[Federal Register Volume 69, Number 191 (Monday, October 4, 2004)]
[Notices]
[Pages 59240-59250]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 04-22183]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0226]


Food and Drug Administration Modernization Act of 1997; 
Modifications to the List of Recognized Standards, Recognition List 
Number: 011

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: 011'' (Recognition List Number: 011), 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 on a 3.5'' 
diskette of ``Modifications to the List of Recognized Standards, 
Recognition List Number: 011'' to the Division of Small Manufacturers 
Assistance, Center for Devices and Radiological Health (HFZ-220), Food 
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send 
two self-addressed adhesive labels to assist that office in processing 
your requests, or fax your request to 301-443-8818. 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: 
standards@cdrh.fda.gov. This document may also be accessed on FDA's 
Internet site at http://www.fda.gov/cdrh/fedregin.html. 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: 011 modifications and other standards related 
information.

FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices 
and Radiological Health (HFZ-84), Food and

[[Page 59241]]

Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-
4766, ext.156.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal 
Food, Drug, and Cosmetic Act (the 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 will implement its standard recognition program and provided 
the initial list of FDA recognized consensus standards.
    In Federal Register notices published on 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), and June 18, 2004 (69 FR 34176), FDA modified its initial list 
of FDA recognized consensus standards. These notices described 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 Recognition List Number: 011

    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: 011'' to identify these current 
modifications.
    In table 1 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 1.
------------------------------------------------------------------------
Old Item                                                    Replacement
   No.                 Standard                 Change       Item No.
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
  1       ASTM F920-93 (1999), Standard      Withdrawn    50
           Specification for Minimum          and
           Performance and Safety             replaced
           Requirements for Resuscitators     with newer
           Intended for Use With Humans       version
------------------------------------------------------------------------
  2       ASTM F1100-90 (1997), Standard     Withdrawn    51
           Specification for Ventilators      and
           Intended for Use in Critical       replaced
           Care                               with newer
                                              version
------------------------------------------------------------------------
  5       ASTM F1463-93 (1999), Standard     Withdrawn    52
           Specification for Alarm Signals    and
           in Medical Equipment Used in       replaced
           Anesthesia and Respiratory Care    with newer
                                              version
------------------------------------------------------------------------
  6       ASTM F1464-93 (1999), Standard     Withdrawn    53
           Specification for Oxygen           and
           Concentrators for Domiciliary      replaced
           Use                                with newer
                                              version
------------------------------------------------------------------------
  8       PVHO-1-2002, Safety Standard for   Withdrawn    54
           Pressure Vessels for Human         and
           Occupancy                          replaced
                                              with newer
                                              version
------------------------------------------------------------------------
  23      ASTM F1054-01, Standard            Withdrawn    55
           Specification for Conical          and
           Fittings                           replaced
                                              with newer
                                              version
------------------------------------------------------------------------
  24      ASTM F1456-01, Standard            Withdrawn    59
           Specification for Minimum          and
           Performance and Safety             replaced
           Requirements for Capnometers       with newer
                                              version
------------------------------------------------------------------------
  25      ASTM F1462-93, Specification for   Withdrawn    ..............
           Oxygen Analyzers
------------------------------------------------------------------------
  34      ASTM PS127: 2000, Standard Test    Withdrawn    ..............
           Method for Evaluating the
           Ignition Sensitivity and Fault
           Tolerance of Oxygen Regulators
           Used for Medical and Emergency
           Applications
------------------------------------------------------------------------
  40      CGA V-7.1: 1997 (reaffirmed        Withdrawn    56
           2003), Standard Method for         and
           Determining Cylinder Valve         replaced
           Outlet Connections for Medical     with newer
           Gases                              version
------------------------------------------------------------------------
  45      ASTM 1101-90 (2003) e1, Standard   Withdrawn    57
           Specification for Ventilators      and
           Intended for Use During            replaced
           Anesthesia                         with newer
                                              version
������������������������������������������������������������������������
B. Cardiovascular/Neurology
------------------------------------------------------------------------

[[Page 59242]]

 
  1       ANSI/AAMI EC12: 2000, Disposable   Withdrawn    52
           Electrocardiogram (ECG)            and
           Electrodes                         replaced
                                              with newer
                                              version
------------------------------------------------------------------------
  4       AAMI SP10: 1992, Electronic or     Change in    ..............
           Automated Sphygmomanometers        processes
                                              affected
                                              and
                                              contact
                                              person
------------------------------------------------------------------------
  44      ANSI/AAMI BP22: 1994 (R2001),      Change in    ..............
           Blood Pressure Transducers         processes
                                              affected
                                              and
                                              contact
                                              person
������������������������������������������������������������������������
C. Dental/Ear, Nose, and Throat
------------------------------------------------------------------------
  22      ASTM/F1377-92, Standard            Transfer to  ..............
           Specification for Cobalt-          materials
           Chromium-Molybdenum Powder for
           Coating of Orthopaedic Implants
------------------------------------------------------------------------
  42      ANSI/ADA Specification No. 3:      Withdrawn    ..............
           1994, Dental Impression Compound
------------------------------------------------------------------------
  43      ANSI/ADA Specification No. 5:      Change date  ..............
           1997, Dental Casting Alloys        of
                                              standard
------------------------------------------------------------------------
  44      ANSI/ADA Specification No. 11:     Withdrawn    110
           1997, Agar Impression Material     and
                                              replaced
                                              with newer
                                              version
------------------------------------------------------------------------
  45      ANSI/ADA Specification No. 13:     Withdrawn    111
           1999, Dental Cold-Curing Repair    and
           Resin                              replaced
                                              with newer
                                              version
------------------------------------------------------------------------
  48      ANSI/ADA Specification No. 16:     Withdrawn    112
           1999, Dental Impression Paste      and
           Zinc Oxide-Eugenol Materials       replaced
                                              with newer
                                              version
------------------------------------------------------------------------
  51      ANSI/ADA Specification No. 20:     Withdrawn    113
           1995, Dental Duplicating           and
           Material                           replaced
                                              with newer
                                              version
------------------------------------------------------------------------
  55      ANSI/ADA Specification No. 48:     Withdrawn    114
           1989, Ultraviolet Activator and    and
           Disclosing Lights                  replaced
                                              with newer
                                              version
------------------------------------------------------------------------
  67      ISO 6871-1: 1994, Dental Base      Title        ..............
           Metal Casting Alloys--Part 1:      correction
           Cobalt-Based Alloys--Technical
           Corrigendum 1: 1998
------------------------------------------------------------------------
  80      ISO 9917-1: 2003, Dental Water     Withdrawn    115
           Based Cements--Part 1: Powder/     and
           Liquid Acid-Base Cements--first    replaced
           edition                            with newer
                                              version
------------------------------------------------------------------------
  81      ISO 10139-1: 1999, Dentistry--     Withdrawn    116
           Resilient Lining Materials for     and
           Removable Dentures--Part 1:        replaced
           Short-Term Materials               with newer
                                              version
------------------------------------------------------------------------
  90      ANSI/ASA S3.39: 1987 (R2002),      Change date  ..............
           Specification for Instruments to   of
           Measure Aural Acoustic Impedance   standard
           and Admittance (Aural Acoustic
           Immittance)
------------------------------------------------------------------------
  103     ANSI/ADA Specification No. 12:     Withdrawn    117
           2002, Denture Base Polymers        and
                                              replaced
                                              with newer
                                              version
------------------------------------------------------------------------
  105     ANSI/ADA Specification No. 75:     Title        ..............
           1997 (R2003), Resilient Lining     correction
           Materials for Removable
           Dentures--Part 1: Short-Term
           Materials
------------------------------------------------------------------------
  106     ANSI/ADA Specification No. 82:     Withdrawn    119
           2003, Dental Reversible/           and
           Irreversible Hydrocolloid          replaced
           Impression Material System         with newer
                                              version
------------------------------------------------------------------------
  108     ISO 10139-2: 1999, Dentistry--     Withdrawn    120
           Soft Lining Materials for          and
           Removable Dentures--Part 2:        replaced
           Materials for Long-Term Use        with newer
                                              version
������������������������������������������������������������������������
D. General
------------------------------------------------------------------------
  10      AAMI/ISO 14971-1, Medical          Withdrawn    ..............
           Devices--Risk Management--Part
           1: Application of Risk Analysis
------------------------------------------------------------------------
  21      CEN EN 1441: 1997, Medical         Withdrawn    ..............
           Devices--Risk Management
������������������������������������������������������������������������
E. In Vitro Diagnostic
------------------------------------------------------------------------
  23      NCCLS H1-A5, Tubes and Additives   Withdrawn    102
           for Venous Blood Specimen          and
           Collection; Approved Standard      replaced
                                              with newer
                                              version
------------------------------------------------------------------------

[[Page 59243]]

 
  69      NCCLS H3-A5, Procedures for the    Withdrawn    103
           Collection of Diagnostic Blood     and
           Specimens by Venipuncture;         replaced
           Approved Standard                  with newer
                                              version
------------------------------------------------------------------------
  24      NCCLS H7-A3, Procedure for         Withdrawn    104
           Determining Packed Cell Volume     and
           by the Microhematocrit Method;     replaced
           Approved Standard--third edition   with newer
                                              version
------------------------------------------------------------------------
  33      NCCLS H30-A2, Procedure for the    Withdrawn    105
           Determination of Fibrinogen in     and
           Plasma; Approved Guideline--       replaced
           second edition                     with newer
                                              version
------------------------------------------------------------------------
  57      NCCLS M2-A8, Performance           Withdrawn    106
           Standards for Antimicrobial Disk   and
           Susceptibility Tests; Approved     replaced
           Standard--eighth edition           with newer
                                              version
------------------------------------------------------------------------
  75      NCCLS M11-A6, Methods for          Withdrawn    107
           Dilution Antimicrobial             and
           Susceptibility Tests for           replaced
           Bacteria That Grow Aerobically,    with newer
           Approved Standard--sixth edition   version
------------------------------------------------------------------------
  56      NCCLS M7-A6, Methods for           Withdrawn    108
           Antimicrobial Susceptibility       and
           Testing of Anaerobic Bacteria;     replaced
           Approved Standard--sixth edition   with newer
                                              version
������������������������������������������������������������������������
F. Materials
------------------------------------------------------------------------
  5       ASTM F138-03, Standard             Withdrawn    76
           Specification for Wrought 18       and
           Chromium-14 Nickel-2.5             replaced
           Molybdenum Stainless Steel Bar     with newer
           and Wire for Surgical Implants     version
           (UNS S31673)
------------------------------------------------------------------------
  6       ASTM F139-03, Standard             Withdrawn    77
           Specification for Wrought 18       and
           Chromium-14 Nickel-2.5             replaced
           Molybdenum Stainless Steel Sheet   with newer
           and Strip for Surgical Implants    version
           (UNS S31673)
------------------------------------------------------------------------
  7       ASTM F560-04, Standard             Withdrawn    78
           Specification for Unalloyed        and
           Tantalum for Surgical Implant      replaced
           Applications (UNS R05200, UNS      with newer
           R05400)                            version
------------------------------------------------------------------------
  13      ASTM F648-00e1, Standard           Change date  ..............
           Specification for Ultra-High-      of
           Molecular-Weight Polyethylene      standard
           Powder and Fabricated Form for
           Surgical Implants
------------------------------------------------------------------------
  16      ASTM F746-87 (1999), Standard      Change in    ..............
           Test Method for Pitting or         processes
           Crevice Corrosion of Metallic      affected
           Surgical Implant Materials
------------------------------------------------------------------------
  19      ASTM F961-03, Standard             Withdrawn    79
           Specification for Cobalt-35        and
           Nickel-20 Chromium-10 Molybdenum   replaced
           Alloy Forgings for Surgical        with newer
           Implants (UNS R30035)              version
------------------------------------------------------------------------
  21      ASTM F1088-04, Standard            Withdrawn    80
           Specification for Beta-            and
           Tricalcium Phosphate for           replaced
           Surgical Implantation              with newer
                                              version
------------------------------------------------------------------------
  33      ASTM F1609-03, Standard            Withdrawn    81
           Specification for Calcium          and
           Phosphate for Coatings for         replaced
           Implantable Materials              with newer
                                              version
------------------------------------------------------------------------
  34      ASTM F1659-95, Standard Test       Change in    ..............
           Method for Bending and Shear       processes
           Fatigue Testing of Calcium         affected
           Phosphate Coatings on Solid
           Metallic Substrates
------------------------------------------------------------------------
  35      ASTM F1713-03, Standard            Withdrawn    82
           Specification for Wrought          and
           Titanium-13 Niobium-13 Zirconium   replaced
           Alloy for Surgical Implant         with newer
           Applications                       version
------------------------------------------------------------------------
  40      ASTM F2063-00, Standard            Change in    ..............
           Specification for Wrought Nickel-  extent of
           Titanium Shape Memory Alloys for   recognitio
           Medical Devices and Surgical       n, contact
           Implants                           person,
                                              and
                                              processes
                                              affected
------------------------------------------------------------------------
  42      ASTM F2119-01, Standard Test       Change in    ..............
           Method for Evaluation of MR        processes
           Image Artifacts From Passive       affected
           Implants
------------------------------------------------------------------------
  48      ASTM F899-02, Standard             Change in    ..............
           Specification for Stainless        processes
           Steel for Surgical Instruments     affected
------------------------------------------------------------------------
  70      ASTM F2052-02, Standard Test       Withdrawn    ..............
           Method for Measurement of
           Magnetically Induced
           Displacement Force on Medical
           Devices in the Magnetic
           Resonance Environment
------------------------------------------------------------------------
  72      ASTM F2213-04, Standard Test       Change in    ..............
           Method for Measurement of          processes
           Magnetically Induced Torque on     affected
           Medical Devices in the Magnetic
           Resonance Environment
------------------------------------------------------------------------
  Ortho   ASTM F561-97 (2003), Practice for  Transferred  73
    Microbial       Withdrawn    127
           Limits Test                        and
                                              replaced
                                              with newer
                                              version
------------------------------------------------------------------------
  110     USP 27: 2004, <71>                 Withdrawn    128
           Microbiological Tests, Sterility   and
           Tests                              replaced
                                              with newer
                                              version
------------------------------------------------------------------------
  111     USP 27: 2004, <85> Biological      Withdrawn    129
           Tests and Assays, Bacterial        and
           Endotoxin Test (LAL)               replaced
                                              with newer
                                              version
------------------------------------------------------------------------
  112     USP 27: 2004, <151> Pyrogen Test   Withdrawn    130
           (USP Rabbit Test)                  and
                                              replaced
                                              with newer
                                              version
------------------------------------------------------------------------
  113     USP 27: 2004, <1211>               Withdrawn    131
           Sterilization and Sterility        and
           Assurance of Compendial Articles   replaced
                                              with newer
                                              version
------------------------------------------------------------------------
  114     USP 27: 2004, <161> Transfusion    Withdrawn    132
           and Infusion Assemblies and        and
           Similar Medical Devices            replaced
                                              with newer
                                              version
------------------------------------------------------------------------
  115     USP 27: 2004, Biological           Withdrawn    133
           Indicator for Steam                and
           Sterilization--Self-Contained      replaced
                                              with newer
                                              version
------------------------------------------------------------------------
  116     ANSI/AAMI ST72: 2002, Bacterial    Change in    ..............
           Endotoxins--Test Methodologies,    relevant
           Routine Monitoring, and            guidance
           Alternatives to Batch Testing
------------------------------------------------------------------------

III. Listing of New Entries

    The listing of new entries and consensus standards added as 
modifications to the list of recognized standards, under Recognition 
List Number: 011, follows:

                                Table 2.
------------------------------------------------------------------------
                                                          Reference No.
  Item No.                Title of Standard                  and Date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
  58          Standard Test Method for Evaluating the    ASTM G175-03
               Ignition Sensitivity and Fault Tolerance
               of Oxygen Regulators Used for Medical
               and Emergency Applications
������������������������������������������������������������������������
B. Dental/ENT
------------------------------------------------------------------------
  121         Dentistry--Dental Units--Part 2: Water     ISO 7494-2:
               and Air Supply                             2003
������������������������������������������������������������������������
C. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
  112         Liquid Barrier Performance and             ANSI/AAMI PB70:
               Classification of Protective Apparel and   2003
               Drapes Intended for Use in Health Care
               Facilitates
------------------------------------------------------------------------
  113         Standard Specification for Performance of  ASTM F2100-04
               Materials Used in Medical Face Masks
������������������������������������������������������������������������
D. Materials
------------------------------------------------------------------------

[[Page 59248]]

 
  85          Standard Test Method for Stereological     ASTM F1854-01
               Evaluation of Porous Coatings on Medical
               Implants
------------------------------------------------------------------------
  86          Standard Test Method for Evaluation of     ASTM F1926-03
               the Environmental Stability of Calcium
               Phosphate Coatings
------------------------------------------------------------------------
  87          Standard Test Method for Measuring         ASTM F1978-00e1
               Abrasion Resistance of Metallic Thermal
               Spray Coatings by Using the TaberT
               Abraser
------------------------------------------------------------------------
  88          Standard Practice for X-Ray Diffraction    ASTM F2024-00
               Determination of Phase Content of Plasma-
               Sprayed Hydroxyapatite Coatings
------------------------------------------------------------------------
  89          Standard Specification for High-Purity     ASTM F1873-98
               Dense Yttria Tetragonal Zirconium Oxide
               Polycrystal (Y-TZP) for Surgical Implant
               Applications
------------------------------------------------------------------------
  90          Standard Test Method for Strength          ASTM F2255-03
               Properties of Tissue Adhesives in Lap
               Shear by Tension Loading
------------------------------------------------------------------------
  91          Standard Test Method for Strength          ASTM F2256-03
               Properties of Tissue Adhesives in T-Peel
               by Tension Loading
------------------------------------------------------------------------
  92          Standard Test Method for Strength          ASTM F2258-03
               Properties of Tissue Adhesives in
               Tension
------------------------------------------------------------------------
  96          Standard Test Method for In Vitro          ASTM 1635-95
               Degradation Testing of Poly (L-lactic      (2000)
               Acid) Resin and Fabricated Form for
               Surgical Implants
------------------------------------------------------------------------
  97          Standard Test Method for Conducting        ASTM F2129-04
               Cyclic Potentiodynamic Polarization
               Measurements to Determine the Corrosion
               Susceptibility of Small Implant Devices
------------------------------------------------------------------------
  98          Standard Specification for Acrylic Bone    ASTM F451-99ae1
               Cement
------------------------------------------------------------------------
  99          Standard Test Method for Transformation    ASTM F2004-03
               Temperature of Nickel-Titanium Alloys by
               Thermal Analysis
------------------------------------------------------------------------
  100         Standard Terminology for Nickel-Titanium   ASTM F2005-00
               Shape Memory Alloys
------------------------------------------------------------------------
  101         Test Method for Constant Amplitude of      ASTM F2118-03
               Force Controlled Fatigue Testing of
               Acrylic Bone Cement Materials
------------------------------------------------------------------------
  102         Standard Test Method for Determination of  ASTM F2082-03
               Transformation Temperature of Nickel-
               Titanium Shape Memory Alloys by Bend and
               Free Recovery
������������������������������������������������������������������������
E. OB-GYN/Gastroenterology
------------------------------------------------------------------------
  30          Water Treatment Equipment for              ANSI/AAMI RD62:
               Hemodialysis Applications                  2001
������������������������������������������������������������������������
F. Ophthalmic
------------------------------------------------------------------------
  33          Contact Lens Care Products--Vocabulary,    ANSI Z80.18
               Performance Specifications, and Test
               Methodology
������������������������������������������������������������������������
G. Orthopaedic
------------------------------------------------------------------------
  178         Standard Practice for Cyclic Fatigue       ASTM F1440-92
               Testing of Metallic Stemmed Hip            (2002)
               Arthroplasty Femoral Components Without
               Torsion
------------------------------------------------------------------------
  179         Standard Specification for Femoral         ASTM F2068-03
               Prostheses--Metallic Implants
������������������������������������������������������������������������
H. Physical Medicine
------------------------------------------------------------------------
  46          Determination of Performance of Stand-Up   ANSI/RESNA WC/
               Type Wheelchairs                           volume 1--
                                                          1998, section
                                                          20
------------------------------------------------------------------------
  47          Set Up Procedures                          ANSI/RESNA WC/
                                                          volume 1--
                                                          1998, section
                                                          22
------------------------------------------------------------------------
  48          Maximum Overall Dimensions                 ANSI/RESNA WC/
                                                          volume 1--
                                                          1998, section
                                                          93
------------------------------------------------------------------------
  49          Nomenclature, Terms, and Definitions       ANSI/RESNA WC/
                                                          volume 1--
                                                          1998, section
                                                          0
������������������������������������������������������������������������
I. Radiology
------------------------------------------------------------------------

[[Page 59249]]

 
  101         Recommended Practice for Photobiological   ANSI/ESNA RP-
               Safety for Lamps and Lamp Systems--        27.1.96
               General Requirements
------------------------------------------------------------------------
  102         Recommended Practice for Photobiological   ANSI/ESNA RP-
               Safety for Lamps and Lamp Systems--        27.2.00
               Measurement Techniques
------------------------------------------------------------------------
  103         Recommended Practice for Photobiological   ANSI/ESNA RP-
               Safety for Lamps and Lamp Systems--Risk    27.3.96
               Group Classification and Labeling
------------------------------------------------------------------------
  106         Optics and Optical Instruments--Lasers     ISO 17526: 2003
               and Laser-Related Equipment--Lifetime of
               Lasers
------------------------------------------------------------------------
  107         Lasers and Laser-Related Equipment--Test   ISO 11146: 1999
               Methods for Laser Beam Parameters--Beam
               Widths, Divergence Angle, and Beam
               Propagation Factor
------------------------------------------------------------------------
  108         Lasers and Laser-Related Equipment--       ISO 11254-1:
               Determination of Laser-Induced Damage      2000
               Threshold of Optical Surfaces--Part 1: 1-
               on-1 Test
------------------------------------------------------------------------
  109         Lasers and Laser-Related Equipment--       ISO 11254-2:
               Determination of Laser-Induced Damage      2001
               Threshold of Optical Surfaces--Part 2: S-
               on-1 Test
------------------------------------------------------------------------
  110         Optics and Optical Instruments--Lasers     ISO 11551: 2003
               and Laser-Related Equipment--Test Method
               for Absorptance of Optical Laser
               Components (revision of ISO 11551: 1997)
------------------------------------------------------------------------
  111         Optics and Optical Instruments--Lasers     ISO 11554: 2003
               and Laser-Related Equipment--Test
               Methods for Laser Beam Power, Energy,
               and Temporal Characteristics (revision
               of ISO 11554: 1998)
------------------------------------------------------------------------
  112         Lasers and Laser-Related Equipment--Test   ISO 11670: 2003
               Methods for Laser Beam Parameters--Beam
               Positional Stability (revision of ISO
               11670: 1999)
------------------------------------------------------------------------
  113         Lasers and Laser-Related Equipment--Test   ISO 12005: 2003
               Methods for Laser Beam Parameters--
               Polarization (revision of ISO 12005:
               1999)
------------------------------------------------------------------------
  114         Optics and Optical Instruments--Lasers     ISO 13694: 2000
               and Laser-Related Equipment--Test
               Methods for Laser Beam Power (Energy)
               Density Distribution
------------------------------------------------------------------------
  115         Optics and Photonics--Lasers and Laser-    ISO 13695: 2004
               Related Equipment--Test Methods for the
               Spectral Characteristics of Lasers
------------------------------------------------------------------------
  116         Optics and Optical Instruments--Test       ISO 13696: 2002
               Methods for Radiation Scattered by
               Optical Components
------------------------------------------------------------------------
  117         Lasers and Laser-Related Equipment--Test   ISO 15367-1:
               Methods for Determination of the Shape     2003
               of a Laser Beam Wavefront--Part 1:
               Terminology and Fundamental Aspects
------------------------------------------------------------------------
  120         Particular Requirements for the Safety of  IEC 60601-2-44
               X-Ray Equipment for Computed Tomography    (ed. 2.1)
������������������������������������������������������������������������
J. Sterility
------------------------------------------------------------------------
  134         Resistometers Used for Characterizing the  ANSI/AAMI ST44:
               Performance of Biological and Chemical     2002
               Indicators
------------------------------------------------------------------------
  135         Sterilization of Health Care Products--    ANSI/AAMI ST63:
               Requirements for the Development,          2002
               Validation, and Routine Control of an
               Industrial Sterilization Process for
               Medical Devices--Dry Heat
------------------------------------------------------------------------
  136         Sterilization of Health Care Products--    ANSI/AAMI ST67:
               Requirements for Products Labeled          2003
               ``Sterile''
------------------------------------------------------------------------
  137         Sterilization of Health Care Products--    ANSI/AAMI/ISO
               Vocabulary                                 TIR 11139:
                                                          2002
------------------------------------------------------------------------
  138         Aseptic Processing of Health Care          ISO 13408-2:
               Products--Part 2: Filtration               2003
------------------------------------------------------------------------
  139         Cleanrooms and Associated Controlled       ISO 14644-1:
               Environments--Part 1: Classification of    1999
               Air Cleanliness
------------------------------------------------------------------------
  140         Cleanrooms and Associated Controlled       ISO 14644-2:
               Environments--Part 2: Specifications for   2000
               Testing and Monitoring to Prove
               Continued Compliance With ISO 14644-1
------------------------------------------------------------------------
  141         Cleanrooms and Associated Controlled       ISO 14644-4:
               Environments--Part 4: Design,              2001
               Construction, and Start-Up
------------------------------------------------------------------------
  142         Cleanrooms and Associated Controlled       ISO 14698-1:
               Environments--Biocontamination Control--   2003
               Part 1: General Principles and Methods
------------------------------------------------------------------------
  143         Cleanrooms and Associated Controlled       ISO 14698-2:
               Environments--Biocontamination Control--   2003
               Part 2: Evaluation and Interpretation of
               Biocontamination Data
������������������������������������������������������������������������

[[Page 59250]]

 
K. Tissue Engineering
------------------------------------------------------------------------
  5           Standard Guide for Characterization and    ASTM F2347-2003
               Testing of Hyaluronan as Starting
               Material Intended for Use in Biomedical
               and Tissue Engineered Medical Product
               Applications
------------------------------------------------------------------------

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 document 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 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

    In order to receive ``Guidance on the Recognition and Use of 
Consensus Standards'' via your fax machine, call the Center for Devices 
and Radiological Health (CDRH) Facts-On-Demand system at 800-899-0381 
or 301-827-0111 from a touch-tone telephone. Press 1 to enter the 
system. At the second voice prompt press 1 to order a document. Enter 
the document number 321 followed by the pound sign. Follow the 
remaining voice prompts to complete your request.
    You may also obtain a copy of ``Guidance on the Recognition and Use 
of Consensus Standards'' by using the Internet. 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 
includes the guidance as well as the current list of recognized 
standards and other standards related documents. After publication in 
the Federal Register, this document announcing ``Modifications to the 
List of Recognized Standards, Recognition List Number: 011,'' will be 
available on the CDRH home page. You may access the CDRH home page at 
http://www.fda.gov/cdrh.
    You may access ``Guidance on the Recognition and Use of Consensus 
Standards,'' and the searchable database for FDA recognized consensus 
standards, through the hyperlink at http://www.fda.gov/cdrh/
stdsprog.html.
    This Federal Register document on modifications in FDA's 
recognition of consensus standards is available at http://www.fda.gov/
cdrh/fedregin.html.

VII. Submission of Comments and Effective Date

    Interested persons may submit to the contact person (see FOR 
FURTHER INFORMATION CONTACT) written or electronic comments regarding 
this document. Two copies of any mailed comments are to be submitted, 
except that individuals may submit one paper copy. 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: 011. These modifications 
to the list or recognized standards are effective upon publication of 
this document in the Federal Register.

    Dated: September 21, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-22183 Filed 10-1-04; 8:45 am]
BILLING CODE 4160-01-S