[Federal Register Volume 65, Number 221 (Wednesday, November 15, 2000)]
[Notices]
[Pages 69022-69030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D-0530]


FDA Modernization Act of 1997: Modifications to the List of 
Recognized Standards, Recognition List Number: 004

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a 
publication containing modifications the agency is making to the list 
of standards FDA will recognize for use in premarket reviews (FDA 
Recognized Consensus Standards). This publication entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 004'' (Recognition List Number: 004) will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES: Written comments concerning this document may be submitted at 
any time. See section VI 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:

[[Page 69023]]

004,'' to the Division of Small Manufacturers Assistance (DSMA), 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. Written comments 
concerning this document must be submitted to the contact person 
(address below). Comments should be identified with the docket number 
found in brackets in the heading of this document. This document may 
also be accessed on FDA's Internet site at http://www.fda.gov/cdrh/fedregin.html. See section V of this document for electronic access to 
the searchable data base for the current list of ``FDA Recognized 
Consensus Standards,'' including Recognition List Number: 004 
modifications, and other standards related information.

FOR FURTHER INFORMATION CONTACT: To comment on this document and/or to 
recommend additional standards for recognition: Donald E. Marlowe, 
Center for Devices and Radiological Health (HFZ-100), Food and Drug 
Administration, 12725 Twinbrook Pkwy., Rockville, MD 20852, 301-827-
4777.

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.'' This notice described 
how FDA will implement its standards program recognizing the use of 
certain standards and provided the initial list of recognized 
standards.
    In Federal Register notices published on October 16, 1998 (63 FR 
55617) and July 12, 1999 (64 FR 37546), FDA modified its initial list 
of recognized standards. These notices described the addition, 
withdrawal, and revision of certain standards recognized by FDA. When 
these notices were published, the agency maintained ``html'' and 
``pdf'' versions of the list of ``FDA Recognized Consensus Standards.'' 
Both versions were publicly accessible at the agency's Internet site. 
The agency maintains the current list in a searchable data base 
accessible to the public. See section V of this document for electronic 
access information.

II. Discussion of Modifications to the List of Recognized 
Standards, Recognition List Number: 004

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the agency will recognize for 
use in satisfying premarket reviews for devices. FDA will incorporate 
these modifications in the list of ``FDA Recognized Consensus 
Standards'' in the agency's searchable data base. FDA will use the term 
``Recognition List Number: 004'' to identify supplementary information 
sheets for standards added to the list for the first time, standards 
added to replace withdrawn standards, and still recognized standards 
for which minor revisions are made to clarify the application of the 
standards.
    At the end of this notice, FDA lists modifications the agency is 
making that involve: (1) The initial addition of standards not 
previously recognized by FDA and (2) the addition of standards in 
conjunction with the withdrawal of other standards that are replaced by 
these later, or amended, or different standards.
    Under headings ``A'' through ``L'' below, FDA describes 
modifications that involve: (1) The withdrawal of standards and their 
replacement by others (``replacement'' standards are included in the 
list at the end of this notice, but not ``withdrawn'' standards); (2) 
the correction of errors made in previously recognized standards, e.g., 
the name of the standard; (3) the withdrawal of standards not replaced; 
and (4) the minor revision of supplementary information sheets for 
standards that FDA still recognizes, e.g., to clarify the extent of 
recognition, or applicable devices.
    Item numbers discussed below identify entries in the searchable 
data base list of ``FDA Recognized Consensus Standards.'' ``Previous 
item'' refers to entries in the list after modification on July 12, 
1999 (64 FR 37546). ``Current item'' refers to entries in the list 
after Recognition List Number: 004 modifications are included. Within 
each category of standards, entries begin (or began) with item 1. Item 
numbers are not repeated if an entry is withdrawn, replaced, or added.

A. Biocompatibility

    1. ASTM E1397-91 is withdrawn under previous item 5. ASTM E1397-91 
(1998) is added under current item 37.
    2. ASTM E1398-91 is withdrawn under previous item 6. ASTM E1398-91 
(1998) is added under current item 38.
    3. ASTM F763-87 (1993) is withdrawn under previous item 35. ASTM 
F763-99 is added under current item 40.
    4. ASTM F981-93 is withdrawn under previous item 14. ASTM F981-99 
is added under current item 41.
    5. USP 23, ``Biological Reactivity Tests, In Vitro-Direct Contact 
Test (87),'' is withdrawn under previous item 23. The USP 24 version, 
Biological Tests 87>, is added under current item 46.
    6. USP 23, ``Biological Reactivity Tests, In Vitro-Elution Test 
(87),'' is withdrawn under previous item 24. The USP 24 version, 
Biological Tests 87> is added under current item 47.
    7. USP 23 (1988), ``Biological Reactivity Tests, In Vivo, 
Classification of Plastics Sample Preparation,'' is withdrawn under 
previous item 31. The USP 24 version, Biological Tests 88>, is added 
under current item 48.
    8. USP 23, ``Biological Reactivity Test, In Vivo, Classification of 
Plastics-Intracutaneous Test (88),'' is withdrawn under previous item 
25. The USP 24 version, Biological Tests 88>, is added under current 
item 49.
    9. USP 23, ``Biological Reactivity Tests, In Vivo-Systemic 
Injection Test (88),'' is withdrawn under previous item 27. The USP 24 
version, Biological Tests 88>, is added under current item 50.

B. Cardiovascular/Neurology

    1. ASTM F1058-91 is withdrawn under previous item 13. ASTM F1058-97 
is added under current item 28.
    2. IEC 60601-2-30 (1995-03) is withdrawn, under previous item 19. 
IEC 60601-2-30: 1999-12 is added under current item 29.
    3. IEC 60601-2-25 (1993-03) is withdrawn under previous item 17. 
IEC 60601-2-25 Amendment 1 (1999) is added under current item 30.

C. Dental/ENT

    1. ANSI/ADA Specification No.15a (1992) is withdrawn under previous 
item 47. ANSI/ADA Specification No. 15: 1999 is added under current 
item 85.
    2. ANSI/ADA Specification No. 38 (1991) is withdrawn under previous 
item 54. ANSI/ADA Specification No. 38: 2000 is added under current 
item 86.
    3. ANSI/ADA Specification No. 69 (1991) is withdrawn under previous 
item 57. ANSI/ADA Specification No. 69: 1999 is added under current 
item 87.

[[Page 69024]]

    4. ANSI/ADA Specification No. 78 (1994) is withdrawn under previous 
item 58. ANSI/ADA Specification No. 78: 2000 is added under current 
item 88.

D. General (General Applicability)

    1. ANSI/AAMI/ISO 10993-1 (1997) is withdrawn under previous item 
13. ANSI/AAMI/ISO 10993-1 (1997) is added back to the list as current 
item 51 under the Biocompatibility category of standards.

E. General Plastic Surgery/General Hospital

    1. ASTM D6124-97 is withdrawn under previous item 45. ASTM D6124-00 
is added under current item 51.
    2. ASTM D5250 (1992) is withdrawn under previous item 35. ASTM 
D5250-00 is added under current item 52.
    3. ASTM D5151 (1992) is withdrawn under previous item 34. ASTM 
D5151-99 is added under current item 53.
    4. ASTM D3578 (1995) is withdrawn under previous item 31. ASTM 
D3578-00 is added under current item 54.
    5. ASTM D3577 (1998) is withdrawn under previous item 30. ASTM 
D3577-00 is added under current item 55.
    6. USP 23 11>, ``Sterile Sodium Chloride for Injection,'' is 
withdrawn. The USP 24 11> version of this standard is added under 
current item 56.
    7. USP 23 11>, ``Sterile Water for Injection,'' is withdrawn under 
previous item 28. The USP 24 11> version of this standard is added 
under current item 57.
    8. USP 23, ``Absorbable Surgical Sutures,'' is withdrawn under 
previous item 40. The USP 24 version of this standard is added under 
current item 58.
    9. USP 23, ``Tensile Strength,'' is withdrawn under previous item 
44. The USP 24 version of this standard is added under current item 59.
    10. USP 23, ``Sutures-Diameter 861>,'' is withdrawn under previous 
item 42. The USP 24 861> version of this standard is added under 
current item 60.
    11. USP 23, ``Suture Needle Attachment 871>,'' is withdrawn under 
previous item 43. The USP 24 871> version of this standard is added, 
under current item 61.

F. In Vitro Devices

    1. NCCLS standard M11-A3 (1993) is withdrawn under previous item 9. 
FDA intended to replace this standard with NCCLS standard M11-A4 
(1997), which it added to the list on July 12, 1999 (64 FR 37546) and 
which remains as current item 45.

G. OB GYN/Gastroenterology

    1. In the supplementary information sheet(s) for IEC 60601-2-18: 
1996, which was identified under previous item 5, minor revisions are 
made to the devices affected, related Code of Federal Regulations (CFR) 
citation(s) and procode(s), and relevant guidance. This standard 
remains recognized and identified under current item 5.

H. Ophthalmic

    1. ISO 9394: 1994 is withdrawn under previous item 6, from the list 
of recognized consensus standards. ISO 9394: 1998 is added under 
current item 15.

I. Orthopaedics

    1. ASTM F75-92 is withdrawn under previous item 2. ASTM F75-98 is 
added under current item 86.
    2. ASTM F90-96 is withdrawn under previous item 4. ASTM F90-97 is 
added under current item 87.
    3. ASTM F136-96 is withdrawn under previous item 5. ASTM F136-98 is 
added under current item 88.
    4. ASTM F138-92 is withdrawn under previous item 6. ASTM F138-97 is 
added under current item 89.
    5. ASTM F560-92 is withdrawn under previous item 9. ASTM F560-98 is 
added under current item 90.
    6. ASTM F561-87 is withdrawn under previous item 10. ASTM F561-97 
is added under current item 91.
    7. ASTM F565-85 (R1996) is withdrawn under previous item 12. ASTM 
F565-85 (1996)(e1) is added under current item 92.
    8. ASTM F601-86 (1992) is withdrawn under previous item 13. ASTM 
F601-98 is added under current item 93.
    9. ASTM F603-83 is withdrawn under previous item 14. ASTM F603-83 
(1995) is added under current item 94.
    10. ASTM F620-96 is withdrawn under previous item 16. ASTM F620-97 
is added under current item 96.
    11. ASTM F621-92 is withdrawn under previous item 17. ASTM F621-97 
is added under current item 97.
    12. ASTM F629-86 is withdrawn under previous item 18. ASTM F629-97 
is added under current item 98.
    13. ASTM F648-84 is withdrawn under previous item 19. ASTM F648-98 
is added under current item 99, with changes to the extent of 
recognition made in the supplementary information sheet(s).
    14. ASTM F746-87 is withdrawn under previous item 22. ASTM F746-87 
(1994) is added under current item 100.
    15. ASTM F786-82 is withdrawn under previous item 23. It is not 
replaced.
    16. ASTM F787-82, is withdrawn under previous item 24. It is not 
replaced.
    17. ASTM F897-84 (R1993) is withdrawn under previous item 26. ASTM 
F897-84 (1997) is added under current item 101.
    18. The title of ASTM F961-96, identified under previous item 28, 
is corrected to read ``Standard Specification for Cobalt-35 Nickel-20 
Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (R30035).'' 
It remains identified as current item 28.
    19. ASTM F983-86 is withdrawn under previous item 29. ASTM F983-86 
(1996) is added under current item 102.
    20. ASTM F1089-87 is withdrawn under previous item 32. ASTM F1089-
87 (1994) is added, under current item 104.
    21. ASTM F1091-91 (R1996) is withdrawn under previous item 33. ASTM 
F1091-91 (1996) E01 is added under current item 105.
    22. ASTM F1147-95 is withdrawn under previous item 35. ASTM F1147-
99 is added under current item 107.
    23. ASTM F1160-91 is withdrawn under previous item 36. ASTM F1160-
98 is added under current item 108.
    24. ASTM F1185-88 (1993) is withdrawn under previous item 37. ASTM 
F1185-88 (1993) E01 is added under current item 109.
    25. ASTM F1264-96a is withdrawn under previous item 38. ASTM F1264-
99 is added under current item 110.
    26. ASTM F1350-96 is withdrawn under previous item 42. ASTM F1350-
91 (1996) E01 is added under current item 112.
    27. ASTM F1377-92 is withdrawn under previous item 43. ASTM F1377-
98a is added under current item 113.
    28. In the supplementary information sheet(s) for ASTM F1672-95, 
identified under previous item 55, minor changes are made to the extent 
of recognition, devices affected, and related CFR citation(s) and 
procode(s). This standard remains recognized and identified under 
current item 55.
    29. ASTM F1798 is withdrawn under previous item 59. ASTM F1798-97 
is added under current item 114.
    30. ASTM F1800 is withdrawn under previous item 60. ASTM F1800-97 
is added under current item 115.
    31. ASTM F1801 is withdrawn under previous item 61. ASTM F1801-97 
is added under current item 116.
    32. ISO 5832-2: 1993 is withdrawn under previous item 63. ISO 5832-
2:1999 is added under current item 117.
    33. ISO 5832-9: 1992 is withdrawn under previous item 68. ISO 5832-
9:1995 is added under current item 118.

[[Page 69025]]

    34. ISO 5832-10: 1996 is withdrawn under previous item 69. It is 
not replaced.
    35. ISO 5834-2: 1985 is withdrawn under previous item 72. ISO 5834-
2: 1998 is added under current item 119.
    36. In the supplementary information sheets for ISO 7206-4: 1989 
and ISO 7206-8: 1995, which were identified under previous items 78 and 
79, respectively, minor changes are made to the devices affected, 
processes impacted, type of standards, and related CFR citations and 
procodes. They remain recognized and identified under current items 78 
and 79.

J. Radiology

    1. UL-122 is withdrawn under previous item 30. UL-122 (Fourth 
Edition) is added under current item 50.
    2. UL-187 is withdrawn under previous item 31. UL-187 (Seventh 
Edition) is added under current item 51.
    3. UL-544 (Third Edition) is withdrawn under previous item 32. UL-
544 (Fourth Edition) is added under current item 52.
    4. IEC 60601-2-8 (1987-04) is withdrawn under previous item 35. IEC 
60601-2-8 (1999-04) is added under current item 54.
    5. IEC 60601-2-29 (1993-04) is withdrawn under previous item 41. 
IEC 60601 2-9 (1999-01) is added under current item 55.

K. Software

    1. In the supplementary information sheets for ISO/IEC 12207 and 
IEEE/EIA 12207.0-1996, which were identified under previous items 1 and 
3, respectively, minor changes are made to the identities of 
organizations associated with the standards and the extent of 
recognition. These standards remain recognized and identified under 
current items 1 and 3.

L. Sterility

    1. ANSI/AAMI ST24: 1992 is withdrawn under previous item 13. ANSI/
AAMI ST24: 1999 is added under current item 38.
    2. USP 23: 1995, is withdrawn under previous item 29. USP 24: 2000 
is added under current item 39.
    3. USP 23: 1995, ``Biological Indicator for Dry-Heat Sterilization, 
Paper Strip,'' is withdrawn under previous item 30. The USP 24: 2000 
version of this standard is added under current item 40.
    4. USP 23: 1995, ``Biological Indicator for Ethylene Oxide 
Sterilization, Paper Strip,'' is withdrawn under previous item 31. The 
USP 24: 2000 version of this standard is added under current item 41.
    5. USP 23: 1995, ``Microbial Limits Test 61>,'' is withdrawn under 
previous item 32. The USP 24: 2000 61> version of this standard is 
added under current item 42.
    6. USP 23: 1995, ``Microbiological Tests, Sterility Tests 71>,'' is 
withdrawn under previous item 33. The USP 24: 2000 71> version of this 
standard is added under current item 43.
    7. USP 23: 1995, ``Biological Tests and Assays, Bacterial Endotoxin 
Test (LAL) 85>,'' is withdrawn under previous item 34. The USP 24: 2000 
85> version of this standard is added under current item 44.
    8. USP 23: 1995, ``Pyrogen Test (USP Rabbit Test) 151>,'' is 
withdrawn under previous item 35. The USP 24: 2000 151> version of this 
standard is added under current item 45.
    9. USP 23: 1995, ``Sterilization and Sterility Assurance of 
Compendial Articles 1211>,'' is withdrawn under previous item 36. The 
USP 24: 2000 1211> version of this standard is added under current item 
46.

III. List of Recognized Standards

    FDA maintains the agency's current list of ``FDA Recognized 
Consensus Standards'' in a searchable data base that may be accessed 
directly at FDA's Intranet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. The modifications and minor 
revisions described in this notice will be incorporated into the data 
base and, upon publication in the Federal Register, this recognition of 
consensus standards will be effective.
    Additional modifications and minor revisions as needed, to the list 
of recognized consensus standards, will be announced in the Federal 
Register once a year, or more often, if necessary.

IV. 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 (address above). To be properly considered, such 
recommendations should contain, at a minimum, the following 
information: (1) Title of 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.

V. 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 (FOD) 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.
    Persons interested in obtaining a copy of ``Guidance on the 
Recognition and Use of Consensus Standards'' may also do so by using 
the Internet. CDRH maintains a site on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with access to the Internet. Updated on a 
regular basis, the CDRH home page includes this guidance as well as the 
current list of recognized standards and other standards related 
documents. After publication in the Federal Register, this notice 
announcing ``Modifications to the List of Recognized Standards, 
Recognition List Number: 004'' will be available on the CDRH home page.
    The CDRH home page may be accessed at http://www.fda.gov/cdrh. The 
``Guidance on the Recognition and Use of Consensus Standards,'' and the 
searchable data base for ``FDA Recognized Consensus Standards,'' may be 
accessed through hyper links 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.

VI. Submission of Comments and Effective Date

    Interested persons may, at any time, submit to the contact person 
(address above) written comments regarding this document. Two copies of 
any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. Received comments will be 
considered in determining whether to amend the current listing of 
``Modifications to the List of Recognized Standards, Recognition list: 
004.''
    The recognition of standards announced in this notice of 
modifications will become effective on

[[Page 69026]]

[insert date of publication in the Federal Register].

VII. Listing of New Entries

    The list of new entries and consensus standards added as 
``Modifications to the List of Recognized Standards,'' under 
Recognition List Number: 004, is as follows:

 
----------------------------------------------------------------------------------------------------------------
Item  Number                  Title of Standard                             Reference Number and Date
----------------------------------------------------------------------------------------------------------------
                                                Biocompatibility
----------------------------------------------------------------------------------------------------------------
              Standard Practice for the In Vitro Rat            ASTM E1397-91 (1998)
               Hepatocyte DNA Repair Assay
         38   Standard Practice for the In Vivo Rat Hepatocyte  ASTM E1398-91 (1998)
               DNA Repair Assay
         39   Standard Practice for Selecting Generic           ASTM F748-98
               Biological Test Methods for Materials and
               Devices
         40   Standard Practice for Short-Term Screening of     ASTM F763-99
               Implant Materials
         41   Standard Practice for Assessment of               ASTM F981-99
               Compatibility of Biomaterials for Surgical
               Implants with Respect to Effect of Materials on
               Muscle and Bone
         42   Standard Practice for Testing for Whole           ASTM F1984-99
               Complement Activation in Serum by Solid
               Materials
         43   Standard Practice for Testing for Biological      ASTM F1903-98
               Responses to Particles In Vitro
         44   Standard Practice for Testing for Biological      ASTM F1904-98
               Responses to Particles In Vivo
         45   Standard Practice for Assessment of               ASTM F1983-99
               Compatibility of Absorbable/Resorbable
               Biomaterials for Implant Applications
         46   Biological Reactivity Test, In Vitro--Direct      USP 24 Biological Tests 87>
               Contact Test
         47   Biological Reactivity Test, In Vitro--Elution     USP 24 Biological Tests 87>
               Test
         48   Biological Reactivity Test, In Vivo--Procedure--  USP 24 Biological Test 88>
               Preparation of Sample
         49   Biological Reactivity Test, In Vivo--             USP 24 Biological Tests 88>
               Intracutaneous Test
         50   Biological Reactivity Tests, In Vivo--Systemic    USP 24 Biological Test 88>
               Injection Test
         51   Biological Evaluation of Medical Devices--Part    ANSI/AAMI/ISO 10993-1 (1997)
               1: Evaluation and Testing
----------------------------------------------------------------------------------------------------------------
                                            Cardiovascular/ Neurology
----------------------------------------------------------------------------------------------------------------
         25   Cardiac Defibrillators--Connector Assembly for    ISO 11318-93/Amendment 1:1996 (E)
               Implantable Defibrillators-Dimensional and Test
               Requirements
         26   Medical Electrical Equipment, Part 2: Particular  IEC 60601-2-23: 1993
               Requirements for the Safety of Transcutaneous
               Partial Pressure Monitoring Equipment
         27   Medical Electrical Equipment, Part 2: Particular  IEC 60601-2-34 (1994-12)
               Requirements for the Safety of Direct Blood
               Pressure Monitoring Equipment
         28   Standard Specification for Wrought Cobalt-        ASTM F1058-97
               Chromium-Nickel-Molybdenum-Iron Alloys for
               Surgical Implant Applications (UNS R30003 and
               UNS R30008)
         29   Medical Electrical Equipment, Part 2: Particular  IEC 60601-2-30: 1999-12
               Requirements for the Safety, Including
               Essential Performance, of Automatic Cycling Non-
               Invasive Blood Pressure Monitoring Equipment
         30   Medical Electrical Equipment, Part 2: Particular  IEC 60601-2-25 Amendment 1 (1999)
               Requirements for the Safety of
               Electrocardiographs
----------------------------------------------------------------------------------------------------------------
                                                   Dental/ ENT
----------------------------------------------------------------------------------------------------------------
         85   Synthetic Resin Teeth                             ANSI/ADA Specification No. 15: 1999
         86   Metal-Ceramic Systems                             ANSI/ADA Specification No. 38: 2000
         87   Dental Ceramic                                    ANSI/ADA Specification No. 69: 1999
         88   Endodontic Obturating Points                      ANSI/ADA Specification No. 78: 2000
         89   Polymer-Based Crown and Bridge Resins             ANSI/ADA Specification No. 53: 1999
         90   Specifications for Instruments to Measure Aural   ANSI/ASA S3.39: 1996
               Acoustic Impedance and Admittance (Aural
               Acoustic Immittance)
----------------------------------------------------------------------------------------------------------------
                                         General (Generally Applicable)
----------------------------------------------------------------------------------------------------------------
         22   General Tolerances--Part 1: Tolerances for        ISO 2768-1 (1989)
               Linear and Angular Dimensions Without
               Individual Tolerance Indications
         23   General Tolerances--Part 2: Geometrical           ISO 2768-2 (1989)
               Tolerances for Features Without Individual
               Tolerance Indications
         24   Analysis Techniques for System Reliability--      IEC 60812 (1985)
               Procedure for Failure Modes and Effects
               Analysis (FMEA)
----------------------------------------------------------------------------------------------------------------

[[Page 69027]]

 
                                    General Plastic Surgery/ General Hospital
----------------------------------------------------------------------------------------------------------------
         46   Medical Electrical Equipment--Part 2: Particular  IEC 60601-2-2: Third Edition 1998-09
               Requirements for the Safety of High Frequency
               Surgical Equipment
         47   Standard Test Method for Analysis of Protein in   ASTM D5712-99
               Natural Rubber and its Products Using the
               Modified Lowry Method
         48   Standard Test Method for the Immunological        ASTM D6499-00
               Measurement of Antigenic Protein in Natural
               Rubber and its Products
         49   Standard Test Method for Human Repeat Insult      ASTM D6355-98
               Patch Testing or Medical Gloves
         50   Standard Specification for Nitrile Examination    ASTM D6319-00
               Gloves for Medical Application
         51   Standard Test Method for Residual Powder on       ASTM D6124-00
               Medical Gloves
         52   Standard Specification for Poly (Vinyl Chloride)  ASTM D5250-00
               Gloves for Medical Application
         53   Standard Test Method for Detection of Holes in    ASTM D5151-99
               Medical Gloves
         54   Standard Specification for Rubber Examination     ASTM D3578-00
               Gloves
         55   Standard Specification for Rubber Surgical        ASTM D3577-00
               Gloves
         56   Sterile Sodium Chloride For Irrigation            USP 24 11>
         57   Sterile Water for Injection                       USP 24 11>
         58   Absorbable Surgical Sutures                       USP 24
         59   Tensile Strength                                  USP 24
         60   Sutures--Diameters                                USP 24 861>
         61   Sutures Needle Attachment                         USP 24 871>
----------------------------------------------------------------------------------------------------------------
                                            OB GYN/ Gastroenterology
----------------------------------------------------------------------------------------------------------------
         19   Optical and Optical Instruments--Medical          ISO 8600-1: 1997
               Endoscopes and Endoscopic Accessories--Part 1:
               General Requirements
         20   Optical and Optical Instruments--Medical          ISO 8600-3: 1997
               Endoscopes and Endoscopic Accessories--Part 3:
               Determination of Field of View and Direction of
               View of Endoscopes with Optics
         21   Optical and Optical Instruments--Medical          ISO 8600-4: 1997
               Endoscopes and Certain Accessories--Part 4:
               Determination of Maximum Width of Insertion
               Portion
         22   Standard Practice for Cleaning and Disinfecting   ASTM F1518-94
               of Flexible Fiberoptic and Video Endoscopes
               Used in the Examination of Hollow Viscera
----------------------------------------------------------------------------------------------------------------
                                                   Ophthalmic
----------------------------------------------------------------------------------------------------------------
         15   Optics and Optical Instruments--Determination of  ISO 9394-1998
               Biological Compatibility of Contact Lens
               Material--Testing of the Contact Lens System by
               Ocular Study with Rabbit Eyes
         16   Optics and Optical Instruments--Contact Lenses--  ISO 9913-2: 2000
               Part 2: Determination of Oxygen Permeability
               and Transmissibility by the Coulometeric Method
         17   Optics and Optical Instruments--Ophthalmic        ISO 10939: 1998
               Instruments--Slit-Lamp Microscopes
         18   Optics and Optical Instruments--Ophthalmic        ISO 10943: 1999
               Instruments--Indirect Ophthalmoscopes
         19   Ophthalmic Optics--Contact Lenses--               ISO 11539: 1999
               Classification of Contact Lenses and Contact
               Lens Materials
         20   Ophthalmic Implants--Intraocular Lenses--Part 1:  ISO 11979-1: 1999
               Vocabulary
         21   Ophthalmic Implants--Intraocular Lenses--Part 2:  ISO 11979-2: 2000
               Optical Properties and Tests Methods
         22   Ophthalmic Implants--Intraocular Lenses--Part 3:  ISO 11979-3: 1999
               Mechanical Properties and Test Methods
         23   Ophthalmic Optics--Contact Lenses and Contact     ISO 11981-1999
               Lens Care Products--Determination of Physical
               Compatibility of Contact Lens Care Products
               with Contact Lenses
         24   Ophthalmic Optics--Contact Lenses and Contact     ISO 11986: 1999
               Lens Care Products--Guidelines for
               Determination of Preservative Uptake and
               Release
         25   Optics and Optical Instruments--Ophthalmic        ISO 12865: 1998
               Instruments--Retinoscopes
         26   Ophthalmic Optics--Contact Lens Care Products--   ISO 13212: 1999
               Guidelines for Determination of Shelf-Life
----------------------------------------------------------------------------------------------------------------

[[Page 69028]]

 
                                                  Orthopaedics
----------------------------------------------------------------------------------------------------------------
         86   Standard Specification for Cobalt-28 Chromium-6   ASTM F75-98
               Molybdenum Casting Alloy and Cast Products for
               Surgical Implants (UNS R30075)
         87   Standard Specification for Wrought Cobalt-20      ASTM F90-97
               Chromium-15 Tungsten-10 Nickel Alloy for
               Surgical Implant Applications (UNS R30605)
         88   Standard Specification for Wrought Titanium-6     ASTM F136-98
               Aluminum-4 Vanadium ELI (Extra Low
               Interstitial) Alloy (R56401) for Surgical
               Implant Applications
         89   Standard Specification for Wrought 18 Chromium-   ASTM F138-97
               14 Nickel-2.5 Molybdenum Stainless Steel Bar
               and Wire For Surgical Implants (UNS S31673)
         90   Standard Specification for Unalloyed Tantalum     ASTM F560-98
               for Surgical Implant Applications (UNS R 05200,
               UNS R05400)
         91   Recommended Practice for Retrieval and Analysis   ASTM F561-97
               of Implanted Medical Devices, and Associated
               Tissues
         92   Standard Practice for Care and Handling of        ASTM F 565-85 (1996) (e1)
               Orthopedic Implants and Instruments
         93   Standard Practice for Fluorescent Penetrant       ASTM F601-98
               Inspection of Metallic Surgical Implants
         94   Standard Specification for High-Purity Dense      ASTM F603-83 (1995)
               Aluminum Oxide for Surgical Implant Application
         95   Standard Test Method for Constant Amplitude       ASTM F1539-95
               Bending Fatigue Tests of Metallic Bone Staples
         96   Standard Specification for Titanium-6 Aluminum-4  ASTM F620-97
               Vanadium ELI Alloy Forgings for Surgical
               Implants (UNS R56401)
         97   Standard Specification for Stainless Steel        ASTM F621-97
               Forgings for Surgical Implants
         98   Standard Practice for Radiography of Cast         ASTM F629-97
               Metallic Surgical Implants
         99   Standard Specification for Ultra-High-Molecular-  ASTM F648-98
               Weight Polyethylene Powder and Fabricated Form
               for Surgical Implants
        100   Standard Test Method for Pitting or Crevice       ASTM F746-87 (1994)
               Corrosion of Metallic Surgical Implant
               Materials
        101   Standard Test Method for Measuring Fretting       ASTM F897-84 (1997)
               Corrosion of Osteosynthesis Plates and Screws
        102   Standard Practice for Permanent Marking of        ASTM F983-86 (1996)
               Orthopaedic Implant Components
        103   Standard Test Method for Pull-Out Fixation        ASTM F1540-95
               Strength of Metallic Bone Staples
        104   Standard Test Method for Corrosion of Surgical    ASTM F1089-87 (1994)
               Instruments
        105   Standard Specification for Wrought Cobalt-        ASTM F1091-91 (1996) E01
               Chromium Alloy Surgical Fixation Wire
        106   Standard Test Method for Determining Axial Pull-  ASTM F1691-96
               Out Strength of Medical Bone Screws
        107   Standard Test Method for Tension Testing of       ASTM F1147-99
               Calcium Phosphate and Metallic Coatings
        108   Standard Test Method for Shear and Bending        ASTM F1160-98
               Fatigue Testing of Calcium Phosphate and
               Metallic Medical Coatings
        109   Standard Specification for Composition of         ASTM F1185-88 (1993) E01
               Ceramic Hydroxylapatite for Surgical Implants
        110   Standard Specification and Test Methods for       ASTM F1264-99
               Intramedullary Fixation Devices
        111   Standard Guide for Evaluating Modular Hip and     ASTM F1814-97a
               Knee Joint Components
        112   Standard Specification for Stainless Steel        ASTM F1350-91 (1996) E01
               Surgical Fixation Wire
        113   Standard Specification for Cobalt-28 Chromium-6   ASTM F1377-98a
               Molybdenum Powder for Coating of Orthopedic
               Implants (UNS R30075)
        114   Standard Guide for Evaluating the Static and      ASTM F1798-97
               Fatigue Properties of Interconnection
               Mechanisms and Subassemblies Used in Spinal
               Arthrodesis Implants
        115   Standard Test Method for Cyclic Fatigue Testing   ASTM F1800-97
               of Metal Tibial Tray Components of Total Knee
               Joint Replacements
        116   Standard Practice for Corrosion Fatigue Testing   ASTM F1801-97
               of Metallic Implant Materials
        117   Implants for Surgery--Metallic Materials--Part    ISO 5832-2:1999
               2: Unalloyed Titanium

[[Page 69029]]

 
        118   Implants for Surgery--Metallic Materials--Part    ISO 5832-9: 1995
               9: Wrought High Nitrogen Stainless Steel
        119   Implants for Surgery--Ultra-high-Molecular-       ISO 5834-2: 1998
               Weight Polyethylene--Part 2: Moulded Forms
        120   Standard Specification and Test Method for        ASTM F0382-99
               Metallic Bone Plates
        121   Implants for Surgery--Femoral and Tibial          ISO 7207-1: 1994
               Components for Partial and Total Knee Joint
               Prosthesis--Part 1: Classification, Definitions
               and Designation of Dimensions--Second Edition
        122   Implants for Surgery--Components for Partial and  ISO 7207-2: 1994
               Total Knee Joint Prosthesis--Part 2:
               Articulating Surfaces Made of Metal, Ceramic
               and Plastics Materials
----------------------------------------------------------------------------------------------------------------
                                                    Radiology
----------------------------------------------------------------------------------------------------------------
         50   Standard for Safety of Photographic Equipment--   UL-122
               Fourth Edition
         51   Standard for Safety: X-ray Equipment--Seventh     UL-187
               Edition
         52   Standard for Safety: Medical and Dental           UL-544
               Equipment--Fourth Edition
         53   Radiation Protection--Sealed Radioactive          ISO 2919 (1999)
               Sources--General Requirements and
               Classification
         54   Medical Electrical Equipment--Part 2: Particular  IEC 60601-2-8 (1999-04)
               Requirements for the Safety of Therapeutic X-
               ray Equipment Operating in the Range 10kV to
               1MV
         55   Medical Electrical Equipment--Part 2: Particular  IEC 60601-2-29 (1999-01)
               Requirements for the Safety of Radiotherapy
               Simulators
         56   Medical Electrical Equipment--Dosimeters with     IEC 61674-1997
               Ionization Chambers and/or Semi-Conductor
               Detectors as used in X-ray Diagnostic Imaging
         57   Medical Electrical Equipment--Dosimeters with     IEC 60731-1997
               Ionization Chambers as used in Radiotherapy
         58   Classification of Sealed Radioactive Sources      ANSI/HPS N43.6-1997
         59   Radiotherapy Simulators--Functional Performance   IEC 61168: 1993
               Characteristics--First Edition
         60   Radiotherapy Equipment--Coordinates, Movements,   IEC 1217-1996
               and Scales
----------------------------------------------------------------------------------------------------------------
                                                    Software
----------------------------------------------------------------------------------------------------------------
          4   Software in Programmable Components               ANSI/UL 1998
          5   Standard for Developing Software Life Cycle       IEEE 1074: 1997
               Processes
          6   Standard for Software Verification and            IEEE 1012: 1998
               Validation
----------------------------------------------------------------------------------------------------------------
                                                    Sterility
----------------------------------------------------------------------------------------------------------------
         38   Automatic General Purpose Ethylene Oxide          ANSI/AAMI ST 24: 1999
               Sterilizers and Ethylene Oxide Sterilant
               Sources Intended for Use in Health Care
               Facilities, Third Edition
         39   Biological Indicator for Dry-Heat Sterilization,  USP 24: 2000
               Paper Strip
         40   Biological Indicator for Ethylene Oxide           USP 24: 2000
               Sterilization, Paper Strip
         41   Biological Indicator for Steam Sterilization,     USP 24: 2000
               Paper Strip
         42   Microbial Limits Test 61>                         USP 24: 2000
         43   Microbiological Tests, Sterility Tests 71>        USP 24: 2000
         44   Biological Tests and Assays, Bacterial Endotoxin  USP 24: 2000
               Test (LAL) 85>
         45   Pyrogen Test (USP Rabbit Test) 151>               USP 24: 2000
         46   Sterilization and Sterility Assurance of          USP 24: 2000
               Compendial Articles 1211>
         47   Flash Sterilization: Steam Sterilization of       ANSI/AAMI ST37: 1996
               Patient Care Items for Immediate Use
         48   Table-Top Dry Heat (Heated Air) Sterilization     ANSI/AAMI ST40: 1992/(R) 1998
               and Sterility Assurance in Dental and Medical
               Facilities
         49   Ethylene Oxide Sterilization in Health Care       ANSI/AAMI ST41: 1999
               Facilities: Safety and Effectiveness
         50   Steam Sterilization and Sterility Assurance       ANSI/AAMI ST42: 1998
               Using Table-Top Sterilizers in Office-Based,
               Ambulatory-Care Medical, Surgical, and Dental
               Facilities
         51   Safe Use and Handling of Glutaraldehyde-Based     ANSI/AAMI ST58: 1996
               Products in Health Care Facilities
         52   Biological Indicators Part 1: General             ANSI/AAMI ST59: 1999
               Requirements Sterilization of Health Care
               Products

[[Page 69030]]

 
         53   Sterilization of Health Care Products--Chemical   ANSI/AAMI ST66: 1999
               Indicators--Part 2: Class 2 Indicators for Air
               Removal Test Sheets and Packs
         54   Sterilization of Medical Devices--                ANSI/AAMI/ISO 11737-2: 1998
               Microbiological Methods--Part 2: Tests of
               Sterility Performed in the Validation of a
               Sterilization Process
         55   Sterilization of Single-Use Medical Devices       ANSI/AAMI/ISO 14160: 1998
               Incorporating Materials of Animal Origin--
               Validation and Routine Control of Sterilization
               by Liquid Chemical Sterilants
         56   Standard Test Method for Determination of Leaks   ASTM D3078: 1994
               in Flexible Packaging by Bubble Emission
         57   Standard Practice for Performance Testing of      ASTM D4169: 1999
               Shipping Containers and Systems
         58   Standard Test Method for Seal Strength of         ASTM F88: 1999
               Flexible Barrier Materials
         59   Standard Test Methods for Failure Resistance of   ASTM F1140: 1996
               Unrestrained and Nonrigid Packages for Medical
               Applications
         60   Standard Terminology Relating to Barrier          ASTM F1327: 1998
               Materials for Medical Packaging
         61   Standard Guide for Integrity Testing of Porous    ASTM F1585: 1995
               Barrier Medical Packages
         62   Standard Test Method for Microbial Ranking of     ASTM F1608: 1995
               Porous Packaging Materials (Exposure Chamber
               Method)
         63   Standard Test Method for Determining Integrity    ASTM F1886: 1998
               of Seals for Medical Packaging by Visual
               Inspection
         64   Standard Test Method for Detecting Seal Leaks in  ASTM F1929: 1998
               Porous Medical Packaging by Dye Penetration
         65   Standard Guide for Accelerated Aging of Sterile   ASTM F1980: 1999
               Medical Device Packages
         66   Transfusion and Infusion Assemblies and Similar   USP 24: 2000
               Medical Devices 161>
----------------------------------------------------------------------------------------------------------------


    Dated: October 31, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-29165 Filed 11-14-00; 8:45 am]
BILLING CODE 4160-01-F