[Federal Register Volume 69, Number 45 (Monday, March 8, 2004)]
[Notices]
[Pages 10712-10725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E4-479]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1997D-0530]


Food and Drug Adminstration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 009

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 of the List of Recognized Standards, Recognition List 
Number: 009'' (Recognition List Number: 009), 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 ``Modification to the List of Recognized Standards, 
Recognition List Number: 009'' 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 to recommend 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: 009 modifications and other standards related information.

FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices 
and Radiological Health (CDRH) (HFZ-84), Food and Drug Administration, 
2094 Gaither Rd., Rockville, MD 20850, 301-594-4766, ext.156.

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 guidance entitled 
``Recognition and Use of Consensus Standards.'' This notice described 
how FDA will implement its standard recognition program and provided 
the initial list of recognized 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), and April 28, 2003 (68 FR 22391), FDA modified its 
initial list of recognized 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 the List of Recognized Standards, Recognition List 
Number: 009

    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

[[Page 10713]]

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: 009'' to identify these current 
modifications.
    In the following table, FDA describes modifications that involve: 
(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.

A. Biocompatibility

------------------------------------------------------------------------
 Old Item                                                   Replacement
    No.             Standard                Change           Item No.
------------------------------------------------------------------------
36          ASTM F1408-02e1,          Withdrawn and       71
             Standard Practice for     replaced with
             Subcutaneous Screening    newer version.
             Test for Implant
             Materials
------------------------------------------------------------------------
16          ASTM F1439-02, Standard   Withdrawn and       72
             Guide for Performance     replaced with
             of Lifetime Bioassay      newer version.
             for the Tumorigenic
             Potential of Implant
             Materials
------------------------------------------------------------------------
65          ASTM F2065-00e1,          Withdrawn and       73
             Standard Practice for     replaced with
             Testing for Alternative   newer version.
             Pathway Complement
             Activation in Serum by
             Solid Materials
------------------------------------------------------------------------
58          USP 26-NF 21 <87, Biological           replaced with
             Reactivity Test, In       newer version.
             Vitro--Direct Contact
             Test
------------------------------------------------------------------------
59          USP 26-NF 21 <87, Biological           replaced with
             Reactivity Test, In       newer version.
             Vitro--Elution Test
------------------------------------------------------------------------
60          USP 26-NF 21<88, Biological           replaced with
             Reactivity Tests, In      newer version.
             Vivo--Procedure--Prepar
             ation of Sample
------------------------------------------------------------------------
61          USP 26-NF 21<88, Biological           replaced with
             Reactivity Test, In       newer version.
             Vivo--Intracutaneous
             Test
------------------------------------------------------------------------
62          USP 26-NF 21<88, Biological           replaced with
             Reactivity Tests, In      newer version
             Vivo--Systemic
             Injection Test
------------------------------------------------------------------------

B. Dental/ENT

------------------------------------------------------------------------
 Old Item                                                   Replacement
    No.             Standard                Change           Item No.
------------------------------------------------------------------------
46          ANSI/ADA Specification    Withdrawn and       94
             No. 14:1998, Dental       replaced with
             Base Metal Casting        newer version;
             Alloys                    Contact person
------------------------------------------------------------------------
49          ANSI/ADA Specification    Withdrawn and       95
             No. 17:1999, Denture      replaced with
             Base Temporary Relining   newer version.
             Resin
------------------------------------------------------------------------
53          ANSI/ADA Specification    Withdrawn and       96
             No. 30:2002, Dental       replaced with
             Zinc Oxide-Eugenol and    newer version.
             Zinc Oxide Non-Eugenol
             Cements
------------------------------------------------------------------------
56          ANSI/ADA Specification    Withdrawn and       97
             No. 57:2000, Endodontic   replaced with
             Sealing Materials         newer version.
------------------------------------------------------------------------
60          ANSI/ADA Specification    Withdrawn and       98
             No. 96:2000, Dental       replaced with
             Water-Based Cements       newer version.
------------------------------------------------------------------------
66          ISO 4049:2000,            Withdrawn and       99
             Dentistry--Polymer-       replaced with
             Based Filling,            newer version.
             Restorative and Luting
             Materials
------------------------------------------------------------------------
71           ISO 6876:2001, Dental    Withdrawn and       100
             Root Canal Sealing        replaced with
             Materials                 newer version.
------------------------------------------------------------------------
77          ISO 8891:1998, Dental     Withdrawn and       101
             Casting Alloys with       replaced with
             Noble Metal Content of    newer version;
             At Least 25% but less     Contact person
             than 75%
------------------------------------------------------------------------
79          ISO 9693, Metal-Ceramic   Withdrawn and       102
             Dental Restorative        replaced with
             Systems                   newer version;
                                       Contact person
------------------------------------------------------------------------

C. General Hospital/General Plastic Surgery

[[Page 10714]]



------------------------------------------------------------------------
 Old Item                                                   Replacement
    No.             Standard                Change           Item No.
------------------------------------------------------------------------
82          USP 26, Nonabsorbable     Withdrawn and       97
             Surgical Sutures          replaced with
                                       newer version
------------------------------------------------------------------------
88          USP 26 <11,    Withdrawn and       98
             Sterile Sodium Chloride   replaced with
             for Irrigation            newer version
------------------------------------------------------------------------
89          USP 26, Absorbable        Withdrawn and       99
             Surgical Sutures          replaced with
                                       newer version
------------------------------------------------------------------------
90          USP 26 <881,   Withdrawn and       100
             Tensile Strength          replaced with
                                       newer version
------------------------------------------------------------------------
91          USP 26 <861,   Withdrawn and       101
             Sutures--Diameter         replaced with
                                       newer version
------------------------------------------------------------------------
92          USP 26<871,    Withdrawn and       102
             Sutures Needle            replaced with
             Attachment                newer version
------------------------------------------------------------------------
93          USP 26, Sterile Water     Withdrawn and       103
             for Irrigation            replaced with
                                       newer version
------------------------------------------------------------------------
94          USP 26, Heparin Lock      Withdrawn and       104
             Flush Solution            replaced with
                                       newer version
------------------------------------------------------------------------
95          USP 26, Sodium Chloride   Withdrawn and       105
             Injection                 replaced with
                                       newer version
------------------------------------------------------------------------
33          ASTM D3772-01, Standard   Withdrawn and       106
             Specification for         replaced with
             Rubber Finger Cots        newer version
------------------------------------------------------------------------
5           ASTM F882-84 (2002),      Withdrawn and       107
             Standard Performance      replaced with
             and Safety                newer version
             Specification for
             Cryosurgical Medical
             Instrumentation
------------------------------------------------------------------------

D. In Vitro Diagnostic

------------------------------------------------------------------------
 Old Item                                                   Replacement
    No.             Standard                Change           Item No.
------------------------------------------------------------------------
14          NCCLS C24-A2 Statistical  Withdrawn and       85
             Quality Control for       replaced with
             Quantitative              newer version
             Measurements:
             Principles and
             Definitions: Approved
             Guideline--Second
             Edition
------------------------------------------------------------------------
17          NCCLS C29-A2              Withdrawn and       86
             Standardization of        replaced with
             Sodium and Potassium      newer version
             Ion Selective Electrode
             Systems to the Flame
             Photometric Reference
             Method; Approved
             Standard--Second
             Edition
------------------------------------------------------------------------
19          NCCLS C31-A2 Ionized      Withdrawn and       87
             Calcium Determinations:   replaced with
             Precollection             newer version
             Variables, Specimen
             Choice, Collection and
             Handling: Approved
             Guideline--Second
             Edition
------------------------------------------------------------------------
2           NCCLS EP09-A2 Method      Withdrawn and       92
             Comparison and Bias       replaced with
             Estimation Using          newer version
             Patient Samples;
             Approved Guideline--
             Second Edition
------------------------------------------------------------------------
66          NCCLS EP10-A2             Withdrawn and       93
             Preliminary Evaluation    replaced with
             of Quantitative           newer version
             Clinical Laboratory
             Methods; Approved
             Guideline--Second
             Edition
------------------------------------------------------------------------

E. Materials

------------------------------------------------------------------------
 Old Item                                                   Replacement
    No.             Standard                Change           Item No.
------------------------------------------------------------------------
1           ASTM F67-00, Standard     Update              1
             Specification for         ``Process(es)
             Unalloyed Titanium for    Impacted'' to
             Surgical Implant          include Design
             Applications (UNS         Controls.
             R50250, UNS R50550, UNS
             R50700)
------------------------------------------------------------------------

[[Page 10715]]

 
2           ASTM F75-01, Standard     Update              2
             Specification for         ``Process(es)
             Cobalt-28 Chromium-6      Impacted'' to
             Molybdenum Alloy          include Design
             Castings and Casting      Controls.
             Alloy for Surgical
             Implants (UNS R30075)
------------------------------------------------------------------------
3           ASTM F90-01, Standard     Update              3
             Specification for         ``Process(es)
             Wrought Cobalt-20         Impacted'' to
             Chromium-15 Tungsten-10   include Design
             Nickel Alloy for          Controls.
             Surgical Implant
             Applications (UNS
             R30605)
------------------------------------------------------------------------
5           ASTM F138-00, Standard    Update              5
             Specification for         ``Process(es)
             Wrought 18 Chromium-14    Impacted'' to
             Nickel-2.5 Molybdenum     include Design
             Stainless Steel Bar and   Controls.
             Wire for Surgical
             Implants (UNS S31673)
------------------------------------------------------------------------
6           ASTM F139-00, Standard    Update              6
             Specification for         ``Process(es)
             Wrought 18 Chromium-14    Impacted'' to
             Nickel-2.5 Molybdenum     include Design
             Stainless Steel Sheet     Controls.
             and Strip for Surgical
             Implants (UNS S31673)
------------------------------------------------------------------------
7           ASTM F560-98, Standard    Update              7
             Specification for         ``Process(es)
             Unalloyed Tantalum for    Impacted'' to
             Surgical Implant          include Design
             Applications (UNS         Controls.
             R05200, UNS R05400)
------------------------------------------------------------------------
9           ASTM F563-00, Standard    Update              9
             Specification for         ``Process(es)
             Wrought Cobalt-20         Impacted'' to
             Nickel-20 Chromium-3.5    include Design
             Molybdenum-3.5 Tungsten-  Controls.
             5 Iron Alloy for
             Surgical Implant
             Applications (UNS
             R30563)
------------------------------------------------------------------------
10          ASTM 603-00, Standard     Update              10
             Specification for High-   ``Process(es)
             Purity Dense Aluminum     Impacted'' to
             Oxide for Surgical        include Design
             Implant Application       Controls.
------------------------------------------------------------------------
11          ASTM 620-00, Standard     Update              11
             Specification for         ``Process(es )
             Titanium-6 Aluminum-4     Impacted'' to
             Vanadium ELI Alloy        include Design
             Forgings for Surgical     Controls.
             Implants (UNS R56401)
------------------------------------------------------------------------
13          ASTM F648-00, Standard    Update              13
             Specification for Ultra-  ``Process(es)
             High-Molecular-Weight     Impacted'' to
             Polyethylene Powder and   include Design
             Fabricated Form for       Controls.
             Surgical Implants
------------------------------------------------------------------------
14          ASTM 688-00, Standard     Update              14
             Specification for         ``Process(es)
             Wrought Cobalt-35         Impacted'' to
             Nickel-20 Chromium-10     include Design
             Molybdenum Alloy Plate,   Controls.
             Sheet, and Foil for
             Surgical Implants
------------------------------------------------------------------------
15          ASTM F745-00, Standard    Update              15
             Specification for 18      ``Process(es)
             Chromium-12.5             Impacted'' to
             Molybdenum Stainless      include Design
             Steel for Cast and        Controls.
             Solution-Annealed
             Surgical Implant
             Applications
------------------------------------------------------------------------
16           ASTM F746-87 (1999),     Update              16
             Standard Test Method      ``Process(es)
             for Pitting or Crevice    Impacted'' to
             Corrosion of Metallic     include Design
             Surgical Implant          Controls.
             Materials
------------------------------------------------------------------------
19          ASTM F961-96, Standard    Update              19
             Specification for         ``Process(es)
             Cobalt-35 Nickel-20       Impacted'' to
             Chromium-10 Molybdenum    include Design
             Alloy Forgings for        Controls.
             Surgical Implants (UNS
             R30035)
------------------------------------------------------------------------
21          ASTM F1088-87(1992)e1,    Update              21
             Standard Specification    ``Process(es)
             for Beta-Tricalcium       Impacted'' to
             Phosphate for Surgical    include Design
             Implantation              Controls.
------------------------------------------------------------------------
25          ASTM F1295-01, Standard   Update              25
             Specification for         ``Process(es)
             Wrought Titanium-6        Impacted'' to
             Aluminum-7 Niobium        include Design
             Alloy for Surgical        Controls.
             Implant Applications
------------------------------------------------------------------------
26          ASTM F1314-01, Standard   Update              26
             Specification for         ``Process(es)
             Wrought Nitrogen          Impacted'' to
             Strengthened-22           include Design
             Chromium-12.5 Nickel-5    Controls.
             Manganese-2.5
             Molybdenum Stainless
             Steel Bar and Wire for
             Surgical Implants
------------------------------------------------------------------------
27          ASTM F1341-99, Standard   Update              27
             Specification for         ``Process(es)
             Unalloyed Titanium Wire   Impacted'' to
             for Surgical Implant      include Design
             Applications              Controls.
------------------------------------------------------------------------
30          ASTM F1537-00, Standard   Update              30
             Specification for         ``Process(es)
             Wrought Cobalt-28-        Impacted'' to
             Chromium-6-Molybdenum     include Design
             Alloy for Surgical        Controls.
             Implants
------------------------------------------------------------------------

[[Page 10716]]

 
32          ASTM F1586-02, Standard   Update              32
             Specification for         ``Process(es)
             Wrought Nitrogen          Impacted'' to
             Strengthened-21           include Design
             Chromium-10 Nickel-3      Controls.
             Manganese-2.5
             Molybdenum Stainless
             Steel Bar for Surgical
             Implants
------------------------------------------------------------------------
33          ASTM F1609-95, Standard   Update              33
             Specification for         ``Process(es)
             Calcium Phosphate         Impacted'' to
             Coatings for              include Design
             Implantable Materials     Controls.
------------------------------------------------------------------------
34          ASTM F1659-95, Standard   Update              34
             Test Method for Bending   ``Process(es)
             and Shear Testing of      Impacted'' to
             Calcium Phosphate         include Design
             Coatings on Solid         Controls.
             Metallic Substrates
------------------------------------------------------------------------
35          ASTM F1713-96, Standard   Clarification of    35
             Specification for         Extent of
             Wrought Titanium-13       Recognition;
             Niobium-13 Zirconium      Update
             Alloy for Surgical        ``Process(es)
             Implant Applications      Impacted'' to
                                       include Design
                                       Controls.
------------------------------------------------------------------------
36          ASTM F1801-97, Standard   Update              36
             Practice for Corrosion    ``Process(es)
             Fatigue Testing of        Impacted'' to
             Metallic Implant          include Design
             Materials                 Controls.
------------------------------------------------------------------------
37          ASTM F1813-01, Standard   Clarification of    37
             Specification for         Extent of
             Wrought Titanium--12      Recognition;
             Molybdenum-6 Zirconium-   Update
             2 Iron Alloy for          ``Process(es)
             Surgical Implant (UNS     Impacted'' to
             R58120)                   include Design
                                       Controls.
------------------------------------------------------------------------
38          ASTM F2005-00, Standard   Update              38
             Terminology for Nickel-   ``Process(es)
             Titanium Shape Memory     Impacted'' to
             Alloys                    include Design
                                       Controls.
------------------------------------------------------------------------
39          ASTM F2052-00, Standard   Update              39
             Test Method for           ``Process(es)
             Measurement of            Impacted'' to
             Magnetically Induced      include Design
             Displacement Force on     Controls.
             Passive Implants in the
             Magnetic Resonance
             Environment
------------------------------------------------------------------------
40          ASTM F2063-00, Standard   Cardiovascular      40
             Specification for         contact person.
             Wrought Nickel-Titanium   Clarification to
             Shape Memory Alloys for   Extent of
             Medical Devices and       Recognition with
             Surgical Implants         regard to
                                       biocompatibility
                                       requirements.
------------------------------------------------------------------------
41          ASTM F2066-01, Standard   Cardiovascular      41
             Specification for         contact person;
             Wrought Titanium-15       Clarification to
             Molybdenum Alloy for      Extent of
             Surgical Implant          Recognition
             Applications (UNS
             R58150)
------------------------------------------------------------------------
43          ASTM F2146-01, Standard   Cardiovascular      43
             Specification for         contact person;
             Wrought Titanium-         Clarification to
             3Aluminum-2.5Vanadium     Extent of
             Alloy Seamless Tubing     Recognition
             for Surgical Implant
             Applications (UNS
             R56320)
------------------------------------------------------------------------
44          ASTM F136-02, Standard    Update              44
             Specification for         ``Process(es)
             Wrought Titanium-6        Impacted'' to
             Aluminum-4 Vanadium ELI   include Design
             (Extra Low                Controls.
             Interstitial) Alloy for
             Surgical Implant
             Applications (UNS
             R56401)
------------------------------------------------------------------------
45          ASTM F562-02, Standard     Update             45
             Specification for         ``Process(es)
             Wrought 35Cobalt-         Impacted'' to
             35Nickel-20Chromium-10M   include Design
             olybdenum Alloy for       Controls.
             Surgical Implant
             Applications (UNS
             R30035)
------------------------------------------------------------------------
46          ASTM F621-02, Standard    Update              46
             Specification for         ``Process(es)
             Stainless Steel           Impacted'' to
             Forgings for Surgical     include Design
             Implants                  Controls
------------------------------------------------------------------------
47          ASTM F799-02, Standard    Update              47
             Specification for         ``Process(es)
             Cobalt-28 Chromium-6      Impacted'' to
             Molybdenum Alloy          include Design
             Forgings for Surgical     Controls.
             Implants (UNS R31537,
             R31538, R31539)
------------------------------------------------------------------------
48          ASTM F899-02, Standard    Update              48
             Specification for         ``Process(es)
             Stainless Steel for       Impacted'' to
             Surgical Instruments      include Design
                                       Controls.
------------------------------------------------------------------------
49          ASTM F1058-02, Standard   Update              49
             Specification for         ``Process(es)
             Wrought 40Cobalt-         Impacted'' to
             20Chromium-16Iron-15Nic   include Design
             kel-7Molybdenum Alloy     Controls.
             Wire and Strip for
             Surgical Implant
             Applications (UNS
             R30003 and UNS R30008)
------------------------------------------------------------------------
50          ASTM F1091-02, Standard   Update              50
             Specification for         ``Process(es)
             Wrought Cobalt-20         Impacted'' to
             Chromium-15 Tungsten-10   include Design
             Nickel Alloy Surgical     Controls.
             Fixation Wire (UNS
             R30605)
------------------------------------------------------------------------

[[Page 10717]]

 
51          ASTM 1108-02, Standard    Update              51
             Specification for         ``Process(es)
             Titanium -6Aluminum -     Impacted'' to
             4Vanadium Alloy           include Design
             Castings for Surgical     Controls.
             Implants (UNS R56406)
------------------------------------------------------------------------
52          ASTM F1350-02, Standard   Update              52
             Specification for         ``Process(es)
             Wrought 18 Chromium-14    Impacted'' to
             Nickel-2.5 Molybdenum     include Design
             Stainless Steel           Controls.
             Surgical Fixation Wire
             (UNS S31673)
------------------------------------------------------------------------
53          ASTM F1472-02, Standard   Update              53
             Specification for         ``Process(es)
             Wrought Titanium -        Impacted'' to
             6Aluminum -4Vanadium      include Design
             Alloy for Surgical        Controls.
             Implant Applications
             (UNS R56400)
------------------------------------------------------------------------
54          ASTM F1580-01, Standard   Update              54
             Specification for         ``Process(es)
             Titanium and Titanium-6   Impacted'' to
             Aluminum-4 Vanadium       include Design
             Alloy Powders for         Controls.
             Coatings of Surgical
             Implants
------------------------------------------------------------------------
55          ASTM F2182-02, Standard   Update              55
             Test Method for           ``Process(es)
             Measurement of Radio      Impacted'' to
             Frequency Induced         include Design
             Heating Near Passive      Controls.
             Implants During
             Magnetic Resonance
             Imaging
------------------------------------------------------------------------
Dental 30   ISO 5832-1:1997,          Transferred from    56
 Ortho 62    Implants for Surgery--    dental/ENT and
             Metallic Materials--      orthopaedics.
             Part 1: Wrought
             stainless steel
------------------------------------------------------------------------
Dental 31   ISO 5832-2:1999,          Transferred from    57
 Ortho 117   Implants for Surgery--    dental/ENT and
             Metallic Materials--      orthopaedics.
             Part 2: Unalloyed
             Titanium
------------------------------------------------------------------------
Dental 32   ISO 5832-3:1996,          Transferred from    58
 Ortho 64    Implants for Surgery--    dental/ENT and
             Metallic Materials--      orthopaedics.
             Part 3: Wrought
             titanium 6-aluminium 4-
             vanadium alloy
------------------------------------------------------------------------
Dental 33   ISO 5382-4:1996,          Transferred from    59
 Ortho 65    Implants for Surgery--    dental/ENT and
             Metallic Materials--      orthopaedics.
             Part 4: Cobalt-chromium-
             molybdenum casting
             alloy
------------------------------------------------------------------------
Dental 34   ISO 5832-5:1993,          Transferred from    60
 Ortho 66    Implants for Surgery--    dental/ENT and
             Metallic Materials--      orthopaedics.
             Part 5: Wrought cobalt-
             chromium-tungsten-
             nickel alloy
------------------------------------------------------------------------
Dental 35   ISO 5832-6:1997,          Transferred from    61
 Ortho 67    Implants for Surgery--    dental/ENT and
             Metallic Materials--      orthopaedics.
             Part 6: Wrought cobalt-
             nickel-chromium-
             molybdenum alloy
------------------------------------------------------------------------
Dental 36   ISO 5832-9: 1992,         Transferred from    62
 Ortho 118   Implants for Surgery--    dental/ENT and
             Metallic Materials--      orthopaedics.
             Part 9: Wrought high
             nitrogen stainless
             steel
------------------------------------------------------------------------
Dental 38   ISO 5832-11: 1994,        Transferred from    63
 Ortho 70    Implants for Surgery--    dental/ENT and
             Metallic Materials--      orthopaedics.
             Part 11: Wrought
             titanium 6-aluminium 7-
             niobium alloy
------------------------------------------------------------------------
Dental 39   ISO 5832-12: 1996,        Transferred from    64
 Ortho 71    Implants for Surgery--    dental/ENT and
             Metallic Materials--      orthopaedics.
             Part 12: Wrought cobalt-
             chromium-molybdenum
             alloy
------------------------------------------------------------------------
Ortho 119   ISO 5834-2: 1998,         Transferred from    65
             Implants for Surgery--    orthopaedics.
             Ultra-High-Molecular-
             Weight Polyethylene--
             Part 2: Moulded Forms
------------------------------------------------------------------------
Ortho 76    ISO 6474:1994, Implants   Transferred from    66
             for Surgery--Ceramic      orthopaedics.
             materials based on high
             purity alumina
------------------------------------------------------------------------
Ortho 143   ISO 7153-1:1991/Amd       Transferred from    67
             1:1999, Surgical          orthopaedics.
             Instruments--Metallic
             Materials--Part 1:
             Stainless steel
------------------------------------------------------------------------
Ortho 84    ISO 13782: 1996,          Transferred from    68
             Implants for Surgery--    orthopaedics.
             Metallic Materials--
             Unalloyed tantalum for
             surgical implant
             applications
------------------------------------------------------------------------
Dental 37   ISO 5832-10:1996,         Transferred from    69
             Implants for Surgery--    dental/ENT.
             Metallic Materials--
             Part 10: Wrought
             titanium 5-aluminium
             2,5-iron
------------------------------------------------------------------------

F. Ophthalmic

[[Page 10718]]



------------------------------------------------------------------------
 Old Item                                                   Replacement
    No.             Standard                Change           Item No.
------------------------------------------------------------------------
30          ANSI Z80.7-2002:          Correction in       30
             Ophthalmics--Intraocula   publication date
             r Lenses
------------------------------------------------------------------------

G. Orthopaedics

------------------------------------------------------------------------
 Old Item                                                   Replacement
    No.             Standard                Change           Item No.
------------------------------------------------------------------------
58          ASTM F1781-97, Standard   Added ``Design       58
             Specification for         Controls'' to
             Elastomeric Flexible      Process(es)
             Hinge Finger Total        Impacted
             Joint Implants
------------------------------------------------------------------------
62          ISO 5832-1:1997,          Withdrawn and       62
             Implants for Surgery--    transferred to
             Metallic materials--      Materials
             Part 1: Wrought
             stainless steel
------------------------------------------------------------------------
64           ISO 5832-3:1996,         Withdrawn and       64
             Implants for Surgery--    transferred to
             Metallic materials--      Materials
             Part 3: Wrought
             titanium 6-aluminum 4-
             vanadium alloy
------------------------------------------------------------------------
65          ISO 5832-4:1996,          Withdrawn and       65
             Implants for Surgery--    transferred to
             Metallic materials--      Materials
             Part 4: Cobalt-chromium-
             molybdenum casting
             alloy
------------------------------------------------------------------------
66          ISO 5832-5:1993,          Withdrawn and       66
             Implants for Surgery--    transferred to
             Metallic materials--      Materials
             Part 5: Wrought cobalt-
             chromium-tungsten-
             nickel alloy
------------------------------------------------------------------------
67          ISO 5832-6:1997,          Withdrawn and       67
             Implants for Surgery--    transferred to
             Metallic materials--      Materials
             Part 6: Wrought cobalt-
             nickel-chromium-
             molybdenum alloy
------------------------------------------------------------------------
70          ISO 5832-11:1994,         Withdrawn and       70
             Implants for Surgery--    transferred to
             Metallic materials--      Materials
             Part 11: Wrought
             titanium 6-aluminum 7-
             niobium alloy
------------------------------------------------------------------------
71          ISO 5832-12:1996,         Withdrawn and       71
             Implants for Surgery--    transferred to
             Metallic materials--      Materials
             Part 12: Wrought cobalt-
             chromium-molybdenum
             alloy
------------------------------------------------------------------------
73          ISO 5838-1:1995,          Added ``Design      73
             Implants for Surgery--    Controls'' to
             Skeletal Pins and         Process(es)
             Wires--Part 1: Material   Impacted
             and Mechanical
             Requirements
------------------------------------------------------------------------
74          ISO 5838-2:1991,          Added ``Design      74
             Implants for Surgery--    Controls'' to
             Skeletal Pins and         Process(es)
             Wires--Part 2:            Impacted
             Steinmann Skeletal
             Pins--Dimensions
------------------------------------------------------------------------
75          ISO 5838-3:1993,          Added ``Design      75
             Implants for Surgery--    Controls'' to
             Skeletal Pins and         Process(es)
             Wires--Part 3:            Impacted
             Kirschner Skeletal
             Wires
------------------------------------------------------------------------
76          ISO 6474-94, Implants     Withdrawn and       ..............
             for surgery--Ceramic      transferred to
             materials based on high   Materials
             purity alumina
------------------------------------------------------------------------
78          ISO 7206-4:2002,          Withdrawn and       165
             Implants for Surgery--    replaced with
             Partial and Total Hip     newer version;
             Joint Prostheses--Part    Title change;
             4: Determination of       Added ``Design
             Endurance Properties of   Controls'' to
             Stemmed Femoral           Process(es)
             Components                Impacted
------------------------------------------------------------------------
79          ISO 7206-8:1995,          Added ``Design      79
             Implants for Surgery--    Controls'' to
             Partial and Total Hip     Process(es)
             Joint Prostheses--Part    Impacted
             8: Endurance
             Performance of Stemmed
             Femoral Components with
             Application of Torsion
------------------------------------------------------------------------
83          ISO 13402-95, Surgical    Added ``Design      83
             and Dental Hand           Controls'' to
             Instruments--Determinat   Process(es)
             ion of Resistance         Impacted
             Against Autoclaving,
             Corrosion and Thermal
             Exposure
------------------------------------------------------------------------
84          ISO 13782:1996, Implants  Withdrawn and       ..............
             for Surgery--Metallic     transferred to
             materials--Unalloyed      Materials
             tantalum for surgical
             implant applications
------------------------------------------------------------------------
85          ISO 14630:1997, Non-      Added ``Design      85
             Active Surgical           Controls'' to
             Implants--General         Process(es)
             Requirements              Impacted
------------------------------------------------------------------------

[[Page 10719]]

 
101         ASTM F897-02, Standard    Withdrawn and       166
             Test Method for           replaced with
             Measuring Fretting        newer version;
             Corrosion of              Added ``Design
             Osteosynthesis Plates     Controls'' to
             and Screws                Process(es)
                                       Impacted
------------------------------------------------------------------------
104         ASTM F1089-02, Standard   Withdrawn and       167
             Test Method for           replaced with
             Corrosion of Surgical     newer version;
             Instruments               Added ``Design
                                       Controls'' to
                                       Process(es)
                                       Impacted
------------------------------------------------------------------------
107         ASTM F1147-99, Standard   Added ``Design      107
             Test Method for Tension   Controls'' to
             Testing of Calcium        Process(es)
             Phosphate and Metallic    Impacted
             Coatings
------------------------------------------------------------------------
111         ASTM F1814-97a, Standard  Added ``Design      111
             Guide for Evaluating      Controls'' to
             Modular Hip and Knee      Process(es)
             Joint Components          Impacted
------------------------------------------------------------------------
113         ASTM F1377-98a, Standard  Added ``Design      113
             Specification for         Controls'' to
             Cobalt-28 Chromium-6      Process(es)
             Molybdenum Powder for     Impacted
             Coating of Orthopedic
             Implants (UNS R30075)
------------------------------------------------------------------------
114         ASTM F1798-97, Standard   Added ``Design      114
             Guide for Evaluating      Controls'' to
             the Static and Fatigue    Process(es)
             Properties of             Impacted
             Interconnection
             Mechanisms and
             Subassemblies Used in
             Spinal Arthrodesis
             Implants
------------------------------------------------------------------------
115         ASTM F1800-97, Standard   Added ``Design      115
             Test Method for Cyclic    Controls'' to
             Fatigue Testing of        Process(es)
             Metal Tibial Tray         Impacted
             Components of Total
             Knee Joint Replacements
------------------------------------------------------------------------
117         ISO 5832-2:1999,          Withdrawn and       ..............
             Implants for Surgery--    transferred to
             Metallic Materials--      Materials
             Part 2: Unalloyed
             Titanium
------------------------------------------------------------------------
 118        ISO 5832-9:1992,          Withdrawn and       ..............
             Implants for Surgery--    transferred to
             Metallic Materials--      Materials
             Part 9: Wrought High
             Nitrogen Stainless
             Steel
------------------------------------------------------------------------
119         ISO 5834-2:1998,          Withdrawn and       ..............
             Implants for Surgery--    transferred to
             Ultra-High-Molecular      Materials
             Weight Polyethylene--
             Part 2: Moulded Forms
------------------------------------------------------------------------
120         ASTM F382-99, Standard    Added ``Design       120
             Specification and Test    Controls'' to
             Method for Metallic       Process(es)
             Bone Plates               Impacted
------------------------------------------------------------------------
121          ISO 7207-1:1994,         Added ``Design      121
             Implants for Surgery--    Controls'' to
             Components for partial    Process(es)
             and total knee joint      Impacted
             prostheses--Part 1:
             Classification,
             definitions and
             designation of
             dimensions
------------------------------------------------------------------------
 126        ASTM F366-82(2000),       Added ``Design      126
             Standard Specification    Controls'' to
             for Fixation Pins and     Process(es)
             Wires                     Impacted
------------------------------------------------------------------------
131         ASTM F1044-99, Standard   Added ``Design      131
             Test Method for Shear     Controls'' to
             Testing of Calcium        Process(es)
             Phosphate Coatings and    Impacted
             Metallic Coatings
------------------------------------------------------------------------
140         ASTM F1582-98, Standard   Added ``Design      140
             Terminology Relating to   Controls'' to
             Spinal Implants           Process(es)
                                       Impacted
------------------------------------------------------------------------
141         ASTM F1612-95(2000),      Added ``Design      141
             Standard Practice for     Controls'' to
             Cyclic Fatigue Testing    Process(es)
             of Metallic Stemmed Hip   Impacted
             Arthroplasty Femoral
             Components With Torsion
------------------------------------------------------------------------
142         ASTM F1672-95(2000),      Added ``Design      142
             Standard Specification    Controls'' to
             for Resurfacing           Process(es)
             Patellar Prosthesis       Impacted
------------------------------------------------------------------------
143         ISO 7153-1:1991/Amd.      Withdrawn and       143
             1:1999, Surgical          transferred to
             Instruments--Metallic     Materials
             Materials--Part 1:
             Stainless steel
------------------------------------------------------------------------
152         ASTM F1160-00e1,          Added ``Design      152
             Standard Test Method      Controls'' to
             for Shear and Bending     Process(es)
             Fatigue Testing of        Impacted
             Calcium Phosphate and
             Metallic Medical and
             Composite Calcium
             Phosphate/Metallic
             Coatings
------------------------------------------------------------------------
155         ISO 7207-2:1998,          Added ``Design      155
             Implants for Surgery--    Controls'' to
             Components for partial    Process(es)
             and total knee joint      Impacted
             prostheses--Part 2:
             Articulating surfaces
             made of metal, ceramic
             and plastics materials
------------------------------------------------------------------------

[[Page 10720]]

 
159         ASTM F1717-01, Standard   Added ``Design      159
             Test Methods for Spinal   Controls'' to
             Implant Constructs in a   Process(es)
             Vertebrectomy Model       Impacted
------------------------------------------------------------------------
161         ASTM F1264-01, Standard   Added ``Design      161
             Specification and Test    Controls'' to
             Methods for               Process(es)
             Intramedullary Fixation   Impacted
             Devices
------------------------------------------------------------------------
162         ASTM F564-02, Standard    Added ``Design      162
             Specification and Test    Controls'' to
             Methods for Metallic      Process(es)
             Bone Staples              Impacted
------------------------------------------------------------------------
163         ASTM F543-02 Standard     Added ``Design      163
             Specification and Test    Controls'' to
             Methods for Metallic      Process(es)
             Medical Bone Screws       Impacted
------------------------------------------------------------------------
164         ASTM F1541-02, Standard   Added ``Design      164
             Specification and Test    Controls'' to
             Methods for External      Process(es)
             Skeletal Fixation         Impacted
             Devices
------------------------------------------------------------------------

H. Radiology

------------------------------------------------------------------------
 Old Item                                                   Replacement
    No.             Standard                Change           Item No.
------------------------------------------------------------------------
38          IEC 60601-2-15, Medical   Withdrawn           ..............
             Electrical Equipment--
             Part 2: Particular
             Requirements for the
             Safety of Capacitor
             Discharge X-ray
             Generators (1988)
------------------------------------------------------------------------
43          IEC 60601-2-33: Medical    Withdrawn and      86
             Electrical Equipment--    replaced with
             Part 2, Particular        newer version
             Requirements for the
             Safety of Magnetic
             Resonance Equipment for
             Medical Diagnosis (2002-
             2005)
------------------------------------------------------------------------
60          IEC 61217 (2002-03),      Withdrawn and       87
             Radiotherapy Equipment--  replaced with
             Coordinates, movements,   newer version
             and scales
------------------------------------------------------------------------
64          IEC 60601-2-45, Ed. 2.0,  Correction date     64
             (2001-05): Medical        inserted
             Electrical Equipment--
             Part 2-45: Particular
             Requirements for the
             Safety of Mammographic
             X-ray Equipment and
             Mammographic
             Stereotactic Devices
------------------------------------------------------------------------
78          NEMA PS 3.1 through PS    Correction Parts    78
             3.16 2000, Digital        inserted in title
             Imaging and
             Communications in
             Medicine (DICOM)
------------------------------------------------------------------------

I. Sterility

------------------------------------------------------------------------
 Old Item                                                   Replacement
    No.             Standard                Change           Item No.
------------------------------------------------------------------------
1           AOAC 6.2.01:2000,         Withdrawn and       94
             Official Method 955.14,   replaced with
             Testing Disinfectants     newer version
             Against Salmonella
             choleraesuis, Use-
             Dilution Method
------------------------------------------------------------------------
2           AOAC 6.2.02:2000,         Withdrawn and       95
             Official Method 991.47,   replaced with
             Testing Disinfectants     newer version
             Against Salmonella
             choleraesuis, Hard
             Surface Carrier Test
             Method
------------------------------------------------------------------------
3           AOAC 6.2.03:2000,         Withdrawn and       96
             Official Method 99l.48,   replaced with
             Testing Disinfectants     newer version.
             Against Staphylococcus
             aureus, Hard Surface
             Carrier Test Method
------------------------------------------------------------------------
4           AOAC 6.2.04:2000,         Withdrawn and       97
             Official Method 955.15,   replaced with
             Testing Disinfectants     newer version
             Against Staphylococcus
             aureus, Use-Dilution
             Method
------------------------------------------------------------------------
5           AOAC 6.2.05:2000,         Withdrawn and       98
             Official Method 99l.49,   replaced with
             Testing Disinfectants     newer version
             Against Pseudomonas
             aeruginosa, Hard
             Surface Carrier Test
             Method
------------------------------------------------------------------------
6            AOAC 6.2.06:2000,        Withdrawn and       99
             Official Method 964.02,   replaced with
             Testing Disinfectants     newer version
             Against Pseudomonas
             aeruginosa, Use-
             Dilution Method
------------------------------------------------------------------------

[[Page 10721]]

 
7           AOAC 6.3.02, Official     Withdrawn and       100
             Method 955.17,            replaced with
             Fungicidal Activity of    newer version
             Disinfectants Using
             Trichophyton
             mentagrophytes
------------------------------------------------------------------------
8           AOAC 6.3.05:2000,         Withdrawn and       101
             Official Method 966.04,   replaced with
             Sporicidal Activity of    newer version
             Disinfectants
------------------------------------------------------------------------
9           AOAC 6.3.06:2000,         Withdrawn and       102
             Official Method 965.12,   replaced with
             Tuberculocidal Activity   newer version
             of Disinfectants
------------------------------------------------------------------------
24          ANSI/AAMI/ISO             Contact person      24
             11134:1993,
             Sterilization of Health
             Care Products--
             Requirements for
             Validation and Routine
             Control-Industrial
             Moist Heat
             Sterilization
------------------------------------------------------------------------
25          ANSI/AAMI/ISO 11135-      Contact person      25
             1994, Medical Devices--
             Validation and Routine
             Control of Ethylene
             Oxide Sterilization
------------------------------------------------------------------------
27          AAMI/ANSI/ISO             Withdrawn and       103
             11607:2000, Packaging     replaced with
             for Terminally            newer version;
             Sterilized Medical        Add to Extent of
             Devices                   Recognition
------------------------------------------------------------------------
51          ANSI/AAMI ST58:1996,      Withdrawn and       104
             Safe Use and Handling     replaced with
             of Glutaraldehyde-Based   newer version
             Products in Health Care
             Facilities and ANSI/
             AAMI ST58:1996/
             Amendment 1 2002
------------------------------------------------------------------------
52          ANSI/AAMI ST59:1999,      Updated Relevant    52
             Sterilization of Health   Guidance
             Care Products--
             Biological Indicators
             Part 1: General
             Requirements
------------------------------------------------------------------------
73          ANSI/AAMI ST46:2002,       Withdrawn and      105
             Steam Sterilization and   replaced with
             Sterility Assurance in    newer version
             Health Care Facilities
------------------------------------------------------------------------
75          ANSI/AAMI/ISO             Title Correction;   75
             11137:1994,               Additional
             Sterilization of Health   Relevant
             Care Products-            Guidance; Contact
             Requirements for          person
             Validation and Routine
             Control-Radiation
             Sterilization and
             ISO11137:1995
             (Amendment 1:2002)
------------------------------------------------------------------------
76          AAMI/ANSI/ISO 10993-      Delete (e.g.         76
             7:1995 (R) 2001,          hemodialyzers)
             Biological Evaluation     from the Extent
             of Medical Devices--      of Recognition
             Part 7: Ethylene Oxide
             Sterilization Residuals
------------------------------------------------------------------------
78          USP 26:2003, Biological   Withdrawn and       106
             Indicator for Dry Heat    replaced with
             Sterilization, Paper      newer version
             Carrier
------------------------------------------------------------------------
79          USP 26:2003, Biological   Withdrawn and       107
             Indicator for Ethylene    replaced with
             Oxide Sterilization,      newer version
             Paper Carrier
------------------------------------------------------------------------
80          USP 26:2003, Biological   Withdrawn and       108
             Indicator for Steam       replaced with
             Sterilization, Paper      newer version
             Carrier
------------------------------------------------------------------------
81          USP 26:2003, <61 Microbial Limits      replaced with
             Test                      newer version
------------------------------------------------------------------------
82          USP 26:2003, <71, Microbiological      replaced with
             Tests, Sterility Tests    newer version
------------------------------------------------------------------------
83          USP 26:2003, <85 Biological Tests      replaced with
             and Assays, Bacterial     newer version
             Endotoxin Test (LA)
------------------------------------------------------------------------
84          USP 26:2003, <151 Pyrogen Test (USP     replaced with
             Rabbit Test)              newer version
------------------------------------------------------------------------
85          USP 26:2003 <1211 Sterilization and     replaced with
             Sterility Assurance of    newer version
             Compendial Articles
------------------------------------------------------------------------
87          USP 26:2003, Transfusion  Withdrawn and       114
             and Infusion Assemblies   replaced with
             and Similar Medical       newer version
             Devices <161
------------------------------------------------------------------------
93          USP 26:2003, Biological   Withdrawn and       115
             Indicator for Steam       replaced with
             Sterilization             newer version
------------------------------------------------------------------------

III. Listing of New Entries

[[Page 10722]]

    The listing of new entries and consensus standards added as 
``Modifications to the List of Recognized Standards'', under 
Recognition List Number: 009,'' is as follows:

A. Anesthesia

------------------------------------------------------------------------
                                                     Reference No. and
       Item No.             Title of Standard               Date
------------------------------------------------------------------------
45                     Standard Specification for  F1101-90 (1996)
                        Ventilators Intended for
                        use During Anesthesia
------------------------------------------------------------------------
46                     Breathing Tubes Intended    ISO 5367:2000
                        for use with Anesthetic
                        Apparatus and Ventilators
------------------------------------------------------------------------

B. Biocompatibility

------------------------------------------------------------------------
                                                      Reference No. and
       Item No.             Title of Standard               Date
------------------------------------------------------------------------
79                     Standard Practice for        ASTM F619-02
                        Extraction of Medical
                        Plastics
------------------------------------------------------------------------
80                     Standard Practice for        ASTM F1877-98
                        Characterization of
                        Particles
------------------------------------------------------------------------
81                     Standard Practice for        ASTM F1905-98
                        Selecting Tests for
                        Determining the Propensity
                        of Materials to Cause
                        Immunotoxicity
------------------------------------------------------------------------
82                     Standard Practice for        ASTM F2147-01
                        Evaluation of Immune
                        Responses In
                        Biocompatibility Testing
                        Using ELISA Tests,
                        Lymphocyte, Proliferation,
                        and Cell Migration
------------------------------------------------------------------------

C. Cardiovascular/Neurology

------------------------------------------------------------------------
                                                      Reference No. and
       Item No.             Title of Standard               Date
------------------------------------------------------------------------
50                     Cardiac Defibrillator        ANSI/AAMI DF2-1996
                        Devices                      (Revision of ANSI/
                                                     AAMI DF2-1989)
------------------------------------------------------------------------
51                     Automatic External           ANSI/AAMI DF39-1993
                        Defibrillators and Remote-
                        Control Defibrillators
------------------------------------------------------------------------

D. Dental/ENT

------------------------------------------------------------------------
                                                      Reference No. and
       Item No.             Title of Standard               Date
------------------------------------------------------------------------
103                    Denture Base Polymers        ANSI/ADA
                                                     Specification No.
                                                     12:1999
------------------------------------------------------------------------
104                    Pit and Fissure Sealants     ANSI/ADA
                                                     Specification No.
                                                     39: 1999
------------------------------------------------------------------------
105                    Resilient Lining Materials   ANSI/ADA
                        for Removable Dentures,      Specification No.
                        Part 2: Short-Term           75: 1997
                        Materials
------------------------------------------------------------------------
106                    Dental Reversible/           ANSI/ADA
                        Irreversible Hydrocolloid    Specification No.
                        Impression Material System   82: 1998
------------------------------------------------------------------------
107                    Dental, Water-Based Cements  ISO 9917-2:1998
------------------------------------------------------------------------
108                    Dentistry, Resilient Lining  ISO 10139-1:1991
                        Materials for Removable
                        Dentures--Part 1: Short-
                        Term Materials
------------------------------------------------------------------------
109                    Dentistry, Reversible-       ISO 13716: 1999
                        Irreversible Hydrocolloid
                        Impression Material
                        Systems
------------------------------------------------------------------------

E. In Vitro Diagnostic

[[Page 10723]]



------------------------------------------------------------------------
                                                      Reference No. and
       Item No.             Title of Standard               Date
------------------------------------------------------------------------
88                     Preparation and Validation   NCCLS C37-A:1999
                        of Commutable Frozen Human
                        Serum Pools as Secondary
                        Reference Materials for
                        Cholesterol Measurement
                        Procedures: Approved
                        Guideline
------------------------------------------------------------------------
89                     A Designated Comparison      NCCLS C39-A:2000
                        Method for the Measurement
                        of Ionized Calcium in
                        Serum; Approved Standard
------------------------------------------------------------------------
------------------------------------------------------------------------
------------------------------------------------------------------------
94                     User Protocol for            NCCLS EP12-A:2002
                        Evaluation of Qualitative
                        Test Performance; Approved
                        Guideline
------------------------------------------------------------------------
95                     User Demonstration of        NCCLS EP15-A:2001
                        Performance for Precision
                        and Accuracy; Approved
                        Guideline
------------------------------------------------------------------------
96                     Quality Management for Unit- NCCLS EP18-A:2002
                        Use Testing; Approved
                        Guideline
------------------------------------------------------------------------
97                     Urinalysis and Collection,   NCCLS GP16-A2:2001
                        Transportation, and
                        Preservation of Urine
                        Specimens--Second Edition;
                        Approved Guideline
------------------------------------------------------------------------

F. OB-GYN/Gastroenterology

------------------------------------------------------------------------
                                                      Reference No. and
       Item No.             Title of Standard               Date
------------------------------------------------------------------------
28                     Hemodialyzers                ANSI/AAMI RD 16:1996/
                                                     A1:2002 Amendment 1
                                                     to ANSI/AAMI RD
                                                     16:1996
------------------------------------------------------------------------
29                     Hemodialyzer Blood Tubing    ANSI/AAMI RD 17:1994/
                                                     A1:2002 Amendment 1
                                                     to ANSI/AAMI RD
                                                     17:1994
------------------------------------------------------------------------

G. Ophthalmic

------------------------------------------------------------------------
                                                      Reference No. and
       Item No.             Title of Standard               Date
------------------------------------------------------------------------
31                     Optics and Optical           ISO 11810:2002
                        Instruments--Lasers and
                        Laser-related Equipment--
                        Test Method for the Laser-
                        resistance of Surgical
                        Drapes and/or Patient-
                        protective Covers
------------------------------------------------------------------------
32                     Optics and Optical           ISO 11990:2003
                        Instruments--Lasers and
                        Laser-related Equipment--
                        Determination of Laser
                        Resistance of Tracheal
                        Tube Shafts
------------------------------------------------------------------------

H. Radiology

------------------------------------------------------------------------
                                                      Reference No. and
       Item No.             Title of Standard               Date
------------------------------------------------------------------------
88                     Medical Electrical           IEC 60601-2-17
                        Equipment--Part 2:           (1989)
                        Particular Requirements
                        for the Safety of Remote-
                        Controlled Automatically-
                        Driven Gamma-Ray
                        Afterloading Equipment
                        (1989)
------------------------------------------------------------------------
89                     Optics and optical           ISO 11810:2002
                        instruments--Lasers and
                        Laser-Related Equipment--
                        Test Method for the Laser-
                        Resistance of Surgical
                        Drapes and/or Patient-
                        Protective Covers
------------------------------------------------------------------------
90                     Medical Electrical           IEC 60601-2-1
                        Equipment--Part 2:           Amendment 1--Ed.
                        Particular Requirements      2.0 (2002-05)
                        for Medical Electron
                        Accelerators
------------------------------------------------------------------------

[[Page 10724]]

 
91                     Medical Electrical           IEC 60601-2-8
                        Equipment--Part 2:           Amendment 1 (1997-
                        Particular Requirements      98)
                        for the Safety of
                        Therapeutic X-ray
                        Equipment Operating in the
                        Range 10 kV to 1 MV
------------------------------------------------------------------------
92                     Medical Electrical           IEC 61674 (1997-10)
                        Equipment--Dosimeters with
                        Ionization Chambers and/or
                        Semi-Conductor Detectors
                        as used in X-ray
                        Diagnostic Imaging
------------------------------------------------------------------------
93                     Medical Electrical           IEC 61674 Amendment
                        Equipment--Dosimeters with   1 (2002-06)
                        Ionization Chambers and/or
                        Semi-Conductor Detectors
                        as used in X-ray
                        Diagnostic Imaging
------------------------------------------------------------------------
94                     Medical Electrical           IEC 60731 Amendment
                        Equipment--Dosimeters with   1 (2002-06)
                        Ionization Chambers as
                        used in Radiotherapy
------------------------------------------------------------------------

I. Sterility

------------------------------------------------------------------------
                                                      Reference No. and
       Item No.             Title of Standard               Date
------------------------------------------------------------------------
116                    Bacterial Endotoxins--Test   ANSI/AAMI ST72:2002
                        Methodologies, Routine
                        Monitoring, and
                        Alternatives to Batch
                        Testing
------------------------------------------------------------------------

J. Tissue Engineering

------------------------------------------------------------------------
                                                      Reference No. and
       Item No.             Title of Standard               Date
------------------------------------------------------------------------
3                      Standard Guide for           ASTM F2212-2002
                        Characterization of Type 1
                        Collagen as a Starting
                        Material for Surgical
                        Implants and Substrates
                        for Tissue Engineered
                        Medical Products
------------------------------------------------------------------------

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 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 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 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 notice announcing ``Modification to the List of 
Recognized Standards, Recognition List Number: 009'' 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 hyperlink at http://www.fda.gov/cdrh/stdsprog.html. This Federal Register notice of 
modifications in FDA's recognition of consensus standards will be 
available, upon publication, 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:

[[Page 10725]]

009.'' These modifications to the list or recognized standards are 
effective upon publication of this notice in the Federal Register.

    Dated: February 13, 2004.
Beverly Chernaik Rothstein,
Acting Deputy Director for Policy and Regulations, Center for Devices 
and Radiological Health.
[FR Doc. E4-479 Filed 3-5-04; 8:45 am]
BILLING CODE 4160-01-S