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Notice

FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 006

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

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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 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.

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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.

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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 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-Start Printed Page 177623 (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.Start Printed 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 Start Printed Page 1778800-899-0381 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: 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 ­NumberTitle of StandardsReference Number and Date
Biocompatibility
52Standard Practice for Testing for Biological Responses to Particles In VivoASTM F1904-98e1
53Standard Test Method for Conducting a 90-Day Oral Toxicity Study in RatsASTM E1372-95 (1999)
54Biological Evaluation of Medical Devices—Part 5: Tests for Cytotoxicity: In Vitro MethodsANSI/AAMI/ISO 10993-5:1999
55Biological Evaluation of Medical Device—Part 6: Test for Local Effects After ImplantationANSI/AAMI/ISO 10993-6:1994
Cardiovascular/Neurology
34Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical ImplantsASTM F138-00
35Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy for Surgical Implant ApplicationsASTM F562-00
36Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstital) Alloy (UNS R56401) for Surgical Implant ApplicationsASTM F136-98e1
37Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of Transcutaneous Partial Pressure Monitoring EquipmentIEC 60601-2-23 (1999-12)
38Medical Electrical Equipment-Part 2: Partial Requirements for the Safety of Direct Blood Pressure Monitoring EquipmentIEC 60601-2-34 (2000-10)
39Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical ApplicationASTM F647-94 (2000)
40Nonautomated SphygmomanometersANSI/AAMI SP9:1994
41Diagnostic Electrocardiographic DevicesANSI/AAMI EC11:1991
42Cardiac Monitors, Heart Rate Meters, and AlarmsANSI/AAMI EC13:1992
43Ambulatory ElectrocardiographsANSI/AAMI EC38:1998
44Blood Pressure TransducersANSI/AAMI BP22:1994
General
27Medical Electrical Equipment—Part 1: General Requirements for Safety; Safety Requirements for Medical Electrical SystemsIEC 60601-1-1:2000
28Medical Electrical Equipment—Part 1: General Requirements for Safety; Electromagnetic Compatibility—Requirements and TestsIEC 60601-1-2, Second Edition, 2001
29Human Factors Design Process for Medical DevicesANSI/AAMI HE74-2001
General Hospital/ General Plastic Surgery
62Infusion Equipment for Medical Use—Part 6: Freeze Drying Closures for Infusion BottlesISO 8536-6, First Edition, 1996-04-01
63Infusion Equipment, Caps Made of Aluminum-Plastic Combinations for Infusion BottlesISO 8536-7, Second Edition, 1999-09-01
64Infusion Equipment for Medical Use—Part 3: Aluminum Caps for Infusion BottlesISO 8536-3, Second Edition, 1999-09-01
65Infusion Equipment for Medical Use—Part 2: Closures for Infusion BottlesISO 8536-2, First Edition, 1992-09-15
66Infusion Equipment for Medical Use—Part 1: Infusion Glass BottlesISO 8536-1, Second Edition, 2000-06-01
67Infusion Equipment for Medical Use—Part 5: Burette Type Infusion SetsISO 8536-5, First Edition, 1992-01-15
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68Sterile Hypodermic Syringes for Single Use—Part 2: Syringes for Use With Powder-Driven Syringes PumpsISO 7886-2, First Edition, 1996-05-15
69Stainless Steel Needle Tubing for Manufacture of Medical DevicesISO 9626, First Edition, 1991-09-11
70Standard Specification of Phase Change—Type Disposable Thermometer for Intermittent Determination of Human TemperatureASTM E825-87
71Standard Specification of Clinical Thermometers (Maximum Self-Registering, Mercury-In-Glass)ASTM E667-86
72Sterile, Single-Use Intravascular Catheters—Part 5: Over-Needle Peripheral Catheters, Amendment 1ISO 10555-5, First Edition, 1996-06-15
73Standard Specification for Clinical Thermometers Probe Covers and SheathsASTM E1104-86
74Standard Specification for Clinical Thermometers for Intermittent Determination of Patient TemperatureASTM E1965-98
75Infusion Equipment for Medical Use—Part 4: Infusion Sets for Single Use, Gravity FeedISO 8536-4, Second Edition, 1998-02-15
76Transfusion Equipment for Medical Use—Part 4: Transfusion Sets for Single UseISO 1135-4, Second Edition, 1998-03-15
77Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)ASTM F1862-00a
78Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic BloodASTM F1670-98
79Conical Fittings With a 6 Percent (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment—Part 2: Lock FittingsISO 594-2:1998
80Standards Specification for Electronic Thermometers for Intermittent Determination of Patient TemperatureASTM E1112-00 (reapproved 1991)
81Standard Specification for Direct-Reading Liquid Crystal Forehead ThermometersASTM E1601-85
In Vitro Devices
54Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials Second Edition; Approved GuidelineNCCLS: D12-A2
55Procedures for the Handling and Processing of Blood Specimens; Approved Guideline; Second EditionNCCLS: H18-A2
56Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobiacally; Approved Standard; Fifth EditionNCCLS: M7-A5
57Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard; Seventh EditionNCCLS: M2-A7
58Procedures for the Collection of Arterial Blood Specimens; Approved StandardNCCLS: H1-A3
59Laboratory Automation: Bar Codes for Specimen Container Identification; Approved StandardNCCLS: AUTO2-A
60Laboratory Automation: Specimen Container/Specimen Carrier; Approved StandardNCCLS: AUTO1-A
61Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved StandardNCCLS: AUTO3-A
Obstetrics-Gynecology/Gastroenterology
23Standard Practice For Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of Hollow VisceraASTM F1518-00
24Standard Performance Specifications for Foley CathetersASTM F623-99
25Electrosurgical DevicesANSI/AAMI HF18-2001
Ophthalmic
27Ophthalmic Implants—Intraocular Lenses—Part 7: Clinical InvestigationsISO 11979-7:2001
28Ophthalmic Optics—Contact Lens Care Products—Microbiological Requirements and Test Methods for Products and Regimens for Hygienic Management of Contact LensesISO 14729:2001
29Ophthalmic Optics—Contact Lens Care Products—Antimicrobial Preservative Efficacy Testing and Guidance on Determining Discard DateISO 14730:2000
Orthopaedic
123Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)ASTM F67-00
124Standard Practice for Surface Preparation and Marking of Metallic Surgical ImplantsASTM F86-01
125Standard Specification for Wrought-18 Chromium-14 Nickel-2.5 Molybdenum Stainless Sheet and Strip for Surgical ImplantsASTM F139-00
125Standard Specification for Wrought-18 Chromium-14 Nickel-2.5 Molybdenum Stainless Sheet and Strip for Surgical ImplantsASTM F139-00
126Standard Specification for Fixation Pins and WiresASTM F366-82 (2000)
127Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy for Surgical Implant ApplicationsASTM F562-00
128Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)ASTM F688-00
129Standard Specification for 18 Chromium-12.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant ApplicationsASTM F745-00
130Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)ASTM F799-99
131Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic CoatingsASTM F1044-99
132Standard Specification for Beta-Tricalcium Phosphate for Surgical ImplantationASTM F1088-87 (1992) e1
133Standard Specification for Ti6A14V Alloy Castings for Surgical Implants (UNS R56406)ASTM F1108-97a
134Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)ASTM F1295-97a
135Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700 for Surgical Implant ApplicationsASTM F1341-99
136Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant ApplicationsASTM F1472-00
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137Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)ASTM F1537-000
138Standard Specification and Test Methods for External Skeletal Fixation DevicesASTM F1541-00
139Standard Specification for Titanium and Titanium-6 Percent Aluminum-4 Percent Vanadium Alloy Powders for Coatings of Surgical ImplantsASTM F1580-95e1
140Standard Terminology Relating to Spinal ImplantsASTM F1582-98
141Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with TorsionASTM F1612-95 (2000)
142Standard Specification for Resurfacing Patellar ProsthesisASTM F1672-95 (2000)
143Surgical Instruments—Metallic Materials—Part 1: Stainless SteelISO 7153-1:1991/Amd.1:1999
144Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)ASTM F138-00
145Standard Practice for Care and Handling of Orthopedic Implants and InstrumentsASTM F565-00
146Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant ApplicationASTM F603-00
147Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical ImplantsASTM F620-00
148Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsASTM F648-00
149Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsASTM F746-87 (1999)
150Standard Practice for Permanent Marking of Orthopaedic Implant ComponentsASTM F983-86 (2000)
151Standard Specification for Wrought Cobalt-Chromium Alloy Surgical Fixation WireASTM F1091-91 (2000)
152Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic CoatingsASTM F1160-00
153Standard Specification and Test Methods for Intramedullary Fixation DevicesASTM F1264-00
154Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)ASTM F1350-91 (2000)
155Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and PlasticsISO 7207-2:1998
156Standard Specification and Test Methods for Metallic Bone StaplesASTM F564-00
157Standard Specification and Test Methods for Metallic Medical Bone ScrewsASTM F543-01
Physical Medicine
158Wheelchairs—Part 1: Determination of Static StabilityISO 7176-1:1999
159Wheelchairs—Part 2: Determination of Dynamic Stability of Electric WheelchairsISO 7176-2:2001
160Requirements and Test Methods for Electromagnetic CompatibilityANSI/RESNA WC/Vol.2-1998, Section 21
Radiology
63Medical Electrical Equipment—Part 2-43: Particular Requirements for the Safety of X-ray Equipment for Interventional ProceduresIEC 60601-2-43-Ed. 1.0
64Medical Electrical Equipment—Part 2-45: Particular Requirements for the Safety of Mammographic X-ray Equipment and Mammographic Stereotatic DevicesIEC 60601-2-45-Ed. 20
65Standard Test Method for Measurement of Magnetically Induced Displacment Force on Passive Implants in the Magnetic Resonance EnvironmentASTM F2052-00
66Medical Ultrasound Safety (R1999)AIUM
67Determination of Signal to Noise Ratio (SNR) in Diagnostic Magnetic Resonance ImagesNEMA MS-1 (R-2000)
68Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging DeviceNEMA MS-4 (R1998)
69Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance ImagesNEMA MS6-2000
70Digital Imaging and Communications in Medicine-Set Includes PS3.1 Through PS3.14NEMA PS3 (Set), DICOM Set
71Acoustic Output Measurement Standard for Diagnostic Ultrasound EquipmentNEMA UD 2-1998 (revision 2)
72Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound EquipmentNEMA UD 3-1998 (revision 1)
73Medical Electrical Equipment: Radionuclide Calibrators—Particular Methods for Describing Performance Calibration and Usage of IonizationIEC 61303 (1994-10)
74Calibration and Usage of Ionization Chamber Systems for Assay of RadionuclidesIEC 61145 (1992-05)
75Standard for Safety of Photographic Equipment—Fourth EditionUL-122 (2001)
76Measurement Procedure for Time-Varying Gradient Fields (dB/dt) for Magnetic Resonance Imaging SystemsNEMA MS7-1998
Software
7Medical Device Software—Software Life Cycle ProcessesANSI/AAMI SW68:2001
Sterility
70Sterilization of Health Care Products—Biological Indicators—Guidance for the Selection, Use and Interpretation of Results, Second EditionANSI/AAMI/ISO 14161-2000
Start Signature
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Dated: December 18, 2001.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

End Signature End Supplemental Information

[FR Doc. 02-852 Filed 1-11-02; 8:45 am]

BILLING CODE 4160-01-S