[Federal Register Volume 70, Number 102 (Friday, May 27, 2005)]
[Notices]
[Pages 30756-30761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-10626]


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

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: 012

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: 012'' (Recognition List Number: 012), 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: 012'' to the Division of Small Manufacturers, 
International and Consumer 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: [email protected]. 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: 012 
modifications and other standards related information.

FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices 
and Radiological Health (HFZ-84), Food and Drug Administration, 12720 
Twinbrook Pkwy., MD 20857, 301-827-0021.

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), June 18, 2004 (69 FR 34176), and October 4, 2004 (69 FR 59240), 
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 at 
http://www.fda.gov/cdrh/stdsprog.html. 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: 012

    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: 012'' 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
------------------------------------------------------------------------
3         ASTM F1161-88, Standard            Contact      ..............
           Specification for Minimum          person
           Performance and Safety
           Requirements for Components and
           Systems of Anesthesia Gas
           Machines
------------------------------------------------------------------------
4         ASTM F1242-96, Standard            Withdrawn    ..............
           Specification for Cuffed and
           Uncuffed Tracheal Tubes
------------------------------------------------------------------------
7         ASTM F1627-95, Standard            Withdrawn    ..............
           Specification for Pediatric
           Tracheostomy Tubes
------------------------------------------------------------------------

[[Page 30757]]

 
9         IEC 60601-2-12 (2001-10), Medical  Withdrawn    60
           Electrical Equipment--Part 2-12:   and
           Particular Requirements for the    replaced
           Safety of Lung Ventilators--       with newer
           Critical Care Ventilators          version
------------------------------------------------------------------------
15        ISO 5361-4: 1987, Tracheal Tubes-- Contact      ..............
           Part 4: Cole Type                  person
------------------------------------------------------------------------
18        ISO 8359: 1996, Oxygen             Contact      ..............
           Concentrators for Medical Use--    person
           Safety Requirements
------------------------------------------------------------------------
19        ISO 8382: 1988, Resuscitators      Contact      ..............
           Intended for Use With Humans       person
------------------------------------------------------------------------
20        ISO 9703-1: 1992, Anesthesia and   Withdrawn    ..............
           Respiratory Care Alarm Signals--
           Part 1: Visual Alarm Signals
------------------------------------------------------------------------
21        ISO 9703-2: 1994, Anesthesia and   Withdrawn    ..............
           Respiratory Care Alarm Signals--
           Part 2: Auditory Alarm Signals
------------------------------------------------------------------------
30        IEC 60601-2-13 (2003-05), Medical  Withdrawn    61
           Electrical Equipment--Part 2-13:   and
           Particular Requirements for the    replaced
           Safety and Essential Performance   with newer
           of Anesthetic Systems              version
------------------------------------------------------------------------
31        ISO 5356-1: 2004, Anaesthetic and  Withdrawn    62
           Respiratory Equipment--Conical     and
           Connectors--Part 1: Cones and      replaced
           Sockets                            with newer
                                              version
------------------------------------------------------------------------
35        ISO 5361: 1999, Anaesthetic and    Contact      ..............
           Respiratory Equipment--Tracheal    person
           Tubes and Connectors
------------------------------------------------------------------------
38        CGA V-1: 2003, Standard for        Withdrawn    63
           Compressed Gas Cylinder Valve      and
           Outlet and Inlet Connections       replaced
                                              with newer
                                              version
------------------------------------------------------------------------
42        ISO 5360: 1993, Anaesthetic        Contact      ..............
           Vaporizers--Agent Specific         person
           Filling Systems
------------------------------------------------------------------------
44        ISO 5366-1: 2000, Anaesthetic and  Contact      ..............
           Respiratory Equipment--            person and
           Tracheostomy Tubes--Part 1:        type of
           Tubes and Connectors for Use in    standard
           Adults
------------------------------------------------------------------------
50        ASTM F920-93 (1999), Standard      Contact      ..............
           Specification for Minimum          person
           Performance and Safety
           Requirements for Resuscitators
           Intended for Use With Humans
------------------------------------------------------------------------
52        ASTM F1463-93 (1999), Standard     Contact      ..............
           Specification for Alarm Signals    person
           in Medical Equipment Used in
           Anesthesia and Respiratory Care
------------------------------------------------------------------------
53        ASTM F1464-93 (1999), Standard     Contact      ..............
           Specification for Oxygen           person
           Concentrators for Domiciliary
           Use
------------------------------------------------------------------------
54        ASME PVHO-1-2002-2003, Safety      Withdrawn    64
           Standard for Pressure Vessels      and
           for Human Occupancy                replaced
                                              with newer
                                              version
------------------------------------------------------------------------
55        ASTM F1054-01, Standard            Contact      ..............
           Specification for Conical          person
           Fittings
------------------------------------------------------------------------
57        ASTM F1101-90 (2003)e1, Standard   Contact      ..............
           Specification for Ventilators      person
           Intended for Use During
           Anesthesia
------------------------------------------------------------------------
59        ASTM F1456-01, Standard            Contact      ..............
           Specification for Minimum          person
           Performance and Safety
           Requirements for Capnometers
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
B. Cardiovascular/Neurology
------------------------------------------------------------------------
3         AAMI NS28: 1988/(R)1993,           Contact      ..............
           Intracranial Pressure Monitoring   person
------------------------------------------------------------------------
18        IEC 60601-2-27 (1994), Medical     Contact      ..............
           Electrical Equipment--Part 2:      person and
           Particular Requirements for the    processes
           Safety of Electrocardiographic     affected
           Monitoring Equipment
------------------------------------------------------------------------
43        ANSI/AAMI EC38: 1998, Ambulatory   Contact      ..............
           Electrocardiographs                person,
                                              processes
                                              affected
                                              and extent
                                              of
                                              recognitio
                                              n
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
C. Dental/Ear, Nose, and Throat
------------------------------------------------------------------------
61        ISO 1562: 1993, Dental Casting     Contact      ..............
           Gold Alloys                        person
------------------------------------------------------------------------
116       ISO 10139-1: 1991, Dentistry--     Date of      ..............
           Resilient Lining Materials for     standard
           Removable Dentures--Part 1:
           Short-Term Materials
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
D. General Hospital/General Plastic Surgery
------------------------------------------------------------------------

[[Page 30758]]

 
1         AAMI BF7: (R2002), Blood           Withdrawn    119
           Transfusion Micro-Filters          and
                                              replaced
                                              with newer
                                              version
------------------------------------------------------------------------
29        IEC 60601-2-19 1996-10,            Title        ..............
           ``Amendment 1''--Medical
           Electrical Equipment--Part 2:
           Particular Requirements for
           Safety of Baby Incubators
------------------------------------------------------------------------
32        IEC 60601-2-20 1996-10,            Title        ..............
           ``Amendment 1''--Medical
           Electrical Equipment--Part 2:
           Particular Requirements for the
           Safety of Transport Incubators
------------------------------------------------------------------------
37        ASTM F1054-01, Standard            Withdrawn    120
           Specification for Conical          and
           Fittings                           replaced
                                              with newer
                                              version
------------------------------------------------------------------------
63        ISO 8536-7-1999, Infusion          Title        ..............
           Equipment for Medical Use--Part
           7: Caps Made of Aluminum-
           Plastics Combinations for
           Infusion Bottles
------------------------------------------------------------------------
65        ISO 8536-2-2001, Infusion          Withdrawn    121
           Equipment for Medical Use--Part    and
           2: Closures for Infusion Bottles   replaced
                                              with newer
                                              version
------------------------------------------------------------------------
67        ISO 8536-5-2004, Infusion          Withdrawn    122
           Equipment for Medical Use--Part    and
           5: Burette Type Infusion Sets      replaced
           for Single Use, Gravity Feed       with newer
                                              version
------------------------------------------------------------------------
71        ASTM E667-03, Standard             Withdrawn    123
           Specification for Mercury-in-      and
           Glass, Maximum Self-Registering    replaced
           Clinical Thermometers              with newer
                                              version
------------------------------------------------------------------------
73        ASTM E1104-03, Standard            Withdrawn    124
           Specification for Clinical         and
           Thermometer Probe Covers and       replaced
           Sheaths                            with newer
                                              version
------------------------------------------------------------------------
74        ASTM E1965-03, Standard            Withdrawn    125
           Specification for Infrared         and
           Thermometers for Intermittent      replaced
           Determination of Patient           with newer
           Temperature                        version
------------------------------------------------------------------------
75        ISO 8536-4-2004, Infusion          Withdrawn    126
           Equipment for Medical Use--Part    and
           4: Infusion Sets for Single Use,   replaced
           Gravity Feed                       with newer
                                              version
------------------------------------------------------------------------
76        ISO 1135-4-2004, Transfusion       Withdrawn    127
           Equipment for Medical Use--Part    and
           4: Transfusion Sets for Single     replaced
           Use                                with newer
                                              version
------------------------------------------------------------------------
78        ASTM F1670-03, Standard Test       Withdrawn    128
           Method for Resistance of           and
           Materials Used in Protective       replaced
           Clothing to Penetration by         with newer
           Synthetic Blood                    version
------------------------------------------------------------------------
79        ISO 594/2-1998, Conical Fittings   Withdrawn    129
           With a 6% (Luer) Taper for         and
           Syringes, Needles and Certain      replaced
           Other Medical Equipment--Part 2:   with newer
           Lock Fittings                      version
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
E. Materials
------------------------------------------------------------------------
36        ASTM F1801-97 (2004), Standard     Withdrawn    103
           Practice for Corrosion Fatigue     and
           Testing of Metallic Implant        replaced
           Materials                          with newer
                                              version
------------------------------------------------------------------------
51        ASTM F1108-04, Standard            Withdrawn    104
           Specification for Titanium-        and
           6Aluminum-4Vanadium Alloy          replaced
           Castings for Surgical Implants     with newer
           (UNS R56406)                       version
------------------------------------------------------------------------
69        Title: ISO 5832-10: 1996,          Withdrawn    ..............
           Implants for Surgery--Metallic
           Materials--Part 10: Wrought
           Titanium 5-Aluminum 2,5-Iron
------------------------------------------------------------------------
70        Title: ASTM F2052-02, Standard     Error in     70
           Test Method for Measurement of     October 4,
           Magnetically Induced               2004
           Displacement Force on Medical      Federal
           Devices in the Magnetic            Register
           Resonance Environment              Notice (69
                                              FR 59240)
                                              (Recogniti
                                              on List
                                              Number:
                                              011)
                                              [Docket
                                              No. 2004N-
                                              0226]--not
                                              withdrawn
------------------------------------------------------------------------
96        ASTM F1635-04(a), Standard Test    Withdrawn    105
           Method for In Vitro Degradation    and
           Testing of Hydrolytically          replaced
           Degradable Polymer Resins and      with newer
           Fabricated Forms for Surgical      version
           Implants
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
F. Ophthalmic
------------------------------------------------------------------------
5         ISO 9363-1: 1994, Optics and       Withdrawn    ..............
           Optical Instruments--Contact
           Lenses--Determination of
           Cytotoxicity of Contact Lens
           Material--Part 1: Agar Overlay
           Test and Growth Inhibition Test
------------------------------------------------------------------------

[[Page 30759]]

 
14        ANSI Z80.20-2004, Ophthalmics--    Withdrawn    34
           Contact Lenses--Standard           and
           Terminology, Tolerances,           replaced
           Measurements and Physicochemical   with newer
           Properties                         version
------------------------------------------------------------------------
15        ISO 9394:1998, Ophthalmic Optics-- Title        ..............
           Contact Lenses and Contact Lens
           Care Products--Determination of
           Biocompatibility by Ocular Study
           Using Rabbit Eyes
------------------------------------------------------------------------
30        ANSI Z80.7-2002, Ophthalmics--     Title        ..............
           Intraocular Lenses
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
G. Radiology
------------------------------------------------------------------------
1         ANSI PH 2.43-1982, Method for      Title        ..............
           Sensitometry/Medical X-Ray
           Screen-Film
------------------------------------------------------------------------
5         ANSI PH 2.50-1983, Method/         Title        ..............
           Sensitometry Direct-Exposure
           Medical/Dental
------------------------------------------------------------------------
7         IEC/ISO 10918-1: 1994,             Title        ..............
           Information Technology--Digital
           Compression and Coding of
           Continuous-Tone Still Images--
           Part 1: Requirements and
           Guidelines
------------------------------------------------------------------------
8         IEC 60336 (R1993), X-Ray Tube      Title and    ..............
           Assemblies for Medical             standards
           Diagnosis--Characteristics of      developmen
           Focal Spots                        t
                                              organizati
                                              on
------------------------------------------------------------------------
14        NEMA MS 5-2003, Determination of   Withdrawn    125
           Slice Thickness in Diagnostic      and
           Magnetic Resonance Imaging         replaced
                                              with newer
                                              version
------------------------------------------------------------------------
22        IEC NEMA XR5-1992 (R1999),         Withdrawn    ..............
           Measurement of Dimensions and
           Properties of Focal Spots of
           Diagnostic X-Ray Tubes
------------------------------------------------------------------------
23        NEMA XR 10-1986 (R1992, R1998),    Contact      ..............
           Measurement of the Maximum         person,
           Symmetrical Radiation Field From   title, and
           a Rotating Anode X-Ray Tube Used   standards
           for Medical Diagnosis              developmen
                                              t
                                              organizati
                                              on
------------------------------------------------------------------------
33        IEC 60601-2-1: 1998, Medical       Withdrawn    ..............
           Electrical Equipment--Part 2:
           Particular Requirements for
           Medical Electron Accelerators in
           the Range 1 MeV to 50 MeV
------------------------------------------------------------------------
36        IEC 60601-2-9 (1996-10), Medical   Title        ..............
           Electrical Equipment--Part 2:
           Particular Requirements for the
           Safety of Patient Contact
           Dosimeters Used in Radiotherapy
           With Electrically Connected
           Radiation Detectors--ed. 2.0
------------------------------------------------------------------------
40        IEC 60601-2-28: 2003, Medical      Withdrawn    126
           Electrical Equipment--Part 2:      and
           Particular Requirements for the    replaced
           Safety of X-Ray Source             with newer
           Assemblies and X-Ray Tube          version
           Assemblies for Medical
           Diagnosis--ed. 1.0
------------------------------------------------------------------------
42        IEC 60601-2-32: 2003, Medical      Withdrawn    127
           Electrical Equipment--Part 2:      and
           Particular Requirements for the    replaced
           Safety of Associated Equipment     with newer
           of X-Ray Equipment--ed. 1.0        version
------------------------------------------------------------------------
50        IEEE N42.13-1993, Calibration and  Withdrawn    128
           Usage of ``Dose Calibrator''       and
           Ionization Chambers for the        replaced
           Assay of Radionuclides             with newer
                                              version
------------------------------------------------------------------------
52        UL 544 (1998), Standard for        Title        ..............
           Medical and Dental Equipment--
           ed. 4.0
------------------------------------------------------------------------
58        ANSI N43.6-1997, Sealed            Title and    ..............
           Radioactive Sources,               standards
           Classification                     developmen
                                              t
                                              organizati
                                              on
------------------------------------------------------------------------
61        UL 122 (1999), Standard for        Title        ..............
           Photographic Equipment--ed. 4.0
------------------------------------------------------------------------
62        UL 187 (1998), Standard for X-Ray  Title        ..............
           Equipment--ed. 7.0
------------------------------------------------------------------------
74        NEMA MS 7-1998, Measurement        Withdrawn    ..............
           Procedure for Time-Varying
           Gradient Fields (dB/dt) for
           Magnetic Resonance Imaging
           Systems
------------------------------------------------------------------------
75        NEMA NU 1-2004, Performance        Withdrawn    129
           Measurements of Scintillation      and
           Cameras                            replaced
                                              with newer
                                              version
------------------------------------------------------------------------
83        IEC 60601-2-37 2004, Medical       Withdrawn    130
           Electrical Equipment--Part 2-37:   and
           Particular Requirements for the    replaced
           Safety of Ultrasonic Medical       with newer
           Diagnostic and Monitoring          version
           Equipment Consolidated, ed. 1.1
------------------------------------------------------------------------
87        IEC 61217 2003, Radiotherapy       Withdrawn    131
           Equipment--Coordinates,            and
           Movements and Scales               replaced
           Consolidated, ed. 1.1              with newer
                                              version
------------------------------------------------------------------------

[[Page 30760]]

 
90        IEC 60601-2-1 (1998-06), Medical   Title        ..............
           Electrical Equipment--Part 2-1:
           Particular Requirements for the
           Safety of Electron Accelerators
           in the Range 1 MeV to 50 MeV
------------------------------------------------------------------------
91        IEC 60601-2-8 (1997-08),           Title        ..............
           Amendment 1--Medical Electrical
           Equipment--Part 2: Particular
           Requirements for the Safety of
           Therapeutic X-Ray Equipment
           Operating in the Range 10 kV to
           1 MV
------------------------------------------------------------------------
98        IEC 60731 (2002-06), Amendment 1-- Withdrawn    132
           Medical Electrical Equipment--     and
           Dosimeters With Ionization         replaced
           Chambers as Used in Radiotherapy   with newer
                                              version
------------------------------------------------------------------------
120       IEC 60601-2-44 (2002-11), Medical  Title        ..............
           Electrical Equipment--Part 2-44:
           Particular Requirements for the
           Safety of X-Ray Equipment for
           Computed Tomography--ed. 2.1
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
H. Sterility
------------------------------------------------------------------------
121       ASTM D4169-04a, Standard Practice  Extent of    ..............
           for Performance Testing of         recognitio
           Shipping Containers and Systems    n
------------------------------------------------------------------------
123       ASTM F2096-04, Standard Test       Title        ..............
           Method for Detecting Gross Leaks
           in Medical Packaging by Internal
           Pressurization (Bubble Test)
------------------------------------------------------------------------
135       ANSI/AAMI ST63: 2002,              Title        ..............
           Sterilization of Health Care
           Products--Requirements for the
           Development, Validation and
           Routine Control of an Industrial
           Sterilization Process for
           Medical Devices--Dry Heat
------------------------------------------------------------------------

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: 012, follows:

                                Table 2.
------------------------------------------------------------------------
                                                          Reference No.
  Item No.                Title of Standard                  and Date
------------------------------------------------------------------------
A. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
114           Pen-Injectors for Medical Use--Part 1:     ISO 11608-1:
               Pen-Injectors--Requirements and Test       2000
               Methods
------------------------------------------------------------------------
115           Pen-Injectors for Medical Use--Part 2:     ISO 11608-2:
               Needles--Requirements and Test Methods     2000
------------------------------------------------------------------------
116           Pen-Injectors for Medical Use--Part 3:     ISO 11608-3:
               Finished Cartridges--Requirements and      2000
               Test Methods
------------------------------------------------------------------------
117           Standard Specification for Blood/          ASTM F2172-02
               Intravenous Fluid/Irrigation Fluid
               Warmers
------------------------------------------------------------------------
118           Standard Specification for Circulating     ASTM F2196-02
               Liquid and Forced Air Patient
               Temperature Management Devices
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
B. Radiology
------------------------------------------------------------------------
121           Ultrasonics--Surgical Systems--            IEC 61847: 1998
               Measurement and Declaration of the Basic
               Output Characteristics, ed. 1.0
------------------------------------------------------------------------
122           Medical Electrical Equipment--             IEC 62083: 2000
               Requirements for the Safety of
               Radiotherapy Treatment Planning Systems,
               ed. 1.0
------------------------------------------------------------------------
123           Ultrasonics--Physiotherapy Systems--       IEC 61689: 1996
               Performance Requirements and Methods of
               Measurement in the Frequency Range 0.5
               MHz to 5 MHz, ed. 1.0
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
C. Sterility
------------------------------------------------------------------------
144           Standard Test Method for Linear            ASTM F2203-02e1
               Measurement Using Precision Steel Rule
------------------------------------------------------------------------
145           Standard Practice for Coating/Adhesive     ASTM F2217-02
               Weight Determination
------------------------------------------------------------------------
146           Standard Test Method of Leaks in Non-      ASTM F2227-02
               Sealed and Empty Medical Packaging Trays
               by CO2 Tracer Gas Method
------------------------------------------------------------------------
147           Standard Test Method for Non-Destructive   ASTM F2228-02
               Detection of Leaks in Medical Packaging
               Which Incorporates Porous Barrier
               Material by CO2 Tracer Gas Method
------------------------------------------------------------------------

[[Page 30761]]

 
148           Standard Practice for Evaluation of        ASTM F2250-03
               Chemical Resistance of Printed Inks and
               Coatings on Flexible Packaging Materials
------------------------------------------------------------------------
149           Standard Test Method for Thickness         ASTM F2251-03e1
               Measurement of Flexible Packaging
               Materials
------------------------------------------------------------------------
150           Standard Practice for Evaluating Ink or    ASTM F2252-03
               Coating Adhesion to Flexible Packaging
               Materials Using Tape
------------------------------------------------------------------------
151           Standard Test Method for Nondestructive    ASTM F2338-04
               Detection of Leaks in Packages by Vacuum
               Decay Method
------------------------------------------------------------------------

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 ``Modification to the 
List of Recognized Standards, Recognition List Number: 012'' 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: 012. These modifications 
to the list or recognized standards are effective upon publication of 
this notice in the Federal Register.

    Dated: May 16, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-10626 Filed 5-26-05; 8:45 am]
BILLING CODE 4160-01-S