[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26465-26475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12222]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 049

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
a publication containing modifications the Agency is making to the list 
of standards FDA recognizes for use in premarket reviews (FDA 
Recognized Consensus Standards). This publication, entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 049'' (Recognition List Number: 049), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES: These modifications to the list of recognized standards are 
applicable June 7, 2018.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of 
1997: Modifications to the List of Recognized Standards, Recognition 
List Number: 049.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday. FDA will 
consider any comments received in determining whether to amend the 
current listing of modifications to the list of recognized standards, 
Recognition List Number: 049.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the

[[Page 26466]]

``Search'' box and follow the prompts and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of Recognition List Number: 049 is available on 
the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
    See section IV for electronic access to the searchable database for 
the current list of FDA recognized consensus standards, including 
Recognition List Number: 049 modifications and other standards related 
information. Submit written requests for a single hard copy of the 
document entitled ``Modifications to the List of Recognized Standards, 
Recognition List Number: 049'' to Scott Colburn, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-847-8144.

FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended 
section 514 allows FDA to recognize consensus standards developed by 
international and national organizations for use in satisfying portions 
of device premarket review submissions or other requirements.
    In the Federal Register notice of February 25, 1998 (63 FR 9561), 
FDA announced the availability of a guidance entitled ``Recognition and 
Use of Consensus Standards.'' The notice described how FDA would 
implement its standard recognition program and provided the initial 
list of recognized standards. The guidance was updated in September 
2007 and is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077274.htm.
    Modifications to the initial list of recognized standards, as 
published in the Federal Register, can be accessed at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
    These notices describe the addition, withdrawal, and revision of 
certain standards recognized by FDA. The Agency maintains hypertext 
markup language (HTML) and portable document format (PDF) versions of 
the list of FDA Recognized Consensus Standards. Additional information 
on the Agency's standards program is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 049

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the Agency is recognizing for 
use in premarket submissions and other requirements for devices. FDA is 
incorporating these modifications to the list of FDA Recognized 
Consensus Standards in the Agency's searchable database. FDA is using 
the term ``Recognition List Number: 049'' to identify the current 
modifications.
    In table 1, FDA describes the following modifications: (1) The 
withdrawal of standards and their replacement by others, if applicable; 
(2) the correction of errors made by FDA in listing previously 
recognized standards; and (3) the changes to the supplementary 
information sheets of recognized standards that describe revisions to 
the applicability of the standards.
    In section III, FDA lists modifications the Agency is making that 
involve the initial addition of standards not previously recognized by 
FDA.

                           Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
                                     Replacement
       Old recognition No.           recognition         Title of standard \1\                  Change
                                         No.
----------------------------------------------------------------------------------------------------------------
                                                A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-86.............................  ..............  ISO 8185 Third edition 2008-06-   Withdrawn. See 1-138.
                                                    15 (Corrected version),
                                                    Respiratory tract humidifiers
                                                    for medical use--Particular
                                                    requirements for respiratory
                                                    humidification systems.
1-95.............................  ..............  ISO 5366-3 Second edition 2001-   Withdrawn. See 1-117.
                                                    08-15 Anaesthetic and
                                                    Respiratory Equipment--
                                                    Tracheostomy Tubes--Part 3:
                                                    Paediatric Tracheostomy Tubes
                                                    [Including TECHNICAL
                                                    CORRIGENDUM 1 (2003)].
1-107............................  ..............  ANSI/AAMI/ISO 5356-1:2004         Transferred. See 1-62.
                                                    Anaesthetic and respiratory
                                                    equipment--Conical connectors--
                                                    Part 1: Cones and sockets.
1-109............................  ..............  ANSI/AAMI/ISO 5362:2006           Transferred. See 1-75.
                                                    Anaesthetic reservoir bags.
1-121............................           1-129  ISO 5359 Fourth edition 2014-10-  Withdrawn and replaced with
                                                    01 Anaesthetic and respiratory    newer version including
                                                    equipment--Low-pressure hose      amendment.
                                                    assemblies for use with medical
                                                    gases [Including AMENDMENT 1
                                                    (2017)].
1-128............................           1-130  ISO 18082 First edition 2014-06-  Withdrawn and replaced with
                                                    15 Anaesthetic and respiratory    newer version including
                                                    equipment--Dimensions of          amendment.
                                                    noninterchangeable screw-
                                                    threaded (NIST) low-pressure
                                                    connectors for medical gases
                                                    [Including AMENDMENT 1 (2017)].
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-118............................  ..............  ANSI/AAMI/ISO 10993-11:2006/      Transferred. See 2-176.
                                                    (R)2010 Biological evaluation
                                                    of medical devices--Part 11:
                                                    Tests for systemic toxicity.
2-120............................  ..............  ANSI/AAMI/ISO 10993-6:2007/       Withdrawn.
                                                    (R)2014 Biological evaluation
                                                    of medical devices--Part 6:
                                                    Tests for local effects after
                                                    implantation.
2-153............................  ..............  ANSI/AAMI/ISO 10993-5:2009/       Transferred. See 2-245.
                                                    (R)2014 Biological evaluation
                                                    of medical devices--Part 5:
                                                    Tests for in vitro cytotoxicity.

[[Page 26467]]

 
2-156............................  ..............  ANSI/AAMI/ISO 10993-1:2009/       Transferred. See 2-220.
                                                    (R)2013 Biological evaluation
                                                    of medical devices--Part 1:
                                                    Evaluation and testing within a
                                                    risk management process.
2-163............................  ..............  ANSI/AAMI/ISO 10993-9:2009/       Transferred. See 2-168.
                                                    (R)2014 Biological evaluation
                                                    of medical devices--Part 9:
                                                    Framework for identification
                                                    and quantification of potential
                                                    degradation products.
2-165............................  ..............  ANSI/AAMI/ISO 10993-14:2001/(R)   Transferred. See 2-170.
                                                    2011 Biological evaluation of
                                                    medical devices--Part 14:
                                                    Identification and
                                                    quantification of degradation
                                                    products form ceramics.
2-171............................           2-249  ISO 10993-16 Third edition 2017-  Withdrawn and replaced with
                                                    05 Biological evaluation of       newer version.
                                                    medical devices--Part 16:
                                                    Toxicokinetic study design for
                                                    degradation products and
                                                    leachables.
2-172............................  ..............  ANSI/AAMI/TIR 10993-19:2006       Transferred. See 2-167.
                                                    Biological evaluation of
                                                    medical devices--Part 19:
                                                    Physicochemical, morphological,
                                                    and topographical
                                                    characterization of materials.
2-173............................  ..............  ANSI/AAMI/ISO 10993-10:2010/      Transferred. See 2-174.
                                                    (R)2014 Biological evaluation
                                                    of medical devices--Part 10:
                                                    Tests for irritation and skin
                                                    sensitization.
2-180............................  ..............  ANSI/AAMI/ISO 10993-16:2010/      Withdrawn.
                                                    (R)2014 Biological evaluation
                                                    of medical devices--Part 16:
                                                    Toxicokinetic study design for
                                                    degradation products and
                                                    leachables from medical devices.
2-181............................  ..............  ANSI/AAMI/ISO 14155:2011          Transferred. See 2-205.
                                                    Clinical investigation of
                                                    medical devices for human
                                                    subjects--Good clinical
                                                    practice [Including: Technical
                                                    Corrigendum 1 (2011)].
2-190............................  ..............  ANSI/AAMI/ISO 10993-13:2010/      Transferred. See 2-169.
                                                    (R)2014 Biological evaluation
                                                    of medical devices--Part 13:
                                                    Identification and
                                                    quantification of degradation
                                                    products from polymeric medical
                                                    devices.
2-198............................  ..............  ANSI/AAMI/ISO 10993-12:2012       Transferred. See 2-191.
                                                    Biological evaluation of
                                                    medical devices--Part 12:
                                                    Sample preparation and
                                                    reference materials.
2-207............................           2-250  ASTM F756-17 Standard Practice    Withdrawn and replaced with
                                                    for Assessment of Hemolytic       newer version.
                                                    Properties of Materials.
2-221............................  ..............  ANSI/AAMI/ISO 10993-2:2006        Transferred. See 2-222.
                                                    (R2014) Biological evaluation
                                                    of medical devices--Part 2:
                                                    Animal welfare requirements.
2-226............................  ..............  ANSI/AAMI/ISO 10993-3:2014        Transferred. See 2-228.
                                                    Biological evaluation of
                                                    medical devices--Part 3: Tests
                                                    for genotoxicity,
                                                    carcinogenicity, and
                                                    reproductive toxicity.
2-229............................           2-251  USP 40-NF35:2017 <87> Biological  Withdrawn and replaced with
                                                    Reactivity Test, In Vitro--       newer version.
                                                    Direct Contact Test.
2-230............................           2-252  USP 40-NF35:2017 <87> Biological  Withdrawn and replaced with
                                                    Reactivity Test, In Vitro--       newer version.
                                                    Elution Test.
2-231............................           2-253  USP 40-NF35:2017 <88> Biological  Withdrawn and replaced with
                                                    Reactivity Tests, In Vivo.        newer version.
2-232............................           2-254  USP 40-NF35:2017 <151> Pyrogen    Withdrawn and replaced with
                                                    Test (USP Rabbit Test).           newer version. Extent of
                                                                                      Recognition.
2-234............................  ..............  ANSI/AAMI/ISO 10993-4:2002/(R)    Withdrawn.
                                                    2013 & A1:2006/(R)2013
                                                    Biological evaluation of
                                                    medical devices--Part 4:
                                                    Selection of tests for
                                                    interaction with blood
                                                    [Including AMENDMENT 1 (2006)].
2-236............................  ..............  ANSI/AAMI/ISO 10993-17:2002(R)    Transferred. See 2-237.
                                                    2012 Biological evaluation of
                                                    medical devices--Part 17:
                                                    Establishment of allowable
                                                    limits for leachable substances.
2-239............................  ..............  ANSI/AAMI/ISO TIR 10993-20:2006   Transferred. See 2-240.
                                                    Biological Evaluation of
                                                    Medical Devices--Part 20:
                                                    Principles and methods for
                                                    immunotoxicology testing of
                                                    medical devices.
2-242............................  ..............  ANSI/AAMI/ISO TIR 37137:2014      Transferred. See 2-241.
                                                    Cardiovascular biological
                                                    evaluation of medical devices--
                                                    Guidance for absorbable
                                                    implants.
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-80.............................  ..............  ANSI/AAMI/ISO 81060-1:2007/       Transferred. See 3-96.
                                                    (R)2013 Non-invasive
                                                    sphygmomanometers--Part 1:
                                                    Requirements and test methods
                                                    for non-automated measurement
                                                    type.
3-83.............................  ..............  ANSI/AAMI/ISO 14708-5:2010        Transferred. See 3-92.
                                                    Implants for surgery--Active
                                                    implantable medical devices--
                                                    Part 5: Circulatory support
                                                    devices.
3-101............................  ..............  ANSI/AAMI/IEC 60601-2-27:2011     Transferred. See 3-126.
                                                    Medical electrical equipment--
                                                    Part 2-27: Particular
                                                    requirements for the basic
                                                    safety and essential
                                                    performance of
                                                    electrocardiographic monitoring
                                                    equipment.
3-106............................  ..............  ANSI/AAMI/IEC 60601-2-25:2011/    Transferred. See 3-105.
                                                    (R)2016 Medical electrical
                                                    equipment--Part 2-25:
                                                    Particular requirements for the
                                                    basic safety and essential
                                                    performance of
                                                    electrocardiographs.

[[Page 26468]]

 
3-109............................  ..............  ANSI/AAMI/ISO 27186:2010 Active   Transferred. See 3-89.
                                                    implantable medical devices--
                                                    Four-pole connector system for
                                                    implantable cardiac rhythm
                                                    management devices--Dimensional
                                                    and test requirements.
3-111............................  ..............  ANSI/AAMI/ISO 25539-3:2011        Transferred. See 3-103.
                                                    Cardiovascular implants--
                                                    Endovascular devices--Part 3:
                                                    Vena cava filters.
3-112............................  ..............  ANSI/AAMI/ISO 7199:2009           Transferred. See 3-124.
                                                    Cardiovascular implants and
                                                    artificial organs--Blood gas
                                                    exchangers (oxygenators).
3-117............................  ..............  ANSI/AAMI/ISO 81060-2 Second      Transferred. See 3-122.
                                                    edition 2013-05-01 Non-invasive
                                                    sphygmomanometers--Part 2:
                                                    Clinical validation of
                                                    automated measurement type.
3-120............................  ..............  ANSI/AAMI/ISO 25539-2:2012        Transferred. See 3-116.
                                                    Cardiovascular implants--
                                                    Endovascular devices--Part 2:
                                                    Vascular stents.
3-124............................           3-150  ISO 7199 Third edition 2016-11-   Withdrawn and replaced with
                                                    15 Cardiovascular implants and    newer version.
                                                    artificial organs--Blood-gas
                                                    exchangers (oxygenators).
3-128............................  ..............  ANSI/AAMI/ISO 14117:2012 Active   Transferred. See 3-139.
                                                    implantable medical devices--
                                                    Electromagnetic compatibility--
                                                    EMC test protocols for
                                                    implantable cardiac pacemakers,
                                                    implantable cardioverter
                                                    defibrillators, and cardiac
                                                    resynchronization devices.
3-130............................           3-151  ANSI/AAMI/IEC 80601-2-30:2009 &   Reaffirmation. Extent of
                                                    A1:2013/(R2016) Medical           Recognition. Transferred.
                                                    electrical equipment--Part 2-     See 3-123.
                                                    30: Particular requirements for
                                                    the basic safety and essential
                                                    performance of automated non-
                                                    invasive sphygmomanometers.
3-131............................  ..............  ANSI/AAMI/ISO 27185:2012 Cardiac  Transferred. See 3-132.
                                                    rhythm management devices--
                                                    Symbols to be used with cardiac
                                                    rhythm management device
                                                    labels, and information to be
                                                    supplied--General requirements.
3-140............................  ..............  ANSI/AAMI/ISO 5840-3:2013         Transferred. See 3-133.
                                                    Cardiovascular implants--
                                                    Cardiac valve prostheses--Part
                                                    3: Heart valve substitutes
                                                    implanted by transcatheter
                                                    techniques.
3-141............................  ..............  ANSI/AAMI/ISO 5841-3:2013         Transferred. See 3-125.
                                                    Implants for surgery--Cardiac
                                                    pacemakers--Part 3: Low-profile
                                                    connectors (IS-1) for
                                                    implantable pacemakers.
3-146............................  ..............  ANSI/AAMI/ISO 5840-1:2015         Transferred. See 3-145.
                                                    Cardiovascular implants--
                                                    Cardiac valve prostheses--Part
                                                    1: General requirements.
3-148............................  ..............  ANSI/AAMI/ISO 5840-2:2015         Transferred. See 3-147.
                                                    Cardiovascular implants--
                                                    Cardiac valve prostheses--Part
                                                    2: Surgically implanted heart
                                                    valve substitutes.
----------------------------------------------------------------------------------------------------------------
                                      D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-50.............................  ..............  ADA Specification No. 18: 1992    Withdrawn. See 4-240.
                                                    Alginate Impression Materials.
4-89.............................  ..............  ANSI/ADA Specification No. 53     Reaffirmation.
                                                    Reaffirmed by ANSI: August 2013
                                                    Polymer-Based Crown and Bridge
                                                    Materials.
4-91.............................  ..............  ANSI/ADA Standard No. 80/ISO      Transferred. See 4-241.
                                                    7491:2000 Reaffirmed by ANSI:
                                                    May 2013 Dental Materials--
                                                    Determination of Color
                                                    Stability.
4-119............................  ..............  ANSI/ADA Specification No.        Withdrawn. See 4-240.
                                                    82:1998/ISO 13716:1999
                                                    Reaffirmed by ANSI: January
                                                    2009 Dental Reversible/
                                                    Irreversible Hydrocolloid
                                                    Impression Material Systems.
4-193............................  ..............  ANSI/ADA Standard No. 15-2008/    Transferred. See 4-151.
                                                    ISO 22112:2005 Reaffirmed by
                                                    ANSI: May 2013 Artificial Teeth
                                                    for Dental Prostheses.
4-230............................  ..............  ANSI/ADA Standard No. 30/ISO      Transferred. See 4-198.
                                                    3107:2011 Approved by ANSI:
                                                    February 2013 Dental Zinc Oxide/
                                                    Eugenol & Zinc Oxide/Non-
                                                    Eugenol Cements.
4-235............................  ..............  ANSI/ADA Standard No. 100/ISO     Transferred. See 4-218.
                                                    27020:2010 Approved by ANSI:
                                                    November 2012 Orthodontic
                                                    Brackets and Tubes.
4-237............................  ..............  ANSI/ADA Standard No.120-2009/    Transferred. See 4-238.
                                                    ISO 20127:2005 Reaffirmed by
                                                    ANSI: September 8, 2014 Powered
                                                    Toothbrushes.
----------------------------------------------------------------------------------------------------------------
                             E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-65.............................  ..............  ANSI/AAMI/ISO 80369-1:2010 Small  Transferred. See 5-63.
                                                    bore connectors for liquids and
                                                    gases in healthcare
                                                    applications--Part 1: General
                                                    requirements.
5-70.............................  ..............  ANSI/AAMI/ISO 14971:2007/(R)2010  Transferred. See 5-40.
                                                    (Corrected 4 October 2007)
                                                    Medical devices--Application of
                                                    risk management to medical
                                                    devices.
5-92.............................  ..............  ANSI/AAMI/IEC 60601-1-8:2006 and  Transferred. See 5-76.
                                                    A1:2012 Medical Electrical
                                                    Equipment--Part 1-8: General
                                                    requirements for basic safety
                                                    and essential performance--
                                                    Collateral Standard: General
                                                    requirements, tests and
                                                    guidance for alarm systems in
                                                    medical electrical equipment
                                                    and medical electrical systems.
5-96.............................  ..............  ANSI/AAMI/IEC 62366-1:2015        Transferred. See 5-114.
                                                    Medical devices--Part 1:
                                                    Application of usability
                                                    engineering to medical devices.

[[Page 26469]]

 
5-100............................  ..............  ANSI/AAMI/ISO 80369-20:2015       Transferred. See 5-97.
                                                    Small-bore connectors for
                                                    liquids and gases in healthcare
                                                    applications--Part 20: Common
                                                    test methods.
5-118............................  ..............  ANSI/AAMI/ISO 15223-1:2016        Transferred. See 5-117.
                                                    Medical devices--Symbols to be
                                                    used with medical device
                                                    labels, labelling and
                                                    information to be supplied--
                                                    Part 1: General requirements.
5-119............................  ..............  ANSI/AAMI/ISO 80369-5:2016 Small- Transferred. See 5-107.
                                                    bore connectors for liquids and
                                                    gases in healthcare
                                                    applications--Part 5:
                                                    Connectors for limb cuff
                                                    inflation applications.
----------------------------------------------------------------------------------------------------------------
                    F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-2.............................  ..............  ANSI/AAMI/IEC 60601-1-2:2007      Transferred. See 19-1.
                                                    (R2012) Medical electrical
                                                    equipment--Part 1-2: General
                                                    requirements for basic safety
                                                    and essential performance--
                                                    Collateral standard:
                                                    Electromagnetic compatibility--
                                                    Requirements and tests.
19-12............................  ..............  ANSI/AAMI/IEC 60601-1-2:2014      Transferred. See 19-8.
                                                    Medical electrical equipment--
                                                    Part 1-2: General requirements
                                                    for basic safety and essential
                                                    performance--Collateral
                                                    Standard: Electromagnetic
                                                    disturbances--Requirements and
                                                    tests.
----------------------------------------------------------------------------------------------------------------
                              G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-149............................           6-401  ASTM D7160-16 Standard Practice   Withdrawn and replaced with
                                                    for Determination of Expiration   newer version.
                                                    Dating for Medical Gloves.
6-178............................  ..............  ASTM D6124-06 (Reapproved 2017)   Reaffirmation.
                                                    Standard Test Method for
                                                    Residual Powder on Medical
                                                    Gloves.
6-214............................  ..............  ASTM D6355-07 (Reapproved 2017)   Reaffirmation.
                                                    Standard Test Method for Human
                                                    Repeat Insult Patch Testing of
                                                    Medical Glove.
6-217............................           6-402  ASTM F1670/F1670M-17 Standard     Withdrawn and replaced with
                                                    Test Method for Resistance of     newer version.
                                                    Materials Used in Protective
                                                    Clothing to Penetration by
                                                    Synthetic Blood.
6-227............................  ..............  ANSI/AAMI/IEC 60601-2-21:2009     Transferred. See 6-388.
                                                    Medical electrical equipment--
                                                    Part 2-21: Particular
                                                    requirements for the basic
                                                    safety and essential
                                                    performance of infant radiant
                                                    warmers.
6-229............................  ..............  ANSI/AAMI/IEC 60601-2-2:2009      Transferred. See 6-389.
                                                    Medical electrical equipment--
                                                    Part 2-2: Particular
                                                    requirements for the basic
                                                    safety and essential
                                                    performance of high frequency
                                                    surgical equipment.
6-232............................           6-403  ISO 80601-2-56 Second edition     Withdrawn and replaced with
                                                    2017-03 Medical electrical        newer version.
                                                    equipment--Part 2-56:
                                                    Particular requirements for
                                                    basic safety and essential
                                                    performance of clinical
                                                    thermometers for body
                                                    temperature measurement.
6-230............................  ..............  ANSI/AAMI/IEC 60601-2-19:2009     Transferred. See 6-385.
                                                    Medical electrical equipment--
                                                    Part 2-19: Particular
                                                    requirements for the basic
                                                    safety and essential
                                                    performance of infant
                                                    incubators.
6-235............................  ..............  ANSI/AAMI/IEC 60601-2-50:2009     Transferred. See 6-387.
                                                    Medical electrical equipment--
                                                    Part 2-50: Particular
                                                    requirements for the basic
                                                    safety and essential
                                                    performance of infant
                                                    phototherapy equipment.
6-270............................  ..............  ASTM F1840-10 (Reapproved 2016)   Reaffirmation.
                                                    Standard Terminology for
                                                    Surgical Suture Needles.
6-304............................           6-404  ISO 7886-1 Second edition 2017-   Withdrawn and replaced with
                                                    05 Sterile hypodermic syringes    newer version.
                                                    for single use--Part 1:
                                                    Syringes for manual use.
6-307............................           6-405  IEC 80601-2-59 Edition 2.0 2017-  Withdrawn and replaced with
                                                    09 Medical electrical             newer version.
                                                    equipment--Part 2-59:
                                                    Particular requirements for the
                                                    basic safety and essential
                                                    performance of screening
                                                    thermographs for human febrile
                                                    temperature screening.
6-323............................           6-406  ASTM F1862/F1862M-17 Standard     Withdrawn and replaced with
                                                    Test Method for Resistance of     newer version.
                                                    Medical Face Masks to
                                                    Penetration by Synthetic Blood
                                                    (Horizontal Projection of Fixed
                                                    Volume at a Known Velocity).
6-337............................  ..............  ANSI/AAMI/IEC 60601-2-20:2009     Transferred. See 6-386.
                                                    Medical electrical equipment--
                                                    Part 2-20: Particular
                                                    requirements for the basic
                                                    safety and essential
                                                    performance of transport
                                                    incubators [Including AMENDMENT
                                                    1 (2016)].
----------------------------------------------------------------------------------------------------------------
                                          H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-271............................  ..............  CLSI M100 27th Edition            Extent of recognition.
                                                    Performance Standards for
                                                    Antimicrobial Susceptibility
                                                    Testing.
----------------------------------------------------------------------------------------------------------------

[[Page 26470]]

 
                                                  I. Materials
----------------------------------------------------------------------------------------------------------------
8-113............................  ..............  ASTM F1147-05 (Reapproved 2017)   Reaffirmation.
                                                    [egr]\1\ Standard Test Method
                                                    for Tension Testing of Calcium
                                                    Phosphate and Metallic Coatings.
8-337............................  ..............  ASTM F621-12 (Reapproved 2017)    Reaffirmation.
                                                    Standard Specification for
                                                    Stainless Steel Forgings for
                                                    Surgical Implants.
8-356............................  ..............  ASTM F67-13 (Reapproved 2017)     Reaffirmation.
                                                    Standard Specification for
                                                    Unalloyed Titanium, for
                                                    Surgical Implant Applications
                                                    (UNS R50250, UNS R50400, UNS
                                                    R50550, UNS R50700).
8-446............................           8-460  ASTM F2848-17 Standard            Withdrawn and replaced with
                                                    Specification for Medical-Grade   newer version. Extent of
                                                    Ultra-High Molecular Weight       recognition.
                                                    Polyethylene Yarns.
----------------------------------------------------------------------------------------------------------------
                                                J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
                                                   No new entries at this time       ...........................
----------------------------------------------------------------------------------------------------------------
                                                  K. Neurology
----------------------------------------------------------------------------------------------------------------
17-1.............................  ..............  ANSI/AAMI NS28:1988/(R)2015       Reaffirmation. Extent of
                                                    Intracranial pressure             recognition.
                                                    monitoring devices.
17-8.............................           17-15  ISO 14708-3 Second edition 2017-  Withdrawn and replaced with
                                                    04 Implants for surgery--Active   newer version.
                                                    implantable medical devices--
                                                    Part 3: Implantable
                                                    neurostimulators.
17-10............................  ..............  ANSI/AAMI/ISO 14708-3:2008/       Withdrawn.
                                                    (R)2011 Implants for surgery--
                                                    Active implantable medical
                                                    devices--Part 3: Implantable
                                                    neurostimulators.
17-11............................           17-16  IEC 60601-2-10 Edition 2.1 2016-  Withdrawn and replaced with
                                                    04 Medical electrical             newer version.
                                                    equipment--Part 2-10:
                                                    Particular requirements for the
                                                    basic safety and essential
                                                    performance of nerve and muscle
                                                    stimulators.
----------------------------------------------------------------------------------------------------------------
                      L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
9-64.............................  ..............  ANSI/AAMI/IEC 60601-2-2:2009      Withdrawn. Duplicate
                                                    Medical electrical equipment--    recognition. See 6-229.
                                                    Part 2-2: Particular
                                                    requirements for the basic
                                                    safety and essential
                                                    performance of high frequency
                                                    surgery equipment and high
                                                    frequency surgical accessories.
9-66.............................  ..............  ANSI/AAMI/ISO 8638:2010           Transferred. See 9-89.
                                                    Cardiovascular implants and
                                                    extracorporeal blood circuit
                                                    for hemodialyzers,
                                                    hemodiafilters, and hemofilters.
9-81.............................  ..............  ANSI/AAMI/IEC 60601-2-16:2012     Transferred. See 9-80
                                                    Medical electrical equipment--
                                                    Part 2-16: Particular
                                                    requirements for basic safety
                                                    and essential performance of
                                                    hemodialysis, hemodiafiltration
                                                    and hemofiltration equipment.
9-91.............................  ..............  ANSI/AAMI/ISO 8637:2010           Transferred. See 9-92.
                                                    Cardiovascular implants and
                                                    extracorporeal systems--
                                                    Hemodialyzers, hemodiafilters,
                                                    hemofilters, and
                                                    hemoconcentrators [Including
                                                    AMENDMENT 1 (2013)].
9-91.............................           9-114  IEC 60601-2-18: Edition 3.0 2009- Withdrawn and replaced with
                                                    08, medical electrical            new recognition number.
                                                    equipment--part 2-18:
                                                    particular requirements for the
                                                    basic safety and essential
                                                    performance of endoscopic
                                                    equipment.
9-93.............................           9-115  ISO 25841 Third edition 2017-08   Withdrawn and replaced with
                                                    Female condoms--Requirements      newer version.
                                                    and test methods.
9-103............................  ..............  ANSI/AAMI/ISO 26722:2014 Water    Transferred. See 9-101.
                                                    treatment equipment for
                                                    haemodialysis applications and
                                                    related therapies.
9-104............................  ..............  ANSI/AAMI/ISO 13958:2014          Transferred. See 9-97.
                                                    Concentrates for hemodialysis
                                                    and related therapies.
9-105............................  ..............  ANSI/AAMI/ISO 13959:2014 Water    Transferred. See 9-98.
                                                    for hemodialysis and related
                                                    therapies.
9-106............................  ..............  ANSI/AAMI/ISO 11663:2014 Quality  Transferred. See 9-100.
                                                    of dialysis fluid for
                                                    hemodialysis and related
                                                    therapies.
9-107............................  ..............  ANSI/AAMI/ISO 23500:2014          Transferred. See 9-99.
                                                    Guidance for the preparation
                                                    and quality management of
                                                    fluids for hemodialysis and
                                                    related therapies.
----------------------------------------------------------------------------------------------------------------
                                                  M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-43............................          10-105  ISO 11979-8 Third edition 2017-   Withdrawn and replaced with
                                                    04 Ophthalmic Implants--          newer version.
                                                    Intraocular lenses--Part 8:
                                                    Fundamental requirements.
10-46............................          10-106  ISO 18369-3 Second edition 2017-  Withdrawn and replaced with
                                                    08 Ophthalmic optics--Contact     newer version.
                                                    lenses--Part 3: Measurement
                                                    methods.
10-54............................          10-107  ISO 18369-4 Second edition 2017-  Withdrawn and replaced with
                                                    08 Ophthalmic optics--Contact     newer version.
                                                    lenses--Part 4: Physicochemical
                                                    properties of contact lens
                                                    materials.
10-80............................          10-108  ISO 18369-2 Third edition 2017-   Withdrawn and replaced with
                                                    08 Ophthalmic optics--Contact     newer version.
                                                    lenses--Part 2: Tolerances.

[[Page 26471]]

 
10-83............................          10-109  ISO 18369-1 Second edition 2017-  Withdrawn and replaced with
                                                    08 Ophthalmic optics--Contact     newer version.
                                                    lenses--Part 1: Vocabulary,
                                                    classification system and
                                                    recommendations for labelling
                                                    specifications.
----------------------------------------------------------------------------------------------------------------
                                                  N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-259...........................  ..............  ASTM F2887--12 Standard           Withdrawn. See 11-321.
                                                    Specification for Total Elbow
                                                    Prostheses.
----------------------------------------------------------------------------------------------------------------
                                              O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-200...........................          16-201  ISO 7176-19 Second edition 2008-  Withdrawn and replaced with
                                                    07-15 AMENDMENT 1 2015-11-15.     a newer version including
                                                    Wheelchairs--Part 19: Wheeled     amendment.
                                                    mobility devices for use as
                                                    seats in motor vehicles
                                                    [Including AMENDMENT 1 (2015)].
----------------------------------------------------------------------------------------------------------------
                                                  P. Radiology
----------------------------------------------------------------------------------------------------------------
12-139...........................  ..............  NEMA UD 2-2004 (R2009) Acoustic   Withdrawn. Duplicate
                                                    Output Measurement Standard for   recognition. See 12-105.
                                                    Diagnostic Ultrasound
                                                    Equipment, Revision 3.
12-202...........................          12-308  IEC 60601-2-43 Edition 2.1 2017-  Withdrawn and replaced with
                                                    05 CONSOLIDATED VERSION Medical   newer version.
                                                    electrical equipment--Part 2-
                                                    43: Particular requirements for
                                                    the safety and essential
                                                    performance of X-Ray Equipment
                                                    for interventional procedures.
12-204...........................          12-309  IEC 60601-2-28 Edition 3.0 2017-  Withdrawn and replaced with
                                                    06 Medical electrical             newer version.
                                                    equipment--Part 2-28:
                                                    Particular requirements for the
                                                    basic safety and essential
                                                    performance of X-ray tube
                                                    assemblies for medical
                                                    diagnosis.
12-251...........................          12-310  IEC 60601-2-63 Edition 1.1 2017-  Withdrawn and replaced with
                                                    07 CONSOLIDATED VERSION Medical   newer version.
                                                    electrical equipment--Part 2-
                                                    63: Particular requirements for
                                                    the basic safety and essential
                                                    performance of dental extra-
                                                    oral X-Ray equipment.
12-252...........................          12-311  IEC 60601-2-65 Edition 1.1 2017-  Withdrawn and replaced with
                                                    05 CONSOLIDATED VERSION Medical   newer version.
                                                    electrical equipment--Part 2-
                                                    65: Particular requirements for
                                                    the basic safety and essential
                                                    performance of dental intra-
                                                    oral X-Ray equipment.
12-227...........................          12-312  IEC 61391-1 Edition 1.1 2017-07   Withdrawn and replaced with
                                                    CONSOLIDATED VERSION              newer version.
                                                    Ultrasonics--Pulse-echo
                                                    scanners--Part 1: Techniques
                                                    for calibrating spatial
                                                    measurement systems and
                                                    measurement of system point-
                                                    spread function response.
12-276...........................          12-313  IEC TS 62462 Edition 2.0 2017-07  Withdrawn and replaced with
                                                    Ultrasonics--Output test--        newer version.
                                                    Guidance for the maintenance of
                                                    ultrasound physiotherapy
                                                    systems.
12-155...........................          12-314  ISO 11554 Fourth edition 2017-07  Withdrawn and replaced with
                                                    Optics and photonics--Lasers      newer version.
                                                    and laser-related equipment--
                                                    Test methods for laser beam
                                                    power, energy and temporal
                                                    characteristics.
12-192...........................          12-315  NEMA Standards Publication MS 8-  Withdrawn and replaced with
                                                    2016 Characterization of the      newer version.
                                                    Specific Absorption Rate (SAR)
                                                    for Magnetic Resonance Imaging
                                                    Systems.
12-258...........................          12-316  IEC 62359 Edition 2.1 2017-09     Withdrawn and replaced with
                                                    CONSOLIDATED VERSION              newer version.
                                                    Ultrasonics--Field
                                                    characterization--Test methods
                                                    for the determination of
                                                    thermal and mechanical indices
                                                    related to medical diagnostic
                                                    ultrasonic fields.
----------------------------------------------------------------------------------------------------------------
                                             Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-39............................  ..............  ANSI/AAMI/IEC 80001-1:2010        Transferred. See 13-38.
                                                    Application of risk management
                                                    for IT Networks incorporating
                                                    medical devices--Part 1: Roles,
                                                    responsibilities and activities.
13-41............................  ..............  ANSI/AAMI/IEC TIR80001-2-1:2012   Transferred. See 13-40.
                                                    Application of risk management
                                                    for IT-networks incorporating
                                                    medical devices--Part 2-1: Step
                                                    by step risk management of
                                                    medical IT-networks; Practical
                                                    applications and examples.
13-43............................  ..............  ANSI/AAMI/IEC TIR80001-2-2:2012   Transferred. See 13-42.
                                                    Technical Information Report
                                                    Application of risk management
                                                    for IT-networks incorporating
                                                    medical devices--Part 2-2:
                                                    Guidance for the disclosure and
                                                    communication of medical device
                                                    security needs, risks and
                                                    controls.
13-45............................  ..............  ANSI/AAMI/IEC TIR80001-2-3:2012   Transferred. See 13-44.
                                                    Technical Information Report
                                                    Application of risk management
                                                    for IT-networks incorporating
                                                    medical devices--Part 2-3:
                                                    Guidance for wireless networks.

[[Page 26472]]

 
13-64............................  ..............  ANSI/AAMI/IEC TIR80001-2-4:2012   Transferred. See 13-63.
                                                    Technical Information Report
                                                    Application of risk management
                                                    for IT-networks incorporating
                                                    medical devices--Part 2-4:
                                                    General implementation guidance
                                                    for healthcare delivery
                                                    organizations.
----------------------------------------------------------------------------------------------------------------
                                                  R. Sterility
----------------------------------------------------------------------------------------------------------------
14-221...........................  ..............  ANSI/AAMI/ISO TIR 11139:2006      Transferred. See 14-325.
                                                    Sterilization of health care
                                                    products--Vocabulary.
14-222...........................  ..............  ANSI/AAMI/ISO 18472:2006/(R)2010  Transferred. See 14-354.
                                                    Sterilization of health care
                                                    products--Biological and
                                                    chemical indicators--Test
                                                    equipment.
14-227...........................  ..............  ANSI/AAMI/ISO 11737-1:2006        Transferred. See 14-407.
                                                    (R)2011 Sterilization of health
                                                    care products--Microbiological
                                                    methods--Part 1: Determination
                                                    of the population of
                                                    microorganisms on product.
14-238...........................  ..............  ANSI/AAMI/ISO 11140-5:2007/       Transferred. See 14-332.
                                                    (R)2012 Sterilization of health
                                                    care products--Chemical
                                                    indicators--Part 5: Class 2
                                                    indicators for Bowie and Dick
                                                    air removal test sheets and
                                                    packs.
14-261...........................  ..............  ANSI/AAMI/ISO 17665-1:2006/       Transferred. See 14-333.
                                                    (R)2013 Sterilization of health
                                                    care products--Moist heat--Part
                                                    1: Requirements for the
                                                    development, validation, and
                                                    routine control of a
                                                    sterilization process for
                                                    medical devices.
14-274...........................  ..............  ANSI/AAMI/ISO 15882:2008/(R)2013  Transferred. See 14-334.
                                                    Sterilization of health care
                                                    products--Chemical indicators--
                                                    Guidance for selection, use and
                                                    interpretation of results.
14-278...........................  ..............  ANSI/AAMI/ISO 10993-              Transferred. See 14-408.
                                                    7:2008(R)2012 Biological
                                                    evaluation of medical devices--
                                                    Part 7: Ethylene oxide
                                                    sterilization residuals.
14-285...........................  ..............  ANSI/AAMI/ISO 14161:2009/(R)2014  Transferred. See 14-336.
                                                    Sterilization of health care
                                                    products--Biological
                                                    indicators--Guidance for the
                                                    selection, use and
                                                    interpretation of results.
14-287...........................  ..............  ANSI/AAMI/ISO 11737-2:2009/       Transferred. See 14-327.
                                                    (R)2014 Sterilization of
                                                    medical devices--
                                                    Microbiological methods--Part
                                                    2: Tests of sterility performed
                                                    in the definition, validation
                                                    and maintenance of a
                                                    sterilization process.
14-291...........................  ..............  ANSI/AAMI/ISO 14937:2009/(R)2013  Transferred. See 14-337.
                                                    Sterilization of health care
                                                    products--General requirements
                                                    for characterization of a
                                                    sterilizing agent and the
                                                    development, validation and
                                                    routine control of a
                                                    sterilization process for
                                                    medical devices.
14-295...........................  ..............  ANSI/AAMI ST81:2004/(R)2016       Reaffirmation.
                                                    Sterilization of medical
                                                    devices--Information to be
                                                    provided by the manufacturer
                                                    for the processing of
                                                    resterilizable medical devices.
14-298...........................  ..............  ANSI/AAMI/ISO 11137-3:2006/       Withdrawn. See 14-510.
                                                    (R)2010 Sterilization of health
                                                    care products--Radiation--Part
                                                    3: Guidance on dosimetric
                                                    aspects.
14-330...........................          14-510  ISO 11137-3 Second edition 2017-  Withdrawn and replaced with
                                                    06 Sterilization of health care   newer version.
                                                    products--Radiation--Part 3:
                                                    Guidance on dosimetric aspects
                                                    of development, validation and
                                                    routine control.
14-339...........................  ..............  ANSI/AAMI/ISO 20857:2010/(R)2015  Transferred. See 14-340.
                                                    Sterilization of health care
                                                    products--Dry heat--
                                                    Requirements for the
                                                    development, validation and
                                                    routine control of a
                                                    sterilization process for
                                                    medical devices.
14-348...........................  ..............  ANSI/AAMI/ISO 13408-2:2003/       Transferred. See 14-138.
                                                    (R)2013 Aseptic processing of
                                                    health care products--Part 2:
                                                    Filtration.
14-349...........................  ..............  ANSI/AAMI/ISO 13408-3:2006/       Transferred. See 14-239.
                                                    (R)2015 Aseptic processing of
                                                    health care products--Part 3:
                                                    Lyophilization.
14-350...........................  ..............  ANSI/AAMI/ISO 13408-4:2005/       Transferred. See 14-191.
                                                    (R)2014 Aseptic processing of
                                                    health care products--Part 4:
                                                    Clean-in-place technologies.
14-351...........................  ..............  ANSI/AAMI/ISO 13408-5:2006/       Transferred. See 14-240.
                                                    (R)2015 Aseptic processing of
                                                    health care products--Part 5:
                                                    Sterilization in place.
14-358...........................  ..............  ANSI/AAMI/ISO 14160:2011/(R)2016  Transferred. See 14-361.
                                                    Sterilization of health care
                                                    products--Liquid chemical
                                                    sterilizing agents for single-
                                                    use medical devices utilizing
                                                    animal tissues and their
                                                    derivatives--Requirements for
                                                    characterization, development,
                                                    validation and routine control
                                                    of a sterilization process for
                                                    medical devices.
14-376...........................  ..............  ANSI/AAMI/ISO TIR 17665-2:2009    Transferred. See 14-277.
                                                    Sterilization of health care
                                                    products--Moist heat--Part 2:
                                                    Guidance on the application of
                                                    ANSI/AAMI/ISO 17665-1.
14-387...........................  ..............  ANSI/AAMI/ISO 13408-7:2012        Transferred. See 14-388.
                                                    Aseptic processing of health
                                                    care products--Part 7:
                                                    Alternative processes for
                                                    medical devices and combination
                                                    products.
14-425...........................  ..............  ANSI/AAMI/ISO 13408-6:2005/(R)    Transferred. See 14-424.
                                                    2013 & A1:2013 Aseptic
                                                    processing of health care
                                                    products--Part 6: Isolator
                                                    systems [Including AMENDMENT1
                                                    (2013)].

[[Page 26473]]

 
14-426...........................  ..............  ANSI/AAMI/ISO 13408-1:2008        Transferred. See 14-427.
                                                    (R2011) Aseptic processing of
                                                    health care products--Part 1:
                                                    General requirements [Including
                                                    AMENDMENT1 (2013)].
14-438...........................  ..............  ANSI/AAMI/ISO 11137-2:2013        Transferred. See 14-409.
                                                    Sterilization of health care
                                                    products--Radiation--Part 2:
                                                    Establishing the sterilization
                                                    dose.
14-439...........................          14-511  ANSI/AAMI ST79:2017               Withdrawn and replaced with
                                                    Comprehensive guide to steam      newer version.
                                                    sterilization and sterility
                                                    assurance in health care
                                                    facilities.
14-457...........................  ..............  ANSI/AAMI/ISO 11607-1:2006/       Transferred. See 14-454.
                                                    (R)2010 Packaging for
                                                    terminally sterilized medical
                                                    devices--Part 1: Requirements
                                                    for materials, sterile barrier
                                                    systems and packaging
                                                    [Including AMENDMENT 1 (2013)].
14-458...........................  ..............  ANSI/AAMI/ISO 11607-2:2006/       Transferred. See 14-455.
                                                    (R)2010 Packaging for
                                                    terminally sterilized medical
                                                    devices--Part 2: Validation
                                                    requirements for forming,
                                                    sealing and assembly processes
                                                    [Including AMENDMENT 1 (2013)].
14-459...........................  ..............  ANSI/AAMI/ISO 11140-1:2014        Transferred. See 14-460.
                                                    Sterilization of health care
                                                    products--Chemical indicators--
                                                    Part 1: General requirements.
14-461...........................  ..............  ANSI/AAMI/ISO 11137-1:2006/       Transferred. See 14-428.
                                                    (R)2010 Sterilization of health
                                                    care products--Radiation--Part
                                                    1: Requirements for
                                                    development, validation and
                                                    routine control of a
                                                    sterilization process for
                                                    medical devices [Including
                                                    AMENDMENT 1 (2013)].
14-479...........................  ..............  ANSI/AAMI/ISO 11135:2014          Transferred. See 14-452.
                                                    Sterilization of health care
                                                    products--Ethylene oxide--
                                                    Requirements for development,
                                                    validation and routine control
                                                    of a sterilization process for
                                                    medical devices.
----------------------------------------------------------------------------------------------------------------
                                              S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-17............................  ..............  ASTM F2311-08 Standard Guide for  Withdrawn.
                                                    Classification of Therapeutic
                                                    Skin Substitutes.
15-23............................  ..............  ASTM F2739-08 Standard Guide for  Withdrawn. See 15-50.
                                                    Quantitating Cell Viability
                                                    within Biomaterial Scaffolds.
15-37............................           15-51  ASTM F2347-15 Standard Guide for  Withdrawn and replaced with
                                                    Characterization and Testing of   newer version.
                                                    Hyaluronan as Starting
                                                    Materials Intended for Use in
                                                    Biomedical and Tissue
                                                    Engineered Medical Product
                                                    Applications.
15-42............................           15-52  ASTM F2064-17 Standard Guide for  Withdrawn and replaced with
                                                    Characterization and Testing of   newer version.
                                                    Alginates as Starting Materials
                                                    Intended for Use in Biomedical
                                                    and Tissue Engineered Medical
                                                    Product Applications.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

    In table 2, FDA provides the listing of new entries and consensus 
standards added as modifications to the list of recognized standards 
under Recognition List Number: 049.

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                          Reference No.
   Recognition No.          Title of standard \1\           and Date
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
1-131................  Medical suction equipment--Part  ISO 10079-1
                        1: Electrically powered          Third Edition
                        suction equipment.               2015-11-01.
1-132................  Medical suction equipment--Part  ISO 10079-2
                        2: Manually powered suction      Third Edition
                        equipment.                       2014-05-01.
1-133................  Medical suction equipment--Part  ISO 10079-3
                        3: Suction equipment powered     Third Edition
                        from a vacuum or positive        2014-05-01.
                        pressure gas source.
1-134................  Biocompatibility evaluation of   ISO 18562-1
                        breathing gas pathways in        First edition
                        healthcare applications--Part    2017-03.
                        1: Evaluation and testing
                        within a risk management
                        process.
1-135................  Biocompatibility evaluation of   ISO 18562-2
                        breathing gas pathways in        First edition
                        healthcare applications--Part    2017-03.
                        2: Tests for emissions of
                        particulate matter.
1-136................  Biocompatibility evaluation of   ISO 18562-3
                        breathing gas pathways in        First edition
                        healthcare applications--Part    2017-03.
                        3: Tests for emissions of
                        volatile organic compounds.
1-137................  Biocompatibility evaluation of   ISO 18562-4
                        breathing gas pathways in        First edition
                        healthcare applications--Part    2017-03.
                        4: Tests for leachables in
                        condensate.
1-138................  Medical electrical equipment--   ISO 80601-2-74
                        Part 2-74: Particular            First edition
                        requirements for basic safety    2017-05.
                        and essential performance of
                        respiratory humidifying
                        equipment.
------------------------------------------------------------------------

[[Page 26474]]

 
                           B. Biocompatibility
------------------------------------------------------------------------
                       No new entries at this time      ................
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
                       No new entries at this time      ................
------------------------------------------------------------------------
                  D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-240................  Dentistry--Hydrocolloid          ISO 21563 First
                        impression materials.            edition 2013-08-
                                                         15.
4-241................  Dental materials--Determination  ISO 7491 Second
                        of colour stability.             edition 2000-09-
                                                         01.
------------------------------------------------------------------------
         E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
                       No new entries at this time      ................
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
                       No new entries at this time      ................
------------------------------------------------------------------------
          G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-407................  Standard Specification for       ASTM F3186-17.
                        Adult Portable Bed Rails and
                        Related Products.
------------------------------------------------------------------------
                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-274................  Verification and Validation of   CLSI MM17-A Vol.
                        Multiplex Nucleic Acid Assays;   28 No. 9
                        Approved Guideline.              (Replaces MM17-
                                                         P Vol. 27 No.
                                                         21).
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-461................  Standard Guide for Selecting     ASTM F3208-17.
                        Test Soils for Validation of
                        Cleaning Methods for Reusable
                        Medical Devices.
8-462................  Standard Test Method for         ASTM F3260-17.
                        Determining the Flexural
                        Stiffness of Medical Textiles.
8-463................  Standard Guide for Additive      ISO/ASTM 52901
                        Manufacturing--General           First edition
                        Principles--Requirements for     2017-08.
                        Purchased AM Parts.
8-464................  Assessment of the safety of      ISO 10974 Second
                        magnetic resonance imaging for   edition 2018.
                        patients with an active
                        implantable medical device.
------------------------------------------------------------------------
                            J. Nanotechnology
------------------------------------------------------------------------
18-9.................  Nanotechnologies--Guidance on    ISO/TR 13014
                        physico-chemical                 First edition
                        characterization of engineered   2012-05-15.
                        nanoscale materials for
                        toxicologic assessment
                        [Including CORRIGENDUM 1
                        (2012)].
18-10................  Nanotechnologies--Endotoxin      ISO 29701 First
                        test on nanomaterial samples     edition 2010-09-
                        for in vitro systems--Limulus    15.
                        amebocyte lysate (LAL) test.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
                       No new entries at this time      ................
------------------------------------------------------------------------
  L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
9-115................  Condoms--Guidance on clinical    ISO 29943-1
                        studies--Part 1: Male condoms,   First edition
                        clinical function studies        2017-07.
                        based on self-reports.
9-116................  Condoms--Guidance on clinical    ISO 29943-2
                        studies--Part 2: Female          First edition
                        condoms, clinical function       2017-07.
                        studies based on self-reports.
------------------------------------------------------------------------
                              M. Ophthalmic
------------------------------------------------------------------------
10-110...............  Ophthalmic implants--Ophthalmic  ISO 15798 Third
                        viscosurgical devices            edition 2013-09-
                        [Including AMENDMENT 1 (2017)].  15 AMENDMENT 1
                                                         2017-05.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
                       No new entries at this time      ................
------------------------------------------------------------------------

[[Page 26475]]

 
                          O. Physical Medicine
------------------------------------------------------------------------
16-202...............  RESNA Standard for Wheelchairs   RESNA WC-4:2017.
                        Volume 4: Wheelchairs and
                        Transportation.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
                       No new entries at this time      ................
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
13-104...............  Software Cybersecurity for       ANSI/UL 2900-2-
                        Network-Connectable Products,    1, First
                        Part 2-1: Particular             Edition
                        Requirements for Network         September 1,
                        Connectable Components of        2017.
                        Healthcare and Wellness
                        Systems.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
                       No new entries at this time      ................
------------------------------------------------------------------------
                          S. Tissue Engineering
------------------------------------------------------------------------
15-53................  Standard Guide for Assessing     ASTM F3206 -17.
                        Medical Device
                        Cytocompatibility with
                        Delivered Cellular Therapies.
15-54................  Standard Guide for in vivo       ASTM F3207-17.
                        Evaluation of Rabbit Lumbar
                        Intertransverse Process Spinal
                        Fusion Model.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

IV. List of Recognized Standards

    FDA maintains the current list of FDA Recognized Consensus 
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA 
will be incorporating the modifications and revisions described in this 
notice into the database and, upon publication in the Federal Register, 
this recognition of consensus standards will be effective. FDA will be 
announcing additional modifications and revisions to the list of 
recognized consensus standards, as needed, in the Federal Register once 
a year, or more often if necessary. Beginning with recognition list 
049, FDA will no longer include in the database the CDRH Office and 
Division associated with recognized standards, Devices Affected, and 
Processes Affected. Beginning with recognition list 049 FDA will 
automatically incorporate, upon publication, a U.S. parallel adoption 
of an existing recognized international standard.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for 
recognition under section 514 of the FD&C Act by submitting such 
recommendations, with reasons for the recommendation, to 
[email protected]. To be considered, such recommendations 
should contain, at a minimum, the following information available at 
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123739.htm.

    Dated: May 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12222 Filed 6-6-18; 8:45 am]
BILLING CODE 4164-01-P