4164-01-P
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: 062
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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: 062”
(Recognition List Number: 062), will assist manufacturers who elect to declare conformity with
consensus standards to meet certain requirements for medical devices.
DATES: Submit either electronic or written comments on the notice at any time. These
modifications to the list of recognized standards are applicable [INSERT DATE OF
PUBLICATION IN THE FEDERAL REGISTER].
ADDRESSES: You may submit comments on the current list of FDA Recognized Consensus
Standards at any time 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: 062.” 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, 240-402-7500. 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: 062.
•

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.govinfo.gov/content/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 “Search” box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, 240-402-7500.
An electronic copy of Recognition List Number: 062 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 FDArecognized consensus standards, including Recognition List Number: 062 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: 062” to Terry Woods, Center for Devices and Radiological Health, Food and Drug

Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993, 301-7962503. 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: Terry Woods, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66,
Silver Spring, MD 20993, 301-796-2503, CDRHStandardsStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act of 1997 (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 of the FD&C Act 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 of September 14, 2018 (83 FR 46738), FDA announced the
availability of a guidance entitled “Appropriate Use of Voluntary Consensus Standards in
Premarket Submissions for Medical Devices.” The guidance describes how FDA has
implemented its standards recognition program and is available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-usevoluntary-consensus-standards-premarket-submissions-medical-devices. Modifications to the
initial list of recognized standards, as published in the Federal Register, can be accessed at
https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federalregister-documents.
These notices describe the addition, withdrawal, and revision of certain standards
recognized by FDA. The Agency maintains on its website HTML and PDF versions of the list of
FDA Recognized Consensus Standards, available at https://www.fda.gov/medicaldevices/standards-and-conformity-assessment-program/federal-register-documents. Additional

information on the Agency’s Division of Standards and Conformity Assessment is available at
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program.
II. Modifications to the List of Recognized Standards, Recognition List Number: 062
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: 062” 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 new entries and
consensus standards added as modifications to the list of recognized standards under Recognition
List Number: 062.
Old
Recognition
No.
1-81
1-97
1-100
1-101
1-103
1-126

Table 1.--Modifications to the List of Recognized Standards
Replacement
Title of Standard1
Change
Recognition
No.
A. Anesthesiology
1-167
CGA V-5:2019 Standard for Diameter Index Safety Withdrawn and replaced with
System (Noninterchangeable Low Pressure
newer version.
Connections for Medical Gas Applications).
1-168
CGA V-7.1:2021 Standard Method of Determining Withdrawn and replaced with
Cylinder Valve Outlet Connections for Medical
newer version.
Gases.
1-169
CGA V-1:2021 Standard for Compressed Gas
Withdrawn and replaced with
Cylinder Valve Outlet and Inlet Connections.
newer version.
1-170
CGA C-9:2019 Standard Color Marking of
Withdrawn and replaced with
Compressed Gas Containers for Medical Use.
newer version.
1-171
ISO 5367 Sixth edition 2023-07 Anaesthetic and
Extent of recognition.
respiratory equipment--Breathing sets and
Withdrawn and replaced with
connectors.
newer version.
1-172
ISO 11712 Second edition 2023-11 Anaesthetic
Withdrawn and replaced with
and respiratory equipment--Supralaryngeal airways newer version.
and connectors.

Old
Recognition
No.
1-134

1-135

1-136

1-137

1-138

3-163

4-215

19-19

6-295
6-322
6-408

8-159
8-527

Table 1.--Modifications to the List of Recognized Standards
Replacement
Title of Standard1
Change
Recognition
No.
1-173
ISO 18562-1 Second edition 2024-03
Withdrawn and replaced with
Biocompatibility evaluation of breathing gas
newer version.
pathways in healthcare applications--Part 1:
Evaluation and testing within a risk management
process.
1-174
ISO 18562-2 Second edition 2024-03
Withdrawn and replaced with
Biocompatibility evaluation of breathing gas
newer version.
pathways in healthcare applications--Part 2: Tests
for emissions of particulate matter.
1-175
ISO 18562-3 Second edition 2024-03
Withdrawn and replaced with
Biocompatibility evaluation of breathing gas
newer version.
pathways in healthcare applications--Part 3: Tests
for emissions of volatile organic substances.
1-176
ISO 18562-4 Second edition 2024-03
Withdrawn and replaced with
Biocompatibility evaluation of breathing gas
newer version.
pathways in healthcare applications--Part 4: Tests
for leachables in condensate.
1-177
ISO 80601-2-74 Second edition 2021-07 Medical
Withdrawn and replaced with
electrical equipment-Part 2-74: Particular
newer version.
requirements for basic safety and essential
performance of respiratory humidifying equipment.
B. Biocompatibility
No new entries at this time.
C. Cardiovascular
3-191
ISO 18242 First edition 2016-09-01 [Including
Withdrawn and replaced with
AMD1:2023] Cardiovascular implants and
newer version.
extracorporeal systems--Centrifugal blood pumps
[Including AMENDMENT 1 (2023)].
D. Dental/Ear, Nose, and Throat (ENT)
4-325
ANSI/ADA Standard No. 96-2020 Dental WaterWithdrawn and replaced with
based Cements.
newer version.
E. General I (Quality Systems/Risk Management) (QS/RM)
No new entries at this time.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
19-50
IEC TS 60601-4-2 Edition 1.0 2024-03 Medical
Withdrawn and replaced with
electrical equipment--Part 4-2: Guidance and
newer version.
interpretation--Electromagnetic immunity:
performance of medical electrical equipment and
medical electrical systems.
G. General Hospital/General Plastic Surgery (GH/GPS)
ANSI AAMI BF7:2012 Blood transfusion
Withdrawn.
microfilters.
6-498
ISO 10555-4 Third edition 2023-11 Intravascular
Withdrawn and replaced with
catheters--Sterile and single-use catheters--Part 4:
newer version.
Balloon dilatation catheters.
6-499
ISO 10555-1 Third edition 2023-11 Intravascular
Withdrawn and replaced with
catheters--Sterile and single-use catheters--Part 1:
newer version.
General requirements.
H. In Vitro Diagnostics (IVD)
No new entries at this time.
I. Materials
8-611
ISO 9584 Second edition 2023-10 Implants for
Withdrawn and replaced with
surgery--Nondestructive testing--Radiographic
newer version.
examination of cast metallic surgical implants.
8-612
ASTM F899-23 Standard Specification for
Withdrawn and replaced with
Wrought Stainless Steels for Surgical Instruments.
newer version.

Old
Recognition
No.
8-580
8-581
8-582

17-13

10-56
10-70
10-125

10-126

12-232
12-242

12-268

13-52

Table 1.--Modifications to the List of Recognized Standards
Replacement
Title of Standard1
Change
Recognition
No.
IEC 63145-20-10 Edition 1.0 2019-08 Eyewear
Transferred. See 12-357.
display--Part 20-10: Fundamental measurement
methods--Optical properties.
IEC 63145-20-20 Edition 1.0 2019-09 Eyewear
Transferred. See 12-358.
display--Part 20-20: Fundamental measurement
methods--Image quality.
IEC 63145-22-10 Edition 1.0 2020-01 Eyewear
Transferred. See 12-359.
display--Part 22-10: Specific measurement methods
for AR type--Optical properties.
J. Nanotechnology
No new entries at this time.
K. Neurology
17-18
IEEE Std 2010-2023 Recommended Practice for
Withdrawn and replaced with
Electroencephalography (EEG) Neurofeedback
newer version.
Systems.
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
No new entries at this time.
M. Ophthalmic
ANSI Z80.12-2007 (R2022) American National
Withdrawn with transition.
Standard for Ophthalmics--Multifocal Intraocular
See 10-135.
Lenses.
10-134
ISO 10943 Fourth edition 2023-01--ophthalmic
Withdrawn and replaced with
instruments--Indirect ophthalmoscopes.
newer version.
10-135
ISO 11979-7 Fifth edition 2024-01 Ophthalmic
Withdrawn and replaced with
implants--Intraocular lenses--Part 7: Clinical
newer version.
investigations of intraocular lenses that are
implanted in the eye in order to correct aphakia.
10-136
IEC 80601-2-58 Edition 3.0 2024-03 Medical
Withdrawn and replaced with
electrical equipment--Part 2-58: Particular
newer version.
requirements for basic safety and essential
performance of lens removal devices and
vitrectomy devices for ophthalmic surgery.
N. Orthopedic
No new entries at this time.
O. Physical Medicine
No new entries at this time.
P. Radiology
12-354
NEMA MS 4-2023 Acoustic Noise Measurement
Withdrawn and replaced with
Procedure for Magnetic Resonance Equipment.
newer version.
12-355
IEC 60601-2-57 Edition 2.0 2023-07 Medical
Withdrawn and replaced with
Electrical Equipment--Part 2-57: Particular
newer version.
requirements for the basic safety and essential
performance of non-laser light source equipment
intended for therapeutic, diagnostic, monitoring,
cosmetic and aesthetic use.
12-356
IEC 60601-2-22 Edition 4.0 2019-11 Medical
Withdrawn and replaced with
electrical equipment--Part 2-22: Particular
newer version.
requirements for basic safety and essential
performance of surgical, cosmetic, therapeutic and
diagnostic laser equipment.
Q. Software/Informatics
13-132
ISO/IEEE 11073-10408 Second edition 2022-12
Withdrawn and replaced with
newer version.
Health informatics--Point-of-care medical device
communication--Part 10408: Device specialization-Thermometer.

Table 1.--Modifications to the List of Recognized Standards
Replacement
Title of Standard1
Change
Recognition
No.
13-133
ISO/IEEE 11073-10415 Second edition 2022-12
Withdrawn and replaced with
newer version.
Health informatics--Point-of-care medical device
communication--Part 10415: Device specializationWeighing scale.
13-54
13-134
ISO/IEEE 11073-10404 Second edition 2022-12
Withdrawn and replaced with
newer version.
Health informatics--Personal health device
communication--Part 10404: Device specialization-Pulse oximeter.
13-57
13-135
ISO/IEEE 11073-10407 Second edition 2022-12
Withdrawn and replaced with
newer version.
Health informatics--Personal health device
communication--Part 10407: Device
Specialization--Blood pressure monitor.
13-113
13-136
ISO/IEEE 11073-20601 Third Edition 2022-12
Withdrawn and replaced with
Health informatics--Personal health device
newer version.
communication--Part 20601: Application profile-Optimized exchange protocol.
13-114
13-137
IEEE Std 11073-10101b-2023 Health informatics-- Withdrawn and replaced with
Point-of-care medical device communication--Part
newer version.
10101: Nomenclature.
R. Sterility
14-242
14-598
ISO 14644-3 Second edition 2020-06 Cleanrooms
Withdrawn and replaced with
and associated controlled environments--Part 3:
newer version.
Test methods.
14-243
ISO 14644-6 First edition 2007-07 Cleanrooms and Withdrawn.
associated controlled environments--Part 6:
Vocabulary.
14-277
ISO TS 17665-2 First edition 2009-01 Sterilization Withdrawn with transition.
of health care products--Moist heat--Part 2:
See 14-601.
Guidance on the application of ISO 17665-1.
14-333
ISO 17665-1 First edition 2006-08 Sterilization of
Withdrawn with transition.
health care products--Moist heat--Part 1:
See 14-601.
Requirements for the development, validation and
routine control of a sterilization process for medical
devices.
14-389
14-599
ISO 14644-9 Second edition Cleanrooms and
Withdrawn and replaced with
associated controlled environments--Part 9:
newer version.
Assessment of surface cleanliness for particle
concentration.
14-484
14-600
ASTM F1929-23 Standard Test Method for
Withdrawn and replaced with
Detecting Seal Leaks in Porous Medical Packaging newer version.
by Dye Penetration.
S. Tissue Engineering
No new entries at this time.
1 All standard titles in this table conform to the style requirements of the respective organizations.
Old
Recognition
No.
13-53

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: 062. These
entries are of standards not previously recognized by FDA.

Table 2.--New Entries to the List of Recognized Standards
Recognition No.
1-178
1-179

3-192
4-326
4-327
5-142

6-500
6-501
6-502
7-321
8-613
8-614
8-615
8-616
8-617

17-19

Title of Standard1
A. Anesthesiology
Anaesthetic and respiratory equipment--Peak expiratory flow
meters for the assessment of pulmonary function in spontaneously
breathing humans.
Anaesthetic and respiratory equipment--Spirometers intended for
the measurement of time forced expired volumes in humans
[Including: Technical Corrigendum 1 (2009)].
B. Biocompatibility
No new entries at this time.
C. Cardiovascular
Cardiovascular implants--Transcatheter cardiac occluders.
D. Dental/ENT
Dentistry--Graphical symbols for dental equipment [Including
AMENDMENT 1 (2018)].
Dentistry--Graphical symbols for dental instruments.
E. General I (QS/RM)
Packaging--Distribution packaging--Graphical symbols for
handling and storage of packages.
F. General II (ES/EMC)
No new entries at this time.
G. GH/GPS
Ultrasonics--Non-focusing short pressure pulse sources including
ballistic pressure pulse sources--Characteristics of fields.
Plastic containers for intravenous injections.
Injection systems for self-administration by paediatric patients-Requirements and guidelines for design.
H. IVD
Molecular Methods for Genotyping and Strain Typing of
Infectious Organisms.
I. Materials
Standard Specification for Wrought Seamless and Welded and
Drawn Cobalt Alloy Small Diameter Tubing for Surgical
Implants.
Standard Guide for Powder Reuse Schema in Powder Bed Fusion
Processes for Medical Applications for Additive Manufacturing
Feedstock Materials.
Additive manufacturing of metals--Qualification principles--Part
1: General qualification of operators.
Additive manufacturing of metals--Qualification principles--Part
2: Qualification of operators for PBF-LB.
Additive manufacturing of metals--Qualification principles--Part
3: Qualification of operators for PBF-EB.
J. Nanotechnology
No new entries at this time.
K. Neurology
Medical electrical equipment--Part 2-85: Particular requirements
for the basic safety and essential performance of cerebral tissue
oximeter equipment.
L. OB-Gyn/G/Urology
No new entries at this time.
M. Ophthalmic
No new entries at this time.
N. Orthopedic
No new entries at this time.
O. Physical Medicine

Reference No. and Date
ISO 23747 Second edition
2015-08.
ISO 26782 First edition 200907.

ISO 22679 First edition 202111.
ISO 9687 Second edition
2015-02.
ISO 21531 First edition 200902.
ISO 780 Fifth edition 2015-1201.

IEC 63045 Edition 1.0 202005.
ISO 15747 Third edition 201809.
ISO 23217 First edition 202402.
CLSI MM24 1st Edition.
ASTM F2527-24.
ASTM F3456-22.
ISO/ASTM 52926-1 First
edition 2023-11.
ISO/ASTM 52926-2 First
edition 2023-11.
ISO/ASTM 52926-3 First
edition 2023-11.

ISO 80601-2-85 Edition 1.0
2021-03.

Table 2.--New Entries to the List of Recognized Standards
Recognition No.

12-360

Title of Standard1
No new entries at this time.
P. Radiology
Eyewear display--Part 20-10: Fundamental measurement
methods--Optical properties.
Eyewear display--Part 20-20: Fundamental measurement
methods--Image quality.
Eyewear display--Part 22-10: Specific measurement methods for
AR type--Optical properties.
Eyewear display--Part 10: Specifications.

12-361

Information Display Measurements Standard.

12-357
12-358
12-359

Reference No. and Date
IEC 63145-20-10 Edition 1.0
2019-08.
IEC 63145-20-20 Edition 1.0
2019-09.
IEC 63145-22-10 Edition 1.0
2020-01.
IEC 63145-10 Edition 1.0
2023-09.
ICDM IDMS Version 1.2 May
2023.

Q. Software/Informatics
Health Informatics--Device Interoperability Part 10700:
IEEE Std 11073‐10700‐2022.
Point‐of‐Care Medical Device Communication--Standard for
Base Requirements for Participants in a Service‐Oriented Device
Connectivity (SDC) System.
13-139
Health informatics--Device interoperability--Part 10206: Personal IEEE Std 11073-10206-2022.
health device communication--Abstract Content Information
Model.
R. Sterility
14-601
Sterilization of health care products--Moist heat--Requirements
ISO 17665 First edition 2024for the development, validation and routine control of a
03.
sterilization process for medical devices.
14-602
Designing, testing, and labeling medical devices intended for
AAMI TIR12:2020/(R)2023.
processing by health care facilities: A guide for device
manufacturers.
14-603
Product adoption and process equivalence for ethylene oxide
AAMI TIR28:2016/(R)2020.
sterilization.
S. Tissue Engineering
No new entries at this time.
1 All standard titles in this table conform to the style requirements of the respective organizations.
13-138

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. Such standards are
those that FDA has recognized by notice published in the Federal Register or that FDA has
decided to recognize but for which recognition is pending (because a periodic notice has not yet
appeared in the Federal Register). 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.
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 CDRHStandardsStaff@fda.hhs.gov. To be considered, such
recommendations should contain, at a minimum, the information available at
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program#process.
Dated: June 18, 2024.

Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13777 Filed: 6/21/2024 8:45 am; Publication Date: 6/24/2024]