[Federal Register Volume 91, Number 33 (Thursday, February 19, 2026)]
[Notices]
[Pages 7994-8001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-03310]
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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: 065
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the 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: 065'' (Recognition List Number: 065), 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 February 19, 2026.
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: 065.'' 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: 065.
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
[[Page 7995]]
``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: 065 is available on
the internet at https://www.fda.gov/medical-devices/division-standards-and-conformity-assessment/federal-register-documents. See section IV
for electronic access to the searchable database for the current list
of FDA-recognized consensus standards, including Recognition List
Number: 065 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: 065'' to 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. 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, Rm. 5612, Silver Spring, MD 20993, 301-796-2503,
[email protected].
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-use-voluntary-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/federal-register-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/medical-devices/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/premarket-submissions-selecting-and-preparing-correct-submission/division-standards-and-conformity-assessment.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 065
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: 065'' 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 of this notice, 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: 065.
Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Replacement
Old Recognition No. Recognition No. Title of standard \1\ Change
----------------------------------------------------------------------------------------------------------------
A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-106........................... 1-197 ISO 17510 Second Edition 2025- Withdrawn and replaced
11 Medical devices--Sleep with newer version.
apnoea breathing therapy--
Masks and application
accessories.
1-149........................... 1-198 ISO 7376 Third edition 2020-08 Withdrawn and replaced
[Including AMD1:2025] with newer version.
Anaesthetic and respiratory
equipment--Laryngoscopes for
tracheal intubation--Amendment
1: Clarification of optical
output and illumination
requirements [Including
Amendment 1 (2025)].
[[Page 7996]]
1-151........................... 1-199 ISO 80601-2-70 Third edition Withdrawn and replaced
2025-11 Medical electrical with newer version.
equipment--Part 2-70:
Particular requirements for
the basic safety and essential
performance of sleep apnoea
breathing therapy equipment.
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-141........................... 2-308 ASTM F1984-25 Standard Practice Withdrawn and replaced
for Testing for Whole with newer version.
Complement Activation in Serum
by Solid Materials.
2-155........................... ................. ASTM F2147-01 (Reapproved 2016) Withdrawn.
Standard Practice for Guinea
Pig: Split Adjuvant and Closed
Patch Testing for Contact
Allergens.
2-189........................... 2-309 ASTM F895-25 Standard Test Withdrawn and replaced
Method for Agar Diffusion Cell with newer version.
Culture Screening for
Cytotoxicity.
2-244........................... 2-310 ASTM F748-25 Standard Practice Withdrawn and replaced
for Selecting Biological Test with newer version.
Methods for Materials and
Devices.
2-248........................... 2-311 ISO 10993-4 Third edition 2017- Withdrawn and replaced
04 Amendment 1 2025-1 with newer version.
Biological evaluation of
medical devices--Part 4:
Selection of tests for
interactions with blood
[including AMENDMENT 1 (2025)].
2-256........................... 2-312 ASTM F720-24 Standard Practice Withdrawn and replaced
for Testing Guinea Pigs for with newer version.
Contact Allergens: Guinea Pig
Maximization Test.
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-102........................... 3-201 IEC 60601-2-31 Edition 3.0 2020- Withdrawn and replaced
01 Medical electrical with newer version.
equipment--Part 2-31:
Particular requirements for
the basic safety and essential
performance of external
cardiac pacemakers with
internal power source.
3-115........................... 3-202 IEC 60601-2-34 Edition 4.0 2024- Withdrawn and replaced
10 Medical electrical with newer version.
equipment--Part 2-34:
Particular requirements for
the basic safety and essential
performance of invasive blood
pressure monitoring equipment.
----------------------------------------------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-153........................... 4-348 ISO 9917-1 Third edition 2025- Withdrawn and replaced
05 Dentistry--Water-based with newer version.
cements--Part 1: Acid-base
cements.
4-271........................... 4-349 ANSI/ADA Standard No. 34-2025 Withdrawn and replaced
Dentistry--Cartridge Syringes. with newer version.
4-275........................... 4-350 ASA/ANSI S3.6-2025 American Withdrawn and replaced
National Standard with newer version.
Specification for Audiometers.
4-309........................... 4-351 ISO 6877 Fourth edition 2025-08 Withdrawn and replaced
Dentistry--Endodontic with newer version.
obturating materials.
4-312........................... 4-352 ASA/ANSI S3.35-2025 American Withdrawn and replaced
National Standard Method of with newer version.
Measurement of Performance
Characteristics of Hearing
Aids Under Simulated Real-Ear
Working Conditions.
4-316........................... 4-353 ISO 20127 Third edition 2025-05 Withdrawn and replaced
Dentistry--Physical properties with newer version.
of powered toothbrushes.
4-319........................... 4-354 ISO 17730 Third edition 2025-09 Withdrawn and replaced
Dentistry--Fluoride varnishes. with newer version.
4-336........................... 4-355 ISO 18397 Second edition 2025- Withdrawn and replaced
07 Dentistry--Powered scalers. with newer version.
----------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-108........................... 5-146 ISO 80369-6 Second edition 2025- Withdrawn and replaced
05 Small bore connectors for with newer version.
liquids and gases in
healthcare applications--Part
6: Connectors for neural
applications.
5-121........................... 5-147 ISO 80369-1 Third edition 2025- Withdrawn and replaced
10 Small-bore connectors for with newer version.
liquids and gases in
healthcare applications--Part
1: General requirements.
5-134........................... 5-148 ISO 15223-1 Fourth edition 2021- Withdrawn and replaced
07 Medical devices--Symbols to with newer version.
be used with information to be
supplied by the manufacturer--
Part 1: General requirements
[Including Amendment 1 (2025)].
----------------------------------------------------------------------------------------------------------------
[[Page 7997]]
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-43........................... 19-57 IEC 61326-2-6 Edition 4.0 2025- Withdrawn and replaced
06 Electrical equipment for with newer version.
measurement, control and
laboratory use--EMC
requirements--Part 2-6:
Particular requirements--In
vitro diagnostic (IVD) medical
equipment.
----------------------------------------------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-384........................... 6-514 ISO 1135-4 Seventh edition 2025- Withdrawn and replaced
05 Transfusion equipment for with newer version.
medical use--Part 4:
Transfusion sets for single
use, gravity feed.
6-411........................... 6-515 ASTM D6499-24 Standard Test Withdrawn and replaced
Method for Immunological with newer version.
Measurement of Antigenic
Protein in Hevea Natural
Rubber (HNR) and its Products.
6-439........................... ................. ISO 7886-2 Second edition 2020- Extent of recognition.
04 Sterile hypodermic syringes
for single use--Part 2--
Syringes for use with power-
driven syringe pumps.
6-448........................... 6-516 ASTM F2407/F2407M-23a Standard Withdrawn and replaced
Specification for Surgical with newer version.
Gowns Intended for Use in
Healthcare Facilities.
6-484........................... 6-517 ASTM F3502-25 Standard Withdrawn and replaced
Specification for Barrier Face with newer version.
Coverings.
6-491........................... 6-518 ASTM F1670/F1670M-24a Standard Withdrawn and replaced
Test Method for Resistance of with newer version.
Materials Used in Protective
Clothing to Penetration by
Synthetic Blood.
6-493........................... 6-519 ASTM F2101-25 Standard Test Withdrawn and replaced
Method for Evaluating the with newer version.
Bacterial Filtration
Efficiency (BFE) of Medical
Face Mask Materials, Using a
Biological Aerosol of
Staphylococcus aureus.
6-494........................... 6-520 ASTM F3352/F3352M-23b Standard Withdrawn and replaced
Specification for Isolation with newer version.
Gowns Intended for Use in
Healthcare Facilities.
----------------------------------------------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-239........................... 7-346 CLSI EP32 2nd Edition Withdrawn and replaced
Implementation of Metrological with newer version.
Traceability in Laboratory
Medicine.
7-268........................... 7-347 CLSI EP21 2nd Edition Withdrawn and replaced
Evaluation of Total Analytical with newer version.
Error for Quantitative Medical
Laboratory Measurement
Procedures.
7-284........................... 7-348 CLSI EP37 1st Edition Withdrawn and replaced
Supplemental Tables for with newer version.
Interference Testing in
Clinical Chemistry.
7-298........................... 7-349 CLSI EP35 1st Edition Withdrawn and replaced
Assessment of Equivalence or with newer version.
Suitability of Specimen Types
for Medical Laboratory
Measurement Procedures.
----------------------------------------------------------------------------------------------------------------
I. Materials
----------------------------------------------------------------------------------------------------------------
8-179........................... 8-628 ASTM F754-24 Standard Withdrawn and replaced
Specification for Implantable with newer version.
Polytetrafluoroethylene (PTFE)
Sheet, Tube, and Rod Shapes
Fabricated from Granular
Molding Powders.
8-356........................... 8-629 ASTM F67-24 Standard Withdrawn and replaced
Specification for Unalloyed with newer version.
Titanium, for Surgical Implant
Applications (UNS R50250, UNS
R50400, UNS R50550, UNS
R50700).
8-399........................... 8-630 ASTM F90-24 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Cobalt-20Chromium-15Tungsten-
10Nickel Alloy for Surgical
Implant Applications (UNS
R30605).
8-400........................... 8-631 ASTM F1854-25 Standard Test Withdrawn and replaced
Method for Serological with newer version.
Evaluation of Porous Coatings
on Medical Implants using
Digital Images.
8-449........................... 8-632 ASTM F1058-25 Standard Withdrawn and replaced
Specification for Wrought with newer version.
40Cobalt-20Chromium-16Iron-
15Nickel-7Molybdenum Alloy
Wire, Strip, and Bar for
Surgical Implant Applications
(UNS R30003 and UNS R30008).
8-455........................... 8-633 ASTM F2902-24 Standard Guide Withdrawn and replaced
for Assessment of Absorbable with newer version.
Polymeric Implants.
8-484........................... 8-634 ASTM F2066-23 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Titanium-15 Molybdenum Alloy
for Surgical Implant
Applications (UNS R58150).
8-498........................... 8-635 ASTM F75-23 Standard Withdrawn and replaced
Specification for Cobalt-28 with newer version.
Chromium-6 Molybdenum Alloy
Castings and Casting Alloy for
Surgical Implants (UNS R30075).
8-507........................... 8-636 ASTM F688-25 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Cobalt-35Nickel-20Chromium-
10Molybdenum Alloy Plate,
Sheet, and Foil for Surgical
Implants (UNS R30035).
[[Page 7998]]
8-508........................... 8-637 ASTM F2579-24 Standard Withdrawn and replaced
Specification for Amorphous with newer version.
Poly(lactide) and Poly(lactide-
co-glycolide) Resins for
Surgical Implants.
8-521........................... 8-638 ASTM F2313-24 Standard Withdrawn and replaced
Specification for with newer version.
Poly(glycolide) and
Poly(glycolide-co-lactide)
Resins for Surgical Implants
with Mole Fractions Greater
Than or Equal to 70 %
Glycolide.
8-540........................... 8-639 ASTM F1091-25 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Cobalt-20Chromium-15Tungsten-
10Nickel Alloy Surgical
Fixation Wire (UNS R30605).
8-544........................... 8-640 ASTM F961-25 Standard Withdrawn and replaced
Specification for 35Cobalt- with newer version.
35Nickel-20Chromium-
10Molybdenum Alloy Forgings
for Surgical Implants (UNS
R30035).
8-547........................... 8-641 ASTM F629-24 Standard Practice Withdrawn and replaced
for Radiography of Cast with newer version.
Metallic Surgical Implants.
8-551........................... 8-642 ASTM F2895-24 Standard Practice Withdrawn and replaced
for Digital Radiography of with newer version.
Cast Metallic Implants.
8-574........................... 8-643 ASTM F2820-24 Standard Withdrawn and replaced
Specification for with newer version.
Polyetherketoneketone (PEKK)
Polymers for Surgical Implant
Applications.
8-578........................... 8-644 ASTM F2848-25 Standard Withdrawn and replaced
Specification for Medical- with newer version.
Grade Ultra-High-Molecular-
Weight Polyethylene Yarns.
8-589........................... 8-645 ASTM F1925-24 Standard Withdrawn and replaced
Specification for Semi- with newer version.
Crystalline Poly(lactide)
Polymer and Copolymer Resins
for Surgical Implants.
----------------------------------------------------------------------------------------------------------------
J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
K. Neurology
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-85........................... 10-139 ISO 11980 Fourth edition 2025- Withdrawn and replaced
06 Ophthalmic optics--Contact with newer version.
lenses and contact lens care
products--Requirements and
guidance for clinical
investigations.
----------------------------------------------------------------------------------------------------------------
N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-185.......................... 11-423 ASTM F2267-24 Standard Test Withdrawn and replaced
Method for Measuring Load- with newer version.
Induced Subsidence of
Intervertebral Body Fusion
Device Under Static Axial
Compression.
11-197.......................... 11-424 ASTM F983-24 Standard Practice Withdrawn and replaced
for Permanent Marking of with newer version.
Orthopaedic Implant Components.
11-199.......................... 11-425 ASTM F565-21 Standard Practice Withdrawn and replaced
for Care and Handling of with newer version.
Orthopedic Implants and
Instruments.
11-283.......................... 11-426 ASTM F2943-25 Standard Guide Withdrawn and replaced
for Presentation of End User with newer version.
Labeling Information for
Musculoskeletal Implants.
11-316.......................... 11-427 ASTM F1264-24 Standard Withdrawn and replaced
Specification and Test Methods with newer version.
for Intramedullary Fixation
Devices.
11-322.......................... 11-428 ASTM F1541-24 Standard Withdrawn and replaced
Specification and Test Methods with newer version.
for External Skeletal Fixation
Devices.
11-324.......................... 11-429 ASTM F366-24 Standard Withdrawn and replaced
Specification for Fixation with newer version.
Pins and Wires.
11-325.......................... 11-430 ASTM F564-24 Standard Withdrawn and replaced
Specification and Test Methods with newer version.
for Metallic Bone Staples.
11-326.......................... 11-431 ASTM F384-24 Standard Withdrawn and replaced
Specifications and Test with newer version.
Methods for Metallic Angled
Orthopedic Fracture Fixation
Devices.
11-329.......................... 11-432 ASTM F2180-24 Standard Withdrawn and replaced
Specification for Metallic with newer version.
Implantable Strands and Cables.
11-330.......................... 11-433 ASTM F2028-25a Standard Test Withdrawn and replaced
Methods for Dynamic Evaluation with newer version.
of Glenoid Loosening.
11-340.......................... 11-434 ASTM F3018-25 Standard Guide Withdrawn and replaced
for Assessment of Hard-on-Hard with newer version.
Articulation in Total Hip
Joint Replacement and
Resurfacing Hip Joint
Replacement.
[[Page 7999]]
11-369.......................... 11-435 ASTM F3292-25 Standard Practice Withdrawn and replaced
for Inspection of Spinal with newer version.
Implants Undergoing Testing.
11-374.......................... 11-436 ISO 7207-2 Third edition 2025- Withdrawn and replaced
08 Implants for surgery-- with newer version.
Components for partial and
total knee joint prostheses--
Part 2: Articulating surfaces
made of metal, ceramic and
plastics materials.
11-376.......................... 11-437 ASTM F2033-25 Standard Withdrawn and replaced
Specification for Hip Joint with newer version.
Replacement Bearing Surfaces.
11-378.......................... 11-438 ASTM F2502-24 Standard Withdrawn and replaced
Specification and Test Methods with newer version.
for Absorbable Plates and
Screws for Internal Fixation
Implants.
----------------------------------------------------------------------------------------------------------------
O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-203.......................... 16-237 ASME A18.1:2023 Safety Standard Withdrawn and replaced
for Platform Lifts and with newer version.
Stairway Chairlifts.
----------------------------------------------------------------------------------------------------------------
P. Radiology
----------------------------------------------------------------------------------------------------------------
12-361.......................... 12-384 ICDM IDMS Version 1.3 May 31, Withdrawn and replaced
2025 Information Display with newer version.
Measurements Standard.
12-363.......................... 12-385 NEMA PS 3.1-3.20 2025d Digital Withdrawn and replaced
Imaging and Communications in with newer version.
Medicine (DICOM) Set.
----------------------------------------------------------------------------------------------------------------
Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-69........................... 13-150 IEEE Std 11073-10472-2023 Withdrawn and replaced
Health informatics--Device with newer version.
Interoperability--Part 10472:
Personal Health Device
Communication--Device
Specialization--Medication
Monitor.
13-92, 13-55.................... 13-151 IEEE Std 11073-10421-2023 Withdrawn and replaced
Health Informatics--Device with newer version.
Interoperability--Part 10421:
Personal Health Device
Communication--Device
Specialization--Peak
expiratory flow monitor (peak
flow).
----------------------------------------------------------------------------------------------------------------
R. Sterility
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-67........................... 15-68 ASTM F2212-25 Characterization Withdrawn and replaced
of Type I Collagen as Starting with newer version.
Material for Surgical Implants
and Substrates for Tissue
Engineered Medical Products
(TEMPs).
----------------------------------------------------------------------------------------------------------------
\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: 065. These entries are of standards not
previously recognized by FDA.
Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference number
Recognition No. Title of standard \1\ and date
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
1-200.................... Anaesthetic and ISO 7376-2 First
respiratory equipment-- edition 2025-09.
Part 2: Video
laryngoscopes.
1-201.................... Lung ventilators and ISO 19223-2 First
related equipment-- edition 2025-04.
Vocabulary and
semantics--Part 2: High
frequency and jet
ventilation.
1-202.................... Lung ventilators and ISO 19223-3 First
related equipment-- edition 2025-09.
Vocabulary and
semantics--Part 3:
Respiratory care.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-203.................... Medical electrical IEC 80601-2-49
equipment--Part 2-49: Edition 1.1 2024-
Particular requirements 09 CONSOLIDATED
for the basic safety VERSION.
and essential
performance of
multifunction patient
monitors.
------------------------------------------------------------------------
[[Page 8000]]
D. Dental/ENT
------------------------------------------------------------------------
4-356.................... Dentistry--Orthodontic ANSI/ADA Standard
Wires. No. 32-2024.
4-357.................... Double-Pointed, ANSI/ADA Standard
Parenteral, Single Use No. 54-1986
Needles for Dentistry. (R2024).
4-358.................... Endodontics Instruments-- ANSI/ADA Standard
Enlargers. No. 95-2020.
4-359.................... Dentistry--Coiled ANSI/ADA Standard
Springs for Use in No. 159-2024.
Orthodontics.
4-360.................... Dentistry--Endodontic ISO 3630-1 Third
instruments--Part 1: edition 2019-08.
General requirements.
4-361.................... Dentistry--Endodontic ISO 3630-2 Fourth
instruments--Part 2: edition 2023-02.
Enlargers.
4-362.................... Dentistry--Endodontic ISO 3630-3 Third
instruments--Part 3: edition 2021-06
Compactors. Corrected version
2023-05.
4-363.................... Dentistry--Endodontic ISO 3630-5 Second
instruments--Part 5: edition 2020-08.
Shaping and cleaning
instruments.
4-364.................... Dentistry--Evaluation of ISO 3990 First
antibacterial activity edition 2023-07.
of dental restorative
materials, luting
materials, fissure
sealants and
orthodontic bonding or
luting materials.
4-365.................... Dentistry--Gypsum ISO 6873 Third
products. edition 2013-04.
4-366.................... Dentistry--Endodontic ISO 7551 Second
absorbent points. edition 2023-05.
4-367.................... Dentistry--Cartridge ISO 9997 Third
syringes. edition 2020-01.
------------------------------------------------------------------------
E. General I (QS/RM)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
F. General II (ES/EMC)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
G. GH/GPS
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
H. IVD
------------------------------------------------------------------------
7-351.................... Determining Allowable CLSI EP46 1st
Total Error Goals and Edition.
Limits for Quantitative
Medical Laboratory
Measurement Procedures.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-646.................... Standard Guide for ASTM F624-25.
Evaluation of
Thermoplastic
Polyurethane Solids and
Solutions for Medical
Applications.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
L. OB-Gyn/G/Urology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
10-140................... American National ANSI Z80.1-2020.
Standard for
Ophthalmics--Prescripti
on Ophthalmic Lenses--
Recommendations.
10-141................... Ophthalmic optics-- ISO 11978 Third
Contact lenses and edition 2017-08
contact lens care [Including
products--Labelling AMD1:2020].
[Including Amendment 1
(2020)].
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-439................... Standard Test Methods ASTM F3437-23.
for Metallic Bone
Plates Used in Small
Bone Fracture Fixation.
11-440................... Standard Test Method for ASTM F3738-25.
Hip Simulator Wear
Testing of Metal-on-
Polyethylene
Articulations Under
Adverse Conditions
Using Third-Body
Particles.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
16-238................... Assistive products for ISO 11199-1 Second
walking manipulated by edition 2021-05.
both arms--Requirements
and test methods Part
1: Walking frames.
16-239................... Assistive products for ISO 11199-2 Third
walking manipulated by edition 2021-07
both arms--Requirements [Including
and test methods Part AMD1:2024].
2: Rollators [Including
Amendment 1 (2024)].
------------------------------------------------------------------------
[[Page 8001]]
P. Radiology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-152................... Health informatics-- ISO TS 5615:2025.
Accelerating safe,
effective and secure
remote connected care
and mobile health
through standards-based
interoperability
solutions addressing
gaps revealed by
pandemics.
13-153................... Cybersecurity AAMI CR515.
Consideration Unique to
Machine-Learning
Enabled Medical Devices.
13-154................... Health informatics-- IEEE Std 11073-
Device 10429-2022.
Interoperability--Part
10429: Personal Health
Device Communication--
Device Specialization--
Spirometry.
13-155................... Health informatics-- IEEE Std 11073-
Device Interoperability 10442-2023.
Part 10442: Personal
health device
communication--Device
specialization--Strengt
h fitness equipment.
13-156................... Health Informatics-- IEEE Std 11073-
Device 10471-2023.
Interoperability--Part
10471: Personal Health
Device Communication--
Device Specialization--
Independent Living
Activity Hub.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-612................... Bacterial Endotoxins USP-NF <86>
Test Using Recombinant M16015_02_01.
Reagents.
------------------------------------------------------------------------
S. Tissue Engineering
------------------------------------------------------------------------
15-69.................... Standard Practice for ASTM F2944-20.
Automated Colony
Forming Unit (CFU)
Assays--Image
Acquisition and
Analysis Method for
Enumerating and
Characterizing Cells
and Colonies in Culture.
------------------------------------------------------------------------
\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. 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
[email protected]. To be considered, such recommendations
should contain, at a minimum, the information available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03310 Filed 2-18-26; 8:45 am]
BILLING CODE 4164-01-P