[Federal Register Volume 84, Number 206 (Thursday, October 24, 2019)]
[Notices]
[Pages 57034-57041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23198]


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

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: 052

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: 052'' (Recognition List Number: 052), 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 October 24, 2019.

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: http://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: 052.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday. FDA will 
consider any comments received in determining whether to amend the 
current listing of

[[Page 57035]]

modifications to the list of recognized standards, Recognition List 
Number: 052.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    An electronic copy of Recognition List Number: 052 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: 
052 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: 052'' to Scott Colburn, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 
66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-847-8144.

FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287, 
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 
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 hypertext 
markup language (HTML) and portable document format (PDF) versions of 
the list of FDA Recognized Consensus Standards. Additional information 
on the Agency's Standards 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: 052

    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: 052'' 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: 052.

                           Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
    Old  Recognition No.     Replacement Recognition No.      Title of standard \1\               Change
----------------------------------------------------------------------------------------------------------------
                                                A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-116......................  ...........................  ISO 5360 Fourth edition 2016-  Extent of Recognition.
                                                           02-15 Anaesthetic
                                                           vaporizers--Agent specific
                                                           filling systems.
1-122......................  ...........................  ISO 5364 Fifth edition 2016-   Extent of Recognition.
                                                           09-01 Anaesthetic and
                                                           respiratory equipment--
                                                           Oropharyngeal airways.
1-125......................  ...........................  ISO 8836 Fourth edition 2014-  Extent of Recognition.
                                                           10-15 Suction catheters for
                                                           use in the respiratory tract.

[[Page 57036]]

 
1-126......................  ...........................  ISO 11712 First edition 2009-  Extent of Recognition.
                                                           05-15 Anaesthetic and
                                                           respiratory equipment--
                                                           Supralaryngeal airways and
                                                           connectors.
1-131......................  1-142......................  ISO 10079-1 Third Edition      Withdrawn and replaced
                                                           2015-11-01 Medical suction     with newer version
                                                           equipment--Part 1:             including amendment.
                                                           Electrically powered suction
                                                           equipment [Including
                                                           AMENDMENT 1 (2018)].
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-162......................  2-263......................  ASTM F1903-18 Standard         Withdrawn and replaced
                                                           Practice for Testing for       with newer version.
                                                           Cellular Responses to
                                                           Particles in vitro.
2-206......................  2-264......................  ASTM F2148-18 Standard         Withdrawn and replaced
                                                           Practice for Evaluation of     with newer version.
                                                           Delayed Contact
                                                           Hypersensitivity Using the
                                                           Murine Local Lymph Node
                                                           Assay (LLNA).
2-223......................  2-265......................  ASTM F2901-19 Standard Guide   Withdrawn and replaced
                                                           for Selecting Tests to         with newer version.
                                                           Evaluate Potential
                                                           Neurotoxicity of Medical
                                                           Devices.
2-257......................  2-266......................  ASTM F2382-18 Standard Test    Withdrawn and replaced
                                                           Method for Assessment of       with newer version.
                                                           Circulating Blood-Contacting
                                                           Medical Device Materials on
                                                           Partial Thromboplastin Time
                                                           (PTT).
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-122......................  3-160......................  ISO 81060-2 Third edition      Withdrawn and replaced
                                                           2018-11 Non-invasive           with newer version.
                                                           sphygmomanometers--Part 2:
                                                           Clinical investigation of
                                                           intermittent automated
                                                           measurement type.
3-123......................  ...........................  IEC 80601-2-30 Edition 2.0     Extent of Recognition.
                                                           2018-03 Medical electrical
                                                           equipment--Part 2-30:
                                                           Particular requirements for
                                                           the basic safety and
                                                           essential performance of
                                                           automated non-invasive
                                                           sphygmomanometers.
3-137......................  ...........................  ASTM F3036-13 Standard Guide   Extent of Recognition.
                                                           for Testing Absorbable
                                                           Stents.
----------------------------------------------------------------------------------------------------------------
                                      D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-182......................  4-258......................  ISO 10139-2 Third edition      Withdrawn and replaced
                                                           2016-06-15 Dentistry--Soft     with newer version.
                                                           lining materials for
                                                           removable dentures--Part 2:
                                                           Materials for long-term use.
4-196......................  ...........................  ISO 6872 Third edition 2008-   Withdrawn. See #4-223.
                                                           09-01 Dentistry--Ceramic
                                                           materials.
----------------------------------------------------------------------------------------------------------------
                             E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-109......................  5-123......................  ISO 80369-3 First edition      Withdrawn and replaced
                                                           2016-07-01 Small-bore          with newer version
                                                           connectors for liquids and     including amendment.
                                                           gases in healthcare
                                                           applications --Part 3:
                                                           Connectors for enteral
                                                           applications [Including
                                                           AMENDMENT 1 (2019)].
5-115......................  ...........................  ISO 80369-7 First edition      Transition removed.
                                                           2016-10-15 Small-bore
                                                           connectors for liquids and
                                                           gases in healthcare
                                                           applications--Part 7:
                                                           Connectors for intravascular
                                                           or hypodermic applications.
----------------------------------------------------------------------------------------------------------------
                    F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
                                                          No new entries at this time..
----------------------------------------------------------------------------------------------------------------
                              G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-11.......................  ...........................  ISO 594-1 First edition 1986-  Transition removed.
                                                           06-15 Conical fittings with    Recognition restored.
                                                           a 6% (Luer) taper for
                                                           syringes, needles and
                                                           certain other medical
                                                           equipment--Part 1: General
                                                           requirements.
----------------------------------------------------------------------------------------------------------------
6-129......................  ...........................  ISO 594-2 Second edition 1998- Transition removed.
                                                           09-01 Conical fittings with    Recognition restored.
                                                           a 6% (Luer) taper for
                                                           syringes, needles and
                                                           certain other medical
                                                           equipment--Part 2: Lock
                                                           fittings.
6-403......................  6-421......................  ISO 80601-2-56 Second edition  Withdrawn and replaced
                                                           2017-03 Medical electrical     with newer version
                                                           equipment--Part 2-56:          including amendment.
                                                           Particular requirements for
                                                           basic safety and essential
                                                           performance of clinical
                                                           thermometers for body
                                                           temperature measurement
                                                           [Including AMENDMENT 1
                                                           (2018)].
----------------------------------------------------------------------------------------------------------------
                                          H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-215......................  7-287......................  CLSI M44-S3 (2018) Zone        Withdrawn and replaced
                                                           Diameter Interpretive          with newer version.
                                                           Standards, Corresponding
                                                           Minimal Inhibitory
                                                           Concentration (MIC)
                                                           Interpretive Breakpoints,
                                                           and Quality Control Limits
                                                           for Antifungal Disk
                                                           Diffusion Susceptibility
                                                           Testing of Yeasts; Third
                                                           Informational Supplement.
7-222......................  7-288......................  CLSI M24 3rd Edition           Withdrawn and replaced
                                                           Susceptibility Testing of      with newer version.
                                                           Mycobacteria, Nocardia spp.,
                                                           and Other Aerobic
                                                           Actinomycetes.

[[Page 57037]]

 
7-274......................  7-289......................  CLSI MM17 2nd Edition          Withdrawn and replaced
                                                           Validation and Verification    with newer version.
                                                           of Multiplex Nucleic Acid
                                                           Assays.
----------------------------------------------------------------------------------------------------------------
                                                  I. Materials
----------------------------------------------------------------------------------------------------------------
8-132......................  8-491......................  ASTM F1088-18 Standard         Withdrawn and replaced
                                                           Specification for Beta-        with newer version.
                                                           Tricalcium Phosphate for
                                                           Surgical Implantation.
8-150......................  8-492......................  ISO 5832-9 Third edition 2019- Withdrawn and replaced
                                                           02 Implants for surgery--      with newer version.
                                                           Metallic materials--Part 9:
                                                           Wrought high nitrogen
                                                           stainless steel.
8-188......................  8-493......................  ISO 13779-2 Third edition      Withdrawn and replaced
                                                           2018-12 Implants for           with newer version.
                                                           surgery--Hydroxyapatite--Par
                                                           t 2: Thermally sprayed
                                                           coatings of hydroxyapatite.
8-194......................  8-494......................  ISO 6474-1 Second edition      Withdrawn and replaced
                                                           2019-03 Implants for           with newer version.
                                                           surgery--Ceramic materials--
                                                           Part 1: Ceramic materials
                                                           based on high purity alumina.
8-213......................  8-495......................  ISO 5834-3 Second edition      Withdrawn and replaced
                                                           2019-02 Implants for           with newer version.
                                                           surgery--Ultra-high-
                                                           molecular-weight
                                                           polyethylene--Part 3:
                                                           Accelerated ageing methods.
8-214......................  8-496......................  ISO 5834-4 Second edition      Withdrawn and replaced
                                                           2019-02 Implants for           with newer version.
                                                           surgery--Ultra-high-
                                                           molecular-weight
                                                           polyethylene--Part 4:
                                                           Oxidation index measurement
                                                           method.
8-215......................  8-497......................  ISO 5834-5 Second edition      Withdrawn and replaced
                                                           2019-02 Implants for           with newer version.
                                                           surgery--Ultra-high-
                                                           molecular-weight
                                                           polyethylene--Part 5:
                                                           Morphology assessment method.
8-229......................  8-498......................  ASTM F75-18 Standard           Withdrawn and replaced
                                                           Specification for Cobalt-28    with newer version.
                                                           Chromium-6 Molybdenum Alloy
                                                           Castings and Casting Alloy
                                                           for Surgical Implants (UNS
                                                           R30075).
8-331......................  8-499......................  ASTM F1580-18 Standard         Withdrawn and replaced
                                                           Specification for Titanium     with newer version.
                                                           and Titanium-6 Aluminum-4
                                                           Vanadium Alloy Powders for
                                                           Coatings of Surgical
                                                           Implants.
8-351......................  8-500......................  ISO 5832-12 Third edition      Withdrawn and replaced
                                                           2019-02 Implants for           with newer version.
                                                           surgery--Metallic materials--
                                                           Part 12: Wrought cobalt-
                                                           chromium-molybdenum alloy.
8-352......................  8-501......................  ISO 5834-1 Fourth edition      Withdrawn and replaced
                                                           2019-02 Implants for           with newer version.
                                                           surgery--Ultra-high-
                                                           molecular-weight
                                                           polyethylene--Part 1: Powder
                                                           form.
8-359......................  8-502......................  ASTM F2038--18 Standard Guide  Withdrawn and replaced
                                                           for Silicone Elastomers,       with newer version.
                                                           Gels, and Foams Used in
                                                           Medical Applications Part I--
                                                           Formulations and Uncured
                                                           Materials.
8-360......................  8-503......................  ASTM F2042-18 Standard Guide   Withdrawn and replaced
                                                           for Silicone Elastomers,       with newer version.
                                                           Gels, and Foams Used in
                                                           Medical Applications Part
                                                           II--Crosslinking and
                                                           Fabrication.
8-370......................  8-504......................  ASTM F561-19 Standard          Withdrawn and replaced
                                                           Practice for Retrieval and     with newer version.
                                                           Analysis of Medical Devices,
                                                           and Associated Tissues and
                                                           Fluids.
8-388......................  8-505......................  ISO 6474-2 Second edition      Withdrawn and replaced
                                                           2019-03 Implants for           with newer version.
                                                           surgery--Ceramic materials--
                                                           Part 2: Composite materials
                                                           based on a high-purity
                                                           alumina matrix with zirconia
                                                           reinforcement.
8-397......................  8-506......................  ASTM F2516-18 Standard Test    Withdrawn and replaced
                                                           Method for Tension Testing     with newer version.
                                                           of Nickel-Titanium
                                                           Superelastic Materials.
8-402......................  8-507......................  ASTM F688-19 Standard          Withdrawn and replaced
                                                           Specification for Wrought      with newer version.
                                                           Cobalt-35Nickel-20Chromium-
                                                           10Molybdenum Alloy Plate,
                                                           Sheet, and Foil for Surgical
                                                           Implants (UNS R30035).
8-411......................  8-508......................  ASTM F2579-18 Standard         Withdrawn and replaced
                                                           Specification for Amorphous    with newer version.
                                                           Poly(lactide) and
                                                           Poly(lactide-co-glycolide)
                                                           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
----------------------------------------------------------------------------------------------------------------
10-89......................  ...........................  ANSI Z80.7-2013 (R2018)        Extent of recognition.
                                                           American National Standard
                                                           for Ophthalmic Optics--
                                                           Intraocular Lenses.
----------------------------------------------------------------------------------------------------------------

[[Page 57038]]

 
                                                  N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-250.....................  11-349.....................  ISO 14242-3 First edition      Withdrawn and replaced
                                                           2009-03-15 Implants for        with newer version.
                                                           surgery--Wear of total hip-
                                                           joint prostheses--Part 3:
                                                           Loading and displacement
                                                           parameters for orbital
                                                           bearing type wear testing
                                                           machines and corresponding
                                                           environmental conditions for
                                                           test [Including AMENDMENT 1
                                                           (2019)].
11-251.....................  11-350.....................  ASTM F2554-18 Standard         Withdrawn and replaced
                                                           Practice for Measurement of    with newer version.
                                                           Positional Accuracy of
                                                           Computer Assisted Surgical
                                                           Systems.
11-273.....................  11-351.....................  ISO 18192-1 Second edition     Withdrawn and replaced
                                                           2011-03-01 Implants for        with newer version.
                                                           surgery--Wear of total
                                                           intervertebral spinal disc
                                                           prostheses--Part 1: Loading
                                                           and displacement parameters
                                                           for wear testing and
                                                           corresponding environmental
                                                           conditions for test
                                                           [Including AMENDMENT 1
                                                           (2018)].
11-291.....................  11-352.....................  ISO 14242-1 Third edition      Withdrawn and replaced
                                                           2014-10-15 Implants for        with newer version
                                                           surgery--Wear of total hip-    including amendment.
                                                           joint prostheses --Part 1:
                                                           Loading and displacement
                                                           parameters for wear-testing
                                                           machines and corresponding
                                                           environmental conditions for
                                                           test [Including AMENDMENT 1
                                                           (2018)].
----------------------------------------------------------------------------------------------------------------
                                              O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
                                                          No new entries at this time..
----------------------------------------------------------------------------------------------------------------
                                                  P. Radiology
----------------------------------------------------------------------------------------------------------------
12-225.....................  12-325.....................  NEMA XR 25-2019 Computed       Withdrawn and replaced
                                                           Tomography Dose Check.         with newer version.
----------------------------------------------------------------------------------------------------------------
12-265.....................  12-326.....................  NEMA NU 2-2018 Performance     Withdrawn and replaced
                                                           Measurements of Positron       with newer version.
                                                           Emission Tomographs (PETS).
----------------------------------------------------------------------------------------------------------------
                                             Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
                                                          No new entries at this time..
----------------------------------------------------------------------------------------------------------------
                                                  R. Sterility
----------------------------------------------------------------------------------------------------------------
14-377.....................  14-527.....................  ASTM F2638-18 Standard Test    Withdrawn and replaced
                                                           Method for Using Aerosol       with newer version.
                                                           Filtration for Measuring the
                                                           Performance of Porous
                                                           Packaging Materials as a
                                                           Surrogate Microbial Barrier.
----------------------------------------------------------------------------------------------------------------
14-428.....................  14-528.....................  ISO 11137-1 First edition      Withdrawn and replaced
                                                           2006-04-15 Sterilization of    with newer version
                                                           health care products--         including amendment.
                                                           Radiation--Part 1:
                                                           Requirements for
                                                           development, validation and
                                                           routine control of a
                                                           sterilization process for
                                                           medical devices [Including
                                                           AMENDMENT 1 (2013) and
                                                           AMENDMENT 2 (2018)].
14-452.....................  14-529.....................  ISO 11135 Second edition 2014- Withdrawn and replaced
                                                           07-15 Sterilization of         with newer version
                                                           health-care products--         including amendment.
                                                           Ethylene oxide--Requirements
                                                           for the development,
                                                           validation and routine
                                                           control of a sterilization
                                                           process for medical devices
                                                           [Including: AMENDMENT 1
                                                           (2018)].
14-454.....................  14-530.....................  ISO 11607-1 Second edition     Withdrawn and replaced
                                                           2019-02 Packaging for          with newer version.
                                                           terminally sterilized
                                                           medical devices--Part 1:
                                                           Requirements for materials,
                                                           sterile barrier systems and
                                                           packaging systems.
14-455.....................  14-531.....................  ISO 11607-2 Second edition     Withdrawn and replaced
                                                           2019-02 Packaging for          with newer version.
                                                           terminally sterilized
                                                           medical devices--Part 2:
                                                           Validation requirements for
                                                           forming, sealing and
                                                           assembly processes.
----------------------------------------------------------------------------------------------------------------
                                              S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-27......................  15-57......................  F2315-18 Standard Guide for    Withdrawn and replaced
                                                           Immobilization or              with newer version.
                                                           Encapsulation of Living
                                                           Cells or Tissue in Alginate
                                                           Gels.
----------------------------------------------------------------------------------------------------------------
15-28......................  15-58......................  F2103-18 Standard Guide for    Withdrawn and replaced
                                                           Characterization and Testing   with newer version.
                                                           of Chitosan Salts as
                                                           Starting Materials Intended
                                                           for Use in Biomedical and
                                                           Tissue-Engineered Medical
                                                           Product Applications.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

    In Table 2, FDA provides the listing of new entries and consensus 
standards added as modifications to the list of recognized standards 
under Recognition List Number: 052. These entries are of standards not 
previously recognized by FDA.

[[Page 57039]]



        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                      Reference No. and
    Recognition No.        Title of standard \1\            date
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
1-143..................  Medical electrical         ISO 80601-2-79 First
                          equipment--Part 2-79:      edition 2018-07.
                          Particular requirements
                          for basic safety and
                          essential performance of
                          ventilatory support
                          equipment for
                          ventilatory impairment.
1-144..................  Medical electrical         ISO 80601-2-80 First
                          equipment--Part 2-80:      edition 2018-07.
                          Particular requirements
                          for basic safety and
                          essential performance of
                          ventilatory support
                          equipment for
                          ventilatory
                          insufficiency.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
2-267..................  Standard Practice for      ASTM F2888--19.
                          Platelet Leukocyte
                          Count--An In-Vitro
                          Measure for
                          Hemocompatibility
                          Assessment of
                          Cardiovascular Materials.
2-268..................  Biological evaluation of   ISO/TS 21726 First
                          medical devices--          edition 2019-02.
                          Application of the
                          threshold of
                          toxicological concern
                          (TTC) for assessing
                          biocompatibility of
                          medical device
                          constituents.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
                         No new entries at this
                          time.
------------------------------------------------------------------------
                  D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-259..................  Dentistry--Implants--Dyna  ISO 14801 Third
                          mic loading test for       edition
                          endosseous dental         2016-11-01.
                          implants.
------------------------------------------------------------------------
         E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
                         No new entries at this
                          time.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-35..................  Standard for Standby       UL 1989 Edition 5,
                          Batteries.                 2013-10-02, ANSI
                                                     November 2018.
------------------------------------------------------------------------
          G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-422..................  Medical device safety      AAMI TIR38:2019.
                          assurance case guidance.
6-423..................  CONSOLIDATED VERSION       IEC 60601-2-6
                          Medical electrical         Edition 2.1 2016-
                          equipment--Part 2-6:       04.
                          Particular requirements
                          for the basic safety and
                          essential performance of
                          microwave therapy
                          equipment.
------------------------------------------------------------------------
                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-290..................  Establishing and           CLSI EP34 1st
                          Verifying an Extended      Edition.
                          Measuring Interval
                          Through Specimen
                          Dilution and Spiking.
7-291..................  How to Construct and       CLSI EP27-A Vol. 32
                          Interpret an Error Grid    No. 12, Replaces
                          for Quantitative           EP27-P Vol. 29 No.
                          Diagnostic Assays;         16.
                          Approved Guideline.
7-292..................  Performance Standards for  CLSI M62 1st
                          Susceptibility Testing     Edition.
                          of Mycobacteria,
                          Nocardia spp., and other
                          Aerobic Actinomycetes.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-509..................  Standard Specification     ASTM F702--18.
                          for Polysulfone Resin
                          for Medical Applications.
8-510..................  Standard Specification     ASTM F997--18.
                          for Polycarbonate Resin
                          for Medical Applications.
8-511..................  Standard Specification     ASTM F1925--17.
                          for Semi-Crystalline
                          Poly(lactide) Polymer
                          and Copolymer Resins for
                          Surgical Implants.
8-512..................  Standard Specification     ASTM F2026--17.
                          for Polyetheretherketone
                          (PEEK) Polymers for
                          Surgical Implant
                          Applications.
8-513..................  Implants for surgery--     ISO 20160 First
                          Metallic materials--       edition 2006-05-01.
                          Classification of
                          microstructures for
                          alpha+beta titanium
                          alloy bars.
8-514..................  Implants for surgery--     ISO 5834-2 Fifth
                          Ultra-high-molecular-      edition 2019-02.
                          weight polyethylene--
                          Part 2: Moulded forms.
8-515..................  Implants for surgery--     ISO 13779-3 Second
                          Hydroxyapatite--Part 3:    edition 2018-12.
                          Chemical analysis and
                          characterization of
                          crystallinity ratio and
                          phase purity.
8-516..................  Implants for surgery--     ISO 13779-4 Second
                          Hydroxyapatite--Part 4:    edition 2018-12.
                          Determination of coating
                          adhesion strength.
8-517..................  Non-active surgical        ISO 17327-1 First
                          implants--Implant          edition 2018-02.
                          coating--Part 1: General
                          requirements.
8-518..................  Standard Test Method for   ASTM F3306--19.
                          Ion Release Evaluation
                          of Medical Implants.
------------------------------------------------------------------------

[[Page 57040]]

 
                            J. Nanotechnology
------------------------------------------------------------------------
18-13..................  Nanotechnologies--Electro  ISO/TS 18827 First
                          n spin resonance (ESR)     edition 2017-06.
                          as a method for
                          measuring reactive
                          oxygen species (ROS)
                          generated by metal oxide
                          nanomaterials.
18-14..................  Nanotechnologies--Methodo  ISO/TR 11360 First
                          logy for the               edition 2010-07-15.
                          classification and
                          categorization of
                          nanomaterials.
------------------------------------------------------------------------
                              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
------------------------------------------------------------------------
10-116.................  American National          ANSI Z80.35-2018.
                          Standard for
                          Ophthalmics--Extended
                          Depth of Focus
                          Intraocular Lenses.
10-117.................  American National          ANSI Z80.37-2017.
                          Standard for
                          Ophthalmics--Slit-Lamp
                          Microscopes.
10-118.................  American National          ANSI Z80.38-2017.
                          Standard for
                          Ophthalmics--Light
                          Hazard from Operation
                          Microscopes Used in
                          Ocular Surgery.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
11-353.................  Implants for surgery--     ISO 18192-3 First
                          Wear of total              edition 2017-06.
                          intervertebral spinal
                          disc prostheses --Part
                          3: Impingement-wear
                          testing and
                          corresponding
                          environmental conditions
                          for test of lumbar
                          prostheses under adverse
                          kinematic conditions.
11-354.................  Standard Guide for         ASTM F3295--18.
                          Impingement Testing of
                          Total Disc Prostheses.
11-355.................  Implants for surgery--     ISO 15142-1 First
                          Metal intramedullary       edition 2003-08-01.
                          nailing systems--Part 1:
                          Intramedullary nails.
11-356.................  Implants for surgery--     ISO 15142-2 First
                          Metal intramedullary       edition 2003-08-01.
                          nailing systems--Part 2:
                          Locking components.
11-357.................  Implants for surgery--     ISO 15142-3 First
                          Metal intramedullary       edition 2003-08-01.
                          nailing systems--Part 3:
                          Connection devices and
                          reamer diameter
                          instruments.
11-358.................  Implants for surgery--     ISO 14242-4 First
                          Wear of total hip-joint    edition 2018-05.
                          prostheses--Part 4:
                          Testing hip prostheses
                          under variations in
                          component positioning
                          which results in direct
                          edge loading.
11-359.................  Implants for surgery--     ISO 7206-10 Second
                          Partial and total hip-     edition 2018-08.
                          joint prostheses--Part
                          10: Determination of
                          resistance to static
                          load of modular femoral
                          heads.
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
16-206.................  Wheelchairs--Part 30:      ISO 7176-30 First
                          Wheelchairs for changing   edition 2018-12.
                          occupant posture--Test
                          methods and requirements.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
                         No new entries at this
                          time.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
13-108.................  Health informatics--Point- IEEE Std 11073-20701-
                          of-care medical device     2018.
                          communication--Part
                          20701: Service-Oriented
                          Medical Device Exchange
                          Architecture and
                          Protocol Binding.
13-109.................  (American National         ANSI/AAMI/UL 2800-1:
                          Standard) Standard for     2019.
                          Safety for Medical
                          Device Interoperability.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-532.................  Standard Test Method for   ASTM F3287--17e1.
                          Nondestructive Detection
                          of Leaks in Packages by
                          Mass Extraction Method.
14-533.................  Guidance on aspects of a   ISO/TS 19930 First
                          risk-based approach to     edition 2017-12.
                          assuring sterility of
                          terminally sterilized,
                          single-use health care
                          product that is unable
                          to withstand processing
                          to achieve maximally a
                          sterility assurance
                          level of 10-6.
------------------------------------------------------------------------
                          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.


[[Page 57041]]

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 following information available at 
https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/recognition-standard.

    Dated: October 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23198 Filed 10-23-19; 8:45 am]
 BILLING CODE 4164-01-P


