[Federal Register Volume 67, Number 9 (Monday, January 14, 2002)]
[Notices]
[Pages 1774-1781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-852]


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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: 006

AGENCY: Food and Drug Administration, HHS.

[[Page 1775]]


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: 006'' (Recognition List Number: 006) will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES: Submit written comments concerning this document 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 ``Modification to the List of Recognized Standards, Recognition List 
Number: 006'' to the Division of Small Manufacturers Assistance (DSMA), 
Center for Devices and Radiological Health (CDRH) (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: 006 
modifications, and other standards related information.

FOR FURTHER INFORMATION CONTACT: To comment on this document and/or to 
recommend additional standards for recognition: Carol L. Herman, Center 
for Devices and Radiological Health (HFZ-84), Food and Drug 
Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4766, 
ext. 156.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended 
section 514 allows FDA to recognize consensus standards, developed by 
international and national organizations, for use in satisfying 
portions of device premarket review submissions or other requirements.
    In a notice published in the Federal Register ofFebruary 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 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); July 12, 1999 (64 FR 37546); November 15, 2000 (65 FR 69022); 
and May 7, 2001 (66 FR 23032), 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: 006

    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: 006'' to identify: (1) Supplementary 
information sheets for standards added to the list for the first time, 
(2) standards added to replace withdrawn standards, (3) still 
recognized standards for which minor revisions are made to clarify the 
application of the standards, and (4) standards withdrawn with no 
replacement.
    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, amended, or different standards.
    In this section, FDA describes: (1) Modifications that involve 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 addition of certain recognized standards with 
revisions to the supplementary information sheets involving changes in 
significant applications of the standards.

A. Anesthesia

    1. In the supplementary information sheet for IEC 60601-3-1:1996-
08, identified under previous item 11, a minor change is made to the 
contact person. This standard remains recognized and identified under 
current item 11.
    2. In the supplementary information sheet for ASTM F1456-92, 
identified under previous item 24, a minor change is made to the 
contact person. This standard remains recognized and identified under 
current item 24.
    3. In the supplementary information sheet for ASTM F1462-93, 
identified under previous item 25, a minor change is made to the 
contact person. This standard remains recognized and identified under 
current item 25.
    4. In the supplementary information sheet for ISO 7767:1997, 
identified under previous item 32, a minor change is made to the 
contact person. This standard remains recognized and identified under 
current item 32.
    5. In the supplementary information sheet for ISO 9918:1993, 
identified under previous item 33, a minor change is made to the 
contact person. This standard remains recognized and identified under 
current item 33.

B. Biocompatibility

    1. ASTM F1904-98 is withdrawn under previous item 44. ASTM F1904-
98e1 is added under current item 52.
    2. ASTM E1372-95 is withdrawn under previous item 33. ASTM E1372-95 
(1999) is added under current item 53.
    3. ISO/AAMI/ANSI 10993-5:1998 is withdrawn under previous item 29. 
ANSI/AAMI/ISO 10993-5:1999 is added under current item 54.
    4. ISO/AAMI/ANSI 10993-6:1995 is withdrawn under previous item 18. 
ANSI/AAMI/ISO 10993-6:1994 is added under current item 55.

C. Cardiovascular/Neurology

    1. ASTM F138-97 is withdrawn under previous item 9. ASTM F138-00 is 
added under current item 34.
    2. ASTM F562-95 is withdrawn under previous item 11. ASTM F562-00 
is added under current item 35.
    3. ASTM F136-98 is withdrawn under previous item 23. ASTM F136-98e1 
is added under current item 36.
    4. IEC 60601-2-23:1993 is withdrawn under previous item 26. IEC 
60601-2-

[[Page 1776]]

23 (1999-12) is added under current item 37.
    5. IEC 60601-2-34 (1994-12) is withdrawn under previous item 27. 
IEC 60601-2-34 (2000-10) is added under current item 38.
    6. ASTM F647-94 is withdrawn under previous item 31. ASTM F647-94 
(2000) is added under current item 39.

D. Dental/ENT

    1. In the supplementary information sheet for ISO 7494:1996, 
identified under previous item 74, a minor change is made to the 
contact person. This standard remains recognized and identified under 
current item 74.
    2. In the supplementary information sheet for ISO 7785-1:1997, part 
1, identified under previous item 75, a minor change is made to the 
contact person. This standard remains recognized and identified under 
current item 75.
    3. In the supplementary information sheet for ISO 7785-2:1995, part 
2, identified under previous item 76, a minor change is made to the 
contact person. This standard remains recognized and identified under 
current item 76.
    4. In the supplementary information sheet for ISO 9168:1991, 
identified under previous item 78, a minor change is made to the 
contact person. This standard remains recognized and identified under 
current item 78.
    5. In the supplementary information sheet for ISO 13294:1997, 
identified under previous item 84, a minor change is made to the 
contact person. This standard remains recognized and identified under 
current item 84.

E. General

    1. IEC 60601-1-1:1992-06 amendment 1, 1995-11 is withdrawn under 
previous item 5. IEC 60601-1-1:2000 is added under current item 27.
    2. IEC 60601-1-2, First Edition 1993-04, is withdrawn under 
previous item 6. IEC 60601-1-2, Second Edition 2001, is added under 
current item 28.
    3. ASTM D-4169/1993 is withdrawn under previous item 17. ASTM D-
4169:1999 was recognized by ``Sterility'' in the November 15, 2001, 
recognition list 004.

F. General Hospital/General Plastic Surgery

    1. In the supplementary information sheet for IEC 60601-2-21, 
identified under previous item 09, a minor change is made to the 
contact person. This standard remains recognized and identified under 
current item 09.
    2. In the supplementary information sheet for IEC 60601-2-38, 
identified under previous item 10, a minor change is made to the 
contact person. This standard remains recognized and identified under 
current item 10.
    3. In the supplementary information sheet for IEC 60601-2-19/1996-
10, identified under previous item 29, the a minor change is made to 
contact person. This standard remains recognized and identified under 
current item 29.
    4. In the supplementary information sheet for IEC 60601-2-20/1996-
10, identified under previous item 32, the a minor change is made to 
contact person. This standard remains recognized and identified under 
current item 32.
    5. ISO 8536-4, First Edition 1987-11-01, is withdrawn under 
previous item 17. ISO 8536-4, Second Edition 1998-02-15, is added under 
current item 75.
    6. ISO 1135-4, First Edition 1987-12-01, is withdrawn under 
previous item 19. ISO 1135-4, Second Edition 1998-03-15, is added under 
current item 76.
    7. ASTM F1862-98 is withdrawn under previous item 36. ASTM F1862-
00a is added under current item 77.
    8. ASTM F1670-97 is withdrawn under previous item 39. ASTM F1670-98 
is added under current item 78.
    9. ISO 594/2, First Edition 1991-05-01, is withdrawn under previous 
item 12. ISO 594-2:1998 is added under current item 79.
    10. ASTM E1112-86 (reapproved 1991) is withdrawn under previous 
item 02. ASTM E1112-00 (reapproved 1991) is added under current item 
80.

G. ObGyn/Gastroenterology

    1. ASTM F1518-94 is withdrawn under previous item 22. ASTM F1518-00 
is added under current item 23.
    2. ASTM F623-89 is withdrawn under previous item 3. ASTM F623-99 is 
added under current item 24.
    3. AAMI HF18-93 is withdrawn under previous item 18. ANSI/AAMI 
HF18-2001 is added under current item 25.

H. Orthopaedic

    1. ASTM F67-95 is withdrawn under previous item 1. ASTM F67-00 is 
added under current item 123.
    2. ASTM F86-91 is withdrawn under previous item 3. ASTM F86-01 is 
added under current item 124.
    3. ASTM F139-96 is withdrawn under previous item 7. ASTM F139-00 is 
added under current item 125.
    4. ASTM F366-82 (R1993) is withdrawn under previous item 8. ASTM 
F366-82 (2000) is added under current item 126.
    5. ASTM F562-95 is withdrawn under previous item 11. ASTM F562-00 
is added under current item 127.
    6. ASTM F604-94 is withdrawn under previous item 15 with no 
replacement. ASTM discontinued it in 2001.
    7. ASTM F688-95 is withdrawn under previous item 20. ASTM F688-00 
is added under current item 128.
    8. ASTM F745-95 is withdrawn under previous item 21. ASTM F745-00 
is added under current item 129.
    9. ASTM F799-96 is withdrawn under previous item 25. ASTM F799-99 
is added under current item 130.
    10. ASTM F1044-95 is withdrawn under previous item 30. ASTM F1044-
99 is added under current item 131.
    11. ASTM F1088-87 (1992) is withdrawn under previous item 31. ASTM 
F1088-87 (1992) e1 is added under current item 132.
    12. ASTM F1108-97 is withdrawn under previous item 34. ASTM F1108-
97a is added under current item 133.
    13. ASTM F1295-97 is withdrawn under previous item 39. ASTM F1295-
97a is added under current item 134.
    14. ASTM F1341-92 is withdrawn under previous item 41. ASTM F1341-
99 is added under current item 135.
    15. ASTM F1472-93 is withdrawn under previous item 44. ASTM F1472-
00 is added under current item 136.
    16. ASTM F1501-95 is withdrawn under previous item 45. ASTM 
discontinued it in 2000. It was replaced with ASTM F1147-99 item 107.
    17. ASTM F1537-94 is withdrawn under previous item 46. ASTM F1537-
00 is added under current item 137.
    18. ASTM F1541-94 is withdrawn under previous item 47. ASTM F1541-
00 is added under current 138.
    19. ASTM F1580-95 is withdrawn under previous item 48. ASTM F1580-
95e1 is added under current item 139.
    20. ASTM F1582-95 is withdrawn under previous item 49. ASTM F1582-
98 is added under current item 140.
    21. ASTM F1612-95 is withdrawn under previous item 52. ASTM F1612-
95 (2000) is added under current item 141.
    22. ASTM F1658-95 is withdrawn under previous item 53. ASTM 
discontinued it in 2000. It was replaced with ASTM F1044-99, item 131.
    23. ASTM F1672-95e1 is withdrawn under previous item 55. ASTM 
F1672-95 (2000) is added under current item 142.
    24. ISO 7153-1:1991 is withdrawn under previous item 77. ISO 7153-
1:1991/amended 1:1999 is added under current item 143.
    25. ASTM F138-97 is withdrawn under previous item 89. ASTM F138-00 
is added under current item 144.
    26. ASTM F565-85 (1996) e1 is withdrawn under previous item 92. 
ASTM F565-00 is added under current item 145.

[[Page 1777]]

    27. ASTM F603-83 (1995) is withdrawn under previous item 94. ASTM 
F603-00 is added under current item 146.
    28. ASTM F1539-95 is withdrawn under previous item 95. ASTM 
discontinued it in 2000. It was replaced with ASTM F564-00, item 156.
    29. ASTM F620-97 is withdrawn under previous item 96. ASTM F620-00 
is added under current item 147.
    30. ASTM F648-98 is withdrawn under previous item 99. ASTM F648-00 
is added under current item 148.
    31. ASTM F746-87 (1994) is withdrawn under previous item 100. ASTM 
F746-87 (1999) is added under current item 149.
    32. ASTM F983-86 (1996) is withdrawn under previous item 102. ASTM 
F983-86 (2000) is added under current item 150.
    33. ASTM F1540-95 is withdrawn under previous item 103. ASTM 
discontinued it in 2000. It was replaced with ASTM F564-00, item 156.
    34. ASTM F1091-91 (1996) is withdrawn under previous item 105. ASTM 
F1091-91 (2000) is added under current item 151.
    35. ASTM F1691-96 is withdrawn under previous item 106. ASTM 
discontinued it in 2001. It was replaced with ASTM F543-01, item 157.
    36. ASTM F1160-98 is withdrawn under previous item 108. ASTM F1160-
00 is added under current item 152.
    37. ASTM F1264-99 is withdrawn under previous item 110. ASTM F1264-
00 is added under current item 153.
    38. ASTM F1350-91 (1996) is withdrawn previous item 112. ASTM 
F1350-91 (2001) is added under current item 154.
    39. ISO 7207-2:1994 is withdrawn under previous item 122. ISO 7207-
2:1998 is added under current item 155.

I. Physical Medicine

    1. ISO 7176-1:1986 is withdrawn under previous item 16. ISO 7176-
1:1999 is added under current item 158.
    2. ISO 7176-2:1990 is withdrawn under previous item 17. ISO 7176-
2:2001 is added under current item 159.
    3. ANSI/RESNA WC/Vol. 2-1998, section 21: Requirements and Test 
Methods for Electromagnetic Compatibility--new item #160.

J. Radiology

    1. AIUM--1994 is withdrawn under previous item 4. AIUM--Medical 
Ultrasound Safety (R1999) is added under current item 66.
    2. In the supplementary information sheet for IEC 60806, identified 
under previous item 6, the title has been changed. This standard 
remains recognized and identified under current item 6.
    3. NEMA MS-1-1988 is withdrawn under previous item 10. NEMA MS-1-
1998 (R2000) is added under current item 67.
    4. NEMA MS-4-1989 is withdrawn under previous item 13. NEMA MS-4 
(R1998) is added under current item 68.
    5. NEMA MS6-2000 is withdrawn under previous item 15. NEMA MS6-2000 
is added under current item 69.
    6. NEMA PS3 (set), DICOM Set is withdrawn under previous item 19. 
NEMA PS3 (set), DICOM Set is added under current item 70.
    7. NEMA UD 2-2998, revision 2 is withdrawn under previous item 20. 
NEMA UD 2-1998 revision 2 is added under current item 71.
    8. NEMA UD 3-1998, revision 1 is withdrawn under previous item 21. 
NEMA UD 3-1998 revision 1 is added under current item 72.
    9. In the supplementary information sheet(s) for IEC 60601-2-19, 
identified under previous item 36, the date has been changed. This 
standard remains recognized and identified under current item 36.
    10. In the supplementary information sheet(s) for AIUM-AOMS, 
identified under previous item 44, the title has been changed. This 
standard remains recognized and identified under current item 44.
    11. In the supplementary information sheet(s) for IEC 61303, 
identified under previous item 49, a minor change is made to the 
Standard Development Organization. This standard remains recognized and 
identified under current item 49.
    12. In the supplementary information sheet(s) for IEC 61145, 
identified under previous item 51, the name of the Standards 
Development Organization has been changed. This standard remains 
recognized and identified under current item 51.
    13. In the supplementary information sheet(s) for UL-544, 
identified under previous item 52, the date has been changed. This 
standard remains recognized and identified under current item 52.
    14. UL-122 is withdrawn under previous item 61. UL-122 (2001) is 
added under current item 73.
    15. NEMA MS-7-1998 is withdrawn under previous item 16. NEMA MS-7-
1998 is added under current item 74.

K. Sterility

    1. AAMI/ANSI ST34:1991 is withdrawn under previous item 15. ANSI/
AAMI/ISO 14161:2000 is added under current item 70.
    2. In the supplementary information sheet for ANSI/AAMI ST24:1999, 
identified under previous item 38, the title and the contact person 
have been changed. This standard remains recognized and identified 
under current item 38.
    3. In the supplementary information sheet for ANSI/AAMI ST37:1996, 
identified under previous item 47, the title and the contact person 
have been changed. This standard remains recognized and identified 
under current item 47.
    4. In the supplementary information sheet for ANSI/AAMI ST41:1999, 
identified under previous item 49, the title and the contact person 
have been changed. This standard remains recognized and identified 
under current item 49.

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 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 
data base 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.

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 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.

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 system at

[[Page 1778]]

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 onthe 
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: 006'' 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: 
006.''
    The recognition of standards announced in this notice of 
modifications will become effective on January 14, 2002.

VII. Listing of New Entries

    The listing of new entries and consensus standards added as 
``Modifications to the List of Recognized Standards,'' under 
Recognition List Number: 006, is as follows:

----------------------------------------------------------------------------------------------------------------
 Item  Number                       Title of Standards                            Reference Number and Date
----------------------------------------------------------------------------------------------------------------
                                                Biocompatibility
----------------------------------------------------------------------------------------------------------------
 
52             Standard Practice for Testing for Biological Responses to    ASTM F1904-98e1
                Particles In Vivo
53             Standard Test Method for Conducting a 90-Day Oral Toxicity   ASTM E1372-95 (1999)
                Study in Rats
54             Biological Evaluation of Medical Devices--Part 5: Tests for  ANSI/AAMI/ISO 10993-5:1999
                Cytotoxicity: In Vitro Methods
55             Biological Evaluation of Medical Device--Part 6: Test for    ANSI/AAMI/ISO 10993-6:1994
                Local Effects After Implantation
----------------------------------------------------------------------------------------------------------------
 
                                            Cardiovascular/Neurology
----------------------------------------------------------------------------------------------------------------
 
34             Standard Specification for Wrought 18 Chromium-14 Nickel-    ASTM F138-00
                2.5 Molybdenum Stainless Steel Bar and Wire for Surgical
                Implants
35             Standard Specification for Wrought Cobalt-35 Nickel-20       ASTM F562-00
                Chromium-10 Molybdenum Alloy for Surgical Implant
                Applications
36             Specification for Wrought Titanium-6 Aluminum-4 Vanadium     ASTM F136-98e1
                ELI (Extra Low Interstital) Alloy (UNS R56401) for
                Surgical Implant Applications
37             Medical Electrical Equipment, Part 2: Particular             IEC 60601-2-23 (1999-12)
                Requirements for the Safety of Transcutaneous Partial
                Pressure Monitoring Equipment
38             Medical Electrical Equipment-Part 2: Partial Requirements    IEC 60601-2-34 (2000-10)
                for the Safety of Direct Blood Pressure Monitoring
                Equipment
39             Standard Practice for Evaluating and Specifying Implantable  ASTM F647-94 (2000)
                Shunt Assemblies for Neurosurgical Application
40             Nonautomated Sphygmomanometers                               ANSI/AAMI SP9:1994
41             Diagnostic Electrocardiographic Devices                      ANSI/AAMI EC11:1991
42             Cardiac Monitors, Heart Rate Meters, and Alarms              ANSI/AAMI EC13:1992
43             Ambulatory Electrocardiographs                               ANSI/AAMI EC38:1998
44             Blood Pressure Transducers                                   ANSI/AAMI BP22:1994
----------------------------------------------------------------------------------------------------------------
                                                     General
----------------------------------------------------------------------------------------------------------------
 
27             Medical Electrical Equipment--Part 1: General Requirements   IEC 60601-1-1:2000
                for Safety; Safety Requirements for Medical Electrical
                Systems
28             Medical Electrical Equipment--Part 1: General Requirements   IEC 60601-1-2, Second Edition, 2001
                for Safety; Electromagnetic Compatibility--Requirements
                and Tests
29             Human Factors Design Process for Medical Devices             ANSI/AAMI HE74-2001
----------------------------------------------------------------------------------------------------------------
 
                                    General Hospital/ General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
 
62             Infusion Equipment for Medical Use--Part 6: Freeze Drying    ISO 8536-6, First Edition, 1996-04-
                Closures for Infusion Bottles                                01
63             Infusion Equipment, Caps Made of Aluminum-Plastic            ISO 8536-7, Second Edition, 1999-09-
                Combinations for Infusion Bottles                            01
64             Infusion Equipment for Medical Use--Part 3: Aluminum Caps    ISO 8536-3, Second Edition, 1999-09-
                for Infusion Bottles                                         01
65             Infusion Equipment for Medical Use--Part 2: Closures for     ISO 8536-2, First Edition, 1992-09-
                Infusion Bottles                                             15
66             Infusion Equipment for Medical Use--Part 1: Infusion Glass   ISO 8536-1, Second Edition, 2000-06-
                Bottles                                                      01
67             Infusion Equipment for Medical Use--Part 5: Burette Type     ISO 8536-5, First Edition, 1992-01-
                Infusion Sets                                                15

[[Page 1779]]

 
68             Sterile Hypodermic Syringes for Single Use--Part 2:          ISO 7886-2, First Edition, 1996-05-
                Syringes for Use With Powder-Driven Syringes Pumps           15
69             Stainless Steel Needle Tubing for Manufacture of Medical     ISO 9626, First Edition, 1991-09-11
                Devices
70             Standard Specification of Phase Change--Type Disposable      ASTM E825-87
                Thermometer for Intermittent Determination of Human
                Temperature
71             Standard Specification of Clinical Thermometers (Maximum     ASTM E667-86
                Self-Registering, Mercury-In-Glass)
72             Sterile, Single-Use Intravascular Catheters--Part 5: Over-   ISO 10555-5, First Edition, 1996-06-
                Needle Peripheral Catheters, Amendment 1                     15
73             Standard Specification for Clinical Thermometers Probe       ASTM E1104-86
                Covers and Sheaths
74             Standard Specification for Clinical Thermometers for         ASTM E1965-98
                Intermittent Determination of Patient Temperature
75             Infusion Equipment for Medical Use--Part 4: Infusion Sets    ISO 8536-4, Second Edition, 1998-02-
                for Single Use, Gravity Feed                                 15
76             Transfusion Equipment for Medical Use--Part 4: Transfusion   ISO 1135-4, Second Edition, 1998-03-
                Sets for Single Use                                          15
77             Standard Test Method for Resistance of Medical Face Masks    ASTM F1862-00a
                to Penetration by Synthetic Blood (Horizontal Projection
                of Fixed Volume at a Known Velocity)
78             Standard Test Method for Resistance of Materials Used in     ASTM F1670-98
                Protective Clothing to Penetration by Synthetic Blood
79             Conical Fittings With a 6 Percent (Luer) Taper for           ISO 594-2:1998
                Syringes, Needles and Certain Other Medical Equipment--
                Part 2: Lock Fittings
80             Standards Specification for Electronic Thermometers for      ASTM E1112-00 (reapproved 1991)
                Intermittent Determination of Patient Temperature
81             Standard Specification for Direct-Reading Liquid Crystal     ASTM E1601-85
                Forehead Thermometers
----------------------------------------------------------------------------------------------------------------
 
                                                In Vitro Devices
----------------------------------------------------------------------------------------------------------------
 
54             Immunoprecipitin Analyses: Procedures for Evaluating the     NCCLS: D12-A2
                Performance of Materials Second Edition; Approved
                Guideline
55             Procedures for the Handling and Processing of Blood          NCCLS: H18-A2
                Specimens; Approved Guideline; Second Edition
56             Methods for Dilution Antimicrobial Susceptibility Tests for  NCCLS: M7-A5
                Bacteria That Grow Aerobiacally; Approved Standard; Fifth
                Edition
57             Performance Standards for Antimicrobial Disk Susceptibility  NCCLS: M2-A7
                Tests; Approved Standard; Seventh Edition
58             Procedures for the Collection of Arterial Blood Specimens;   NCCLS: H1-A3
                Approved Standard
59             Laboratory Automation: Bar Codes for Specimen Container      NCCLS: AUTO2-A
                Identification; Approved Standard
60             Laboratory Automation: Specimen Container/Specimen Carrier;  NCCLS: AUTO1-A
                Approved Standard
61             Laboratory Automation: Communications With Automated         NCCLS: AUTO3-A
                Clinical Laboratory Systems, Instruments, Devices, and
                Information Systems; Approved Standard
----------------------------------------------------------------------------------------------------------------
 
                                     Obstetrics-Gynecology/Gastroenterology
----------------------------------------------------------------------------------------------------------------
 
23             Standard Practice For Cleaning and Disinfection of Flexible  ASTM F1518-00
                Fiberoptic and Video Endoscopes Used in the Examination of
                Hollow Viscera
24             Standard Performance Specifications for Foley Catheters      ASTM F623-99
25             Electrosurgical Devices                                      ANSI/AAMI HF18-2001
----------------------------------------------------------------------------------------------------------------
 
                                                   Ophthalmic
----------------------------------------------------------------------------------------------------------------
 
27             Ophthalmic Implants--Intraocular Lenses--Part 7: Clinical    ISO 11979-7:2001
                Investigations
28             Ophthalmic Optics--Contact Lens Care Products--              ISO 14729:2001
                Microbiological Requirements and Test Methods for Products
                and Regimens for Hygienic Management of Contact Lenses
29             Ophthalmic Optics--Contact Lens Care Products--              ISO 14730:2000
                Antimicrobial Preservative Efficacy Testing and Guidance
                on Determining Discard Date
----------------------------------------------------------------------------------------------------------------
 
                                                   Orthopaedic
----------------------------------------------------------------------------------------------------------------
 
123            Standard Specification for Unalloyed Titanium for Surgical   ASTM F67-00
                Implant Applications (UNS R50250, UNS R50400, UNS R50550,
                UNS R50700)
124            Standard Practice for Surface Preparation and Marking of     ASTM F86-01
                Metallic Surgical Implants
125            Standard Specification for Wrought-18 Chromium-14 Nickel-    ASTM F139-00
                2.5 Molybdenum Stainless Sheet and Strip for Surgical
                Implants
125            Standard Specification for Wrought-18 Chromium-14 Nickel-    ASTM F139-00
                2.5 Molybdenum Stainless Sheet and Strip for Surgical
                Implants
126            Standard Specification for Fixation Pins and Wires           ASTM F366-82 (2000)
127            Standard Specification for Wrought Cobalt-35 Nickel-20       ASTM F562-00
                Chromium-10 Molybdenum Alloy for Surgical Implant
                Applications
128            Standard Specification for Wrought Cobalt-35 Nickel-20       ASTM F688-00
                Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for
                Surgical Implants (UNS R30035)
129            Standard Specification for 18 Chromium-12.5 Molybdenum       ASTM F745-00
                Stainless Steel for Cast and Solution-Annealed Surgical
                Implant Applications
130            Standard Specification for Cobalt-28 Chromium-6 Molybdenum   ASTM F799-99
                Alloy Forgings for Surgical Implants (UNS R31537, R31538,
                R31539)
131            Standard Test Method for Shear Testing of Calcium Phosphate  ASTM F1044-99
                Coatings and Metallic Coatings
132            Standard Specification for Beta-Tricalcium Phosphate for     ASTM F1088-87 (1992) e1
                Surgical Implantation
133            Standard Specification for Ti6A14V Alloy Castings for        ASTM F1108-97a
                Surgical Implants (UNS R56406)
134            Standard Specification for Wrought Titanium-6 Aluminum-7     ASTM F1295-97a
                Niobium Alloy for Surgical Implant Applications (UNS
                R56700)
135            Standard Specification for Unalloyed Titanium Wire UNS       ASTM F1341-99
                R50250, UNS R50400, UNS R50550, UNS R50700 for Surgical
                Implant Applications
136            Standard Specification for Wrought Titanium-6Aluminum-       ASTM F1472-00
                4Vanadium Alloy for Surgical Implant Applications

[[Page 1780]]

 
137            Standard Specification for Wrought Cobalt-28-Chromium-6-     ASTM F1537-000
                Molybdenum Alloy for Surgical Implants (UNS R31537, UNS
                R31538, and UNS R31539)
138            Standard Specification and Test Methods for External         ASTM F1541-00
                Skeletal Fixation Devices
139            Standard Specification for Titanium and Titanium-6 Percent   ASTM F1580-95e1
                Aluminum-4 Percent Vanadium Alloy Powders for Coatings of
                Surgical Implants
140            Standard Terminology Relating to Spinal Implants             ASTM F1582-98
141            Standard Practice for Cyclic Fatigue Testing of Metallic     ASTM F1612-95 (2000)
                Stemmed Hip Arthroplasty Femoral Components with Torsion
142            Standard Specification for Resurfacing Patellar Prosthesis   ASTM F1672-95 (2000)
143            Surgical Instruments--Metallic Materials--Part 1: Stainless  ISO 7153-1:1991/Amd.1:1999
                Steel
144            Standard Specification for Wrought 18 Chromium-14 Nickel-    ASTM F138-00
                2.5 Molybdenum Stainless Steel Bar and Wire for Surgical
                Implants (UNS S31673)
145            Standard Practice for Care and Handling of Orthopedic        ASTM F565-00
                Implants and Instruments
146            Standard Specification for High-Purity Dense Aluminum Oxide  ASTM F603-00
                for Surgical Implant Application
147            Standard Specification for Alpha Plus Beta Titanium Alloy    ASTM F620-00
                Forgings for Surgical Implants
148            Standard Specification for Ultra-High-Molecular-Weight       ASTM F648-00
                Polyethylene Powder and Fabricated Form for Surgical
                Implants
149            Standard Test Method for Pitting or Crevice Corrosion of     ASTM F746-87 (1999)
                Metallic Surgical Implant Materials
150            Standard Practice for Permanent Marking of Orthopaedic       ASTM F983-86 (2000)
                Implant Components
151            Standard Specification for Wrought Cobalt-Chromium Alloy     ASTM F1091-91 (2000)
                Surgical Fixation Wire
152            Standard Test Method for Shear and Bending Fatigue Testing   ASTM F1160-00
                of Calcium Phosphate and Metallic Medical and Composite
                Calcium Phosphate/Metallic Coatings
153            Standard Specification and Test Methods for Intramedullary   ASTM F1264-00
                Fixation Devices
154            Standard Specification for Wrought 18 Chromium-14 Nickel-    ASTM F1350-91 (2000)
                2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS
                S31673)
155            Implants for Surgery--Components for Partial and Total Knee  ISO 7207-2:1998
                Joint Prostheses--Part 2: Articulating Surfaces Made of
                Metal, Ceramic and Plastics
156            Standard Specification and Test Methods for Metallic Bone    ASTM F564-00
                Staples
157            Standard Specification and Test Methods for Metallic         ASTM F543-01
                Medical Bone Screws
----------------------------------------------------------------------------------------------------------------
 
                                                Physical Medicine
----------------------------------------------------------------------------------------------------------------
 
158            Wheelchairs--Part 1: Determination of Static Stability       ISO 7176-1:1999
159            Wheelchairs--Part 2: Determination of Dynamic Stability of   ISO 7176-2:2001
                Electric Wheelchairs
160            Requirements and Test Methods for Electromagnetic            ANSI/RESNA WC/Vol.2-1998, Section 21
                Compatibility
 
                                                    Radiology
----------------------------------------------------------------------------------------------------------------
 
63             Medical Electrical Equipment--Part 2-43: Particular          IEC 60601-2-43-Ed. 1.0
                Requirements for the Safety of X-ray Equipment for
                Interventional Procedures
64             Medical Electrical Equipment--Part 2-45: Particular          IEC 60601-2-45-Ed. 20
                Requirements for the Safety of Mammographic X-ray
                Equipment and Mammographic Stereotatic Devices
65             Standard Test Method for Measurement of Magnetically         ASTM F2052-00
                Induced Displacment Force on Passive Implants in the
                Magnetic Resonance Environment
66             Medical Ultrasound Safety (R1999)                            AIUM
67             Determination of Signal to Noise Ratio (SNR) in Diagnostic   NEMA MS-1 (R-2000)
                Magnetic Resonance Images
68             Acoustic Noise Measurement Procedure for Diagnostic          NEMA MS-4 (R1998)
                Magnetic Resonance Imaging Device
69             Characterization of Special Purpose Coils for Diagnostic     NEMA MS6-2000
                Magnetic Resonance Images
70             Digital Imaging and Communications in Medicine-Set Includes  NEMA PS3 (Set), DICOM Set
                PS3.1 Through PS3.14
71             Acoustic Output Measurement Standard for Diagnostic          NEMA UD 2-1998 (revision 2)
                Ultrasound Equipment
72             Standard for Real Time Display of Thermal and Mechanical     NEMA UD 3-1998 (revision 1)
                Acoustic Output Indices on Diagnostic Ultrasound Equipment
73             Medical Electrical Equipment: Radionuclide Calibrators--     IEC 61303 (1994-10)
                Particular Methods for Describing Performance Calibration
                and Usage of Ionization
74             Calibration and Usage of Ionization Chamber Systems for      IEC 61145 (1992-05)
                Assay of Radionuclides
75             Standard for Safety of Photographic Equipment--Fourth        UL-122 (2001)
                Edition
76             Measurement Procedure for Time-Varying Gradient Fields (dB/  NEMA MS7-1998
                dt) for Magnetic Resonance Imaging Systems
 
                                                    Software
----------------------------------------------------------------------------------------------------------------
 
7              Medical Device Software--Software Life Cycle Processes       ANSI/AAMI SW68:2001
----------------------------------------------------------------------------------------------------------------
 
                                                    Sterility
----------------------------------------------------------------------------------------------------------------
 
70             Sterilization of Health Care Products--Biological            ANSI/AAMI/ISO 14161-2000
                Indicators--Guidance for the Selection, Use and
                Interpretation of Results, Second Edition
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------



[[Page 1781]]

    Dated: December 18, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-852 Filed 1-11-02; 8:45 am]
BILLING CODE 4160-01-S