Document ID: FDA-2004-N-0451-0055
Agency: fda
Document Type: Notice
Title: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 060
Posted Date: 2023-08-07T04:00Z

[Federal Register Volume 88, Number 150 (Monday, August 7, 2023)]
[Notices]
[Pages 52173-52179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16770]

-----------------------------------------------------------------------

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: 060

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: 060'' (Recognition List Number: 060), 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 August 7, 2023.

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

[[Page 52174]]

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: 060.'' 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: 060.
     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: 060 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: 
060 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: 060'' to Jianchao Zeng, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5572, Silver Spring, MD 20993, 301-796-6580. 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: Jianchao Zeng, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993, 301-796-6580, 
[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 Standards and Conformity 
Assessment Program is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 060

    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: 060'' 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: 060.

[[Page 52175]]

       Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
                   Replacement
 Old recognition   recognition   Title of standard \1\       Change
       No.             No.
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
1-127...........         1-161  ISO 16628 Second        Withdrawn and
                                 edition 2022-06         replaced with
                                 Anaesthetic and         newer version.
                                 respiratory
                                 equipment--Tracheobro
                                 nchial tubes.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
2-213...........         2-299  ASTM F1904-23 Standard  Withdrawn and
                                 Guide for Testing the   replaced with
                                 Biological Responses    newer version.
                                 to Medical Device
                                 Particulate Debris
                                 and Degradation
                                 Products in vivo.
2-222...........         2-300  ISO 10993-2 Third       Withdrawn and
                                 edition 2022-11         replaced with
                                 Biological evaluation   newer version.
                                 of medical devices--
                                 Part 2: Animal
                                 welfare requirements.
2-227...........         2-301  ASTM F1983-23 Standard  Withdrawn and
                                 Practice for            replaced with
                                 Assessment of           newer version.
                                 Selected Tissue
                                 Effects of Absorbable
                                 Biomaterials for
                                 Implant Applications.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-87............         3-184  ASTM F2477-23 Standard  Withdrawn and
                                 Test Methods for in     replaced with
                                 vitro Pulsatile         newer version.
                                 Durability Testing of
                                 Vascular Stents and
                                 Endovascular
                                 Prostheses.
------------------------------------------------------------------------
                  D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-86............  ............  ANSI/ADA Standard No.   Withdrawn.
                                 38-2000 (R2015) Metal-
                                 Ceramic Dental
                                 Restorative Systems.
4-139...........  ............  ANSI/ADA Standard No.   Withdrawn.
                                 48-2004 (R2015)
                                 Visible Light Curing
                                 Units.
4-181...........         4-298  ISO 4049 Fifth edition  Withdrawn and
                                 2019-05 Dentistry--     replaced with
                                 Polymer-based           newer version.
                                 restorative materials.
4-198...........         4-299  ISO 3107 Fifth edition  Withdrawn and
                                 2022-09 Dentistry--     replaced with
                                 Zinc oxide-eugenol      newer version.
                                 cements and non-
                                 eugenol zinc oxide
                                 cements.
4-227...........         4-300  ISO 22674 Third         Withdrawn and
                                 edition 2022-08         replaced with
                                 Dentistry--Metallic     newer version.
                                 materials for fixed
                                 and removable
                                 restorations and
                                 appliances.
4-231...........  ............  ISO/TS 11405 Third      Withdrawn.
                                 edition 2015-02-01
                                 Dentistry--Testing of
                                 adhesion to tooth
                                 structure.
4-240...........         4-301  ISO 21563 Second        Withdrawn and
                                 edition 2021-08         replaced with
                                 Dentistry--Hydrocollo   newer version.
                                 id impression
                                 materials.
4-248...........         4-302  ISO 10477 Fourth        Withdrawn and
                                 edition 2020-10         replaced with
                                 Dentistry--Polymer-     newer version.
                                 based crown and
                                 veneering materials.
4-249...........  ............  ANSI/ADA Standard No.   Withdrawn.
                                 19-2018 Elastometric
                                 Impression Materials.
4-253...........  ............  ANSI/ADA Standard No.   Withdrawn. See 4-
                                 27-2016 Polymer-based   298.
                                 Restorative Materials.
4-264...........         4-303  ISO 9333 Third edition  Withdrawn and
                                 2022-08 Dentistry--     replaced with
                                 Brazing materials.      newer version.
4-267...........         4-304  ISO 21606 Second        Withdrawn and
                                 edition 2022-08         replaced with
                                 Dentistry--Elastomeri   newer version.
                                 c auxiliaries for use
                                 in orthodontics.
------------------------------------------------------------------------
         E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-34...........  ............  IEC 61010-1 Edition     Recognition
                                 3.1 2017-01             restored.
                                 CONSOLIDATED VERSION
                                 Safety requirements
                                 for electrical
                                 equipment for
                                 measurement, control,
                                 and laboratory use--
                                 Part 1: General
                                 requirements
                                 [Including:
                                 Corrigendum 1 (2019)].
------------------------------------------------------------------------
          G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-253...........         6-486  ISO 10535 Third         Withdrawn and
                                 Edition 2021-10         replaced with
                                 Assistive products--    newer version.
                                 Hoists for the
                                 transfer of persons--
                                 Requirements and test
                                 methods.
6-296...........         6-487  AAMI PB70:2022 Liquid   Withdrawn and
                                 barrier performance     replaced with
                                 and classification of   newer version.
                                 protective apparel
                                 and drapes intended
                                 for use in health
                                 care facilities.
6-306...........         6-488  ASTM F1671/F1671M-22    Withdrawn and
                                 Standard Test Method    replaced with
                                 for Resistance of       newer version.
                                 Materials Used in
                                 Protective Clothing
                                 to Penetration by
                                 Blood-Borne Pathogens
                                 Using Phi-X174
                                 Bacteriophage
                                 Penetration as a Test
                                 System.
6-321...........         6-489  IEC 60601-2-52 Edition  Withdrawn and
                                 1.1 2015-03             replaced with
                                 CONSOLIDATED VERSION    newer version.
                                 Medical electrical
                                 equipment--Part 2-52:
                                 Particular
                                 requirements for the
                                 basic safety and
                                 essential performance
                                 of medical beds.
6-357...........         6-490  ISO 10555-6 First       Withdrawn and
                                 edition 2015-04-15      replaced with
                                 Intravascular           newer version.
                                 catheters--Sterile
                                 and single-use
                                 catheters--Part 6:
                                 Subcutaneous
                                 implanted ports
                                 [Including Amendment
                                 1 (2019)].
6-402...........         6-491  ASTM F1670/F1670M-17a   Withdrawn and
                                 Standard Test Method    replaced with
                                 for Resistance of       newer version.
                                 Materials Used in
                                 Protective Clothing
                                 to Penetration by
                                 Synthetic Blood.

[[Page 52176]]

 
6-425...........         6-492  ASTM F2100-23 Standard  Withdrawn and
                                 Specification for       replaced with
                                 Performance of          newer version.
                                 Materials Used in
                                 Medical Face Masks.
6-427...........         6-493  ASTM F2101-23 Standard  Withdrawn and
                                 Test Method for         replaced with
                                 Evaluating the          newer version.
                                 Bacterial Filtration
                                 Efficiency (BFE) of
                                 Medical Face Mask
                                 Materials, Using a
                                 Biological Aerosol of
                                 Staphylococcus aureus.
6-474...........         6-494  ASTM F3352/F3352M-23a   Withdrawn and
                                 Standard                replaced with
                                 Specification for       newer version.
                                 Isolation Gowns
                                 Intended for Use in
                                 Healthcare Facilities.
------------------------------------------------------------------------
                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-152...........         7-315  CLSI EP12 3rd Edition   Withdrawn and
                                 Evaluation of           replaced with
                                 Qualitative, Binary     newer version.
                                 Output Examination
                                 Performance.
7-244...........         7-316  CLSI NBS01 7th Edition  Withdrawn and
                                 Dried Blood Spot        replaced with
                                 Specimen Collection     newer version.
                                 for Newborn Screening.
7-308...........         7-317  CLSI M100, 33rd         Withdrawn and
                                 Edition Performance     replaced with
                                 Standards for           newer version.
                                 Antimicrobial
                                 Susceptibility
                                 Testing.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-200...........         8-597  ASTM F2003-02(2022)     Withdrawn and
                                 Standard Practice for   replaced with
                                 Accelerated Aging of    newer version.
                                 Ultra-High Molecular
                                 Weight Polyethylene
                                 After Gamma
                                 Irradiation in Air.
8-441...........         8-598  ASTM F3109-22 Standard  Withdrawn and
                                 Practice for            replaced with
                                 Verification of Multi-  newer version.
                                 Axis Force Measuring
                                 Platforms.
8-453...........         8-599  ASTM F1295-22 Standard  Withdrawn and
                                 Specification for       replaced with
                                 Wrought Titanium-       newer version.
                                 6Aluminum-7Niobium
                                 Alloy for Surgical
                                 Implant Applications
                                 (UNS R56700).
8-467...........         8-600  ASTM F1978-22 Standard  Withdrawn and
                                 Test Method for         replaced with
                                 Measuring Abrasion      newer version.
                                 Resistance of
                                 Metallic Thermal
                                 Spray Coatings by
                                 Using the Taber
                                 Abraser.
8-506...........         8-601  ASTM F2516-22 Standard  Withdrawn and
                                 Test Method for         replaced with
                                 Tension Testing of      newer version.
                                 Nickel-Titanium
                                 Superelastic
                                 Materials.
8-528...........         8-602  ASTM F2503-23 Standard  Withdrawn and
                                 Practice for Marking    replaced with
                                 Medical Devices and     newer version.
                                 Other Items for
                                 Safety in the
                                 Magnetic Resonance
                                 Environment.
8-555...........         8-603  ASTM F1472-23 Standard  Withdrawn and
                                 Specification for       replaced with
                                 Wrought Titanium-       newer version.
                                 6Aluminum-4Vanadium
                                 Alloy for Surgical
                                 Implant Applications
                                 (UNS R56400).
------------------------------------------------------------------------
                            J. Nanotechnology
------------------------------------------------------------------------
18-15...........         18-23  ASTM E3025-22 Standard  Withdrawn and
                                 Guide for Tiered        replaced with
                                 Approach to Detection   newer version.
                                 and Characterization
                                 of Silver
                                 Nanomaterials in
                                 Textiles.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
  L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
9-67............         9-145  ASTM D7661-18 Standard  Withdrawn and
                                 Test Method for         replaced with
                                 Determining             newer version.
                                 Compatibility of
                                 Personal Lubricants
                                 with Natural Rubber
                                 Latex Condoms.
9-94............         9-146  ISO 8600-4 Third        Withdrawn and
                                 Edition 2023-01         replaced with
                                 Endoscopes--Medical     newer version.
                                 endoscopes and
                                 endotherapy devices--
                                 Part 4: Determination
                                 of maximum width of
                                 insertion portion.
9-125...........         9-147  ISO/CIE 11664-2 First   Withdrawn and
                                 edition 2022-08         replaced with
                                 Colorimetry--Part 2:    newer version.
                                 CIE standard
                                 illuminants.
9-128...........         9-148  ISO/CIE 11664-6 Second  Withdrawn and
                                 edition 2022-08         replaced with
                                 Colorimetry--Part 6:    newer version.
                                 CIEDE2000 Colour-
                                 difference formula.
9-143...........  ............  ISO 20696 First         Extent of
                                 edition 2018-06         recognition.
                                 Corrected version
                                 2019-12 Sterile
                                 urethral catheters
                                 for single use.
------------------------------------------------------------------------
                              M. Ophthalmic
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
11-294..........        11-399  ASTM F1357-23 Standard  Withdrawn and
                                 Specification for       replaced with
                                 Articulating Total      newer version.
                                 Wrist Implants.
------------------------------------------------------------------------

[[Page 52177]]

 
                          O. Physical Medicine
------------------------------------------------------------------------
16-165..........        16-234  ISO 7176-14 Third       Withdrawn and
                                 Edition 2022            replaced with
                                 Wheelchairs--Part 14    newer version.
                                 Power and control
                                 systems for
                                 electrically powered
                                 wheelchairs and
                                 scooters--Requirement
                                 s and test methods.
16-194..........        16-235  ISO 7176-25 Second      Withdrawn and
                                 Edition 2022            replaced with
                                 Wheelchairs--Part 25:   newer version.
                                 Lead-acid batteries
                                 and chargers for
                                 powered wheelchairs--
                                 Requirements and test
                                 methods.
16-201..........        16-236  ISO 7176-19 Third       Withdrawn and
                                 Edition 2022            replaced with
                                 Wheelchairs--Part 19:   newer version.
                                 Wheeled mobility
                                 devices for use as
                                 seats in motor
                                 vehicles.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
12-6............        12-350  IEC 60806 Edition 2.0   Withdrawn and
                                 2022-11 Determination   replaced with
                                 of the maximum          newer version.
                                 symmetrical radiation
                                 field of X-ray tube
                                 assemblies and X-ray
                                 source assemblies for
                                 medical diagnosis.
12-347..........  ............  IEC 60601-2-33 Edition  Transition
                                 4.0 2022-08 Medical     period
                                 electrical equipment--  extended.
                                 Part 2-33: Particular
                                 requirements for the
                                 basic safety and
                                 essential performance
                                 of magnetic resonance
                                 equipment for medical
                                 diagnosis.
12-329..........        12-351  IEC 60601-2-43 Edition  Withdrawn and
                                 3.0 2022-12 Medical     replaced with
                                 electrical equipment--  newer version.
                                 Part 2-43: Particular
                                 requirements for the
                                 basic safety and
                                 essential performance
                                 of X-ray equipment
                                 for interventional
                                 procedures.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-169..........        14-584  ASTM F2391-22 Standard  Withdrawn and
                                 Test Method for         replaced with
                                 Measuring Package and   newer version.
                                 Seal Integrity Using
                                 Helium as the Tracer
                                 Gas.
14-456..........        14-585  ISO/TS 16775 Second     Withdrawn and
                                 edition 2021-11         replaced with
                                 Packaging for           newer version.
                                 terminally sterilized
                                 medical devices--
                                 Guidance on the
                                 application of ISO
                                 11607-1 and ISO 11607-
                                 2.
14-575..........  ............  ASTM F1980-21 Standard  Transition
                                 Guide for Accelerated   period
                                 Aging of Sterile        extended.
                                 Barrier Systems for
                                 Medical Devices.
------------------------------------------------------------------------
                          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.

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

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                     Reference No. and
   Recognition No.        Title of standard \1\             date
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-185................  Active implantable medical  ANSI/AAMI PC76:2021.
                        devices--Requirements and
                        test protocols for safety
                        of patients with
                        pacemakers and ICDs
                        exposed to magnetic
                        resonance imaging.
3-186................  Implants for surgery--      ISO 14708-2 Third
                        Active implantable          edition 2019-09.
                        medical devices--Part 2:
                        Cardiac pacemakers.
3-187................  Implants for surgery--      ISO 14708-6 Second
                        Active implantable          edition 2019-09.
                        medical devices--Part 6:
                        Particular requirements
                        for active implantable
                        medical devices intended
                        to treat tachyarrhythmia
                        (including implantable
                        defibrillators).

[[Page 52178]]

 
3-188................  Non-invasive                ISO 81060-3 First
                        sphygmomanometers--Part     edition 2022-12.
                        3: Clinical investigation
                        of continuous automated
                        measurement type.
------------------------------------------------------------------------
                              D. Dental/ENT
------------------------------------------------------------------------
4-305................  Dentistry--Central suction  ISO 10637 Second
                        source equipment.           edition 2018-05.
4-306................  Dentistry--Compressed air   ISO 22052 First
                        source equipment.           edition 2020-06.
4-307................  Dentistry--General          ISO 13504 First
                        requirements for            edition 2012-07.
                        instruments and related
                        accessories used in
                        dental implant placement
                        and treatment.
4-308................  Implants for surgery--      ISO 14708-7 Second
                        Active implantable          edition 2019-12
                        medical devices--Part 7:    (Corrected version
                        Particular requirements     2020-05).
                        for cochlear and auditory
                        brainstem implant systems.
------------------------------------------------------------------------
                          E. General I (QS/RM)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                         F. General II (ES/EMC)
------------------------------------------------------------------------
19-49................  Medical electrical          IEC 60601-1 Edition
                        equipment--Part 1:          3.2 2020-08
                        General requirements for    CONSOLIDATED
                        basic safety and            VERSION.
                        essential performance.
------------------------------------------------------------------------
                                G. GH/GPS
------------------------------------------------------------------------
6-495................  Catheter systems for        ISO 20698 First
                        neuraxial application--     Edition 2018-07.
                        Sterile and single-use
                        catheters and accessories.
6-496................  Standard Test Method for    ASTM F739-20.
                        Permeation of Liquids and
                        Gases Through Protective
                        Clothing Materials Under
                        Conditions of Continuous
                        Contact.
------------------------------------------------------------------------
                                 H. IVD
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-604................  Standard Specification for  ASTM F2257-22.
                        Wrought Seamless or
                        Welded and Drawn
                        18Chromium-14Nickel-
                        2.5Molybdenum Stainless
                        Steel Small Diameter
                        Tubing for Surgical
                        Implants (UNS S31673).
------------------------------------------------------------------------
                            J. Nanotechnology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                           L. OB-Gyn/G/Urology
------------------------------------------------------------------------
9-149................  Medical electrical          IEC 60601-2-39
                        equipment--Part 2-39:       Edition 3.0 2018-04.
                        Particular requirements
                        for basic safety and
                        essential performance of
                        peritoneal dialysis
                        equipment.
------------------------------------------------------------------------

[[Page 52179]]

 
                              M. Ophthalmic
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-586...............  Sterilization of health     ISO 22441 First
                        care products--Low          edition 2022-08.
                        temperature vaporized
                        hydrogen peroxide--
                        Requirements for the
                        development, validation
                        and routine control of a
                        sterilization process for
                        medical devices.
14-587...............  Guidance on transferring    AAMI TIR104:2022.
                        health care products
                        between radiation
                        sterilization sources.
14-588...............  Compatibility of materials  AAMI TIR17:2017/
                        subjected to                (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.

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.

    Dated: August 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16770 Filed 8-4-23; 8:45 am]
BILLING CODE 4164-01-P