[Federal Register Volume 81, Number 123 (Monday, June 27, 2016)]
[Notices]
[Pages 41546-41553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15100]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0451]
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 043
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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: 043'' (Recognition List Number: 043), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit electronic or written comments concerning this document
at any time. These modifications to the list of recognized standards
are effective June 27, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of
1997: Modifications to the List of Recognized Standards, Recognition
List Number: 043.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday
[[Page 41547]]
through Friday. 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: 043.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
An electronic copy of Recognition List Number: 043 is available on
the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. 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: 043 modifications and other standards related
information. Submit written requests for a single hard copy of the
document entitled ``Modifications to the List of Recognized Standards,
Recognition List Number: 043'' to the Division of Industry and Consumer
Education, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request, or fax your request to 301-847-
8149.
FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-
6287, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The notice described
how FDA would implement its standard recognition program and provided
the initial list of recognized standards.
Modifications to the initial list of recognized standards, as
published in the Federal Register, can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains hypertext
markup language (HTML) and portable document format (PDF) versions of
the list of FDA Recognized Consensus Standards. Both versions are
publicly accessible at the Agency's Internet site. See section VI 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: 043
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency will recognize for
use in premarket submissions and other requirements for devices. FDA
will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA will use
the term ``Recognition List Number: 043'' to identify these current
modifications.
In table 1, FDA describes the following modifications: (1) The
withdrawal of standards and their replacement by others, if applicable;
(2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
In section III, FDA lists modifications the Agency is making that
involve the initial addition of standards not previously recognized by
FDA.
Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Replacement
Old recognition No. recognition Title of standard \1\ Change
No.
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-91........................... 1-116 ISO 5360 Fourth edition 2016-02- Withdrawn and replaced with
15 Anaesthetic vaporizers--Agent newer version.
specific filling systems.
----------------------------------------------------------------------------------------------------------------
B. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-135.......................... .............. ISO/TS 12417-1:2011 Withdrawn.
Cardiovascular implants and
extracorporeal systems--Vascular
device-drug combination products.
[[Page 41548]]
3-136.......................... .............. AAMI/ANSI/ISO TIR 12417:2011 Withdrawn.
Cardiovascular implants and
extracorporeal systems--Vascular
device-drug combination products.
----------------------------------------------------------------------------------------------------------------
C. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-86........................... .............. ANSI/ADA 38-2000 (R2015) Metal- Reaffirmation.
Ceramic Systems.
4-139.......................... .............. ANSI/ADA 48-2004 (R2015) Visible Reaffirmation.
Light Curing Units.
4-146.......................... 4-227 ISO 22674 Second edition. 2016-01- Withdrawn and replaced with
15 Dentistry--Metallic materials newer version.
for fixed and removable
restorations and appliances.
4-166.......................... 4-228 ANSI/ASA S3.20-2015 (Revision of Withdrawn and replaced with
ANSI S3.20-1995) AMERICAN newer version.
NATIONAL STANDARD: Bioacoustical
Terminology.
4-196.......................... .............. ANSI/ADA 69-2010 (R2015) Dental Reaffirmation.
Ceramics.
4-202.......................... .............. ANSI/ADA 58-2010 (R2015) Root Reaffirmation.
Canal Files, Type H (Hedstrom).
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D. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-36........................... .............. ISO TR 16142 Second edition. 2006- Withdrawn. See 5-105.
1-15, Technical information
report: Medical devices--
Guidances on the selection of
standards in support of
recognized essential principles
of safety and performance of
medical devices.
5-40........................... .............. ISO 14971 Second edition. 2007-03- Relevant guidance.
01 Medical devices--Application
of risk management to medical
devices.
5-57........................... .............. AAMI/ANSI HE75:2009/(R)2013 Human Relevant guidance.
factors engineering--Design of
medical devices.
5-67........................... .............. AAMI/ANSI/IEC 62366:2007/(R) 2013 Transition period.
Medical devices--Application of
usability engineering to medical
devices.
5-70........................... .............. AAMI/ANSI/ISO 14971:2007/(R) 2010 Relevant guidance.
(Corrected 4 October 2007)
Medical devices--Application of
risk management to medical
devices.
5-86........................... .............. IEC 60601-1-8 Edition 2.0. 2006- Relevant guidance.
10 Medical electrical equipment--
Part 1-8: General 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.
5-87........................... .............. IEC 62366 Edition 1.1 2014-01 Transition period.
Medical devices--Application of
usability engineering to medical
devices.
5-89........................... .............. IEC 60601-1-6 Edition 3.1 2013-10 Relevant guidance.
Medical electrical equipment--
Part 1-6: General requirements
for basic safety and essential
performance--Collateral
standard: Usability.
5-92........................... .............. AAMI/ANSI/IEC 60601-1-8:2006 & Relevant guidance.
A1:2012 Medical electrical
equipment--Part 1-8: General
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.
5-93........................... .............. AAMI CN3:2014 Small-bore Withdrawn. See 5-106.
connectors for liquids and gases
in healthcare applications--Part
3: Connectors for enteral
applications.
5-95........................... .............. IEC 62366-1 Edition 1.0 2015-02 Transition period, Relevant
Medical devices--Part 1: guidance.
Application of usability
engineering to medical devices.
5-96........................... .............. AAMI/ANSI/IEC 62366-1:2015 Transition period, Relevant
Medical devices--Part 1: guidance.
Application of usability
engineering to medical devices.
5-101.......................... .............. AAMI CN6:2015 Small-bore Withdrawn. See 5-108.
connectors for liquids and gases
in healthcare applications--Part
6: Connectors for neuraxial
applications.
----------------------------------------------------------------------------------------------------------------
E. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-1........................... .............. IEC 60601-1-2 Edition 3. 2007-03, Transition period.
Medical electrical equipment--
Part 1-2: General requirements
for basic safety and essential
performance--Collateral
standard: Electromagnetic
compatibility--Requirements and
tests.
19-2........................... .............. AAMI/ANSI/IEC 60601-1-2:2007/ Transition period.
(R)2012 Medical electrical
equipment--Part 1-2: General
requirements for basic safety
and essential performance--
Collateral standard:
Electromagnetic compatibility--
Requirements and tests.
19-6........................... .............. IEC 60601-1-11 Edition 1.0. 2010- Relevant guidance.
04 Medical electrical equipment--
Part 1-11: General requirements
for basic safety and essential
performance--Collateral
standard: Requirements for
medical electrical equipment and
medical electrical systems used
in the home healthcare
environment [including:
Technical Corrigendum 1 (2011)].
[[Page 41549]]
19-7........................... .............. AAMI/ANSI HA 60601-1-11:2011 Relevant guidance.
Medical electrical equipment--
Part 1-11: General requirements
for basic safety and essential
performance--Collateral
standard: Requirements for
medical electrical equipment and
medical electrical equipment and
medical electrical systems used
in the home healthcare
environment (IEC 60601-1-11:2010
Mod).
19-8........................... .............. IEC 60601-1-2 Edition 4.0. 2014- Transition period.
02, Medical electrical
equipment--Part 1-2: General
requirements for basic safety
and essential performance--
Collateral standard:
Electromagnetic disturbances--
Requirements and tests.
19-12.......................... .............. AAMI/ANSI/IEC 60601-1-2:2014, Transition period.
Medical electrical equipment--
Part 1-2: General requirements
for basic safety and essential
performance--Collateral
standard: Electromagnetic
disturbances--Requirements and
tests.
19-14.......................... .............. IEC 60601-1-11 Edition 2.0. 2015- Relevant guidance.
01 Medical electrical equipment--
Part 1-11: General requirements
for basic safety and essential
performance--Collateral
standard: Requirements for
medical electrical equipment and
medical electrical systems used
in the home healthcare
environment.
19-15.......................... .............. IEC 60601-1-12 Edition 1.0. 2014- Relevant guidance.
06 Medical electrical equipment--
Part 1-12: General requirements
for basic safety and essential
performance--Collateral
standard: Requirements for
medical electrical equipment and
medical electrical systems
intended for use in the
emergency medical services
environment.
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F. General Hospital/General Plastic Surgery (GH/GPS)
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6-15........................... 6-362 ISO/FDIS 7864 Fourth edition 2016- Withdrawn and replaced with
XX-XX Sterile hypodermic needles newer version.
for single use--Requirements and
test methods.
6-132.......................... 6-363 ISO 11810 Second edition 2015-12- Withdrawn and replaced with
15 Lasers and laser-related newer version.
equipment--Test method and
classification for the laser
resistance of surgical drapes
and/or patient protective
covers--Primary ignition,
penetration, flame spread and
secondary ignition.
6-145.......................... .............. ASTM D3578--05 (Reapproved 2015) Reaffirmation.
Standard Specification for
Rubber Examination Gloves.
6-168.......................... .............. ASTM D3577--09 (Reapproved 2015) Reaffirmation.
Standard Specification for
Rubber Surgical Gloves.
6-175.......................... .............. ASTM D5151--06 (Reapproved 2015) Reaffirmation.
Standard Test Method for
Detection of Holes in Medical
Gloves.
6-183.......................... .............. ASTM D5250--06 (Reapproved 2015) Reaffirmation.
Standard Specification for
Poly(vinyl chloride) Gloves for
Medical Application.
6-202.......................... .............. ISO 11810-2 First edition. 2007- Withdrawn. See 6-362.
05-01, Lasers and laser-related
equipment--Test method and
classification for the laser-
resistance of surgical drapes
and/or patient-protective
covers--Part 2: Secondary
ignition.
6-204.......................... 6-364 ISO 8537 Third edition. 2016-03- Withdrawn and replaced with
15 Sterile single-use syringes, newer version.
with or without needle, for
insulin.
6-244.......................... .............. ASTM D6319--10 (Reapproved 2015) Reaffirmation.
Standard Specification for
Nitrile Examination Gloves for
Medical Application.
6-277.......................... 6-365 ISO 11040-4 Third edition. 2015- Withdrawn and replaced with
04-01 Prefilled syringes--Part newer version.
4: Glass barrels for injectables
and sterilized subassembled
syringes ready for filling.
6-302.......................... 6-366 ISO/FDIS 9626 Second edition 2016- Withdrawn and replaced with
XX-XX Stainless steel needle newer version.
tubing for the manufacture of
medical devices--Requirements
and test methods.
6-343.......................... 6-367 USP 39-NF 34:2016, Sodium Withdrawn and replaced with
Chloride Irrigation. newer version.
6-344.......................... 6-368 USP 39-NF 34:2016, Sodium Withdrawn and replaced with
Chloride Injection. newer version.
6-345.......................... 6-369 USP 39-NF 34:2016, Nonabsorbable Withdrawn and replaced with
Surgical Suture. newer version.
6-346.......................... 6-370 USP 39-NF 34:2016, <881> Tensile Withdrawn and replaced with
Strength. newer version.
6-347.......................... 6-371 USP 39-NF 34:2016, <861> Sutures-- Withdrawn and replaced with
Diameter. newer version.
6-348.......................... 6-372 USP 39-NF 34:2016, <871> Sutures-- Withdrawn and replaced with
Needle Attachment. newer version.
6-349.......................... 6-373 USP 39-NF 34:2016, Sterile Water Withdrawn and replaced with
for Irrigation. newer version.
[[Page 41550]]
6-350.......................... 6-374 USP 39-NF 34:2016, Heparin Lock Withdrawn and replaced with
Flush Solution. newer version.
6-351.......................... 6-375 USP 39-NF 34:2016, Absorbable Withdrawn and replaced with
Surgical Suture. newer version.
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G. In Vitro Diagnostics (IVD)
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7-198.......................... 7-261 CLSI M23 Development of In Vitro Withdrawn and replaced with
Susceptibility Testing Criteria newer version.
and Quality Control Parameters,
4th edition.
7-218.......................... 7-262 CLSI M45 Methods for Withdrawn and replaced with
Antimicrobial Dilution and Disk newer version.
Susceptibility Testing of
Infrequently Isolated or
Fastidious Bacteria; Approved
Guideline, 3rd edition.
7-256.......................... 7-263 CLSI M100-S26 Performance Withdrawn and replaced with
Standards for Antimicrobial newer version.
Susceptibility Testing, 26th
edition.
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H. Materials
----------------------------------------------------------------------------------------------------------------
8-217.......................... .............. ASTM F620-11(Reapproved 2015) Reaffirmation.
Standard Specification for
Titanium Alloy Forgings for
Surgical Implants in the Alpha
Plus Beta Condition.
8-220.......................... 8-421 ASTM F629-11 Standard Practice Withdrawn and replaced with
for Radiography of Cast Metallic newer version.
Surgical Implants.
8-381.......................... 8-422 ASTM F2052-15 Standard Test Withdrawn and replaced with
Method for Measurement of newer version.
Magnetically Induced
Displacement Force on Medical
Devices in the Magnetic
Resonance Environment.
----------------------------------------------------------------------------------------------------------------
I. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-168......................... 11-305 ASTM F1781-15 Standard Withdrawn and replaced with
Specification for Elastomeric newer version.
Flexible Hinge Finger Total
Joint Implants.
11-171......................... 11-306 ASTM F1814-15 Standard Guide for Withdrawn and replaced with
Evaluating Modular Hip and Knee newer version.
Joint Components.
11-203......................... .............. ASTM F1541-02 (Reapproved 2015) Reaffirmation.
Standard Specification and Test
Methods for External Skeletal
Fixation Devices.
11-271......................... .............. ASTM F2180-02 (Reapproved 2015) Reaffirmation.
Standard Specification for
Metallic Implantable Strands and
Cables.
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J. Radiology
----------------------------------------------------------------------------------------------------------------
12-153......................... 12-297 ANSI/IESNA RP-27.1-15 Recommended Withdrawn and replaced with
Practice for Photobiological newer version.
Safety for Lamps and Lamp
Systems--General requirements.
12-158......................... 12-298 NEMA MS 10-2010 Determination of Withdrawn and replaced with
Local Specific Absorption Rate newer version.
(SAR) in Diagnostic Magnetic
Resonance Imaging.
12-207......................... .............. IEC 60601-2-33 Ed. 3.0 2010 Transition period extended.
Medical electrical equipment--
Part 2-33: Particular
requirements for the basic
safety and essential performance
of magnetic resonance equipment
for medical diagnosis.
12-209......................... .............. IEC 60601-2-37 Ed. 2.0:2007 Recognition restored with
Medical electrical equipment-- transition period.
Part 2-37: Particular
requirements for the basic
safety and essential performance
of ultrasonic medical diagnostic
and monitoring equipment.
12-216......................... 12-299 IEC 62563-1 Ed.1.1 2016 Medical Withdrawn and replaced with
electrical equipment--Medical newer version with
image display systems--Part 1: transition.
Evaluation methods.
12-236......................... .............. IEC 60601-2-45 Ed. 3.0: 2011 Recognition restored with
Medical electrical equipment-- transition period.
Part 2-45: Particular
requirements for the basic
safety and essential performance
of mammographic X-ray equipment
and mammographic stereotactic
devices.
12-238......................... 12-300 NEMA Digital Imaging and Withdrawn and replaced with
Communications in Medicine newer version.
(DICOM) set PS3.1-3.20 (2016).
12-254......................... 12-301 IEC 60601-2-8 Ed. 2.1 b:2015 Withdrawn and replaced with
Medical electrical equipment-- newer version.
Part 2-8: Particular
requirements for the basic
safety and essential performance
of therapeutic X-ray equipment
operating in the range 10 kV to
1 MV.
12-256......................... .............. IEC 60601-2-44 Ed. 3.1 2012 Transition extended.
Medical electrical equipment--
Part 2-44: Particular
requirements for the basic
safety and essential performance
of X-ray equipment for computed
tomography.
12-257......................... .............. IEC 60601-2-44 Ed. 3.0 2009 Transition extended.
Medical electrical equipment--
Part 2-44: Particular
requirements for the basic
safety and essential performance
of X-ray equipment for computed
tomography.
12-271......................... .............. IEC 60601-2-33 Ed. 3.1:2013 Recognition restored with
Medical electrical equipment-- transition period.
Part 2-33: Particular
requirements for the basic
safety and essential performance
of magnetic resonance equipment
for medical diagnosis.
[[Page 41551]]
12-274......................... .............. IEC 60601-2-54 Ed. 1.0:2009 Recognition restored with
Medical electrical equipment-- transition period.
Part 2-54: Particular
requirements for the basic
safety and essential performance
of X-ray equipment for
radiography and radioscopy
[Including: Technical
Corrigendum 1: 2010 and
Technical Corrigendum 2:2011].
12-293......................... .............. IEC 60601-2-37 Ed. 2.1:2015 Transition period.
Medical electrical equipment--
Part 2-37: Particular
requirements for the basic
safety and essential performance
of ultrasonic medical diagnostic
and monitoring equipment.
12-294......................... .............. IEC 60601-2-45 Ed. 3.1: 2015 Transition period.
Medical electrical equipment--
Part 2-45: Particular
requirements for the basic
safety and essential performance
of mammographic X-ray equipment
and mammographic stereotactic
devices.
12-295......................... .............. IEC 60601-2-33 Ed. 3.2 b:2015 Transition period extended.
Medical electrical equipment--
Part 2-33: Particular
requirements for the basic
safety and essential performance
of magnetic resonance equipment
for medical diagnosis.
12-296......................... .............. IEC 60601-2-54 Ed. 1.1:2015 Transition period.
Medical electrical equipment--
Part 2-54: Particular
requirements for the basic
safety and essential performance
of X-ray equipment for
radiography and radioscopy.
----------------------------------------------------------------------------------------------------------------
K. Sterility
----------------------------------------------------------------------------------------------------------------
14-139......................... 14-479 ISO 14644-1 Second edition 2015- Withdrawn and replaced with
12-15 Cleanrooms and associated newer version.
controlled environments--Part 1:
Classification of air
cleanliness by particle
concentration.
14-140......................... 14-481 ISO 14644-2 Second edition 2015- Withdrawn and replaced with
12-15 Cleanrooms and associated newer version.
controlled environments--Part 2:
Monitoring to provide evidence
of cleanroom performance related
to air cleanliness by particle
concentration.
14-283......................... 14-482 ASTM F88/F88M--15 Standard Test Withdrawn and replaced with
Method for Seal Strength of newer version.
Flexible Barrier Materials.
14-341......................... 14-483 ISO/ASTM 52303 First edition 2015- Withdrawn and replaced with
07-15 Guide for absorbed-dose newer version.
mapping in radiation processing
facilities.
14-344......................... .............. ASTM F2825--10 (Reapproved 2015) Reaffirmation.
Standard Practice for Climatic
Stressing of Packaging Systems
for Single Parcel Delivery.
14-378......................... 14-484 ASTM F1929--15 Standard Test Withdrawn and replaced with
Method for Detecting Seal Leaks newer version.
in Porous Medical Packaging by
Dye Penetration.
14-466......................... 14-485 USP 39-NF34:2016 <61> Withdrawn and replaced with
Microbiological Examination of newer version.
Nonsterile Products: Microbial
Enumeration Tests.
14-467......................... 14-486 USP 39-NF34:2016 <71> Sterility Withdrawn and replaced with
Tests. newer version.
14-468......................... 14-487 USP 39-NF34:2016 <85> Bacterial Withdrawn and replaced with
Endotoxins Test. newer version.
14-469......................... 14-488 USP 39-NF34:2016 <161> Medical Withdrawn and replaced with
Devices-Bacterial Endotoxin and newer version.
Pyrogen Tests.
14-470......................... 14-489 USP 39-NF34:2016 Biological Withdrawn and replaced with
Indicator for Steam newer version.
Sterilization, Self Contained.
14-471......................... 14-490 USP 39-NF34:2016 Biological Withdrawn and replaced with
Indicator for Dry-Heat newer version.
Sterilization, Paper Carrier.
14-472......................... 14-491 USP 39-NF34:2016 Biological Withdrawn and replaced with
Indicator for Ethylene Oxide newer version.
Sterilization, Paper Carrier.
14-473......................... 14-492 USP 39-NF34:2016 Biological Withdrawn and replaced with
Indicator for Steam newer version.
Sterilization, Paper Carrier.
14-474......................... 14-493 USP 39-NF34:2016 <62> Withdrawn and replaced with
Microbiological Examination of newer version.
Nonsterile Products: Tests for
Specified Microorganisms.
14-475......................... 14-494 USP 39-NF34:2016 <55> Biological Withdrawn and replaced with
Indicators--Resistance newer version.
Performance Tests.
14-476......................... 14-495 USP 39-NF34:2016 <1035> Withdrawn and replaced with
Biological Indicators for newer version.
Sterilization.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.
III. Listing of New Entries
In table 2, FDA provides the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 043.
[[Page 41552]]
Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No.
Recognition No. Title of standard \1\ and date
------------------------------------------------------------------------
A. Cardiovascular
------------------------------------------------------------------------
3-142......................... Cardiovascular ISO/TS
implants and 17137:2014.
extracorporeal
systems--Cardiovascul
ar absorbable
implants.
3-143......................... Cardiovascular ISO 12417 First
implants and edition 2015-10-
extracorporeal 01.
systems--Vascular
device-drug
combination products.
------------------------------------------------------------------------
B. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-105......................... Medical devices-- ISO 16142-1
Recognized essential First edition
principles of safety 2016-03-01.
and performance of
medical devices--Part
1: General essential
principles and
additional specific
essential principles
for all non-IVD
medical devices and
guidance on the
selection of
standards.
5-106......................... Small-bore connectors ISO/FDIS 80369-3
for liquids and gases First edition
in healthcare 2016-02-04.
applications--Part 3:
Connectors for
enteral applications.
5-107......................... Small-bore connectors IEC 80369-5:
for liquids and gases Edition 1.0
in healthcare 2016-03.
applications--Part 5:
Connectors for limb
cuff inflation
applications.
5-108......................... Small bore connectors ISO 80369-6
for liquids and gases First edition.
in healthcare 2016-03-15.
applications--Part 6:
Connectors for
neuraxial
applications.
------------------------------------------------------------------------
C. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-376......................... Hypodermic needles for ISO/FDIS 6009
single use--Colour Fourth edition
coding for 2016-01-18.
identification.
6-377......................... Needle-based injection ISO 11608-5
systems for medical First edition
use--Requirements and 2012-10-01.
test methods--Part 5:
Automated functions.
6-378......................... Needle-based injection ISO/FDIS 11608-7
systems for medical First edition
use--Requirements and 2016-06-16.
test methods--Part 7:
Accessibility for
persons with visual
impairment.
------------------------------------------------------------------------
D. In Vitro Diagnostic
------------------------------------------------------------------------
7-264......................... Genomic Copy Number MM21- Ed. 1.
Microarrays for
Constitutional
Genetic and Oncology
Applications, 1st
edition.
------------------------------------------------------------------------
E. Materials
------------------------------------------------------------------------
8-423......................... Standard Guide for ASTM F2565-13.
Extensively
Irradiation-
Crosslinked Ultra-
High Molecular Weight
Polyethylene
Fabricated Forms for
Surgical Implant
Applications.
8-424......................... Standard Specification ASTM F2695-12.
for Ultra-High
Molecular Weight
Polyethylene Powder
Blended With Alpha-
Tocopherol (Vitamin
E) and Fabricated
Forms for Surgical
Implant Applications.
8-425......................... Standard Specification ASTM F2820-12.
for
Polyetherketoneketone
(PEKK) Polymers for
Surgical Implant
Applications.
8-426......................... Standard Specification ASTM F3087-15.
for Acrylic Molding
Resins for Medical
Implant Applications.
8-427......................... Standard Specification ASTM F1185-03
for Composition of (Reapproved
Hydroxylapatite for 2014).
Surgical Implants.
8-428......................... Standard Specification ASTM F1581-08
for Composition of (Reapproved
Anorganic Bone for 2012).
Surgical Implants.
8-429......................... Standard Specification ASTM F2224-09
for High Purity (Reapproved
Calcium Sulfate 2014).
Hemihydrate or
Dihydrate for
Surgical Implants.
8-430......................... Implants for surgery-- ISO 13356:2015
Ceramic materials Third edition.
based on yttria- 2015-09-15.
stabilized tetragonal
zirconia (Y-TZP).
8-431......................... Standard Practice for ASTM F2971-13.
Reporting Data for
Test Specimens
Prepared by Additive
Manufacturing.
8-432......................... Standard Terminology ISO/ASTM 52921-
for Additive 13 First
Manufacturing- edition 2013-06-
Coordinate Systems 01.
and Test
Methodologies.
8-434......................... Additive ISO/ASTM 52900
manufacturing--Genera First edition
l principles-- 2015-12-15.
Terminology.
------------------------------------------------------------------------
F. Orthopedic
------------------------------------------------------------------------
11-307........................ Standard Practice for ASTM F2385-15.
Determining Femoral
Head Penetration into
Acetabular Components
of Total Hip
Replacement Using
Clinical Radiographs.
11-308........................ Standard Test Method ASTM F3161-16.
for Finite Element
Analysis (FEA) of
Metallic Orthopaedic
Total Knee Femoral
Components under
Closing Conditions.
11-309........................ Standard Specification ASTM F116-12.
for Medical
Screwdriver Bits.
11-310........................ Standard Specification ASTM F1611-00
for Intramedullary (Reapproved
Reamers. 2013).
------------------------------------------------------------------------
G. Radiology
------------------------------------------------------------------------
12-302........................ Medical electrical IEC 60601-2-44
equipment--Part 2-44: Ed. 3.2:2016.
Particular
requirements for the
basic safety and
essential performance
of X-ray equipment
for computed
tomography.
------------------------------------------------------------------------
[[Page 41553]]
H. Software/Informatics
------------------------------------------------------------------------
13-82......................... Application of risk AAMI/ISO TIR
management for IT 80001-2-6:2014.
networks
incorporating
medical--Application
guidance--Part 2-6:
Guidance for
responsibility
agreements.
13-83......................... Principles for medical AAMI TIR
device security--Risk 57:2016.
management.
13-84......................... Health informatics-- ISO/IEEE 11073-
Point-of-care medical 10103 First
device communication-- edition 2014-03-
Part 10103: 01.
Nomenclature--Implant
able device, cardiac.
------------------------------------------------------------------------
I. Tissue Engineering
------------------------------------------------------------------------
15-45......................... Medical devices ISO 22442-1
utilizing animal Second edition
tissues and their 2015-11-1.
derivatives--Part 1:
Application of risk
management.
15-46......................... Medical devices ISO 22442-2
utilizing animal Second edition
tissues and their 2015-11-1.
derivatives--Part 2:
Controls on sourcing,
collection and
handling.
15-47......................... Medical devices ISO 22442-3
utilizing animal First edition
tissues and their 2007-12-15.
derivatives--Part 3:
Validation of the
elimination and/or
inactivation of
viruses and
transmissible
spongiform
encephalopathy (TSE)
agents.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.
IV. List of Recognized Standards
FDA maintains the Agency's current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed directly at
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications
and revisions described in this notice into the database and, upon
publication in the Federal Register, this recognition of consensus
standards will be effective. FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.
Beginning with Recognition List 033, FDA no longer announces minor
revisions to the list of recognized consensus standards such as
technical contact person, devices affected, processes affected, Code of
Federal Regulations citations, and product codes.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
[email protected]. 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
You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. The Center for Devices and
Radiological Health (CDRH) maintains a site on the Internet for easy
access to information including text, graphics, and files that you may
download to a personal computer with access to the Internet. Updated on
a regular basis, the CDRH home page, http://www.fda.gov/MedicalDevices,
includes a link to standards-related documents including the guidance
and the current list of recognized standards. After publication in the
Federal Register, this notice announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 043'' will be available
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. You may access ``Guidance on the Recognition
and Use of Consensus Standards,'' and the searchable database for ``FDA
Recognized Consensus Standards'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.
Dated: June 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-15100 Filed 6-24-16; 8:45 am]
BILLING CODE 4164-01-P