[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13631-13638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5815]


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

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: 026

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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: 026'' (Recognition List Number: 026), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

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

ADDRESSES: Submit written requests for single copies of ``Modifications 
to the List of Recognized Standards, Recognition List Number: 026'' to 
the Division of Small Manufacturers, International and Consumer 
Assistance, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 
20993. Send two self-addressed adhesive labels to assist that office in 
processing your requests, or fax your request to 301-847-8149. Submit 
written comments concerning this document, or recommendations for 
additional standards for recognition, to the contact person (see FOR 
FURTHER INFORMATION CONTACT). Submit electronic comments by e-mail: 
[email protected]. This document may also be accessed on FDA's 
Internet site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of 
this document for electronic access to the searchable database for the 
current list of FDA recognized consensus standards, including 
Recognition List Number: 026 modifications and other standards related 
information.

FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796-
6574.

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 (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, are identified in Table 1 as 
follows:

      Table 1--Previous Publications of Standard Recognition Lists
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
February 25, 1998 (63 FR 9561).
October 16, 1998 (63 FR 55617).
July 12, 1999 (64 FR 37546).
November 15, 2000 (65 FR 69022).
May 7, 2001 (66 FR 23032).
January 14, 2002 (67 FR 1774).
October 2, 2002 (67 FR 61893).
April 28, 2003 (68 FR 22391).
March 8, 2004 (69 FR 10712).
June 18, 2004 (69 FR 34176).
October 4, 2004 (69 FR 59240).
May 27, 2005 (70 FR 30756).
November 8, 2005 (70 FR 67713).
March 31, 2006 (71 FR 16313).
June 23, 2006 (71 FR 36121).
November 3, 2006 (71 FR 64718).
May 21, 2007 (72 FR 28500).
September 12, 2007 (72 FR 52142).
December 19, 2007 (72 FR 71924).
September 9, 2008 (73 FR 52358).
March, 18, 2009 (74 FR 11586).
September 8, 2009 (74 FR 46203).
May 5, 2010 (75 FR 24711).
June 10, 2010 (75 FR 32943).
October 4, 2010 (75 FR 61148).
------------------------------------------------------------------------


[[Page 13632]]

    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.'' Both 
versions are publicly accessible at the Agency's Internet site. See 
section VI of this document 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: 026

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the Agency will recognize for 
use in satisfying premarket reviews 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: 026'' to identify these current 
modifications.
    In table 2 of this document, FDA describes the following 
modifications: (1) The withdrawal of standards and their replacement by 
others, (2) the correction of errors made by FDA in listing previously 
recognized standards, and (3) the changes to the supplementary 
information sheets of recognized standards that describe revisions to 
the applicability of the standards.
    In section III of this document, FDA lists modifications the Agency 
is making that involve the initial addition of standards not previously 
recognized by FDA.

       Table 2--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
                     Replacement
 Old  recognition    recognition     Title of standard        Change
       No.               No.                \1\
------------------------------------------------------------------------
                             A. Anesthesia
------------------------------------------------------------------------
1-56.............  ..............  CGA V-7.1 1997        Reaffirmation.
                                    (R2003) (2008)
                                    Standard Method of
                                    Determining
                                    Cylinder Valve
                                    Outlet Connections
                                    for Medical Gases--
                                    First Edition.
------------------------------------------------------------------------
                          B. Biocompatibility
------------------------------------------------------------------------
2-96.............           2-162  ASTM F1903-10         Withdrawn and
                                    Standard Practice     replaced with
                                    for Testing For       newer version.
                                    Biological
                                    Responses to
                                    Particles In Vitro.
2-117............  ..............  ANSI/AAMI/ISO 10993-  Extent of
                                    3:2003/(R)2009        recognition.
                                    Biological
                                    evaluation of
                                    medical devices--
                                    Part 3: Tests for
                                    genotoxicity,
                                    carcinogenicity,
                                    and reproductive
                                    toxicity.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-54.............  ..............  ANSI/AAMI/ISO         Reaffirmation.
                                    7198:1998/2001/
                                    (R)2010
                                    Cardiovascular
                                    implants--Tubular
                                    vascular prostheses.
3-58.............  ..............  ANSI/AAMI/ISO         Reaffirmation.
                                    5840:2005/(R)2010
                                    Cardiovascular
                                    implants--Cardiac
                                    valve prostheses.
3-66.............  ..............  ASTM F 2081-06        Device
                                    Standard Guide for    affected,
                                    Characterization      Processes
                                    and Presentation of   impacted, Type
                                    the Dimensional       of standard,
                                    Attributes of         CFR citation
                                    Vascular Stents.      and product
                                                          codes, and
                                                          Contact
                                                          person.
------------------------------------------------------------------------
                             D. Dental/ENT
------------------------------------------------------------------------
4-89.............  ..............  ADA Specification     Reaffirmation.
                                    No. 53 Polymer-
                                    Based Crowns and
                                    Bridge Resins.
4-111............  ..............  ADA Specification     Withdrawn.
                                    No. 13 Denture Cold-
                                    Curing Repair
                                    Resins: 1981
                                    (Reaffirmed 2006).
4-112............  ..............  ADA Specification     Withdrawn.
                                    No. 16 Dental
                                    Impression Paste--
                                    Zinc Oxide Eugenol
                                    Type.
4-124............           4-191  ANSI/ASA S3.22-2009   Withdrawn and
                                    American National     replaced with
                                    Standard              newer version.
                                    Specification of
                                    Hearing Aid
                                    Characteristics.
4-127............           4-192  ADA Specification 58  Withdrawn and
                                    Root Canal Files,     replaced with
                                    Type H (Hedstrom)     newer version.
                                    2007.
4-138............           4-193  ADA Specification     Withdrawn and
                                    No. 15 Artificial     replaced with
                                    Teeth for Dental      newer version.
                                    Prostheses.
4-148............           4-194  ADA Specification     Withdrawn and
                                    No. 78 Dental         replaced with
                                    Obturating Cones.     newer version.
4-158............  ..............  ISO 10139-1:2005      Withdrawn
                                    Dentistry--Soft       duplicate. See
                                    lining materials      4-189.
                                    for removable
                                    dentures--Part 1:
                                    Materials for short-
                                    term use Technical
                                    Corrigendum 1:2006.
------------------------------------------------------------------------
              E. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-144............           6-243  ASTM D5712-10         Withdrawn and
                                    Standard Test         replaced with
                                    Method for Analysis   a newer
                                    of Aqueous            version.
                                    Extractable Protein
                                    in Natural Rubber
                                    and Its Products
                                    Using the Modified
                                    Lowry Method.
6-145............  ..............  ASTM D3578-05         Reaffirmation.
                                    Standard
                                    Specification for
                                    Rubber Examination
                                    Gloves.
6-149............  ..............  ASTM D7160-05         Reaffirmation.
                                    (Reapproved 2010)
                                    Standard Practice
                                    for Determination
                                    of Expiration
                                    Dating for Medical
                                    Gloves.

[[Page 13633]]

 
6-150............  ..............  ASTM D7161-05         Reaffirmation.
                                    (Reapproved 2010)
                                    Standard Practice
                                    for Determination
                                    of Real Time
                                    Expiration Dating
                                    of Mature Medical
                                    Gloves Stored Under
                                    Typical Warehouse
                                    Conditions.
6-165............  ..............  ASTM D6977-04         Reaffirmation.
                                    (Reapproved 2010)
                                    Standard
                                    Specification for
                                    Polychloroprene
                                    Examination Gloves
                                    for Medical
                                    Application.
6-167............           6-244  ASTM D6319-10         Withdrawn and
                                    Standard              replaced with
                                    Specification for     newer version.
                                    Nitrile Examination
                                    Gloves for Medical
                                    Application.
6-169............  ..............  ASTM D3772-01         Reaffirmation.
                                    (Reapproved 2010)
                                    Standard
                                    Specification for
                                    Natural Rubber
                                    Finger Cots.
6-201............           6-245  ISO 8536-4 Fifth      Withdrawn and
                                    edition 2010-10-01    replaced with
                                    Infusion equipment    newer version.
                                    for medical use--
                                    Part 4: Infusion
                                    sets for single
                                    use, gravity feed.
6-218............           6-246  USP 33-NF 28 2010     Withdrawn and
                                    <11> Nonabsorbable    replaced with
                                    Surgical Suture.      newer version.
6-220............           6-247  USP 33-NF 28 2010     Withdrawn and
                                    Absorbable Surgical   replaced with
                                    Suture.               newer version.
6-221............           6-248  USP 33-NF 28 2010     Withdrawn and
                                    <881> Tensile         replaced with
                                    Strength.             newer version.
6-222............           6-249  USP 33-NF 28 2010     Withdrawn and
                                    <861> Suture-         replaced with
                                    Diameter.             newer version.
6-223............           6-250  USP 33-NF 28 2010     Withdrawn and
                                    <871> Sutures--       replaced with
                                    Needle Attachment.    newer version.
6-224............           6-251  USP 33 NF-28 2010     Withdrawn and
                                    <11> Sterile Water    replaced with
                                    for Irrigation.       newer version.
6-225............           6-252  USP 33 NF-28 2010     Withdrawn and
                                    <11> Heparin Lock     replaced with
                                    Flush Solution.       newer version.
------------------------------------------------------------------------
                                 F. IVD
------------------------------------------------------------------------
7-183............  ..............  CLSI M38-A2           Withdrawn
                                    Reference Method      duplicate. See
                                    for Broth Dilution    7-171.
                                    Antifungal
                                    Susceptibility
                                    Testing of
                                    Filamentous Fungi.
7-188............           7-218  CLSI M45-A2 Methods   Withdrawn and
                                    for Antimicrobial     replaced with
                                    Dilution and Disk     newer version.
                                    Susceptibility
                                    Testing of
                                    Infrequently
                                    Isolated or
                                    Fastidious
                                    Bacteria; Approved
                                    Guideline--Second
                                    Edition.
------------------------------------------------------------------------
                              G. Materials
------------------------------------------------------------------------
8-10.............  ..............  ASTM F603-00          Withdrawn.
                                    Standard
                                    Specification for
                                    High-Purity Dense
                                    Aluminum Oxide for
                                    Surgical Implant
                                    Application.
8-88.............           8-195  ASTM F2024-10         Withdrawn and
                                    Standard Practice     replaced with
                                    for X-Ray             newer version.
                                    Diffraction
                                    Determination of
                                    Phase Content of
                                    Plasma-Sprayed
                                    Hydroxyapatite
                                    Coatings.
8-101............  ..............  ASTM F 2118--03       Reaffirmation.
                                    (Reapproved 2009)
                                    Standard Test
                                    Method for Constant
                                    Amplitude of Force
                                    Controlled Fatigue
                                    Testing of Acrylic
                                    Bone Cement
                                    Materials.
8-103............  ..............  ASTM F1801--97        Reaffirmation.
                                    (Reapproved
                                    2009)[epsi]\1\
                                    Standard Practice
                                    for Corrosion
                                    Fatigue Testing of
                                    Metallic Implant
                                    Materials.
8-107............  ..............  ASTM F746--04         Reaffirmation.
                                    (Reapproved 2009)
                                    [epsi]\1\ Standard
                                    Test Method for
                                    Pitting or Crevice
                                    Corrosion of
                                    Metallic Surgical
                                    Implant Materials.
8-117............  ..............  ASTM F86--04          Reaffirmation.
                                    (Reapproved 2009)
                                    Standard Practice
                                    for Surface
                                    Preparation and
                                    Marking of Metallic
                                    Surgical Implants.
------------------------------------------------------------------------
                       H. OB-GYN/Gastroenterology
------------------------------------------------------------------------
9-47.............  ..............  AAMI RD16             Withdrawn. See
                                    Cardiovascular        9-65.
                                    implants and
                                    artificial organs--
                                    Hemodialyzers,
                                    hemodiafilters.
9-48.............  ..............  AAMI RD17             Withdrawn. See
                                    Cardiovascular        9-66.
                                    implants and
                                    artificial organs--
                                    Extracorporeal
                                    blood circuit for
                                    hemodialyzers,
                                    hemodiafilters, and
                                    hemofilters.
9-50.............  ..............  ANSI/AAMI RD52:2004/  Reaffirmation.
                                    (R)2010 and ANSI/
                                    AAMI RD52:2004/
                                    A1:2007/(R)2010,
                                    A2:2007/(R)2010,
                                    A3:2009, & A4:2009
                                    (Consolidated Text)
                                    Dialysate for
                                    haemodialysis.
9-51.............            9-65  ANSI/AAMI/ISO         Withdrawn and
                                    8637:2010             replaced with
                                    Cardiovascular        newer version.
                                    implants and
                                    extracorporeal
                                    systems--Hemodialyz
                                    ers,
                                    hemodiafilters,
                                    hemofilters and
                                    hemoconcentrators.
9-52.............            9-66  ANSI/AAMI/ISO         Withdrawn and
                                    8638:2010             replaced with
                                    Cardiovascular        newer version.
                                    implants and
                                    extracorporeal
                                    systems--Extracorpo
                                    real blood circuit
                                    for hemodialyzers,
                                    hemodiafilters and
                                    hemofilters.
9-55.............  ..............  ANSI/AAMI RD62:2006   Reaffirmation.
                                    and ANSI/AAMI
                                    RD62:2006/A1:2009
                                    Water treatment
                                    equipment for
                                    haemodialysis
                                    applications.
------------------------------------------------------------------------

[[Page 13634]]

 
                             I. Orthopedics
------------------------------------------------------------------------
11-168...........  ..............  ASTM F 1781-03        Reaffirmation.
                                    (Reapproved 2009)
                                    Standard
                                    Specification for
                                    Elastomeric
                                    Flexible Hinge
                                    Finger Total Joint
                                    Implants.
11-183...........  ..............  ASTM F1875-98         Reaffirmation.
                                    (Reapproved 2009)
                                    Standard Practice
                                    for Fretting
                                    Corrosion Testing
                                    of Modular Implant
                                    Interfaces: Hip
                                    Femoral Head-Bore
                                    and Cone Taper
                                    Interface.
------------------------------------------------------------------------
                          J. Physical Medicine
------------------------------------------------------------------------
16-30............          16-167  ISO 7176-9: Third     Withdrawn and
                                    edition, 2009-11-15   replaced with
                                    Wheelchairs--Part     newer version.
                                    9: Climatic tests
                                    for electric
                                    wheelchairs.
16-31............          16-168  RESNA WC-1: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    1: Requirements and
                                    Test Methods for
                                    Wheelchairs
                                    (including
                                    Scooters) Section
                                    1: Determination of
                                    static stability.
16-32............          16-169  RESNA WC-2: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    2: Additional
                                    Requirements for
                                    Wheelchairs
                                    (including
                                    Scooters) with
                                    Electrical Systems
                                    Section 2:
                                    Determination of
                                    dynamic stability
                                    of electrically
                                    powered wheelchairs.
16-33............          16-170  RESNA WC-2: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    2: Additional
                                    Requirements for
                                    Wheelchairs
                                    (including
                                    Scooters) with
                                    Electrical Systems
                                    Section 3:
                                    Determination of
                                    effectiveness of
                                    brakes.
16-34............          16-171  RESNA WC-2: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    2: Additional
                                    Requirements for
                                    Wheelchairs
                                    (including
                                    Scooters) with
                                    Electrical Systems
                                    Section 4: Energy
                                    consumption of
                                    electrically
                                    powered wheelchairs
                                    and scooters for
                                    determination of
                                    theoretical
                                    distance range.
16-35............          16-172  RESNA WC-1: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    1: Requirements and
                                    Test Methods for
                                    Wheelchairs
                                    (including
                                    Scooters) Section
                                    5: Determination of
                                    dimensions, mass
                                    and maneuvering
                                    space.
16-36............          16-173  RESNA WC-2: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    2: Additional
                                    Requirements for
                                    Wheelchairs
                                    (including
                                    Scooters) with
                                    Electrical Systems
                                    Section 6:
                                    Determination of
                                    maximum speed,
                                    acceleration and
                                    deceleration of
                                    electrically
                                    powered wheelchairs.
16-37............          16-174  RESNA WC-1: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    1: Requirements and
                                    Test Methods for
                                    Wheelchairs
                                    (including
                                    Scooters) Section
                                    7: Method of
                                    Measurement of
                                    Seating and Wheel
                                    Dimensions.
16-38............          16-175  RESNA WC-1: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    1: Requirements and
                                    Test Methods for
                                    Wheelchairs
                                    (including
                                    Scooters) Section
                                    8: Requirements and
                                    test methods for
                                    static, impact and
                                    fatigue strengths.
16-39............          16-176  RESNA WC-2: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    2: Additional
                                    Requirements for
                                    Wheelchairs
                                    (including
                                    Scooters) with
                                    Electrical Systems
                                    Section 9: Climatic
                                    tests for
                                    electrically
                                    powered wheelchairs.
16-40............          16-177  RESNA WC-2: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    2: Additional
                                    Requirements for
                                    Wheelchairs
                                    (including
                                    Scooters) with
                                    Electrical Systems
                                    Section 10:
                                    Determination of
                                    obstacle-climbing
                                    ability of
                                    electrically
                                    powered wheelchairs.
16-41............          16-178  RESNA WC-1: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    1: Requirements and
                                    Test Methods for
                                    Wheelchairs
                                    (including
                                    Scooters) Section
                                    11: Test dummies.
16-42............          16-179  RESNA WC-1: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    1: Requirements and
                                    Test Methods for
                                    Wheelchairs
                                    (including
                                    Scooters) Section
                                    13: Determination
                                    of coefficient of
                                    friction of test
                                    surfaces.
16-43............          16-180  RESNA WC-2: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    2: Additional
                                    Requirements for
                                    Wheelchairs
                                    (including
                                    Scooters) with
                                    Electrical Systems
                                    Section 14: Power
                                    and control systems
                                    for electrically
                                    powered
                                    wheelchairs--Requir
                                    ements and test
                                    methods.
16-44............          16-181  RESNA WC-1: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    1: Requirements and
                                    Test Methods for
                                    Wheelchairs
                                    (including
                                    Scooters) Section
                                    15: Requirements
                                    for information
                                    disclosure,
                                    documentation and
                                    labeling.

[[Page 13635]]

 
16-45............          16-182  RESNA WC-1: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    1: Requirements and
                                    Test Methods for
                                    Wheelchairs
                                    (including
                                    Scooters) Section
                                    16: Resistance to
                                    ignition of
                                    upholstered parts--
                                    Requirements and
                                    test methods.
16-46............          16-183  RESNA WC-1: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    1: Requirements and
                                    Test Methods for
                                    Wheelchairs
                                    (including
                                    Scooters) Section
                                    20: Determination
                                    of the performance
                                    of stand-up type
                                    wheelchairs.
16-47............          16-184  RESNA WC-1: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    1: Requirements and
                                    Test Methods for
                                    Wheelchairs
                                    (including
                                    Scooters) Section
                                    22: Set-up
                                    procedures.
16-48............  ..............  ANSI/RESNA WC/Volume  Withdrawn.
                                    1-1998, Section 93:
                                    Maximum Overall
                                    Dimensions.
16-49............  ..............  ANSI/RESNA WC/Volume  Withdrawn.
                                    1-1998, Section 0:
                                    Nomenclature,
                                    Terms, and
                                    Definitions.
16-160...........          16-185  RESNA WC-2: 2009      Withdrawn and
                                    American National     replaced with
                                    Standard for          newer version.
                                    Wheelchairs-Volume
                                    2: Additional
                                    Requirements for
                                    Wheelchairs
                                    (including
                                    Scooters) with
                                    Electrical Systems
                                    Section 21:
                                    Requirements and
                                    test methods for
                                    electromagnetic
                                    compatibility of
                                    electrically
                                    powered wheelchairs
                                    and motorized
                                    scooters.
16-161...........          16-186  ASME A18.1-2008       Withdrawn and
                                    (Revision of ASME     replaced with
                                    A18.1-2005) Safety    newer version.
                                    Standard for
                                    Platform Lifts and
                                    Stairway Chairlifts.
------------------------------------------------------------------------
                              K. Radiology
------------------------------------------------------------------------
12-122...........          12-217  IEC 62083 Edition     Withdrawn and
                                    2.0:2009-09 Medical   replaced with
                                    electrical            newer version.
                                    equipment--Requirem
                                    ents for the safety
                                    of radiotherapy
                                    treatment planning
                                    systems.
12-36............  ..............  IEC 60601-2-9 (1996-  Withdrawn.
                                    10) Medical
                                    electrical
                                    equipment--Part 2:
                                    Particular
                                    requirements for
                                    the safety of
                                    patient contact
                                    dosimeters used in
                                    radiotherapy with
                                    electrically
                                    connected radiation
                                    detectors--Ed. 2.0..
12-183...........          12-218  NEMA PS 3.1--3.18     Withdrawn and
                                    (2009) Digital        replaced with
                                    Imaging and           newer version.
                                    Communications in
                                    Medicine (DICOM)
                                    Set.
------------------------------------------------------------------------
                        L. Software/Informatics
------------------------------------------------------------------------
13-4.............  ..............  UL 1998 Standard for  Reaffirmation.
                                    Safety Software in
                                    Programmable
                                    Components, Second
                                    Edition.
------------------------------------------------------------------------
                              M. Sterility
------------------------------------------------------------------------
14-265...........          14-301  USP 33:2010 <61>      Withdrawn and
                                    Microbiological       replaced with
                                    Examination of        newer version.
                                    Nonsterile
                                    Products: Microbial
                                    Enumeration Tests.
14-266...........          14-302  USP 33: 2010 <71>     Withdrawn and
                                    Sterility Tests.      replaced with
                                                          newer version.
14-267...........          14-303  USP 33:2010 <85>      Withdrawn and
                                    Bacterial             replaced with
                                    Endotoxins Test.      newer version.
14-268...........          14-304  USP 33:2010 <151>     Withdrawn and
                                    Pyrogen Test.         replaced with
                                                          newer version.
14-269...........          14-305  USP 33:2010 <161>     Withdrawn and
                                    Transfusion and       replaced with
                                    Infusion Assemblies   newer version.
                                    and Similar Medical
                                    Devices.
14-270...........          14-306  USP 33:2010           Withdrawn and
                                    Biological            replaced with
                                    Indicators for        newer version.
                                    Steam
                                    Sterilization, Self-
                                    Contained.
14-271...........          14-307  USP 33:2010           Withdrawn and
                                    Biological            replaced with
                                    Indicator for Dry-    newer version.
                                    Heat Sterilization,
                                    Paper Carrier.
14-272...........          14-308  USP 33:2010           Withdrawn and
                                    Biological            replaced with
                                    Indicator for         newer version.
                                    Ethylene Oxide
                                    Sterilization,
                                    Paper Carrier.
14-273...........          14-309  USP 33:2010           Withdrawn and
                                    Biological            replaced with
                                    Indicator for Steam   newer version.
                                    Sterilization,
                                    Paper Carrier.
14-278...........          14-310  USP 33:2010 <62>      Withdrawn and
                                    Microbiological       replaced with
                                    Examination of        newer version.
                                    Nonsterile
                                    Products: Tests for
                                    Specified
                                    Microorganisms.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

III. Listing of New Entries

    In table 3 of this document, FDA provides the listing of new 
entries and consensus standards added as modifications to the list of 
recognized standards under Recognition List Number: 026.

[[Page 13636]]



        Table 3--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                      Reference No. and
    Recognition No.        Title of standard \1\            date
------------------------------------------------------------------------
                              A. Anesthesia
------------------------------------------------------------------------
1-84..................  Anaesthetic and             ISO 5366-3:2001
                         respiratory equipment--     TECHNICAL
                         Tracheostomy tubes--Part    CORRIGENDUM 1.
                         3: Paediatric
                         tracheostomy tubes
                         TECHNICAL CORRIGENDUM 1.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
2-163.................  Biological evaluation of    ANSI/AAMI/ISO 10993-
                         medical devices--Part 9:    9:2009.
                         Framework for
                         identification and
                         quantification of
                         potential degradation
                         products.
2-164.................  Biological evaluation of    ANSI/AAMI/ISO 10993-
                         medical devices--Part 13:   13:2010.
                         Identification and
                         quantification of
                         degradation products from
                         polymeric medical devices.
2-165.................  Biological evaluation of    ANSI/AAMI/ISO 10993-
                         medical devices--Part 14:   14:2001.
                         Identification and
                         quantification of
                         degradation products from
                         ceramics.
2-166.................  Biological evaluation of    ANSI/AAMI/ISO 10993-
                         medical devices--Part 16:   16:2010.
                         Toxicokinetic study
                         design for degradation
                         products and leachables.
2-167.................  Biological evaluation of    ISO/TS 10993-19
                         medical devices--Part 19:   First edition 2006-
                         Physico-chemical,           06-01.
                         morphological and
                         topographical
                         characterization of
                         materials.
2-168.................  Biological evaluation of    ISO 10993-9 Second
                         medical devices-- Part 9:   edition 2009-12-15.
                         Framework for
                         identification and
                         quantification of
                         potential degradation
                         products.
2-169.................  Biological evaluation of    ISO 10993-13 First
                         medical devices--Part 13:   edition 1998-11-15.
                         Identification and
                         quantification of
                         degradation products from
                         polymeric medical devices.
2-170.................  Biological evaluation of    ISO 10993-14 First
                         medical devices--Part 14:   edition 2001-11-15.
                         Identification and
                         quantification of
                         degradation products from
                         ceramics.
2-171.................  Biological evaluation of    ISO 10993-16 Second
                         medical devices--Part 16:   edition 2010-02-15.
                         Toxicokinetic study
                         design for degradation
                         products and leachables.
2-172.................  Biological evaluation of    ANSI/AAMI/ISO
                         medical devices--Part 19:   TIR10993-19:2006.
                         Physico-chemical,
                         morphological, and
                         topographical
                         characterization of
                         materials.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-83..................  Implants for surgery--      ANSI/AAMI/ISO 14708-
                         Active implantable          5:2010.
                         medical devices--Part 5:
                         Circulatory support
                         devices.
3-84..................  Cardiovascular implants--   ANSI/AAMI/ISO 25539-
                         Endovascular devices--      1:2003/A1:2005/
                         Part 1: Endovascular        (R)2009.
                         prostheses Amendment 1:
                         Test methods.
3-85..................  Cardiovascular implants--   ANSI/AAMI/ISO 25539-
                         Endovascular devices--      2:2008.
                         Part 2: Vascular stents.
3-86..................  Standard Guide for          ASTM F 2394-07.
                         Measuring Securement of
                         Balloon Expandable
                         Vascular Stent Mounted on
                         Delivery System.
3-87..................  Standard Test Methods for   ASTM F 2477-07.
                         in vitro Pulsatile
                         Durability Testing of
                         Vascular Stents.
3-88..................  Standard Guide for Finite   ASTM F 2514-08.
                         Element Analysis (FEA) of
                         Metallic Vascular Stents
                         Subjected to Uniform
                         Radial Loading.
3-89..................  Active implantable medical  ISO 27186 First
                         devices--Four-pole          edition 2010-03-15.
                         connector system for
                         implantable cardiac
                         rhythm management
                         devices--Dimensional and
                         test requirements.
3-90..................  Cardiovascular implants--   ISO 7198 First
                         Tubular vascular            edition 1998-08-01.
                         prostheses.
3-91..................  Cardiovascular implants--   ISO 5840 Fourth
                         Cardiac valve prostheses.   edition 2005-03-01.
3-92..................  Implants for surgery--      ISO 14708-5 First
                         Active implantable          edition 2010-02-01.
                         medical devices--Part 5:
                         Circulatory support
                         devices.
3-93..................  Cardiovascular implants--   ISO 25539-1 First
                         Endovascular device--Part   edition 2001-11-13
                         1: Endovascular             AMENDMENT 1 2005-07-
                         prostheses AMENDMENT 1:     15.
                         Test methods.
3-94..................  Cardiovascular implants--   ISO 25539-2 First
                         Endovascular devices--      edition 2008-09-01.
                         Part 2: Vascular stents.
------------------------------------------------------------------------
                               D. General
------------------------------------------------------------------------
5-63..................  Small-bore connectors for   ISO 80369-1 First
                         liquids and gases in        edition 2010-12-15.
                         healthcare applications--
                         Part 1: General
                         requirements.
5-64..................  Small bore connectors for   AAMI/ISO/FDS-1 80369-
                         liquids and gases in        01 2010.
                         healthcare applications--
                         Part 1: General
                         requirements.
------------------------------------------------------------------------
                              E. Materials
------------------------------------------------------------------------
8-196.................  Implants for surgery--      ISO 5832-1:2007
                         Metallic materials--Part    TECHNICAL
                         1: Wrought stainless        CORRIGENDUM 1 2008-
                         steel TECHNICAL             04-15.
                         CORRIGENDUM 1.
8-197.................  Implants for surgery--      ISO 5832-12:2007
                         Metallic materials--Part    TECHNICAL
                         12: Wrought cobalt-         CORRIGENDUM 1 2008-
                         chromium-molybdenum alloy   09-15.
                         TECHNICAL CORRIGENDUM 1.
8-198.................  Standard Guide for          ASTM F 2102-
                         Evaluating the Extent of    06[epsi]1.
                         Oxidation in Ultra-High-
                         Molecular-Weight
                         Polyethylene Fabricated
                         Forms Intended for
                         Surgical Implants.

[[Page 13637]]

 
8-199.................  Standard Specification for  ASTM F 2633-07.
                         Wrought Seamless Nickel-
                         Titanium Shape Memory
                         Alloy Tube for Medical
                         Devices and Surgical
                         Implants.
8-200.................  Standard Practice for       ASTM F 2003-02
                         Accelerated Aging of        (Reapproved 2008).
                         Ultra-High Molecular
                         Weight Polyethylene after
                         Gamma Irradiation in Air.
8-201.................  Standard Test Method for    ASTM F 2214-02
                         In Situ Determination of    (Reapproved 2008).
                         Network Parameters of
                         Crosslinked Ultra High
                         Molecular Weight
                         Polyethylene (UHMWPE).
8-202.................  Standard Test Method for    ASTM F 2183-02
                         Small Punch Testing of      (Reapproved 2008).
                         Ultra-High Molecular
                         Weight Polyethylene Used
                         in Surgical Implants.
------------------------------------------------------------------------
                            F. Nanotechnology
------------------------------------------------------------------------
18-1..................  Standard Guide for          ASTM E 2490-09.
                         Measurement of Particle
                         Size Distribution of
                         Nanomaterials in
                         Suspension by Photon
                         Correlation Spectroscopy
                         (PCS).
------------------------------------------------------------------------
                              G. Ophthalmic
------------------------------------------------------------------------
10-62.................  Ophthalmics--Ophthalmic     ANSI Z80.10-2009.
                         Instruments--Tonometers.
10-63.................  Ophthalmic implants--       ISO/TR 22979-2006.
                         Intraocular lenses--
                         Guidance on assessment of
                         the need for clinical
                         investigation of
                         intraocular lens design
                         modifications.
------------------------------------------------------------------------
                              H. Radiology
------------------------------------------------------------------------
12-219................  Medical electrical          IEC 60336 (Fourth
                         equipment--X-ray tube       edition--2005).
                         assemblies for medical
                         diagnosis--Characteristic
                         s of focal spots
                         CORRIGENDUM 1.
12-220................  Safety of laser products--  IEC 60825-1 (Second
                         Part 1: Equipment           edition--2007).
                         classification and
                         requirements CORRIGENDUM
                         1.
12-221................  Evaluation and routine      IEC 61223-3-4 First
                         testing in medical          edition 2000-03.
                         imaging departments--Part
                         3-4: Acceptance tests--
                         Imaging performance of
                         dental X-ray equipment.
12-222................  Evaluation and routine      IEC 61223-3-5 First
                         testing in medical          edition 2004-08.
                         imaging departments--Part
                         3-5: Acceptance tests--
                         Imaging performance of
                         computed tomography X-ray
                         equipment.
12-223................  Evaluation and routine      IEC 61223-3-5 (First
                         testing in medical          edition 2004).
                         imaging departments--Part
                         3-5: Acceptance tests--
                         Imaging performance of
                         computed tomography X-ray
                         equipment CORRIGENDUM 1.
12-224................  Medical electrical          IEC 60601-2-44
                         equipment--Part 2-44:       (Third edition--
                         Particular requirements     2009).
                         for the basic safety and
                         essential performance of
                         X-ray equipment for
                         computed tomography
                         CORRIGENDUM 1.
12-225................  Computed Tomography Dose    NEMA XR 25 2010.
                         Check.
12-226................  Evaluation and routine      IEC 61223-2-6 Second
                         testing in medical          edition 2006-11.
                         imaging departments--Part
                         2-6: Constancy tests--
                         Imaging performance of
                         computed tomography X-ray
                         equipment.
------------------------------------------------------------------------
                          I. Tissue Engineering
------------------------------------------------------------------------
15-25.................  ASTM F2312--10 Standard     ASTM F2312-10.
                         Terminology Relating to
                         Tissue Engineered Medical
                         Products.
15-26.................  ASTM F2211--04 Standard     ASTM F2211-04.
                         Classification for Tissue
                         Engineered Medical
                         Products (TEMPs).
------------------------------------------------------------------------
\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 minor 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 minor revisions to the list of recognized consensus standards, as 
needed, in the Federal Register once a year, or more often, if 
necessary.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for 
recognition under the new provision of section 514 of the FD&C Act by 
submitting such recommendations, with reasons for the recommendation, 
to the contact person (See FOR FURTHER INFORMATION CONTACT). 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. CDRH maintains a site on 
the

[[Page 13638]]

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 includes the 
guidance as well as the current list of recognized standards and other 
standards related documents. After publication in the Federal Register, 
this notice announcing ``Modification to the List of Recognized 
Standards, Recognition List Number: 026'' will be available on the CDRH 
home page. You may access the CDRH home page at http://www.fda.gov/MedicalDevices.
    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.
    This Federal Register document on modifications in FDA's 
recognition of consensus standards is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

VII. Submission of Comments and Effective Date

    Interested persons may submit to the contact person (see FOR 
FURTHER INFORMATION CONTACT) either electronic or written comments 
regarding this document. It is only necessary to send one set of 
comments. It is no longer necessary to send two copies of mailed 
comments. Comments are to be identified with the docket number found in 
brackets in the heading of this document. 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: 026. These modifications to the list or recognized standards 
are effective upon publication of this notice in the Federal Register.

    Dated: March 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5815 Filed 3-11-11; 8:45 am]
BILLING CODE 4160-01-P