Relevant
                             Determination of Image      guidance and
                             Uniformity in Diagnostic    Contact person
                             Magnetic Resonance Images
------------------------------------------------------------------------
12-97         ............  NEMA MS-1-2001              Relevant
                             Determination of Signal-    guidance,
                             to-Noise Ratio (SNR) in     Contact person
                             Diagnostic Magnetic         and CFR
                             Resonance Imaging           Citations
------------------------------------------------------------------------
12-103        12-179        ANSI / IESNA RP-27.3-2007   Withdrawn and
                             Recommended Practice for    replaced with
                             Photobiological Safety      newer version
                             for Lamps--Risk Group
                             Classification and
                             Labeling
------------------------------------------------------------------------
12-120        ............  IEC 60601-2-44 (2002-11):   Relevant
                             Medical Electrical          guidance and
                             Equipment--Part 2-44:       CFR Citations
                             Particular Requirements
                             for the Safety of X-ray
                             Equipment for Computed
                             Tomography--Ed. 2.1
------------------------------------------------------------------------
12-123        12-180        IEC 61689:2007              Withdrawn and
                             Ultrasonics--Physiotherap   replaced with
                             y Systems--Field            newer version
                             Specifications and
                             Methods of Measurement in
                             the Frequency Range 0,5
                             MHz to 5 MHz Ed. 2.0
------------------------------------------------------------------------
12-125        ............  NEMA MS 5-2003              Relevant
                             Determination of Slice      guidance and
                             Thickness in Diagnostic     Contact person
                             Magnetic Resonance
                             Imaging
------------------------------------------------------------------------
12-129        12-181        NU 1-2007 Performance       Withdrawn and
                             Measurements of Gamma       replaced with
                             Cameras                     newer version
------------------------------------------------------------------------
12-131        12-184        IEC 61217 2002              Withdrawn and
                             Consolidated Ed. 1.1,       replaced with
                             2007 Amendment 2 Ed. 1.0    newer version
                             Radiotherapy Equipment--
                             Coordinates, Movements,
                             and Scales
------------------------------------------------------------------------
12-150        ............  IEC / ISO 10918-1:1994      Relevant
                             Technical Corrigendum       guidance,
                             1:2005 Information          Contact person,
                             Technology--Digital         CFR Citations,
                             Compression and Coding of   Product code,
                             Continuous-Tone Still       and Devices
                             Images--Part 1:             affected
                             Requirements
------------------------------------------------------------------------
12-151        ............  NEMA MS 4 (2006) Acoustic   Relevant
                             Noise Measurement           guidance,
                             Procedure for Diagnosing    Contact person
                             Magnetic Resonance          and CFR
                             Imaging Devices             Citations
------------------------------------------------------------------------
12-158        ............  NEMA MS 10-2006             Relevant
                             Determination of Local      guidance,
                             Specific Absorption Rate    Contact person
                             (SAR) in Diagnostic         and CFR
                             Magnetic Resonance          Citations
                             Imaging
------------------------------------------------------------------------
12-159        ............  NEMA MS 11-2006             Relevant
                             Determination of Gradient-  guidance,
                             Induced Electric Fields     Contact person
                             in Diagnostic Magnetic      and CFR
                             Resonance Imaging           Citations
------------------------------------------------------------------------
12-160        ............  NEMA MS 12-2006             Relevant
                             Quantification and          guidance,
                             Mapping of Geometric        Contact person
                             Distortion for Special      and CFR
                             Applications                Citations
------------------------------------------------------------------------
12-161        ............  IEC 60601-2-33 (2006),      Relevant
                             Medical Electrical          guidance and
                             Equipment--Part 2-33:       Contact person
                             Particular Requirements
                             for the Safety of
                             Magnetic Resonance
                             Equipment for Medical
                             Diagnosis
------------------------------------------------------------------------
12-164        12-182        IEC 60601-2-37:2007         Withdrawn and
                             Medical Electrical          replaced with
                             Equipment--Part 2-37:       newer version
                             Particular Requirements
                             for the Basic Safety and
                             Essential Performance of
                             Ultrasonic Medical
                             Diagnostic and Monitoring
                             Equipment
------------------------------------------------------------------------
12-165        ............  NEMA XR 22-2006 ``Quality   Relevant
                             Control Manual'' Template   guidance
                             for Manufacturers of
                             Displays and Workstations
                             Labeled for Final
                             Interpretation in Full-
                             Field Digital Mammography
------------------------------------------------------------------------
12-166        ............  NEMA XR 23-2006 ``Quality   Relevant
                             Control Manual'' Template   guidance
                             for Manufacturers of
                             Hardcopy Output Devices
                             Labeled for Final
                             Interpretation in Full-
                             Field Digital Mammography
------------------------------------------------------------------------
12-168        ............  IEC 60825-1 Ed. 2.0 (2007)  Contact person
                             Safety of Laser Products--  and Processes
                             Part 1: Equipment           impacted
                             Classification, and
                             Requirements
------------------------------------------------------------------------

[[Page 52378]]

 
12-169        ............  IEC 60601-2-22 Ed. 3.0      Contact person,
                             (2007) Medical Electrical   Processes
                             Equipment--Part 2-22:       impacted and
                             Particular Requirements     Title
                             for Basic Safety and
                             Essential Performance of
                             Surgical, Cosmetic,
                             Therapeutic and
                             Diagnostic Laser
                             Equipment
------------------------------------------------------------------------
12-170        12-183        NEMA PS 3.1 - 3.18 (2008)   Withdrawn and
                             Digital Imaging and         replaced with
                             Communications in           newer versions
                             Medicine (DICOM) Set
------------------------------------------------------------------------
5-7           12-185        IEC 60601-1-3 2008 Edition  Transferred
                             2.0 Medical Electrical
                             Equipment--Part 1-
                             3:General Requirements
                             for Basic Safety and
                             Essential Performance--
                             Collateral Standard:
                             Radiation Protection in
                             Diagnostic X-ray
                             Equipment
------------------------------------------------------------------------
N. Software/Informatics
------------------------------------------------------------------------
13-4          ............  ANSI/UL 1998, Software in   CFR Citations,
                             Programmable Components     Product codes,
                                                         Relevant
                                                         guidance and
                                                         Extent of
                                                         recognition
------------------------------------------------------------------------
13-5          ............  IEEE 1074:1997, Standard    Withdrawn
                             for Developing Software
                             Life Cycle Processes
------------------------------------------------------------------------
13-8          ............  IEC 62304 Ed. 1.0, Medical  CFR Citations,
                             Device Software--Software   Product codes,
                             Life Cycle Processes        Relevant
                                                         guidance, and
                                                         Extent of
                                                         recognition
------------------------------------------------------------------------
7-59          13-9          CLSI AUTO2-A2 Laboratory    Transferred
                             Automation: Bar Codes for
                             Specimen Container
                             Identification; Approved
                             Standard
------------------------------------------------------------------------
7-60          13-10         CLSI AUTO1-A Laboratory     Transferred
                             Automation: Specimen
                             Container/Specimen
                             Carrier; Approved
                             Standard
------------------------------------------------------------------------
7-61          13-11         CLSI AUTO3-A Laboratory     Transferred
                             Automation:
                             Communications with
                             Automated Clinical
                             Laboratory Systems,
                             Instruments, Devices, and
                             Information Systems;
                             Approved Standard
------------------------------------------------------------------------
7-62          13-12         CLSI AUTO4-A Laboratory     Transferred
                             Automation: Systems
                             Operational Requirements,
                             Characteristics, and
                             Information Elements;
                             Approved Standard
------------------------------------------------------------------------
7-63          13-13         CLSI AUTO5-A Laboratory     Transferred
                             Automation:
                             Electromechanical
                             Interfaces; Approved
                             Standard
------------------------------------------------------------------------
7-64          13-14         CLSI POCT1-A2 Point-of-     Transferred
                             Care Connectivity;
                             Approved Standard
------------------------------------------------------------------------
7-68          13-15         CLSI GP19-A2 Laboratory     Transferred
                             Instruments and Data
                             Management Systems:
                             Design of Software User
                             Interfaces and End-User
                             Software Systems
                             Validation, Operation,
                             and Monitoring; Approved
                             Guideline--Second Edition
------------------------------------------------------------------------
7-114         13-16         CLSI LIS01-A Standard       Transferred
                             Specification for Low-
                             Level Protocol to
                             Transfer Messages Between
                             Clinical Laboratory
                             Instruments and Computer
                             Systems
------------------------------------------------------------------------
7-115         13-17         CLSI LIS02-A2 Standard      Transferred
                             Specification for
                             Transferring Information
                             Between Clinical
                             Instruments and Computer
                             Systems; Approved
                             Standard-Second Edition
------------------------------------------------------------------------
7-116         13-18         CLSI LIS03-A Standard       Transferred
                             Guide for Selection of a
                             Clinical Laboratory
                             Information Management
                             System
------------------------------------------------------------------------
7-117         13-19         CLSI LIS04-A Standard       Transferred
                             Guide for Documentation
                             of Clinical Laboratory
                             Computer Systems
------------------------------------------------------------------------
7-118         13-20         CLSI LIS05-A Standard       Transferred
                             Specification for
                             Transferring Clinical
                             Observations Between
                             Independent Computer
                             Systems
------------------------------------------------------------------------
7-119         13-21         CLSI LIS06-A Standard       Transferred
                             Practice for Reporting
                             Reliability of Clinical
                             Laboratory Information
                             Systems
------------------------------------------------------------------------

[[Page 52379]]

 
7-120         13-22         CLSI LIS07-A Standard       Transferred
                             Specification for Use of
                             Bar Codes on Specimen
                             Tubes in the Clinical
                             Laboratory
------------------------------------------------------------------------
7-121         13-23         CLSI LIS08-A Standard       Transferred
                             Guide for Functional
                             Requirements of Clinical
                             Laboratory Information
                             Management Systems
------------------------------------------------------------------------
7-122         13-24         CLSI LIS09-A Standard       Transferred
                             Guide for Coordination of
                             Clinical Laboratory
                             Services within the
                             Electronic Health Record
                             Environment and Networked
                             Architectures
------------------------------------------------------------------------
O. Sterility
------------------------------------------------------------------------
14-24         ............  AAMI/ANSI/ISO 11134:1993    Withdrawn
                             Sterilization of Health
                             Care Products--
                             Requirements for
                             Validation and Routine
                             Control-Industrial Moist
                             Heat Sterilization
------------------------------------------------------------------------
14-53         ............  AAMI/ANSI ST66:1996         Withdrawn
                             Sterilization of Health
                             Care Products--Chemical
                             Indicators--Part 2:
                             Indicators for Air
                             Removal Test Sheets and
                             Packs
------------------------------------------------------------------------
14-54         ............  AAMI/ANSI/ISO 11737-2:1998  CFR Citations,
                             Sterilization of Medical    Product codes
                             Devices--Microbiological    and Devices
                             Methods--Part 2: Tests of   affected
                             Sterility Performed in
                             the Validation of a
                             Sterilization Process
------------------------------------------------------------------------
14-55         ............  AAMI/ANSI/ISO 14160:1998    Relevant
                             Sterilization of Single-    guidance
                             Use Medical Devices
                             Incorporating Materials
                             of Animal Origin--
                             Validation and Routine
                             Control of Sterilization
                             by Liquid Chemical
                             Sterilants
------------------------------------------------------------------------
14-60         ............  ASTM F1327:1998 Standard    Withdrawn
                             Terminology Relating to
                             Barrier Materials for
                             Medical Packaging
------------------------------------------------------------------------
14-63         ............  ASTM F1886: 1998 (2004)     CFR Citations
                             Standard Test Method for    and Product
                             Determining Integrity of    codes
                             Seals for Medical
                             Packaging by Visual
                             Inspection
------------------------------------------------------------------------
14-64         ............  ASTM F1929:1998 (2004)      CFR Citations
                             Standard Test Method for    and Product
                             Detecting Seal Leaks in     codes
                             Porous Medical Packaging
                             by Dye Penetration
------------------------------------------------------------------------
14-70         ............  AAMI/ANSI/ISO 14161:2000    CFR Citations,
                             Sterilization of Health     Product codes
                             Care Products--Biological   and Devices
                             Indicators--Guidance for    affected
                             the Selection, Use and
                             Interpretation of
                             Results, 2ed.
------------------------------------------------------------------------
14-76         ............  AAMI/ANSI/ISO 10993-7:1995  CFR Citations,
                             (R) 2001 Biological         Product codes
                             Evaluation of Medical       and Contact
                             Devices--Part 7: Ethylene   person
                             Oxide Sterilization
                             Residuals
------------------------------------------------------------------------
14-88         ............  AAMI/ANSI/ISO 14937:2000    CFR Citations
                             Sterilization of Health     and Product
                             Care Products--General      codes
                             Requirements for
                             Characterization of a
                             Sterilizing Agent and the
                             Development, Validation,
                             and Routine Control of a
                             Sterilization Process for
                             Medical Devices
------------------------------------------------------------------------
14-90         14-256        ASTM F2095-07 Standard      Withdrawn and
                             Test Methods for Pressure   replaced with
                             Decay Leak Test for         newer version
                             Nonporous Flexible
                             Packages With and Without
                             Restraining Plates
------------------------------------------------------------------------
14-116        ............  AAMI ST72:2002 Bacterial    CFR Citations,
                             endotoxins--Test            Product codes,
                             Methodologies, Routine      Type of
                             Monitoring, and             standard,
                             Alternatives to Batch       Guidance and
                             Testing                     Extent of
                                                         recognition
------------------------------------------------------------------------
14-120        ............  ASTM D3078:2002 Standard    CFR Citations,
                             Test Method for             Product codes
                             Determination of Leaks in   and Type of
                             Flexible Packaging by       standard
                             Bubble Emission
------------------------------------------------------------------------
14-123        ............  ASTM F2096-04 Standard      CFR Citations,
                             Test Method for Detecting   Product codes,
                             Gross Leaks in Medical      CDRH Office and
                             Packaging by Internal       Division
                             Pressurization (Bubble      associated with
                             Test)                       recognized
                                                         standard
------------------------------------------------------------------------

[[Page 52380]]

 
14-135        ............  AAMI/ANSI ST63:2002         CFR Citations,
                             Sterilization of Health     Product codes
                             Care Products--             and Type of
                             Requirements for the        standard
                             Development, Validation
                             and Routine Control of an
                             Industrial Sterilization
                             Process for Medical
                             Devices--Dry Heat
------------------------------------------------------------------------
14-136        ............  AAMI/ANSI ST67:2003         CFR Citations,
                             Sterilization of Health     Product codes
                             Care Products--             and Guidance
                             Requirements for Products
                             Labeled 'Sterile' 1st
                             Edition
------------------------------------------------------------------------
14-138        ............  ISO 13408-2:2003 Aseptic    CFR Citations,
                             Processing of Health Care   Product codes,
                             Products--Part 2:           Type of
                             Filtration                  standard and
                                                         Guidance
------------------------------------------------------------------------
14-139        ............  ISO 14644-1:1999            CFR Citations,
                             Cleanrooms and Associated   Product codes
                             Controlled Environments--   and Type of
                             Part 1: Classification of   standard
                             Air Cleanliness
------------------------------------------------------------------------
14-140        ............  ISO 14644-2:2000            CFR Citations,
                             Cleanrooms and Associated   Product codes
                             Controlled Environments--   and Type of
                             Part 2: Specification for   standard
                             Testing and Monitoring to
                             Prove Continued
                             Compliance With ISO 14644-
                             1
------------------------------------------------------------------------
14-141        ............  ISO 14644-4:2001            CFR Citations,
                             Cleanrooms and Associated   Product codes
                             Controlled Environments--   and Type of
                             Part 4: Design,             standard
                             Construction and Startup
------------------------------------------------------------------------
14-142        ............  ISO 14698-1:2003            CFR Citations,
                             Cleanrooms and Associated   Product codes
                             Controlled Environments--   and Type of
                             Biocontamination Control--  standard
                             Part 1: General
                             Principles and Methods
------------------------------------------------------------------------
14-143        ............  ISO 14698-2:2003            CFR Citations,
                             Cleanrooms and Associated   Product codes
                             Controlled Environments--   and Type of
                             Biocontamination Control--  standard
                             Part 2: Evaluation and
                             Interpretation of
                             Biocontamination Data
------------------------------------------------------------------------
14-148        ............  ASTM F2250-03 Standard      CFR Citations,
                             Practice for Evaluation     Product codes
                             of Chemical Resistance of   and Type of
                             Printed Inks and Coatings   standard
                             on Flexible Packaging
                             Materials
------------------------------------------------------------------------
14-149        ............  ASTM F2251-03e1 Standard    CFR Citations,
                             Test Method for Thickness   Product codes
                             Measurement of Flexible     and Type of
                             Packaging Material          standard
------------------------------------------------------------------------
14-150        ............  ASTM F2252-03 Standard      CFR Citations,
                             Practice for Evaluating     Product codes
                             Ink or Coating Adhesion     and Type of
                             to Flexible Packaging       standard
                             Materials Using Tape
------------------------------------------------------------------------
14-164        ............  AAMI/ANSI ST81:2004         CFR Citations,
                             Sterilization of Medical    Product codes,
                             Devices--Information to     and Devices
                             be Provided by the          affected
                             Manufacturer for the
                             Processing of
                             Resterilizable Devices
------------------------------------------------------------------------
14-165        ............  ISO 14644-5:2004            CFR Citations,
                             Cleanrooms and Associated   Product codes
                             Controlled Environments--   and Type of
                             Part 5: Operations          standard
------------------------------------------------------------------------
14-166        ............  ISO 14644-7:2004            CFR Citations,
                             Cleanrooms and Associated   Product codes
                             Controlled Environments--   and Type of
                             Part 7: Separative          standard
                             Devices (Clean Air Hoods,
                             Gloveboxes, Isolators and
                             Mini-Environments)
------------------------------------------------------------------------
14-168        14-245        ASTM F2338-07 Standard      Withdrawn and
                             Test Method for             replaced with
                             Nondestructive Detection    newer version
                             of Leaks in Packages by
                             Vacuum Decay Method
------------------------------------------------------------------------
14-169        ............  ASTM F2391-05 Standard      CFR Citations,
                             Test Method for Measuring   Product codes
                             Package and Seal            and Type of
                             Integrity Using Helium as   standard
                             Tracer Gas
------------------------------------------------------------------------
14-170        ............  ASTM F2475-05 Standard      CFR Citations,
                             Guide for                   Product codes
                             Biocompatibility            and Type of
                             Evaluation of Medical       standard
                             Device Packaging
                             Materials
------------------------------------------------------------------------
14-191        ............  ISO 13408-4:2005 Aseptic    CFR Citations,
                             Processing of Health care   Product codes,
                             Products--Part 4: Clean-    Type of
                             in-Place Technologies       standard and
                                                         Relevant
                                                         guidance
------------------------------------------------------------------------
14-193        ............  AAMI/ANSI/ISO 11607-1:2006  CFR Citations,
                             Packaging for terminally    Product codes,
                             Sterilized Medical          Devices
                             Devices--Part 1:            affected and
                             Requirements for            Relevant
                             Materials, Sterile          guidance
                             Barrier Systems and
                             Packaging Systems, 3d ed.
------------------------------------------------------------------------

[[Page 52381]]

 
14-194        ............  AAMI/ANSI/ISO 11607-2:2006  CFR Citations,
                             Packaging for Terminally    Product codes,
                             Sterilized Medical          Devices
                             Devices--Part 2:            affected and
                             Validation Requirements     Relevant
                             for Forming, Sealing and    guidance
                             Assembly Processes, 1st
                             ed.
------------------------------------------------------------------------
14-197        ............  ASTM F1608:00(2004)         CFR Citations
                             Standard Test Method for    and Product
                             Microbial Ranking of        codes
                             Porous Packaging
                             Materials (Exposure
                             Chamber Method)
------------------------------------------------------------------------
14-199        ............  ASTM D4169-05 Standard      Related CFR
                             Practice for Performance    Citations and
                             Testing of Shipping         Product codes
                             Containers and Systems
------------------------------------------------------------------------
14-202        14-246        USP 31:2008 Biological      Withdrawn and
                             Indicator for Dry-Heat      replaced with
                             Sterilization, Paper        newer version
                             Carrier
------------------------------------------------------------------------
14-203        14-247        USP 31:2008 Biological      Withdrawn and
                             Indicator for Ethylene      replaced with
                             Oxide Sterilization,        newer version
                             Paper Carrier.
------------------------------------------------------------------------
14-204        14-248        USP 31:2008 Biological      Withdrawn and
                             Indicator for Steam         replaced with
                             Sterilization, Paper        newer version
                             Carrier
------------------------------------------------------------------------
14-205        14-249        USP 31:2008 <61> Microbial  Withdrawn and
                             Limits Test                 replaced with
                                                         newer version
------------------------------------------------------------------------
14-206        14-250        USP 31:2008 <71>            Withdrawn and
                             Microbiological Tests,      replaced with
                             Sterility Tests             newer version
------------------------------------------------------------------------
14-207        14-251        USP 31:2008 <85>            Withdrawn and
                             Biological Tests and        replaced with
                             Assays, Bacterial           newer version
                             Endotoxin Test (LAL)
------------------------------------------------------------------------
14-208        14-252        USP 31:2008 <151> Pyrogen   Withdrawn and
                             Test (USP Rabbit Test)      replaced with
                                                         newer version
------------------------------------------------------------------------
14-209        14-253        USP 31:2008 <161>           Withdrawn and
                             Transfusion and Infusion    replaced with
                             Assemblies and Similar      newer version
                             Medical Devices
------------------------------------------------------------------------
14-210        14-254        USP 31:2008 Biological      Withdrawn and
                             Indicator for Steam         replaced with
                             Sterilization--Self         newer version
                             Contained
------------------------------------------------------------------------
14-220        ............  AAMI/ANSI ST79:2006         Type of Standard
                             Comprehensive Guide to
                             Steam Sterilization and
                             Sterility Assurance in
                             Health Care Facilities
------------------------------------------------------------------------
14-221        ............  AAMI/ANSI/ISO TIR           CFR Citations,
                             11139:2006 Sterilization    Product codes,
                             of Health Care Products--   Title, Devices
                             Vocabulary                  affected, and
                                                         Type of
                                                         standard
------------------------------------------------------------------------
14-222        ............  AAMI/ANSI/ISO 18472:2006    Type of standard
                             Sterilization of Health
                             Care Products--Biological
                             and Chemical Indicators--
                             Test Equipment
------------------------------------------------------------------------
14-223        ............  ANSI/AAMI/ISO 11138-1:2006  Type of
                             Sterilization of Health     standard,
                             Care Products--Biological   Guidance and
                             Indicators--Part 1:         Extent of
                             General Requirements        recognition
------------------------------------------------------------------------
14-224        ............  AAMI/ANSI/ISO 11137-1:2006  CFR Citations,
                             Sterilization of Health     Product codes,
                             Care Products--Radiation--  and Type of
                             Part 1: Requirements for    standard
                             Development, Validation,
                             and Routine Control of a
                             Sterilization Process for
                             Medical Devices
------------------------------------------------------------------------
14-225        ............  AAMI/ANSI/ISO 11137-2:2006  CFR Citations,
                             Sterilization of Health     Product codes
                             Care Products--Radiation--  and Type of
                             Part 2: Establishing the    standard
                             Sterilization Dose
------------------------------------------------------------------------
14-226        ............  AAMI/ANSI/ISO 11137-3:2006  CFR Citations,
                             Sterilization of Health     Product codes
                             Care Products--Radiation--  and Type of
                             Part 3: Guidance on         standard
                             Dosimetric Aspects
------------------------------------------------------------------------

[[Page 52382]]

 
14-227        ............  AAMI/ANSI/ISO 11737-1:2006  CFR Citations,
                             Sterilization of Medical    Product codes,
                             Devices-Microbiological     Devices
                             Methods-Part 1:             affected, CDRH
                             Determination of the        Office and
                             Population of               Division
                             Microorganisms on           associated with
                             Products, 2d, ed.           recognized
                                                         standard
------------------------------------------------------------------------
14-228        ............  ANSI/AAMI/ISO 11135-1:2007  CFR Citations,
                             Sterilization of Health     Product codes,
                             Care Products--Ethylene     Devices
                             Oxide--Part 1:              affected, and
                             Requirements for the        Type of
                             Development, Validation,    standard
                             and Routine Control of a
                             Sterilization Process for
                             Medical Devices
------------------------------------------------------------------------
14-229        ............  ASTM F1980-07 Standard      CFR Citations
                             Guide for Accelerated       and Product
                             Aging of Sterile Barrier    codes
                             Systems for Medical
                             Devices
------------------------------------------------------------------------
14-230        ............  ASTM F2203-02(2007)         CFR Citations,
                             Standard Test Method for    Product codes
                             Linear Measurement Using    and Type of
                             Precision Steel Rule        standard
------------------------------------------------------------------------
14-231        ............  ASTM F2217-02(2007)         CFR Citations,
                             Standard Practice for       Product codes
                             Coating/Adhesive Weight     and Type of
                             Determination               standard
------------------------------------------------------------------------
14-232        ............  ASTM F2227-02(2007)         CFR Citations,
                             Standard Test Method for    Product codes
                             Non-Destructive Detection   and Type of
                             of Leaks in Non-Sealed      standard
                             and Empty Medical
                             Packaging Trays by CO2
                             Tracer Gas Method
------------------------------------------------------------------------
14-233        ............  ASTM F2228-02(2007)         CFR Citations,
                             Standard Test Method for    Product codes
                             Non-Destructive Detection   and Type of
                             of Leaks in Medical         standard
                             Packaging Which
                             Incorporates Porous
                             Barrier Material by CO2
                             Tracer Gas Method
------------------------------------------------------------------------
14-234        ............  ASTM F2097-07 Standard      CFR Citations,
                             Guide for Design and        Product codes
                             Evaluation of Primary       and Type of
                             Flexible Packaging for      standard
                             Medical Products
------------------------------------------------------------------------
14-235        ............  ASTM F1140-07 Standard      CFR Citations,
                             Test Methods for Internal   Product codes
                             Pressurization Failure      and Type of
                             Resistance of               standard
                             Unrestrained Packages
------------------------------------------------------------------------
14-236        ............  ASTM F2054-07 Standard      CFR Citations,
                             Test Method for Burst       Product codes
                             Testing of Flexible         and Type of
                             Package Seals Using         standard
                             Internal Air
                             Pressurization Within
                             Restraining Plates
------------------------------------------------------------------------
14-237        ............  ASTM F88-07 Standard Test   CFR Citations,
                             Method for Seal Strength    Product codes
                             of Flexible Barrier         and Type of
                             Materials                   standard
------------------------------------------------------------------------
14-239        ............  ISO 13408-3:2006 Aseptic    CFR Citations
                             Processing of Health Care   and Product
                             Products--Part 3:           codes
                             Lyophilization
------------------------------------------------------------------------
14-240        ............  ISO 13408-5:2006 Aseptic    CFR Citations
                             Processing of Health Care   and Product
                             Products--Part 5:           codes
                             Sterilization-in-Place
------------------------------------------------------------------------
14-241        ............  ISO 13408-6:2005 Aseptic    CFR Citations
                             Processing of Health Care   and Product
                             Products--Part 6:           codes
                             Isolator Systems
------------------------------------------------------------------------
14-242        ............  ISO 14644-3:2005            CFR Citations
                             Cleanrooms and Associated   and Product
                             Controlled Environments--   codes
                             Part 3: Test Methods
------------------------------------------------------------------------
14-243        ............  ISO 14644-6:2007            CFR Citations
                             Cleanrooms and Associated   and Product
                             Controlled Environments--   codes
                             Part 6: Vocabulary
------------------------------------------------------------------------
14-244        ............  ISO 14644-8:2006            CFR Citations
                             Cleanrooms and Associated   and Product
                             Controlled Environments--   codes
                             Part 8: Classification of
                             Airborne Molecular
                             Contamination
------------------------------------------------------------------------
P. Tissue Engineering
------------------------------------------------------------------------
15-12         ............  ASTM F2103-01(2007)e1       CFR Citations
                             Standard Guide for          and Product
                             Characterization and        codes, Relevant
                             Testing of Chitosan Salts   guidance, Type
                             as Starting Materials       of standard and
                             Intended for Use in         CDRH Office and
                             Biomedical and Tissue-      Division
                             Engineered Medical          associated with
                             Product Applications        recognized
                                                         standard
------------------------------------------------------------------------

[[Page 52383]]

 
15-5          ............  ASTM F2347-03, Standard     CFR Citations
                             Guide for                   and Product
                             Characterization and        codes, Relevant
                             Testing of Hyaluronan as    guidance, Type
                             Starting Materials          of standard and
                             Intended for Use in         CDRH Office and
                             Biomedical and Tissue       Division
                             Engineered Medical          associated with
                             Product Applications        recognized
                                                         standard
------------------------------------------------------------------------
15-6          ............  ASTM F2450-04, Standard     CFR Citations
                             Guide for Assessing         and Product
                             Microstructure of           codes, Relevant
                             Polymeric Scaffolds for     guidance, Type
                             Use in Tissue Engineered    of standard and
                             Medical Products            CDRH Office and
                                                         Division
                                                         associated with
                                                         recognized
                                                         standard
------------------------------------------------------------------------
15-7          ............  ASTM F2315-03, Standard     CFR Citations
                             Guide for Immobilization    and Product
                             or Encapsulation of         codes, Relevant
                             Living Cells or Tissue in   guidance, Type
                             Alginate Gels               of standard and
                                                         CDRH Office and
                                                         Division
                                                         associated with
                                                         recognized
                                                         standard
------------------------------------------------------------------------
15-8          ............  ASTM F2064-00(2006),        CFR Citations
                             Standard Guide for          and Product
                             Characterization and        codes, Relevant
                             Testing of Alginates as     guidance, Type
                             Starting Materials          of standard and
                             Intended for use in         CDRH Office and
                             Biomedical and Tissue-      Division
                             Engineered Medical          associated with
                             Products Application        recognized
                                                         standard
------------------------------------------------------------------------
15-9          ............  ASTM F2311-06, Standard     CFR Citations
                             Guide for Classification    and Product
                             of Therapeutic Skin         codes, Relevant
                             Substitutes                 guidance, Type
                                                         of standard and
                                                         CDRH Office and
                                                         Division
                                                         associated with
                                                         recognized
                                                         standard
------------------------------------------------------------------------
15-10         ............  ASTM F2451-05, Standard     CFR Citations
                             Guide for in vivo           and Product
                             Assessment of Implantable   codes, Relevant
                             Devices Intended to         guidance, Type
                             Repair or Regenerate        of standard and
                             Articular Cartilage         CDRH Office and
                                                         Division
                                                         associated with
                                                         recognized
                                                         standard
------------------------------------------------------------------------
15-11         ............  ASTM F2212-02(2007)e1,      CFR Citations
                             Standard Guide for          and Product
                             Characterization of Type    codes, Relevant
                             I Collagen as a Starting    guidance, Type
                             Material for Surgical       of standard and
                             Implants and Substrates     CDRH Office and
                             for Tissue Engineered       Division
                             Medical Products            associated with
                                                         recognized
                                                         standard
------------------------------------------------------------------------

III. Listing of New Entries

    In table 3 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: 020.

        Table 3.--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
  Recognition                                          Reference No. and
      No.                 Title of Standard                  Date
------------------------------------------------------------------------
A. Biocompatibility
------------------------------------------------------------------------
2-127           Biological Evaluation of Medical      ANSI/AAMI BE
                 Devices--Part 10: Tests for           78:2002/A1:2006
                 Irritation and Delayed-Type
                 Hypersensitivity--Amendment 1
------------------------------------------------------------------------
B. Cardiovascular/Neurology
------------------------------------------------------------------------
3-70            Manual, Electronic or Automated       ANSI/AAMI
                 Sphygmomanometers                     SP10:2002/
                                                       A1:2003--Amendmen
                                                       t 1 to ANSI/AAMI
                                                       SP10:2002
------------------------------------------------------------------------
3-71            Manual, Electronic and Automated      ANSI/AAMI
                 Sphygmomanometers                     SP10:2002/
                                                       A2:2006--Amendmen
                                                       t 2 to ANSI/AAMI
                                                       SP10:2002
------------------------------------------------------------------------
C. Dental/ Ear, Nose, and Throat
------------------------------------------------------------------------
4-151           Dentistry--Artificial Teeth for       ISO 22112:2005
                 Dental Prostheses
------------------------------------------------------------------------

[[Page 52384]]

 
4-152           Metal-Ceramic Dental Restorative      ISO 9693:1999/
                 Systems                               Amendment 1:2005
------------------------------------------------------------------------
4-154           Dentistry--Elastometric Impression    ISO 4823:2000
                 Materials-Third Edition
------------------------------------------------------------------------
4-155           Dentistry--Elastomeric Impression     ISO 4823:2000
                 Materials Technical Corrigendum 1-    Technical
                 Third Edition                         Corrigendum
                                                       1:2004
------------------------------------------------------------------------
4-156           Dentistry--Elastomeric Impression     ISO 4823:2000
                 Materials Amendment 1-Third Edition   Amendment 1:2007
------------------------------------------------------------------------
4-157           Dentistry--Zinc Oxide/Eugenol and     ISO 3107: 2004
                 Zinc Oxide/Non-eugenol Cements-
                 Third Edition
------------------------------------------------------------------------
4-158           Dentistry--Soft Lining Materials for  ISO 10139-1:2005
                 Removable Dentures--Part 1:           Technical
                 Materials for Short-Term Use          Corrigendum
                 Technical Corrigendum 1               1:2006
------------------------------------------------------------------------
D. General Hospital/ General Plastic Surgery
------------------------------------------------------------------------
6-214           Standard Test Method for Human        ASTM D6355-07
                 Repeat Insult Patch Testing of
                 Medical Gloves
------------------------------------------------------------------------
E. In Vitro Diagnostic
------------------------------------------------------------------------
7-160           Abbreviated Identification of         CLSI M35-A,
                 Bacteria and Yeast; Approved
                 Guideline
------------------------------------------------------------------------
7-161           Laboratory Detection and              CLSI M48-P
                 Identification of Mycobacteria;
                 Proposed Guideline.
------------------------------------------------------------------------
7-162           Point-of-Care Monitoring of           CLSI H49-A
                 Anticoagulant Therapy; Approved
                 Guideline
------------------------------------------------------------------------
7-163           Body Fluid Analysis for Cellular      CLSI H56-A
                 Composition
------------------------------------------------------------------------
7-164           Microwave Device Use in the           CLSI GP28-A
                 Histology Laboratory; Approved
                 Guideline
------------------------------------------------------------------------
7-165           Reference Leukocyte (WBC)             CLSI H20-A2
                 Differential Count (Proportional)
                 and Evaluation of Instrumental
                 Methods; Approved Standard-Second
                 Edition
------------------------------------------------------------------------
7-166           Fine Needle Aspiration Biopsy (FNAB)  CLSI GP20-A2
                 Techniques; Approved Guideline--
                 Second Edition
------------------------------------------------------------------------
7-167           Nongynecologic Cytologic Specimens:   CLSI GP23-A
                 Collection and Cytopreparatory
                 Techniques; Approved Guideline
------------------------------------------------------------------------
7-168           Reference Method for Broth Dilution   CLSI M38-A
                 Antifungal Susceptibility Testing
                 of Filamentous Fungi; Approved
                 Standard
------------------------------------------------------------------------
F. Materials
------------------------------------------------------------------------
8-161           Standard Test Method for Tension      ASTM F2516-07
                 Testing of Nickel-Titanium
                 Superelastic Materials
------------------------------------------------------------------------
G. OB-GYN/Gastroenterology
------------------------------------------------------------------------
9-46            Medical Electrical Equipment--Part 2- ANSI/AAMI 60601-2-
                 2: Particular Requirements for the    2:2006
                 Safety of High Frequency Surgical
                 Equipment
------------------------------------------------------------------------
9-49            Concentrates for Hemodialysis         AAMI / ANSI
                                                       RD61:2006
------------------------------------------------------------------------
9-50            Dialysate for Hemodialysis            ANSI/AAMI
                                                       RD52:2004
------------------------------------------------------------------------
9-51            Cardiovascular Implants and           ISO 8637:2004
                 Artificial Organs--Haemodialysers,
                 Haemodiafilters, Haemofilters and
                 Haemoconcentrators
------------------------------------------------------------------------
9-52            Cardiovascular Implants and           ISO 8638:2004
                 Artificial Organs--Extracorporeal
                 Blood Circuit for Haemodialysers,
                 Haemodiafilters and Haemofilters
------------------------------------------------------------------------
9-53            Standard Practice for Reprocessing    ASTM F1992-
                 of Reusable, Heat-Stable Endoscopic   99(2007)
                 Accessory Instruments (EAI) Used
                 with Flexible Endoscopes
------------------------------------------------------------------------
9-54            Standard Specification for Rubber     ASTM D6976-08
                 Contraceptives--Vaginal Diaphragms
------------------------------------------------------------------------
H. Ophthalmic
------------------------------------------------------------------------
10-56           Ophthalmics Multifocal Intraocular    ANSI Z80.12-2007
                 Lenses
------------------------------------------------------------------------

[[Page 52385]]

 
10-57           Phakic Intraocular Lenses             ANSI Z80.13-2007
------------------------------------------------------------------------
I. Physical Medicine
------------------------------------------------------------------------
16-161          Safety Standard for Platform Lifts    ASME A18.1-2005
                 and Stairway Chairlifts
------------------------------------------------------------------------
J. Sterility
------------------------------------------------------------------------
14-255          Standard Terminology Relating to      ASTM F17-07a
                 Flexible Barrier Packaging
------------------------------------------------------------------------

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 minor 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 minor revisions to the list of recognized consensus standards, as 
needed, in the Federal Register once a year, or more often, if 
necessary.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for 
recognition under the new provision of section 514 of the 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) Title of the standard, (2) any reference 
number and date, (3) 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

    Persons interested in obtaining a copy of ``Guidance on the 
Recognition and Use of Consensus Standards'' by using the Internet. 
CDRH maintains an entry on the Internet for easy access to information 
including text, graphics, and files that may be downloaded to a 
personal computer with Internet access. Updated on a regular basis, the 
CDRH home page includes device safety alerts, Federal Register 
reprints, information on premarket submissions [including lists of 
approved applications and manufacturers' addresses], small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at http://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available at http://www.regulations.gov.
    This Federal Register document on modifications in FDA's 
recognition of consensus standards is available at http://www.fda.gov/
cdrh/fedregin.html.

VII. Submission of Comments and Effective Date

    Interested persons may submit to the contact person (see FOR 
FURTHER INFORMATION CONTACT) written or electronic comments regarding 
this document. Two copies of any mailed comments are to be submitted, 
except that individuals may submit one paper copy. 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: 020. These modifications 
to the list or recognized standards are effective upon publication of 
this notice in the Federal Register.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: August 27, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-20939 Filed 9-8-08; 8:45 am]
BILLING CODE 4160-01-S