
[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48871-48879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19991]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451; formerly Docket No. 2004N-0226]


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 040

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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: 040'' (Recognition List Number: 040), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES: Submit electronic or written comments concerning this document 
at any time. See section VII for the effective date of the recognition 
of standards announced in this document.

ADDRESSES: An electronic copy of Recognition List Number: 040 is 
available on the Internet at http://

[[Page 48872]]

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/
ucm123792.htm. See section VI for electronic access to the searchable 
database for the current list of FDA recognized consensus standards, 
including Recognition List Number: 040 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: 040'' to the Division of Industry and Consumer 
Education, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request, or fax your request to 301-847-
8149.
    Submit electronic comments on this document to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796-
6287, standards@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, 
Drug, and Cosmetic Act (the 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 a notice published in the Federal Register 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.
    Modifications to the initial list of recognized standards, as 
published in the Federal Register, can be accessed at http://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 HTML and PDF 
versions of the list of FDA Recognized Consensus Standards. Both 
versions are publicly accessible at the Agency's Internet site. See 
section VI for electronic access information. Interested persons should 
review the supplementary information sheet for the standard to 
understand fully the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 040

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the Agency will recognize for 
use in premarket submissions and other requirements for devices. FDA 
will incorporate these modifications in the list of FDA Recognized 
Consensus Standards in the Agency's searchable database. FDA will use 
the term ``Recognition List Number: 040'' to identify these 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. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-46.............................           1-103  ISO 5367 Fifth edition 2014-10-   Withdrawn and replaced with
                                                    15 Anaesthetic and respiratory    newer version.
                                                    equipment--Breathing sets and
                                                    connectors.
1-82.............................  ..............  IEC 60601-2-13 Edition 3.1 2009-  Withdrawn. See 1-104.
                                                    08, Medical electrical
                                                    equipment--Part 2-13:
                                                    Particular requirements for the
                                                    safety and essential
                                                    performance of anaesthetic
                                                    systems.
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-179............................           2-220  ISO 10993-1 Fourth edition 2009-  Withdrawn and replaced with
                                                    10-15 Biological evaluation of    newer version including
                                                    medical devices--Part 1:.         Technical Corrigendum.
                                                   Evaluation and Testing within a
                                                    risk management process
                                                    [Including: Technical
                                                    Corrigendum 1 (2010)].
2-208............................           2-215  USP 38-NF33:2015 <87> Biological  Withdrawn and replaced with
                                                    Reactivity Test, In Vitro--       newer version.
                                                    Direct Contact Test.
2-209............................           2-216  USP 38-NF33:2015 <87> Biological  Withdrawn and replaced with
                                                    Reactivity Test, In Vitro--       newer version.
                                                    Elution Test.
2-210............................           2-217  USP 38-NF33:2015 <88> Biological  Withdrawn and replaced with
                                                    Reactivity Tests, In Vivo,        newer version.
                                                    Procedure Preparation of Sample.
2-211............................           2-218  USP 38-NF33:2015 <88> Biological  Withdrawn and replaced with
                                                    Reactivity Test, In Vitro,        newer version.
                                                    Classification of Plastics--
                                                    Intracutaneous Test.
2-212............................           2-219  USP 38-NF33:2015 <88> Biological  Withdrawn and replaced with
                                                    Reactivity Tests, In Vivo,        newer version.
                                                    Classification of Plastics--
                                                    Systemic Injection Test.
----------------------------------------------------------------------------------------------------------------

[[Page 48873]]

 
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-76.............................  ..............  ASTM F2129-08 Standard Test       Transferred. See 8-177.
                                                    Method for Conducting Cyclic
                                                    Potentiodynamic Polarization
                                                    Measurements to Determine The
                                                    Corrosion Susceptibility of
                                                    Small Implant Devices.
3-117............................  ..............  ANSI/AAMI/ISO 81060-2:2013 Non-   Extent of recognition.
                                                    invasive sphygmomanometers--
                                                    Part 2: Clinical validation of
                                                    automated measurement type.
3-122............................  ..............  ISO 81060-2 Second edition 2013-  Extent of recognition.
                                                    05-01 Non-invasive
                                                    sphygmomanometers--Part 2:
                                                    Clinical validation of
                                                    automated measurement type.
----------------------------------------------------------------------------------------------------------------
                                      D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-105............................  ..............  ANSI/ADA Standard No.75           Reaffirmation.
                                                    (Reaffirmed by ANSI: September
                                                    8, 2014) Resilient Lining
                                                    Materials For Removable
                                                    Dentures, Part 1: Short-Term
                                                    Materials.
4-130............................  ..............  ANSI/ADA Standard No. 17          Reaffirmation.
                                                    (Reaffirmed by ANSI: September
                                                    8, 2014) Denture Base Temporary
                                                    Relining Resins.
4-150............................  ..............  ANSI/ADA Specification No. 19-    Reaffirmation.
                                                    2004/ISO 4823:2000 (Reaffirmed
                                                    by ANSI: October 6, 2014)
                                                    Dental Elastomeric Impression
                                                    Materials.
4-184............................  ..............  ANSI/ASA S3.25-2009 (Revision of  Reaffirmation.
                                                    ANSI S3.25-1989) (Reaffirmed by
                                                    ANSI September 11, 2014)
                                                    American National Standard For
                                                    an Occluded Ear Simulator.
4-191............................           4-220  ANSI/ASA S3.22-2014 AMERICAN      Withdrawn and replaced with
                                                    NATIONAL STANDARD Specification   newer version.
                                                    of Hearing Aid Characteristics.
----------------------------------------------------------------------------------------------------------------
                             E. General I (Quality Systems/Risk Management (QS/RM))
----------------------------------------------------------------------------------------------------------------
5-67.............................  ..............  ANSI/AAMI/IEC 62366:2007/(R)2013  Withdrawn. See 5-96.
                                                    Medical devices--Application of
                                                    usability engineering to
                                                    medical devices.
5-87.............................  ..............  IEC 62366 Edition 1.1 2014-01     Withdrawn. See 5-95.
                                                    Medical devices--Application of
                                                    usability engineering to
                                                    medical devices.
5-94.............................  ..............  AAMI/CN20 (PS):2014 Small-bore    Withdrawn. See 5-97.
                                                    connectors for liquids and
                                                    gases in healthcare
                                                    applications--Part 20: Common
                                                    test methods.
----------------------------------------------------------------------------------------------------------------
                    F. General II (Electrical Safety/Electromagnetic Compatibility (ES/EMC))
----------------------------------------------------------------------------------------------------------------
19-6.............................  ..............  IEC 60601-1-11 Edition 1.0 2010-  Transition Period Added.
                                                    04 Medical Electrical
                                                    Equipment--Part 1-11: General
                                                    Requirements for Basic Safety
                                                    and Essential Performance--
                                                    Collateral Standard:
                                                    Requirements for Medical
                                                    Electrical Equipment and
                                                    Medical Electrical Systems used
                                                    in the Home Healthcare
                                                    Environment [Including:
                                                    Technical Corrigendum 1 (2011)].
----------------------------------------------------------------------------------------------------------------
                              G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-110............................  ..............  ASTM F1441-03 (Reapproved 2014)   Reaffirmation.
                                                    Standard Specification for Soft-
                                                    Tissue Expander Devices.
6-185............................  ..............  ASTM F881-94 (Reapproved 2014)    Reaffirmation.
                                                    Standard Specification for
                                                    Silicone Elastomer Facial
                                                    Implants.
6-200............................  ..............  ASTM E1061-01 (Reapproved 2014)   Reaffirmation.
                                                    Standard Specification for
                                                    Direct-Reading Liquid Crystal
                                                    Forehead Thermometers.
6-274............................           6-341  ISO 11608-1 Third Edition 2014-   Withdrawn and replaced with
                                                    12-15 Needle-based injection      newer version.
                                                    systems for medical use--
                                                    Requirements and test methods--
                                                    Part 1: Needle-based injection
                                                    systems.
6-301............................  ..............  ISO 10555-1 Second Edition 2013-  Extent of Recognition.
                                                    07-01 Sterile, single-use
                                                    intravascular catheters--Part
                                                    1: General requirements.
6-308............................           6-342  IEC 80601-2-35 Edition 2.0 2009-  Withdrawn and replaced with
                                                    10 Medical electrical             newer version including
                                                    equipment--Part 2-35:             Technical Corrigendum.
                                                    Particular requirements for the
                                                    basic safety and essential
                                                    performance of heating devices
                                                    using blankets, pads or
                                                    mattresses and intended for
                                                    heating in medical use
                                                    [Including: Technical
                                                    Corrigendum 1 (2012) and
                                                    Technical Corrigendum 2 (2015)].
6-326............................           6-343  USP 38-NF 33:2015 Sodium          Withdrawn and replaced with
                                                    Chloride Irrigation.              newer version.
6-327............................           6-344  USP 38-NF 33:2015 Sodium          Withdrawn and replaced with
                                                    Chloride Injection.               newer version.
6-328............................           6-345  USP 38-NF33:2015 Nonabsorbable    Withdrawn and replaced with
                                                    Surgical Suture.                  newer version.
6-329............................           6-346  USP 38-NF33:2015 <881> Tensile    Withdrawn and replaced with
                                                    Strength.                         newer version.

[[Page 48874]]

 
6-330............................           6-347  USP 38-NF33:2015 <861> Sutures--  Withdrawn and replaced with
                                                    Diameter.                         newer version.
6-331............................           6-348  USP 38-NF33:2015 <871> Sutures--  Withdrawn and replaced with
                                                    Needle Attachment.                newer version.
6-332............................           6-349  USP 38-NF33:2015 Sterile Water    Withdrawn and replaced with
                                                    for Irrigation.                   newer version.
6-333............................           6-350  USP 38-NF33:2015 Heparin Lock     Withdrawn and replaced with
                                                    Flush Solution.                   newer version.
6-334............................           6-351  USP 38-NF33:2015 Absorbable       Withdrawn and replaced with
                                                    Surgical Suture.                  newer version.
----------------------------------------------------------------------------------------------------------------
                                          H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-110............................           7-251  CLSI EP05-A3 Evaluation of        Withdrawn and replaced with
                                                    Precision Performance of          newer version.
                                                    Quantitative Measurement
                                                    Methods; Approved Guideline-
                                                    Third Edition.
7-143............................           7-252  CLSI EP14-A3 Evaluation of        Withdrawn and replaced with
                                                    Matrix Effects; Approved          newer version.
                                                    Guideline--Third Edition.
7-153............................           7-253  CLSI EP15-A3 User Verification    Withdrawn and replaced with
                                                    of Performance for Precision      newer version.
                                                    and Estimation of Bias;
                                                    Approved Guideline-Third
                                                    Edition.
7-230............................           7-254  CLSI M07-A10 Methods for          Withdrawn and replaced with
                                                    Dilution Antimicrobial            newer version.
                                                    Susceptibility Tests for
                                                    Bacteria that Grow Aerobically;
                                                    Approved Standard--Ninth
                                                    Edition.
7-123............................           7-255  CLSI MM09-A2 Nucleic Acid         Withdrawn and replaced with
                                                    Sequencing Methods in             newer version.
                                                    Diagnostic Laboratory Medicine;
                                                    Approved Guideline--Second
                                                    Edition.
7-247............................           7-256  CLSI M100-S25 Performance         Withdrawn and replaced with
                                                    Standards for Antimicrobial       newer version.
                                                    Susceptibility Testing; Twenty-
                                                    Fifth Informational Supplement.
----------------------------------------------------------------------------------------------------------------
                                                  I. Materials
----------------------------------------------------------------------------------------------------------------
8-59.............................           8-386  ISO 5832-4 Third edition 2014-09- Withdrawn and replaced
                                                    15 Implants for surgery--         newer version.
                                                    Metallic materials--Part 4:
                                                    Cobalt-chromium-molybdenum
                                                    casting alloy.
8-63.............................           8-387  ISO 5832-11 Second edition 2014-  Withdrawn and replaced with
                                                    09-15 Implants for surgery--      newer version.
                                                    Metallic materials--Part 11:
                                                    Wrought titanium 6-aluminium 7-
                                                    niobium alloy.
8-177............................  ..............  ASTM F2129-08 Standard Test       Updated to incorporate
                                                    Method for Conducting Cyclic      transferred recognitions 3-
                                                    Potentiodynamic Polarization      76 and 17-9.
                                                    Measurements to Determine the
                                                    Corrosion Susceptibility of
                                                    Small Implant Devices.
----------------------------------------------------------------------------------------------------------------
                                                  J. Neurology
----------------------------------------------------------------------------------------------------------------
17-9.............................  ..............  ASTM F2129-08 Standard Test       Transferred. See 8-177.
                                                    Method for Conducting Cyclic
                                                    Potentiodynamic Polarization
                                                    Measurements to Determine the
                                                    Corrosion Susceptibility of
                                                    Small Implant Devices.
17-4.............................  ..............  ASTM F647-94(2014) Standard       Reaffirmation.
                                                    Practice for Evaluating and
                                                    Specifying Implantable Shunt
                                                    Assemblies for Neurosurgical
                                                    Application.
----------------------------------------------------------------------------------------------------------------
                 K. Obstetrics-Gynecology-Urology-Gastroenterology (OB-GYN-GU)/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-73.............................           9-104  ANSI/AAMI/ISO 13958:2014          Withdrawn and replaced with
                                                    Concentrates for hemodialysis     newer version.
                                                    and related therapies.
9-97.............................  ..............  ISO 13958 Third edition 2014-04-  Extent of recognition.
                                                    01 Concentrates for
                                                    haemodialysis and related
                                                    therapies.
9-69.............................           9-105  ANSI/AAMI 13959:2014 Water for    Withdrawn and replaced with
                                                    hemodialysis and related          newer version.
                                                    therapies.
9-100............................  ..............  ISO 11663 Second edition 2014-04- Extent of recognition.
                                                    01 Quality of dialysis fluid
                                                    for haemodialysis and related
                                                    therapies.
9-71.............................           9-106  ANSI/AAMI/ISO 11663:2014 Quality  Withdrawn and replaced with
                                                    of dialysis fluid for             newer version.
                                                    hemodialysis and related
                                                    therapies.
9-70.............................           9-107  ANSI/AAMI 23500:2014 Guidance     Withdrawn and replaced with
                                                    for the preparation and quality   newer version.
                                                    management of fluids for
                                                    hemodialysis and related
                                                    therapies.
9-102............................  ..............  ISO 4074 Second edition 2014-08-  Extent of recognition.
                                                    15 Natural latex rubber
                                                    condoms--Requirements and test
                                                    methods.
9-90.............................           9-108  ISO 8009 Second edition 2014-11-  Withdrawn and replaced with
                                                    15 Mechanical contraceptives--    newer version.
                                                    Reusable natural and silicone
                                                    rubber contraceptive
                                                    diaphragms--Requirements and
                                                    tests.
9-56.............................           9-109  ASTM D3492-08 Standard            Withdrawn and replaced with
                                                    Specification for Rubber          newer version.
                                                    Contraceptives (Male Condoms).
----------------------------------------------------------------------------------------------------------------

[[Page 48875]]

 
                                                  L. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-29............................           10-94  ISO 14730 Second edition 2014-10- Withdrawn and replaced with
                                                    01 Ophthalmic Optics--Contact     newer version.
                                                    lens care products--
                                                    antimicrobial preservative
                                                    efficacy testing and guidance
                                                    on determining discard date.
10-55............................           10-95  ISO 11979-6 Third edition 2014-   Withdrawn and replaced with
                                                    10-01 Ophthalmic implants--       newer version.
                                                    intraocular lenses--Part 6:
                                                    Shelf-life and transport
                                                    stability.
10-62............................           10-96  ANSI Z80.10-2014 American         Withdrawn and replaced with
                                                    National Standard for             newer version.
                                                    Opthalmics Ophthalmic
                                                    Instruments--Tonometers.
10-68............................           10-97  ISO 13212 Third edition 2014-09-  Withdrawn and replaced with
                                                    01 Ophthalmic Optics-Contact      newer version.
                                                    lens care products--Guidelines
                                                    for determination of shelf-life.
10-82............................           10-98  ISO 11979-2 Second edition 2014-  Withdrawn and replaced with
                                                    08-15 Ophthalmic implants--       newer version.
                                                    Intraocular lenses--Part 2:
                                                    Optical properties and test
                                                    methods.
----------------------------------------------------------------------------------------------------------------
                                                  M. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-240...........................          11-287  ASTM F382-14 Standard             Withdrawn and replaced
                                                    Specification and Test Method     newer version.
                                                    for Metallic Bone Plates.
11-235...........................          11-288  ASTM F2077-14 Test Methods for    Withdrawn and replaced with
                                                    Intervertebral Body Fusion        newer version.
                                                    Devices.
11-207...........................          11-289  ASTM F2193-14 Standard            Withdrawn and replaced with
                                                    Specifications and Test Methods   newer version.
                                                    for Components Used in the
                                                    Surgical Fixation of the Spinal
                                                    Skeletal System.
11-183...........................  ..............  ASTM F1875-98 (Reapproved 2014)   Reaffirmation.
                                                    Standard Practice for Fretting
                                                    Corrosion Testing of Modular
                                                    Implant Interfaces: Hip Femoral
                                                    Head-Bore and Cone Taper
                                                    Interface.
11-266...........................  ..............  ASTM F2665-09 (Reapproved 2014)   Reaffirmation.
                                                    Standard Specification for
                                                    Total Ankle Replacement
                                                    Prosthesis.
11-224...........................  ..............  ASTM F2706-08 (Reapproved 2014)   Reaffirmation.
                                                    Standard Test Methods for
                                                    Occipital-Cervical and
                                                    Occipital-Cervical-Thoracic
                                                    Spinal Implant Constructs in a
                                                    Vertebrectomy Model..
11-80............................          11-290  ISO 8828 Second edition 2014-11-  Withdrawn and replaced with
                                                    15 Implants for surgery--         newer version.
                                                    Guidance on Care and Handling
                                                    of Orthopaedic Implants.
11-248...........................          11-291  ISO 14242-1 Third edition 2014-   Withdrawn and replaced with
                                                    10-15 Implants for surgery--      newer version.
                                                    Wear of total hip-joint
                                                    prostheses--Part 1: Loading and
                                                    displacement parameters for
                                                    wear testing machines and
                                                    corresponding environmental
                                                    conditions for test.
11-250...........................          11-292  ISO 14243-3 Second edition 2014-  Withdrawn and replaced with
                                                    11-01 Implants for surgery--      newer version.
                                                    Wear of total knee prostheses--
                                                    Part 3: Loading and
                                                    displacement parameters for
                                                    wear--testing machines with
                                                    displacement control and
                                                    corresponding environmental
                                                    conditions for test.
----------------------------------------------------------------------------------------------------------------
                                                  N. Radiology
----------------------------------------------------------------------------------------------------------------
12-102...........................  ..............  ANSI/IESNA RP-27.2-2000           Reaffirmation.
                                                    (Reaffirmed 2011)
                                                    Photobiological Safety for Lamp
                                                    & Lamp Systems-Measurement
                                                    Techniques.
12-212...........................          12-289  IEC 62220-1-1 Edition 1.0 2015-   Withdrawn and replaced with
                                                    03 Medical electrical             newer version.
                                                    equipment--Characteristics of
                                                    digital x-ray imaging devices--
                                                    Part 1-1: Determination of the
                                                    detective quantum efficiency--
                                                    Detectors used in radiographic
                                                    imaging.
12-229...........................          12-290  IEC 61910-1 Edition 1.0 2014-09   Withdrawn and replaced with
                                                    Medical electrical equipment--    newer version.
                                                    Radiation dose documentation--
                                                    Part 1: Radiation dose
                                                    structured reports for
                                                    radiography and radioscopy.
12-278...........................          12-291  IEC 62127-2 Edition 1.1 2013-02   Withdrawn and replaced with
                                                    Ultrasonics Hydrophones--Part     newer version.
                                                    2: Calibration for ultrasonic
                                                    fields up to 40 MHz.
----------------------------------------------------------------------------------------------------------------
                                                  O. Sterility
----------------------------------------------------------------------------------------------------------------
14-193...........................          14-457  ANSI/AAMI/ISO 11607-1:2006/       Withdrawn and replaced with
                                                    (R)2010 Packaging for             newer version including
                                                    terminally sterilized medical     Amendment.
                                                    devices--Part 1: Requirements
                                                    for materials, sterile barrier
                                                    systems and packaging
                                                    [Including: Amendment 1 (2014)].
14-194...........................          14-458  ANSI/AAMI/ISO 11607-2:2006/       Withdrawn and replaced with
                                                    (R)2010 Packaging for             newer version including
                                                    terminally sterilized medical     Amendment.
                                                    devices--Part 2: Validation
                                                    requirements for forming,
                                                    sealing and assembly
                                                    processes[Including: Amendment
                                                    1 (2014)].
14-195...........................          14-459  ANSI/AAMI/ISO 11140-1:2014        Withdrawn and replaced with
                                                    Sterilization of health care      newer version.
                                                    products--Chemical indicators--
                                                    Part 1: General requirements.
14-287...........................  ..............  ANSI/AAMI/ISO 11737-2:2009/       Reaffirmation.
                                                    (R)2014 Sterilization of
                                                    medical devices--
                                                    Microbiological methods--Part
                                                    2: Tests of sterility performed
                                                    in the definition, validation
                                                    and maintenance of a
                                                    sterilization process.

[[Page 48876]]

 
14-297...........................          14-461  ANSI/AAMI/ISO 11137-1:2006/(R)    Withdrawn and replaced with
                                                    2010 Sterilization Of Health      newer version including
                                                    Care Products--Radiation--Part    Amendment.
                                                    1: Requirements For
                                                    Development, Validation, And
                                                    Routine Control Of A
                                                    Sterilization Process For
                                                    Medical Devices [Including:
                                                    Amendment 1 (2013)].
14-300...........................          14-462  ASTM D4169--14 Standard Practice  Withdrawn and replaced with
                                                    for Performance Testing of        newer version.
                                                    Shipping Containers and Systems.
14-327...........................  ..............  ISO 11737-2 Second edition 2009-  Extent of Recognition.
                                                    11-15 Sterilization of medical
                                                    devices--Microbiological
                                                    methods--Part 2: Tests of
                                                    sterility performed in the
                                                    definition, validation and
                                                    maintenance of a sterilization
                                                    process.
14-350...........................  ..............  ANSI/AAMI/ISO 13408-4:2005/       Reaffirmation.
                                                    (R)2014, Aseptic processing of
                                                    health care products--Part 4:
                                                    Clean-in-place technologies.
14-353...........................          14-460  ISO 11140-1 Third edition 2014-   Withdrawn and replaced with
                                                    11-01 Sterilization of health     newer version.
                                                    care products--Chemical
                                                    indicators--Part 1: General
                                                    requirements.
14-391...........................          14-463  ISO/ASTM 51608 Third edition      Withdrawn and replaced with
                                                    2015-03-15 Practice for           newer version.
                                                    dosimetry in an X-ray
                                                    (bremsstrahlung) facility for
                                                    radiation processing at
                                                    energies between 50 KeV and 7.5
                                                    MeV.
14-392...........................          14-464  ISO/ASTM 51649 Third edition      Withdrawn and replaced with
                                                    2015-03-15 Practice for           newer version.
                                                    dosimetry in an electron beam
                                                    facility for radiation
                                                    processing at energies between
                                                    300 keV and 25 MeV.
14-431...........................          14-465  ISO/ASTM 51707 Third edition      Withdrawn and replaced with
                                                    2015-03-15 Guide for estimation   newer version.
                                                    of measurement uncertainty in
                                                    dosimetry for radiation
                                                    processing.
14-440...........................          14-466  USP 38-NF33:2015 <61>             Withdrawn and replaced with
                                                    Microbiological Examination of    newer version.
                                                    Nonsterile Products: Microbial
                                                    Enumeration Tests.
14-441...........................          14-467  USP 38-NF33:2015 <71> Sterility   Withdrawn and replaced with
                                                    Tests.                            newer version.
14-442...........................          14-468  USP 38-NF33:2015 <85> Bacterial   Withdrawn and replaced with
                                                    Endotoxins Test.                  newer version.
14-443...........................          14-477  USP 38-NF33:2015 <151> Pyrogen    Withdrawn and replaced with
                                                    Test (USP Rabbit Test).           newer version.
14-444...........................          14-469  USP 38-NF33:2015 <161>            Withdrawn and replaced with
                                                    Transfusion and Infusion          newer version.
                                                    Assemblies and Similar Medical
                                                    Devices.
14-445...........................          14-470  USP 38-NF33:2015 Biological       Withdrawn and replaced with
                                                    Indicator for Steam               newer version.
                                                    Sterilization--Self Contained.
14-446...........................          14-471  USP 38-NF33:2015 Biological       Withdrawn and replaced with
                                                    Indicator for Dry-Heat            newer version.
                                                    Sterilization, Paper Carrier.
14-447...........................          14-472  USP 38-NF33:2015 Biological       Withdrawn and replaced with
                                                    Indicator for Ethylene Oxide      newer version.
                                                    Sterilization, Paper Carrier.
14-448...........................          14-473  USP 38-NF33:2015 Biological       Withdrawn and replaced with
                                                    Indicator for Steam               newer version.
                                                    Sterilization, Paper Carrier.
14-449...........................          14-474  USP 38-NF33:2015 <62>             Withdrawn and replaced with
                                                    Microbiological Examination of    newer version.
                                                    Nonsterile Products: Tests for
                                                    Specified Microorganisms.
14-450...........................          14-475  USP 38-NF33:2015 <55> Biological  Withdrawn and replaced with
                                                    Indicators--Resistance            newer version.
                                                    Performance Tests.
14-451...........................          14-476  USP 38-NF33:2015 <1035>           Withdrawn and replaced with
                                                    Biological Indicators for         newer version.
                                                    Sterilization.
----------------------------------------------------------------------------------------------------------------
\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: 040.

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                      Reference No. and
     Recognition No.         Title of standard \1\           date
------------------------------------------------------------------------
                              A. Anesthesia
------------------------------------------------------------------------
1-104....................  Medical electrical        ISO 80601-2-13
                            equipment--Part 2-13:     First Edition 2011-
                            Particular Requirements   08-01 and
                            for basic safety and      Amendment 1 2015.
                            essential performance
                            of an anaesthetic
                            workstation [Including:
                            Amendment 1 (2015)].
1-105....................  Medical electrical        ISO 80601-2-72
                            equipment--Part 2-72:     First Edition 2015-
                            Particular requirements   04-11.
                            for basic safety and
                            essential performance
                            of home healthcare
                            environment ventilators
                            for ventilator-
                            dependent patients.
------------------------------------------------------------------------

[[Page 48877]]

 
                           B. Biocompatibility
------------------------------------------------------------------------
2-221....................  Biological Evaluation of  ANSI/AAMI/ISO 10993-
                            Medical Devices: Part     2:2006 (R2014).
                            2--Animal Welfare
                            Requirements.
2-222....................  Biological Evaluation of  ISO 10993-2 Second
                            Medical Devices: Part     edition 2006-07-
                            2--Animal Welfare         15.
                            Requirements.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-135....................  Cardiovascular implants   ISO/TS 12417-1
                            and extracorporeal        First edition 2011-
                            systems--Vascular         06-01.
                            device-drug combination
                            products.
3-136....................  Cardiovascular implants   ANSI/AAMI/ISO
                            and extracorporeal        TIR12417:2011.
                            systems--Vascular
                            device-drug combination
                            products.
3-137....................  Standard Guide for        ASTM F3036-13.
                            Testing Absorbable
                            Stents.
3-138....................  Standard Guide for in     ASTM F2942-13.
                            vitro Axial, Bending,
                            and Torsional
                            Durability Testing of
                            Vascular Stents.
3-139....................  Active implantable        ISO 14117 First
                            medical devices--         edition 2012-07-
                            Electromagnetic           15.
                            compatibility--EMC test
                            protocols for
                            implantable cardiac
                            pacemakers, implantable
                            cardioverter
                            defibrillators and
                            cardiac
                            resynchronization
                            devices.
------------------------------------------------------------------------
             D. General I (Quality Systems/Risk Management)
------------------------------------------------------------------------
5-95.....................  Medical devices--Part 1:  IEC 62366-1 Edition
                            Application of            1.0 2015-02.
                            usability engineering
                            to medical devices.
5-96.....................  Medical devices--Part 1:  ANSI/AAMI/IEC 62366-
                            Application of            1:2015.
                            usability engineering
                            to medical devices.
5-97.....................  Small-bore connectors     ISO 80369-20 First
                            for liquids and gases     edition 2015-05-
                            in healthcare             15.
                            applications--Part 20:
                            Common test methods.
------------------------------------------------------------------------
                         E. General II (ES/EMC)
------------------------------------------------------------------------
19-14....................  Medical electrical        IEC 60601-1-11
                            equipment--Part 1-11:     Edition 2.0 2015-
                            General requirements      01.
                            for basic safety and
                            essential performance--
                            Collateral Standard:
                            Requirements for
                            medical electrical
                            equipment and medical
                            electrical systems used
                            in the home healthcare
                            environment.
19-15....................  Medical electrical        IEC 60601-1-12
                            equipment--Part 1-12:     Edition 1.0 2014-
                            General requirements      06.
                            for basic safety and
                            essential performance--
                            Collateral Standard:
                            Requirements for
                            medical electrical
                            equipment and medical
                            electrical systems
                            intended for use in the
                            emergency medical
                            services environment.
------------------------------------------------------------------------
                                F. GH/GPS
------------------------------------------------------------------------
6-352....................  Standard Specification    ASTM F703-07.
                            for Implantable Breast
                            Prostheses.
6-353....................  Standard Specification    ASTM F2051-00
                            for Implantable Saline    (Reapproved 2014).
                            Filled Breast
                            Prosthesis.
6-354....................  Standard Specification    ASTM D7866-14.
                            for Radiation
                            Attenuating Protective
                            Gloves.
------------------------------------------------------------------------
                                 G. IVD
------------------------------------------------------------------------
7-257....................  Principles and            CLSI M56-A.
                            procedures for
                            Detection of Anaerobes
                            in Clinical Specimens;
                            Approved Guideline.
7-258....................  Performance Standards     CLSI M02-A12.
                            for Antimicrobial Disk
                            Susceptibility Tests;
                            Approved Standards-
                            Twelfth Edition.
------------------------------------------------------------------------
                              H. Materials
------------------------------------------------------------------------
8-388....................  Implants for surgery--    ISO 6474-2 First
                            Ceramic materials--Part   edition 2012-04-
                            2: Composite materials    15.
                            based on a high-purity
                            alumina matrix with
                            zirconia reinforcement.
8-389....................  Implants for surgery--    ISO 15309 First
                            Differential scanning     edition 2013-12-
                            calorimetry of poly       01.
                            ether ether ketone
                            (PEEK) polymers and
                            compounds for use in
                            implantable medical
                            devices.
8-390....................  Standard Specification    ASTM F1925-09.
                            for Semi-Crystalline
                            Poly(lactide) Polymer
                            and Copolymer Resins
                            for Surgical Implants.
8-391....................  Standard Specification    ASTM F2313-10.
                            for Poly(glycolide) and
                            Poly(glycolide-co-
                            lactide) Resins for
                            Surgical Implants with
                            Mole Fractions Greater
                            Than or Equal To 70%
                            Glycolide.
------------------------------------------------------------------------
                            I. Nanotechnology
------------------------------------------------------------------------
18-4.....................  Technical Specification-- ISO/TS 80004-6
                            Nanotechnologies--Vocab   First edition 2013-
                            ulary--Part 6: Nano-      11-01.
                            object characterization.
------------------------------------------------------------------------
                              J. Neurology
------------------------------------------------------------------------
17-14....................  Transcutaneous            ANSI/AAMI NS4:2013.
                            electrical nerve
                            stimulators.
------------------------------------------------------------------------

[[Page 48878]]

 
                      K. OB-GYN-GU/Gastroenterology
------------------------------------------------------------------------
9-103....................  Water treatment           ANSI/AAMI
                            equipment for             26722:2014.
                            hemodialysis and
                            related therapies.
------------------------------------------------------------------------
                              L. Ophthalmic
------------------------------------------------------------------------
10-99....................  Anionic and non-ionic     ISO 4311 First
                            surface active agents--   edition 1979-06-
                            Determination of          01.
                            critical micellization
                            concentration--Method
                            by measuring surface
                            tension with a plate,
                            stirrup, or ring,.
------------------------------------------------------------------------
                              M. Orthopedic
------------------------------------------------------------------------
11-293...................  Standard Test Method for  ASTM F2582-14.
                            Impingement of
                            Acetabular Prostheses.
11-294...................  Standard Specification    ASTM F1357-14.
                            for Articulating Total
                            Wrist Implants.
11-295...................  Standard Practice for     ASTM F2580-13.
                            Evaluation of Modular
                            Connection of
                            Proximally Fixed
                            Femoral Hip Prosthesis.
------------------------------------------------------------------------
                          N. Physical Medicine
------------------------------------------------------------------------
16-194...................  Wheelchairs Part          ISO 7176-25 First
                            25:Batteries and          edition 2013-07-
                            chargers for powered      15.
                            wheelchairs.
------------------------------------------------------------------------
                              O. Radiology
------------------------------------------------------------------------
12-292...................  IEEE Recommended          IEEE Std 3333.2.1-
                            Practice for Three-       2015.
                            Dimensional (3D)
                            Medical Modeling.
------------------------------------------------------------------------
                         P. Software/Informatics
------------------------------------------------------------------------
13-73....................  Systematized              IHTSDO SNOME-CT RF2
                            Nomenclature of           Release 2015.
                            Medicine--Clinical
                            Terms.
13-74....................  Health informatics--      IEEE Std 11073-
                            Personal health device    10424-2014.
                            communication, Part
                            10424: Device
                            Specialization--Sleep
                            Apnoea Breathing
                            Therapy Equipment
                            (SABTE).
13-75....................  Health informatics--      ISO/IEEE 11073-
                            Point-of-care medical     10102 First
                            device communication--    edition 2014-03-
                            Part 10102:               01.
                            Nomenclature--Annotated
                            ECG.
13-76....................  Health informatics--      ISO 11073-91064
                            Standard communication    First edition 2009-
                            protocol--Part 91064:     05-01.
                            Computer-assisted
                            electrocardiography.
13-77....................  Information technology--  ISO/IEC 29147 First
                            Security techniques--     edition 2014-02-
                            Vulnerability             15.
                            disclosure.
13-78....................  Information technology--  ISO/IEC 30111 First
                            Security techniques--     edition 2013-11-
                            Vulnerability handling    01.
                            processes.
------------------------------------------------------------------------
                              Q. Sterility
------------------------------------------------------------------------
14-478...................  Flexible and semi-rigid   ANSI/AAMI
                            endoscope processing in   ST91:2015.
                            health care facilities.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

IV. List of Recognized Standards

    FDA maintains the Agency's current list of FDA Recognized Consensus 
Standards in a searchable database that may be accessed directly at 
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate 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 announce additional modifications 
and revisions to the list of recognized consensus standards, as needed, 
in the Federal Register once a year, or more often if necessary. 
Beginning with Recognition List 033, FDA no longer announces minor 
revisions to the list of recognized consensus standards such as 
technical contact person, devices affected, processes affected, Code of 
Federal Regulations citations, and product codes.

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 
standards@cdrh.fda.gov. To be properly considered, such recommendations 
should contain, at a minimum, the following information: (1) Title of 
the standard, (2) any reference number and date, (3) name and address 
of the national or international standards development organization, 
(4) a proposed list of devices for which a declaration of conformity to 
this standard should routinely apply, and (5) a brief identification of 
the testing or performance or other characteristics of the device(s) 
that would be addressed by a declaration of conformity.

VI. Electronic Access

    You may obtain a copy of ``Guidance on the Recognition and Use of 
Consensus Standards'' by using the Internet. The Center for Devices and 
Radiological Health (CDRH) maintains a site on the Internet for easy 
access to information including text, graphics, and files that you may 
download to a personal computer with access to the Internet. Updated on 
a regular basis, the CDRH home page, http://www.fda.gov/MedicalDevices, 
includes a link to standards-related documents including the guidance 
and the current list of recognized standards. After publication in the 
Federal Register, this notice announcing ``Modification to the List of

[[Page 48879]]

Recognized Standards, Recognition List Number: 040'' will be available 
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. You may access ``Guidance on the Recognition 
and Use of Consensus Standards,'' and the searchable database for ``FDA 
Recognized Consensus Standards'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.

VII. Submission of Comments and Effective Date

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. 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: 040. These 
modifications to the list of recognized standards are effective upon 
publication of this notice in the Federal Register.

    Dated: August 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19991 Filed 8-13-15; 8:45 am]
 BILLING CODE 4164-01-P


