[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26465-26475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12222]
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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: 049
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) 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: 049'' (Recognition List Number: 049), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: These modifications to the list of recognized standards are
applicable June 7, 2018.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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: 049.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday 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: 049.
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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the
[[Page 26466]]
``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
An electronic copy of Recognition List Number: 049 is available on
the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
See section IV for electronic access to the searchable database for
the current list of FDA recognized consensus standards, including
Recognition List Number: 049 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: 049'' to Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 301-847-8144.
FOR FURTHER INFORMATION CONTACT: Scott 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 (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 the Federal Register notice 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. The guidance was updated in September
2007 and is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077274.htm.
Modifications to the initial list of recognized standards, as
published in the Federal Register, can be accessed at https://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. Additional information
on the Agency's standards program is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 049
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency is recognizing for
use in premarket submissions and other requirements for devices. FDA is
incorporating these modifications to the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA is using
the term ``Recognition List Number: 049'' to identify the 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. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-86............................. .............. ISO 8185 Third edition 2008-06- Withdrawn. See 1-138.
15 (Corrected version),
Respiratory tract humidifiers
for medical use--Particular
requirements for respiratory
humidification systems.
1-95............................. .............. ISO 5366-3 Second edition 2001- Withdrawn. See 1-117.
08-15 Anaesthetic and
Respiratory Equipment--
Tracheostomy Tubes--Part 3:
Paediatric Tracheostomy Tubes
[Including TECHNICAL
CORRIGENDUM 1 (2003)].
1-107............................ .............. ANSI/AAMI/ISO 5356-1:2004 Transferred. See 1-62.
Anaesthetic and respiratory
equipment--Conical connectors--
Part 1: Cones and sockets.
1-109............................ .............. ANSI/AAMI/ISO 5362:2006 Transferred. See 1-75.
Anaesthetic reservoir bags.
1-121............................ 1-129 ISO 5359 Fourth edition 2014-10- Withdrawn and replaced with
01 Anaesthetic and respiratory newer version including
equipment--Low-pressure hose amendment.
assemblies for use with medical
gases [Including AMENDMENT 1
(2017)].
1-128............................ 1-130 ISO 18082 First edition 2014-06- Withdrawn and replaced with
15 Anaesthetic and respiratory newer version including
equipment--Dimensions of amendment.
noninterchangeable screw-
threaded (NIST) low-pressure
connectors for medical gases
[Including AMENDMENT 1 (2017)].
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-118............................ .............. ANSI/AAMI/ISO 10993-11:2006/ Transferred. See 2-176.
(R)2010 Biological evaluation
of medical devices--Part 11:
Tests for systemic toxicity.
2-120............................ .............. ANSI/AAMI/ISO 10993-6:2007/ Withdrawn.
(R)2014 Biological evaluation
of medical devices--Part 6:
Tests for local effects after
implantation.
2-153............................ .............. ANSI/AAMI/ISO 10993-5:2009/ Transferred. See 2-245.
(R)2014 Biological evaluation
of medical devices--Part 5:
Tests for in vitro cytotoxicity.
[[Page 26467]]
2-156............................ .............. ANSI/AAMI/ISO 10993-1:2009/ Transferred. See 2-220.
(R)2013 Biological evaluation
of medical devices--Part 1:
Evaluation and testing within a
risk management process.
2-163............................ .............. ANSI/AAMI/ISO 10993-9:2009/ Transferred. See 2-168.
(R)2014 Biological evaluation
of medical devices--Part 9:
Framework for identification
and quantification of potential
degradation products.
2-165............................ .............. ANSI/AAMI/ISO 10993-14:2001/(R) Transferred. See 2-170.
2011 Biological evaluation of
medical devices--Part 14:
Identification and
quantification of degradation
products form ceramics.
2-171............................ 2-249 ISO 10993-16 Third edition 2017- Withdrawn and replaced with
05 Biological evaluation of newer version.
medical devices--Part 16:
Toxicokinetic study design for
degradation products and
leachables.
2-172............................ .............. ANSI/AAMI/TIR 10993-19:2006 Transferred. See 2-167.
Biological evaluation of
medical devices--Part 19:
Physicochemical, morphological,
and topographical
characterization of materials.
2-173............................ .............. ANSI/AAMI/ISO 10993-10:2010/ Transferred. See 2-174.
(R)2014 Biological evaluation
of medical devices--Part 10:
Tests for irritation and skin
sensitization.
2-180............................ .............. ANSI/AAMI/ISO 10993-16:2010/ Withdrawn.
(R)2014 Biological evaluation
of medical devices--Part 16:
Toxicokinetic study design for
degradation products and
leachables from medical devices.
2-181............................ .............. ANSI/AAMI/ISO 14155:2011 Transferred. See 2-205.
Clinical investigation of
medical devices for human
subjects--Good clinical
practice [Including: Technical
Corrigendum 1 (2011)].
2-190............................ .............. ANSI/AAMI/ISO 10993-13:2010/ Transferred. See 2-169.
(R)2014 Biological evaluation
of medical devices--Part 13:
Identification and
quantification of degradation
products from polymeric medical
devices.
2-198............................ .............. ANSI/AAMI/ISO 10993-12:2012 Transferred. See 2-191.
Biological evaluation of
medical devices--Part 12:
Sample preparation and
reference materials.
2-207............................ 2-250 ASTM F756-17 Standard Practice Withdrawn and replaced with
for Assessment of Hemolytic newer version.
Properties of Materials.
2-221............................ .............. ANSI/AAMI/ISO 10993-2:2006 Transferred. See 2-222.
(R2014) Biological evaluation
of medical devices--Part 2:
Animal welfare requirements.
2-226............................ .............. ANSI/AAMI/ISO 10993-3:2014 Transferred. See 2-228.
Biological evaluation of
medical devices--Part 3: Tests
for genotoxicity,
carcinogenicity, and
reproductive toxicity.
2-229............................ 2-251 USP 40-NF35:2017 <87> Biological Withdrawn and replaced with
Reactivity Test, In Vitro-- newer version.
Direct Contact Test.
2-230............................ 2-252 USP 40-NF35:2017 <87> Biological Withdrawn and replaced with
Reactivity Test, In Vitro-- newer version.
Elution Test.
2-231............................ 2-253 USP 40-NF35:2017 <88> Biological Withdrawn and replaced with
Reactivity Tests, In Vivo. newer version.
2-232............................ 2-254 USP 40-NF35:2017 <151> Pyrogen Withdrawn and replaced with
Test (USP Rabbit Test). newer version. Extent of
Recognition.
2-234............................ .............. ANSI/AAMI/ISO 10993-4:2002/(R) Withdrawn.
2013 & A1:2006/(R)2013
Biological evaluation of
medical devices--Part 4:
Selection of tests for
interaction with blood
[Including AMENDMENT 1 (2006)].
2-236............................ .............. ANSI/AAMI/ISO 10993-17:2002(R) Transferred. See 2-237.
2012 Biological evaluation of
medical devices--Part 17:
Establishment of allowable
limits for leachable substances.
2-239............................ .............. ANSI/AAMI/ISO TIR 10993-20:2006 Transferred. See 2-240.
Biological Evaluation of
Medical Devices--Part 20:
Principles and methods for
immunotoxicology testing of
medical devices.
2-242............................ .............. ANSI/AAMI/ISO TIR 37137:2014 Transferred. See 2-241.
Cardiovascular biological
evaluation of medical devices--
Guidance for absorbable
implants.
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-80............................. .............. ANSI/AAMI/ISO 81060-1:2007/ Transferred. See 3-96.
(R)2013 Non-invasive
sphygmomanometers--Part 1:
Requirements and test methods
for non-automated measurement
type.
3-83............................. .............. ANSI/AAMI/ISO 14708-5:2010 Transferred. See 3-92.
Implants for surgery--Active
implantable medical devices--
Part 5: Circulatory support
devices.
3-101............................ .............. ANSI/AAMI/IEC 60601-2-27:2011 Transferred. See 3-126.
Medical electrical equipment--
Part 2-27: Particular
requirements for the basic
safety and essential
performance of
electrocardiographic monitoring
equipment.
3-106............................ .............. ANSI/AAMI/IEC 60601-2-25:2011/ Transferred. See 3-105.
(R)2016 Medical electrical
equipment--Part 2-25:
Particular requirements for the
basic safety and essential
performance of
electrocardiographs.
[[Page 26468]]
3-109............................ .............. ANSI/AAMI/ISO 27186:2010 Active Transferred. See 3-89.
implantable medical devices--
Four-pole connector system for
implantable cardiac rhythm
management devices--Dimensional
and test requirements.
3-111............................ .............. ANSI/AAMI/ISO 25539-3:2011 Transferred. See 3-103.
Cardiovascular implants--
Endovascular devices--Part 3:
Vena cava filters.
3-112............................ .............. ANSI/AAMI/ISO 7199:2009 Transferred. See 3-124.
Cardiovascular implants and
artificial organs--Blood gas
exchangers (oxygenators).
3-117............................ .............. ANSI/AAMI/ISO 81060-2 Second Transferred. See 3-122.
edition 2013-05-01 Non-invasive
sphygmomanometers--Part 2:
Clinical validation of
automated measurement type.
3-120............................ .............. ANSI/AAMI/ISO 25539-2:2012 Transferred. See 3-116.
Cardiovascular implants--
Endovascular devices--Part 2:
Vascular stents.
3-124............................ 3-150 ISO 7199 Third edition 2016-11- Withdrawn and replaced with
15 Cardiovascular implants and newer version.
artificial organs--Blood-gas
exchangers (oxygenators).
3-128............................ .............. ANSI/AAMI/ISO 14117:2012 Active Transferred. See 3-139.
implantable medical devices--
Electromagnetic compatibility--
EMC test protocols for
implantable cardiac pacemakers,
implantable cardioverter
defibrillators, and cardiac
resynchronization devices.
3-130............................ 3-151 ANSI/AAMI/IEC 80601-2-30:2009 & Reaffirmation. Extent of
A1:2013/(R2016) Medical Recognition. Transferred.
electrical equipment--Part 2- See 3-123.
30: Particular requirements for
the basic safety and essential
performance of automated non-
invasive sphygmomanometers.
3-131............................ .............. ANSI/AAMI/ISO 27185:2012 Cardiac Transferred. See 3-132.
rhythm management devices--
Symbols to be used with cardiac
rhythm management device
labels, and information to be
supplied--General requirements.
3-140............................ .............. ANSI/AAMI/ISO 5840-3:2013 Transferred. See 3-133.
Cardiovascular implants--
Cardiac valve prostheses--Part
3: Heart valve substitutes
implanted by transcatheter
techniques.
3-141............................ .............. ANSI/AAMI/ISO 5841-3:2013 Transferred. See 3-125.
Implants for surgery--Cardiac
pacemakers--Part 3: Low-profile
connectors (IS-1) for
implantable pacemakers.
3-146............................ .............. ANSI/AAMI/ISO 5840-1:2015 Transferred. See 3-145.
Cardiovascular implants--
Cardiac valve prostheses--Part
1: General requirements.
3-148............................ .............. ANSI/AAMI/ISO 5840-2:2015 Transferred. See 3-147.
Cardiovascular implants--
Cardiac valve prostheses--Part
2: Surgically implanted heart
valve substitutes.
----------------------------------------------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-50............................. .............. ADA Specification No. 18: 1992 Withdrawn. See 4-240.
Alginate Impression Materials.
4-89............................. .............. ANSI/ADA Specification No. 53 Reaffirmation.
Reaffirmed by ANSI: August 2013
Polymer-Based Crown and Bridge
Materials.
4-91............................. .............. ANSI/ADA Standard No. 80/ISO Transferred. See 4-241.
7491:2000 Reaffirmed by ANSI:
May 2013 Dental Materials--
Determination of Color
Stability.
4-119............................ .............. ANSI/ADA Specification No. Withdrawn. See 4-240.
82:1998/ISO 13716:1999
Reaffirmed by ANSI: January
2009 Dental Reversible/
Irreversible Hydrocolloid
Impression Material Systems.
4-193............................ .............. ANSI/ADA Standard No. 15-2008/ Transferred. See 4-151.
ISO 22112:2005 Reaffirmed by
ANSI: May 2013 Artificial Teeth
for Dental Prostheses.
4-230............................ .............. ANSI/ADA Standard No. 30/ISO Transferred. See 4-198.
3107:2011 Approved by ANSI:
February 2013 Dental Zinc Oxide/
Eugenol & Zinc Oxide/Non-
Eugenol Cements.
4-235............................ .............. ANSI/ADA Standard No. 100/ISO Transferred. See 4-218.
27020:2010 Approved by ANSI:
November 2012 Orthodontic
Brackets and Tubes.
4-237............................ .............. ANSI/ADA Standard No.120-2009/ Transferred. See 4-238.
ISO 20127:2005 Reaffirmed by
ANSI: September 8, 2014 Powered
Toothbrushes.
----------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-65............................. .............. ANSI/AAMI/ISO 80369-1:2010 Small Transferred. See 5-63.
bore connectors for liquids and
gases in healthcare
applications--Part 1: General
requirements.
5-70............................. .............. ANSI/AAMI/ISO 14971:2007/(R)2010 Transferred. See 5-40.
(Corrected 4 October 2007)
Medical devices--Application of
risk management to medical
devices.
5-92............................. .............. ANSI/AAMI/IEC 60601-1-8:2006 and Transferred. See 5-76.
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.
5-96............................. .............. ANSI/AAMI/IEC 62366-1:2015 Transferred. See 5-114.
Medical devices--Part 1:
Application of usability
engineering to medical devices.
[[Page 26469]]
5-100............................ .............. ANSI/AAMI/ISO 80369-20:2015 Transferred. See 5-97.
Small-bore connectors for
liquids and gases in healthcare
applications--Part 20: Common
test methods.
5-118............................ .............. ANSI/AAMI/ISO 15223-1:2016 Transferred. See 5-117.
Medical devices--Symbols to be
used with medical device
labels, labelling and
information to be supplied--
Part 1: General requirements.
5-119............................ .............. ANSI/AAMI/ISO 80369-5:2016 Small- Transferred. See 5-107.
bore connectors for liquids and
gases in healthcare
applications--Part 5:
Connectors for limb cuff
inflation applications.
----------------------------------------------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-2............................. .............. ANSI/AAMI/IEC 60601-1-2:2007 Transferred. See 19-1.
(R2012) Medical electrical
equipment--Part 1-2: General
requirements for basic safety
and essential performance--
Collateral standard:
Electromagnetic compatibility--
Requirements and tests.
19-12............................ .............. ANSI/AAMI/IEC 60601-1-2:2014 Transferred. See 19-8.
Medical electrical equipment--
Part 1-2: General requirements
for basic safety and essential
performance--Collateral
Standard: Electromagnetic
disturbances--Requirements and
tests.
----------------------------------------------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-149............................ 6-401 ASTM D7160-16 Standard Practice Withdrawn and replaced with
for Determination of Expiration newer version.
Dating for Medical Gloves.
6-178............................ .............. ASTM D6124-06 (Reapproved 2017) Reaffirmation.
Standard Test Method for
Residual Powder on Medical
Gloves.
6-214............................ .............. ASTM D6355-07 (Reapproved 2017) Reaffirmation.
Standard Test Method for Human
Repeat Insult Patch Testing of
Medical Glove.
6-217............................ 6-402 ASTM F1670/F1670M-17 Standard Withdrawn and replaced with
Test Method for Resistance of newer version.
Materials Used in Protective
Clothing to Penetration by
Synthetic Blood.
6-227............................ .............. ANSI/AAMI/IEC 60601-2-21:2009 Transferred. See 6-388.
Medical electrical equipment--
Part 2-21: Particular
requirements for the basic
safety and essential
performance of infant radiant
warmers.
6-229............................ .............. ANSI/AAMI/IEC 60601-2-2:2009 Transferred. See 6-389.
Medical electrical equipment--
Part 2-2: Particular
requirements for the basic
safety and essential
performance of high frequency
surgical equipment.
6-232............................ 6-403 ISO 80601-2-56 Second edition Withdrawn and replaced with
2017-03 Medical electrical newer version.
equipment--Part 2-56:
Particular requirements for
basic safety and essential
performance of clinical
thermometers for body
temperature measurement.
6-230............................ .............. ANSI/AAMI/IEC 60601-2-19:2009 Transferred. See 6-385.
Medical electrical equipment--
Part 2-19: Particular
requirements for the basic
safety and essential
performance of infant
incubators.
6-235............................ .............. ANSI/AAMI/IEC 60601-2-50:2009 Transferred. See 6-387.
Medical electrical equipment--
Part 2-50: Particular
requirements for the basic
safety and essential
performance of infant
phototherapy equipment.
6-270............................ .............. ASTM F1840-10 (Reapproved 2016) Reaffirmation.
Standard Terminology for
Surgical Suture Needles.
6-304............................ 6-404 ISO 7886-1 Second edition 2017- Withdrawn and replaced with
05 Sterile hypodermic syringes newer version.
for single use--Part 1:
Syringes for manual use.
6-307............................ 6-405 IEC 80601-2-59 Edition 2.0 2017- Withdrawn and replaced with
09 Medical electrical newer version.
equipment--Part 2-59:
Particular requirements for the
basic safety and essential
performance of screening
thermographs for human febrile
temperature screening.
6-323............................ 6-406 ASTM F1862/F1862M-17 Standard Withdrawn and replaced with
Test Method for Resistance of newer version.
Medical Face Masks to
Penetration by Synthetic Blood
(Horizontal Projection of Fixed
Volume at a Known Velocity).
6-337............................ .............. ANSI/AAMI/IEC 60601-2-20:2009 Transferred. See 6-386.
Medical electrical equipment--
Part 2-20: Particular
requirements for the basic
safety and essential
performance of transport
incubators [Including AMENDMENT
1 (2016)].
----------------------------------------------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-271............................ .............. CLSI M100 27th Edition Extent of recognition.
Performance Standards for
Antimicrobial Susceptibility
Testing.
----------------------------------------------------------------------------------------------------------------
[[Page 26470]]
I. Materials
----------------------------------------------------------------------------------------------------------------
8-113............................ .............. ASTM F1147-05 (Reapproved 2017) Reaffirmation.
[egr]\1\ Standard Test Method
for Tension Testing of Calcium
Phosphate and Metallic Coatings.
8-337............................ .............. ASTM F621-12 (Reapproved 2017) Reaffirmation.
Standard Specification for
Stainless Steel Forgings for
Surgical Implants.
8-356............................ .............. ASTM F67-13 (Reapproved 2017) Reaffirmation.
Standard Specification for
Unalloyed Titanium, for
Surgical Implant Applications
(UNS R50250, UNS R50400, UNS
R50550, UNS R50700).
8-446............................ 8-460 ASTM F2848-17 Standard Withdrawn and replaced with
Specification for Medical-Grade newer version. Extent of
Ultra-High Molecular Weight recognition.
Polyethylene Yarns.
----------------------------------------------------------------------------------------------------------------
J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
No new entries at this time ...........................
----------------------------------------------------------------------------------------------------------------
K. Neurology
----------------------------------------------------------------------------------------------------------------
17-1............................. .............. ANSI/AAMI NS28:1988/(R)2015 Reaffirmation. Extent of
Intracranial pressure recognition.
monitoring devices.
17-8............................. 17-15 ISO 14708-3 Second edition 2017- Withdrawn and replaced with
04 Implants for surgery--Active newer version.
implantable medical devices--
Part 3: Implantable
neurostimulators.
17-10............................ .............. ANSI/AAMI/ISO 14708-3:2008/ Withdrawn.
(R)2011 Implants for surgery--
Active implantable medical
devices--Part 3: Implantable
neurostimulators.
17-11............................ 17-16 IEC 60601-2-10 Edition 2.1 2016- Withdrawn and replaced with
04 Medical electrical newer version.
equipment--Part 2-10:
Particular requirements for the
basic safety and essential
performance of nerve and muscle
stimulators.
----------------------------------------------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
9-64............................. .............. ANSI/AAMI/IEC 60601-2-2:2009 Withdrawn. Duplicate
Medical electrical equipment-- recognition. See 6-229.
Part 2-2: Particular
requirements for the basic
safety and essential
performance of high frequency
surgery equipment and high
frequency surgical accessories.
9-66............................. .............. ANSI/AAMI/ISO 8638:2010 Transferred. See 9-89.
Cardiovascular implants and
extracorporeal blood circuit
for hemodialyzers,
hemodiafilters, and hemofilters.
9-81............................. .............. ANSI/AAMI/IEC 60601-2-16:2012 Transferred. See 9-80
Medical electrical equipment--
Part 2-16: Particular
requirements for basic safety
and essential performance of
hemodialysis, hemodiafiltration
and hemofiltration equipment.
9-91............................. .............. ANSI/AAMI/ISO 8637:2010 Transferred. See 9-92.
Cardiovascular implants and
extracorporeal systems--
Hemodialyzers, hemodiafilters,
hemofilters, and
hemoconcentrators [Including
AMENDMENT 1 (2013)].
9-91............................. 9-114 IEC 60601-2-18: Edition 3.0 2009- Withdrawn and replaced with
08, medical electrical new recognition number.
equipment--part 2-18:
particular requirements for the
basic safety and essential
performance of endoscopic
equipment.
9-93............................. 9-115 ISO 25841 Third edition 2017-08 Withdrawn and replaced with
Female condoms--Requirements newer version.
and test methods.
9-103............................ .............. ANSI/AAMI/ISO 26722:2014 Water Transferred. See 9-101.
treatment equipment for
haemodialysis applications and
related therapies.
9-104............................ .............. ANSI/AAMI/ISO 13958:2014 Transferred. See 9-97.
Concentrates for hemodialysis
and related therapies.
9-105............................ .............. ANSI/AAMI/ISO 13959:2014 Water Transferred. See 9-98.
for hemodialysis and related
therapies.
9-106............................ .............. ANSI/AAMI/ISO 11663:2014 Quality Transferred. See 9-100.
of dialysis fluid for
hemodialysis and related
therapies.
9-107............................ .............. ANSI/AAMI/ISO 23500:2014 Transferred. See 9-99.
Guidance for the preparation
and quality management of
fluids for hemodialysis and
related therapies.
----------------------------------------------------------------------------------------------------------------
M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-43............................ 10-105 ISO 11979-8 Third edition 2017- Withdrawn and replaced with
04 Ophthalmic Implants-- newer version.
Intraocular lenses--Part 8:
Fundamental requirements.
10-46............................ 10-106 ISO 18369-3 Second edition 2017- Withdrawn and replaced with
08 Ophthalmic optics--Contact newer version.
lenses--Part 3: Measurement
methods.
10-54............................ 10-107 ISO 18369-4 Second edition 2017- Withdrawn and replaced with
08 Ophthalmic optics--Contact newer version.
lenses--Part 4: Physicochemical
properties of contact lens
materials.
10-80............................ 10-108 ISO 18369-2 Third edition 2017- Withdrawn and replaced with
08 Ophthalmic optics--Contact newer version.
lenses--Part 2: Tolerances.
[[Page 26471]]
10-83............................ 10-109 ISO 18369-1 Second edition 2017- Withdrawn and replaced with
08 Ophthalmic optics--Contact newer version.
lenses--Part 1: Vocabulary,
classification system and
recommendations for labelling
specifications.
----------------------------------------------------------------------------------------------------------------
N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-259........................... .............. ASTM F2887--12 Standard Withdrawn. See 11-321.
Specification for Total Elbow
Prostheses.
----------------------------------------------------------------------------------------------------------------
O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-200........................... 16-201 ISO 7176-19 Second edition 2008- Withdrawn and replaced with
07-15 AMENDMENT 1 2015-11-15. a newer version including
Wheelchairs--Part 19: Wheeled amendment.
mobility devices for use as
seats in motor vehicles
[Including AMENDMENT 1 (2015)].
----------------------------------------------------------------------------------------------------------------
P. Radiology
----------------------------------------------------------------------------------------------------------------
12-139........................... .............. NEMA UD 2-2004 (R2009) Acoustic Withdrawn. Duplicate
Output Measurement Standard for recognition. See 12-105.
Diagnostic Ultrasound
Equipment, Revision 3.
12-202........................... 12-308 IEC 60601-2-43 Edition 2.1 2017- Withdrawn and replaced with
05 CONSOLIDATED VERSION Medical newer version.
electrical equipment--Part 2-
43: Particular requirements for
the safety and essential
performance of X-Ray Equipment
for interventional procedures.
12-204........................... 12-309 IEC 60601-2-28 Edition 3.0 2017- Withdrawn and replaced with
06 Medical electrical newer version.
equipment--Part 2-28:
Particular requirements for the
basic safety and essential
performance of X-ray tube
assemblies for medical
diagnosis.
12-251........................... 12-310 IEC 60601-2-63 Edition 1.1 2017- Withdrawn and replaced with
07 CONSOLIDATED VERSION Medical newer version.
electrical equipment--Part 2-
63: Particular requirements for
the basic safety and essential
performance of dental extra-
oral X-Ray equipment.
12-252........................... 12-311 IEC 60601-2-65 Edition 1.1 2017- Withdrawn and replaced with
05 CONSOLIDATED VERSION Medical newer version.
electrical equipment--Part 2-
65: Particular requirements for
the basic safety and essential
performance of dental intra-
oral X-Ray equipment.
12-227........................... 12-312 IEC 61391-1 Edition 1.1 2017-07 Withdrawn and replaced with
CONSOLIDATED VERSION newer version.
Ultrasonics--Pulse-echo
scanners--Part 1: Techniques
for calibrating spatial
measurement systems and
measurement of system point-
spread function response.
12-276........................... 12-313 IEC TS 62462 Edition 2.0 2017-07 Withdrawn and replaced with
Ultrasonics--Output test-- newer version.
Guidance for the maintenance of
ultrasound physiotherapy
systems.
12-155........................... 12-314 ISO 11554 Fourth edition 2017-07 Withdrawn and replaced with
Optics and photonics--Lasers newer version.
and laser-related equipment--
Test methods for laser beam
power, energy and temporal
characteristics.
12-192........................... 12-315 NEMA Standards Publication MS 8- Withdrawn and replaced with
2016 Characterization of the newer version.
Specific Absorption Rate (SAR)
for Magnetic Resonance Imaging
Systems.
12-258........................... 12-316 IEC 62359 Edition 2.1 2017-09 Withdrawn and replaced with
CONSOLIDATED VERSION newer version.
Ultrasonics--Field
characterization--Test methods
for the determination of
thermal and mechanical indices
related to medical diagnostic
ultrasonic fields.
----------------------------------------------------------------------------------------------------------------
Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-39............................ .............. ANSI/AAMI/IEC 80001-1:2010 Transferred. See 13-38.
Application of risk management
for IT Networks incorporating
medical devices--Part 1: Roles,
responsibilities and activities.
13-41............................ .............. ANSI/AAMI/IEC TIR80001-2-1:2012 Transferred. See 13-40.
Application of risk management
for IT-networks incorporating
medical devices--Part 2-1: Step
by step risk management of
medical IT-networks; Practical
applications and examples.
13-43............................ .............. ANSI/AAMI/IEC TIR80001-2-2:2012 Transferred. See 13-42.
Technical Information Report
Application of risk management
for IT-networks incorporating
medical devices--Part 2-2:
Guidance for the disclosure and
communication of medical device
security needs, risks and
controls.
13-45............................ .............. ANSI/AAMI/IEC TIR80001-2-3:2012 Transferred. See 13-44.
Technical Information Report
Application of risk management
for IT-networks incorporating
medical devices--Part 2-3:
Guidance for wireless networks.
[[Page 26472]]
13-64............................ .............. ANSI/AAMI/IEC TIR80001-2-4:2012 Transferred. See 13-63.
Technical Information Report
Application of risk management
for IT-networks incorporating
medical devices--Part 2-4:
General implementation guidance
for healthcare delivery
organizations.
----------------------------------------------------------------------------------------------------------------
R. Sterility
----------------------------------------------------------------------------------------------------------------
14-221........................... .............. ANSI/AAMI/ISO TIR 11139:2006 Transferred. See 14-325.
Sterilization of health care
products--Vocabulary.
14-222........................... .............. ANSI/AAMI/ISO 18472:2006/(R)2010 Transferred. See 14-354.
Sterilization of health care
products--Biological and
chemical indicators--Test
equipment.
14-227........................... .............. ANSI/AAMI/ISO 11737-1:2006 Transferred. See 14-407.
(R)2011 Sterilization of health
care products--Microbiological
methods--Part 1: Determination
of the population of
microorganisms on product.
14-238........................... .............. ANSI/AAMI/ISO 11140-5:2007/ Transferred. See 14-332.
(R)2012 Sterilization of health
care products--Chemical
indicators--Part 5: Class 2
indicators for Bowie and Dick
air removal test sheets and
packs.
14-261........................... .............. ANSI/AAMI/ISO 17665-1:2006/ Transferred. See 14-333.
(R)2013 Sterilization of health
care products--Moist heat--Part
1: Requirements for the
development, validation, and
routine control of a
sterilization process for
medical devices.
14-274........................... .............. ANSI/AAMI/ISO 15882:2008/(R)2013 Transferred. See 14-334.
Sterilization of health care
products--Chemical indicators--
Guidance for selection, use and
interpretation of results.
14-278........................... .............. ANSI/AAMI/ISO 10993- Transferred. See 14-408.
7:2008(R)2012 Biological
evaluation of medical devices--
Part 7: Ethylene oxide
sterilization residuals.
14-285........................... .............. ANSI/AAMI/ISO 14161:2009/(R)2014 Transferred. See 14-336.
Sterilization of health care
products--Biological
indicators--Guidance for the
selection, use and
interpretation of results.
14-287........................... .............. ANSI/AAMI/ISO 11737-2:2009/ Transferred. See 14-327.
(R)2014 Sterilization of
medical devices--
Microbiological methods--Part
2: Tests of sterility performed
in the definition, validation
and maintenance of a
sterilization process.
14-291........................... .............. ANSI/AAMI/ISO 14937:2009/(R)2013 Transferred. See 14-337.
Sterilization of health care
products--General requirements
for characterization of a
sterilizing agent and the
development, validation and
routine control of a
sterilization process for
medical devices.
14-295........................... .............. ANSI/AAMI ST81:2004/(R)2016 Reaffirmation.
Sterilization of medical
devices--Information to be
provided by the manufacturer
for the processing of
resterilizable medical devices.
14-298........................... .............. ANSI/AAMI/ISO 11137-3:2006/ Withdrawn. See 14-510.
(R)2010 Sterilization of health
care products--Radiation--Part
3: Guidance on dosimetric
aspects.
14-330........................... 14-510 ISO 11137-3 Second edition 2017- Withdrawn and replaced with
06 Sterilization of health care newer version.
products--Radiation--Part 3:
Guidance on dosimetric aspects
of development, validation and
routine control.
14-339........................... .............. ANSI/AAMI/ISO 20857:2010/(R)2015 Transferred. See 14-340.
Sterilization of health care
products--Dry heat--
Requirements for the
development, validation and
routine control of a
sterilization process for
medical devices.
14-348........................... .............. ANSI/AAMI/ISO 13408-2:2003/ Transferred. See 14-138.
(R)2013 Aseptic processing of
health care products--Part 2:
Filtration.
14-349........................... .............. ANSI/AAMI/ISO 13408-3:2006/ Transferred. See 14-239.
(R)2015 Aseptic processing of
health care products--Part 3:
Lyophilization.
14-350........................... .............. ANSI/AAMI/ISO 13408-4:2005/ Transferred. See 14-191.
(R)2014 Aseptic processing of
health care products--Part 4:
Clean-in-place technologies.
14-351........................... .............. ANSI/AAMI/ISO 13408-5:2006/ Transferred. See 14-240.
(R)2015 Aseptic processing of
health care products--Part 5:
Sterilization in place.
14-358........................... .............. ANSI/AAMI/ISO 14160:2011/(R)2016 Transferred. See 14-361.
Sterilization of health care
products--Liquid chemical
sterilizing agents for single-
use medical devices utilizing
animal tissues and their
derivatives--Requirements for
characterization, development,
validation and routine control
of a sterilization process for
medical devices.
14-376........................... .............. ANSI/AAMI/ISO TIR 17665-2:2009 Transferred. See 14-277.
Sterilization of health care
products--Moist heat--Part 2:
Guidance on the application of
ANSI/AAMI/ISO 17665-1.
14-387........................... .............. ANSI/AAMI/ISO 13408-7:2012 Transferred. See 14-388.
Aseptic processing of health
care products--Part 7:
Alternative processes for
medical devices and combination
products.
14-425........................... .............. ANSI/AAMI/ISO 13408-6:2005/(R) Transferred. See 14-424.
2013 & A1:2013 Aseptic
processing of health care
products--Part 6: Isolator
systems [Including AMENDMENT1
(2013)].
[[Page 26473]]
14-426........................... .............. ANSI/AAMI/ISO 13408-1:2008 Transferred. See 14-427.
(R2011) Aseptic processing of
health care products--Part 1:
General requirements [Including
AMENDMENT1 (2013)].
14-438........................... .............. ANSI/AAMI/ISO 11137-2:2013 Transferred. See 14-409.
Sterilization of health care
products--Radiation--Part 2:
Establishing the sterilization
dose.
14-439........................... 14-511 ANSI/AAMI ST79:2017 Withdrawn and replaced with
Comprehensive guide to steam newer version.
sterilization and sterility
assurance in health care
facilities.
14-457........................... .............. ANSI/AAMI/ISO 11607-1:2006/ Transferred. See 14-454.
(R)2010 Packaging for
terminally sterilized medical
devices--Part 1: Requirements
for materials, sterile barrier
systems and packaging
[Including AMENDMENT 1 (2013)].
14-458........................... .............. ANSI/AAMI/ISO 11607-2:2006/ Transferred. See 14-455.
(R)2010 Packaging for
terminally sterilized medical
devices--Part 2: Validation
requirements for forming,
sealing and assembly processes
[Including AMENDMENT 1 (2013)].
14-459........................... .............. ANSI/AAMI/ISO 11140-1:2014 Transferred. See 14-460.
Sterilization of health care
products--Chemical indicators--
Part 1: General requirements.
14-461........................... .............. ANSI/AAMI/ISO 11137-1:2006/ Transferred. See 14-428.
(R)2010 Sterilization of health
care products--Radiation--Part
1: Requirements for
development, validation and
routine control of a
sterilization process for
medical devices [Including
AMENDMENT 1 (2013)].
14-479........................... .............. ANSI/AAMI/ISO 11135:2014 Transferred. See 14-452.
Sterilization of health care
products--Ethylene oxide--
Requirements for development,
validation and routine control
of a sterilization process for
medical devices.
----------------------------------------------------------------------------------------------------------------
S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-17............................ .............. ASTM F2311-08 Standard Guide for Withdrawn.
Classification of Therapeutic
Skin Substitutes.
15-23............................ .............. ASTM F2739-08 Standard Guide for Withdrawn. See 15-50.
Quantitating Cell Viability
within Biomaterial Scaffolds.
15-37............................ 15-51 ASTM F2347-15 Standard Guide for Withdrawn and replaced with
Characterization and Testing of newer version.
Hyaluronan as Starting
Materials Intended for Use in
Biomedical and Tissue
Engineered Medical Product
Applications.
15-42............................ 15-52 ASTM F2064-17 Standard Guide for Withdrawn and replaced with
Characterization and Testing of newer version.
Alginates as Starting Materials
Intended for Use in Biomedical
and Tissue Engineered Medical
Product Applications.
----------------------------------------------------------------------------------------------------------------
\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: 049.
Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No.
Recognition No. Title of standard \1\ and Date
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
1-131................ Medical suction equipment--Part ISO 10079-1
1: Electrically powered Third Edition
suction equipment. 2015-11-01.
1-132................ Medical suction equipment--Part ISO 10079-2
2: Manually powered suction Third Edition
equipment. 2014-05-01.
1-133................ Medical suction equipment--Part ISO 10079-3
3: Suction equipment powered Third Edition
from a vacuum or positive 2014-05-01.
pressure gas source.
1-134................ Biocompatibility evaluation of ISO 18562-1
breathing gas pathways in First edition
healthcare applications--Part 2017-03.
1: Evaluation and testing
within a risk management
process.
1-135................ Biocompatibility evaluation of ISO 18562-2
breathing gas pathways in First edition
healthcare applications--Part 2017-03.
2: Tests for emissions of
particulate matter.
1-136................ Biocompatibility evaluation of ISO 18562-3
breathing gas pathways in First edition
healthcare applications--Part 2017-03.
3: Tests for emissions of
volatile organic compounds.
1-137................ Biocompatibility evaluation of ISO 18562-4
breathing gas pathways in First edition
healthcare applications--Part 2017-03.
4: Tests for leachables in
condensate.
1-138................ Medical electrical equipment-- ISO 80601-2-74
Part 2-74: Particular First edition
requirements for basic safety 2017-05.
and essential performance of
respiratory humidifying
equipment.
------------------------------------------------------------------------
[[Page 26474]]
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this time ................
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
No new entries at this time ................
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-240................ Dentistry--Hydrocolloid ISO 21563 First
impression materials. edition 2013-08-
15.
4-241................ Dental materials--Determination ISO 7491 Second
of colour stability. edition 2000-09-
01.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
No new entries at this time ................
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
No new entries at this time ................
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-407................ Standard Specification for ASTM F3186-17.
Adult Portable Bed Rails and
Related Products.
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-274................ Verification and Validation of CLSI MM17-A Vol.
Multiplex Nucleic Acid Assays; 28 No. 9
Approved Guideline. (Replaces MM17-
P Vol. 27 No.
21).
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-461................ Standard Guide for Selecting ASTM F3208-17.
Test Soils for Validation of
Cleaning Methods for Reusable
Medical Devices.
8-462................ Standard Test Method for ASTM F3260-17.
Determining the Flexural
Stiffness of Medical Textiles.
8-463................ Standard Guide for Additive ISO/ASTM 52901
Manufacturing--General First edition
Principles--Requirements for 2017-08.
Purchased AM Parts.
8-464................ Assessment of the safety of ISO 10974 Second
magnetic resonance imaging for edition 2018.
patients with an active
implantable medical device.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
18-9................. Nanotechnologies--Guidance on ISO/TR 13014
physico-chemical First edition
characterization of engineered 2012-05-15.
nanoscale materials for
toxicologic assessment
[Including CORRIGENDUM 1
(2012)].
18-10................ Nanotechnologies--Endotoxin ISO 29701 First
test on nanomaterial samples edition 2010-09-
for in vitro systems--Limulus 15.
amebocyte lysate (LAL) test.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this time ................
------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
9-115................ Condoms--Guidance on clinical ISO 29943-1
studies--Part 1: Male condoms, First edition
clinical function studies 2017-07.
based on self-reports.
9-116................ Condoms--Guidance on clinical ISO 29943-2
studies--Part 2: Female First edition
condoms, clinical function 2017-07.
studies based on self-reports.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
10-110............... Ophthalmic implants--Ophthalmic ISO 15798 Third
viscosurgical devices edition 2013-09-
[Including AMENDMENT 1 (2017)]. 15 AMENDMENT 1
2017-05.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
No new entries at this time ................
------------------------------------------------------------------------
[[Page 26475]]
O. Physical Medicine
------------------------------------------------------------------------
16-202............... RESNA Standard for Wheelchairs RESNA WC-4:2017.
Volume 4: Wheelchairs and
Transportation.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
No new entries at this time ................
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-104............... Software Cybersecurity for ANSI/UL 2900-2-
Network-Connectable Products, 1, First
Part 2-1: Particular Edition
Requirements for Network September 1,
Connectable Components of 2017.
Healthcare and Wellness
Systems.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
No new entries at this time ................
------------------------------------------------------------------------
S. Tissue Engineering
------------------------------------------------------------------------
15-53................ Standard Guide for Assessing ASTM F3206 -17.
Medical Device
Cytocompatibility with
Delivered Cellular Therapies.
15-54................ Standard Guide for in vivo ASTM F3207-17.
Evaluation of Rabbit Lumbar
Intertransverse Process Spinal
Fusion Model.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.
IV. List of Recognized Standards
FDA maintains the current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA
will be incorporating 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 be
announcing 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
049, FDA will no longer include in the database the CDRH Office and
Division associated with recognized standards, Devices Affected, and
Processes Affected. Beginning with recognition list 049 FDA will
automatically incorporate, upon publication, a U.S. parallel adoption
of an existing recognized international standard.
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 considered, such recommendations
should contain, at a minimum, the following information available at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123739.htm.
Dated: May 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12222 Filed 6-6-18; 8:45 am]
BILLING CODE 4164-01-P