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Notice

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

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA 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: Start Printed Page 69023004,” 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.

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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.

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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 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. Start Printed 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. Start Printed 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 Start Printed 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 NumberTitle of StandardReference Number and Date
Biocompatibility
37Standard Practice for the In Vitro Rat Hepatocyte DNA Repair AssayASTM E1397-91 (1998)
38Standard Practice for the In Vivo Rat Hepatocyte DNA Repair AssayASTM E1398-91 (1998)
39Standard Practice for Selecting Generic Biological Test Methods for Materials and DevicesASTM F748-98
40Standard Practice for Short-Term Screening of Implant MaterialsASTM F763-99
41Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and BoneASTM F981-99
42Standard Practice for Testing for Whole Complement Activation in Serum by Solid MaterialsASTM F1984-99
43Standard Practice for Testing for Biological Responses to Particles In VitroASTM F1903-98
44Standard Practice for Testing for Biological Responses to Particles In VivoASTM F1904-98
45Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant ApplicationsASTM F1983-99
46Biological Reactivity Test, In Vitro—Direct Contact TestUSP 24 Biological Tests <87>
47Biological Reactivity Test, In Vitro—Elution TestUSP 24 Biological Tests <87>
48Biological Reactivity Test, In Vivo—Procedure—Preparation of SampleUSP 24 Biological Test <88>
49Biological Reactivity Test, In Vivo—Intracutaneous TestUSP 24 Biological Tests <88>
50Biological Reactivity Tests, In Vivo—Systemic Injection TestUSP 24 Biological Test <88>
51Biological Evaluation of Medical Devices—Part 1: Evaluation and TestingANSI/AAMI/ISO 10993-1 (1997)
Cardiovascular/ Neurology
25Cardiac Defibrillators—Connector Assembly for Implantable Defibrillators-Dimensional and Test RequirementsISO 11318-93/Amendment 1:1996 (E)
26Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of Transcutaneous Partial Pressure Monitoring EquipmentIEC 60601-2-23: 1993
27Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of Direct Blood Pressure Monitoring EquipmentIEC 60601-2-34 (1994-12)
28Standard Specification for Wrought Cobalt-Chromium-Nickel-Molybdenum-Iron Alloys for Surgical Implant Applications (UNS R30003 and UNS R30008)ASTM F1058-97
29Medical Electrical Equipment, Part 2: Particular Requirements for the Safety, Including Essential Performance, of Automatic Cycling Non-Invasive Blood Pressure Monitoring EquipmentIEC 60601-2-30: 1999-12
30Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of ElectrocardiographsIEC 60601-2-25 Amendment 1 (1999)
Dental/ ENT
85Synthetic Resin TeethANSI/ADA Specification No. 15: 1999
86Metal-Ceramic SystemsANSI/ADA Specification No. 38: 2000
87Dental CeramicANSI/ADA Specification No. 69: 1999
88Endodontic Obturating PointsANSI/ADA Specification No. 78: 2000
89Polymer-Based Crown and Bridge ResinsANSI/ADA Specification No. 53: 1999
90Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)ANSI/ASA S3.39: 1996
General (Generally Applicable)
22General Tolerances—Part 1: Tolerances for Linear and Angular Dimensions Without Individual Tolerance IndicationsISO 2768-1 (1989)
23General Tolerances—Part 2: Geometrical Tolerances for Features Without Individual Tolerance IndicationsISO 2768-2 (1989)
24Analysis Techniques for System Reliability—Procedure for Failure Modes and Effects Analysis (FMEA)IEC 60812 (1985)
Start Printed Page 69027
General Plastic Surgery/ General Hospital
46Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of High Frequency Surgical EquipmentIEC 60601-2-2: Third Edition 1998-09
47Standard Test Method for Analysis of Protein in Natural Rubber and its Products Using the Modified Lowry MethodASTM D5712-99
48Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and its ProductsASTM D6499-00
49Standard Test Method for Human Repeat Insult Patch Testing or Medical GlovesASTM D6355-98
50Standard Specification for Nitrile Examination Gloves for Medical ApplicationASTM D6319-00
51Standard Test Method for Residual Powder on Medical GlovesASTM D6124-00
52Standard Specification for Poly (Vinyl Chloride) Gloves for Medical ApplicationASTM D5250-00
53Standard Test Method for Detection of Holes in Medical GlovesASTM D5151-99
54Standard Specification for Rubber Examination GlovesASTM D3578-00
55Standard Specification for Rubber Surgical GlovesASTM D3577-00
56Sterile Sodium Chloride For IrrigationUSP 24 <11>
57Sterile Water for InjectionUSP 24 <11>
58Absorbable Surgical SuturesUSP 24
59Tensile StrengthUSP 24
60Sutures—DiametersUSP 24 <861>
61Sutures Needle AttachmentUSP 24 <871>
OB GYN/ Gastroenterology
19Optical and Optical Instruments—Medical Endoscopes and Endoscopic Accessories—Part 1: General RequirementsISO 8600-1: 1997
20Optical and Optical Instruments—Medical Endoscopes and Endoscopic Accessories—Part 3: Determination of Field of View and Direction of View of Endoscopes with OpticsISO 8600-3: 1997
21Optical and Optical Instruments—Medical Endoscopes and Certain Accessories—Part 4: Determination of Maximum Width of Insertion PortionISO 8600-4: 1997
22Standard Practice for Cleaning and Disinfecting of Flexible Fiberoptic and Video Endoscopes Used in the Examination of Hollow VisceraASTM F1518-94
Ophthalmic
15Optics and Optical Instruments—Determination of Biological Compatibility of Contact Lens Material—Testing of the Contact Lens System by Ocular Study with Rabbit EyesISO 9394-1998
16Optics and Optical Instruments—Contact Lenses—Part 2: Determination of Oxygen Permeability and Transmissibility by the Coulometeric MethodISO 9913-2: 2000
17Optics and Optical Instruments—Ophthalmic Instruments—Slit-Lamp MicroscopesISO 10939: 1998
18Optics and Optical Instruments—Ophthalmic Instruments—Indirect OphthalmoscopesISO 10943: 1999
19Ophthalmic Optics—Contact Lenses—Classification of Contact Lenses and Contact Lens MaterialsISO 11539: 1999
20Ophthalmic Implants—Intraocular Lenses—Part 1: VocabularyISO 11979-1: 1999
21Ophthalmic Implants—Intraocular Lenses—Part 2: Optical Properties and Tests MethodsISO 11979-2: 2000
22Ophthalmic Implants—Intraocular Lenses—Part 3: Mechanical Properties and Test MethodsISO 11979-3: 1999
23Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Determination of Physical Compatibility of Contact Lens Care Products with Contact LensesISO 11981-1999
24Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Guidelines for Determination of Preservative Uptake and ReleaseISO 11986: 1999
25Optics and Optical Instruments—Ophthalmic Instruments—RetinoscopesISO 12865: 1998
26Ophthalmic Optics—Contact Lens Care Products—Guidelines for Determination of Shelf-LifeISO 13212: 1999
Start Printed Page 69028
Orthopaedics
86Standard Specification for Cobalt-28 Chromium-6 Molybdenum Casting Alloy and Cast Products for Surgical Implants (UNS R30075)ASTM F75-98
87Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)ASTM F90-97
88Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (R56401) for Surgical Implant ApplicationsASTM F136-98
89Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire For Surgical Implants (UNS S31673)ASTM F138-97
90Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R 05200, UNS R05400)ASTM F560-98
91Recommended Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated TissuesASTM F561-97
92Standard Practice for Care and Handling of Orthopedic Implants and InstrumentsASTM F 565-85 (1996) (e1)
93Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsASTM F601-98
94Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant ApplicationASTM F603-83 (1995)
95Standard Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone StaplesASTM F1539-95
96Standard Specification for Titanium-6 Aluminum-4 Vanadium ELI Alloy Forgings for Surgical Implants (UNS R56401)ASTM F620-97
97Standard Specification for Stainless Steel Forgings for Surgical ImplantsASTM F621-97
98Standard Practice for Radiography of Cast Metallic Surgical ImplantsASTM F629-97
99Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsASTM F648-98
100Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsASTM F746-87 (1994)
101Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and ScrewsASTM F897-84 (1997)
102Standard Practice for Permanent Marking of Orthopaedic Implant ComponentsASTM F983-86 (1996)
103Standard Test Method for Pull-Out Fixation Strength of Metallic Bone StaplesASTM F1540-95
104Standard Test Method for Corrosion of Surgical InstrumentsASTM F1089-87 (1994)
105Standard Specification for Wrought Cobalt-Chromium Alloy Surgical Fixation WireASTM F1091-91 (1996) E01
106Standard Test Method for Determining Axial Pull-Out Strength of Medical Bone ScrewsASTM F1691-96
107Standard Test Method for Tension Testing of Calcium Phosphate and Metallic CoatingsASTM F1147-99
108Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical CoatingsASTM F1160-98
109Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical ImplantsASTM F1185-88 (1993) E01
110Standard Specification and Test Methods for Intramedullary Fixation DevicesASTM F1264-99
111Standard Guide for Evaluating Modular Hip and Knee Joint ComponentsASTM F1814-97a
112Standard Specification for Stainless Steel Surgical Fixation WireASTM F1350-91 (1996) E01
113Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)ASTM F1377-98a
114Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis ImplantsASTM F1798-97
115Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint ReplacementsASTM F1800-97
116Standard Practice for Corrosion Fatigue Testing of Metallic Implant MaterialsASTM F1801-97
117Implants for Surgery—Metallic Materials—Part 2: Unalloyed TitaniumISO 5832-2:1999
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118Implants for Surgery—Metallic Materials—Part 9: Wrought High Nitrogen Stainless SteelISO 5832-9: 1995
119Implants for Surgery—Ultra-high-Molecular-Weight Polyethylene—Part 2: Moulded FormsISO 5834-2: 1998
120Standard Specification and Test Method for Metallic Bone PlatesASTM F0382-99
121Implants for Surgery—Femoral and Tibial Components for Partial and Total Knee Joint Prosthesis—Part 1: Classification, Definitions and Designation of Dimensions—Second EditionISO 7207-1: 1994
122Implants for Surgery—Components for Partial and Total Knee Joint Prosthesis—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastics MaterialsISO 7207-2: 1994
Radiology
50Standard for Safety of Photographic Equipment—Fourth EditionUL-122
51Standard for Safety: X-ray Equipment—Seventh EditionUL-187
52Standard for Safety: Medical and Dental Equipment—Fourth EditionUL-544
53Radiation Protection—Sealed Radioactive Sources—General Requirements and ClassificationISO 2919 (1999)
54Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Therapeutic X-ray Equipment Operating in the Range 10kV to 1MVIEC 60601-2-8 (1999-04)
55Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Radiotherapy SimulatorsIEC 60601-2-29 (1999-01)
56Medical Electrical Equipment—Dosimeters with Ionization Chambers and/or Semi-Conductor Detectors as used in X-ray Diagnostic ImagingIEC 61674-1997
57Medical Electrical Equipment—Dosimeters with Ionization Chambers as used in RadiotherapyIEC 60731-1997
58Classification of Sealed Radioactive SourcesANSI/HPS N43.6-1997
59Radiotherapy Simulators—Functional Performance Characteristics—First EditionIEC 61168: 1993
60Radiotherapy Equipment—Coordinates, Movements, and ScalesIEC 1217-1996
Software
4Software in Programmable ComponentsANSI/UL 1998
5Standard for Developing Software Life Cycle ProcessesIEEE 1074: 1997
6Standard for Software Verification and ValidationIEEE 1012: 1998
Sterility
38Automatic General Purpose Ethylene Oxide Sterilizers and Ethylene Oxide Sterilant Sources Intended for Use in Health Care Facilities, Third EditionANSI/AAMI ST 24: 1999
39Biological Indicator for Dry-Heat Sterilization, Paper StripUSP 24: 2000
40Biological Indicator for Ethylene Oxide Sterilization, Paper StripUSP 24: 2000
41Biological Indicator for Steam Sterilization, Paper StripUSP 24: 2000
42Microbial Limits Test <61>USP 24: 2000
43Microbiological Tests, Sterility Tests <71>USP 24: 2000
44Biological Tests and Assays, Bacterial Endotoxin Test (LAL) <85>USP 24: 2000
45Pyrogen Test (USP Rabbit Test) <151>USP 24: 2000
46Sterilization and Sterility Assurance of Compendial Articles <1211>USP 24: 2000
47Flash Sterilization: Steam Sterilization of Patient Care Items for Immediate UseANSI/AAMI ST37: 1996
48Table-Top Dry Heat (Heated Air) Sterilization and Sterility Assurance in Dental and Medical FacilitiesANSI/AAMI ST40: 1992/(R) 1998
49Ethylene Oxide Sterilization in Health Care Facilities: Safety and EffectivenessANSI/AAMI ST41: 1999
50Steam Sterilization and Sterility Assurance Using Table-Top Sterilizers in Office-Based, Ambulatory-Care Medical, Surgical, and Dental FacilitiesANSI/AAMI ST42: 1998
51Safe Use and Handling of Glutaraldehyde-Based Products in Health Care FacilitiesANSI/AAMI ST58: 1996
52Biological Indicators Part 1: General Requirements Sterilization of Health Care ProductsANSI/AAMI ST59: 1999
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53Sterilization of Health Care Products—Chemical Indicators—Part 2: Class 2 Indicators for Air Removal Test Sheets and PacksANSI/AAMI ST66: 1999
54Sterilization of Medical Devices—Microbiological Methods—Part 2: Tests of Sterility Performed in the Validation of a Sterilization ProcessANSI/AAMI/ISO 11737-2: 1998
55Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin—Validation and Routine Control of Sterilization by Liquid Chemical SterilantsANSI/AAMI/ISO 14160: 1998
56Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble EmissionASTM D3078: 1994
57Standard Practice for Performance Testing of Shipping Containers and SystemsASTM D4169: 1999
58Standard Test Method for Seal Strength of Flexible Barrier MaterialsASTM F88: 1999
59Standard Test Methods for Failure Resistance of Unrestrained and Nonrigid Packages for Medical ApplicationsASTM F1140: 1996
60Standard Terminology Relating to Barrier Materials for Medical PackagingASTM F1327: 1998
61Standard Guide for Integrity Testing of Porous Barrier Medical PackagesASTM F1585: 1995
62Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)ASTM F1608: 1995
63Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual InspectionASTM F1886: 1998
64Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye PenetrationASTM F1929: 1998
65Standard Guide for Accelerated Aging of Sterile Medical Device PackagesASTM F1980: 1999
66Transfusion and Infusion Assemblies and Similar Medical Devices <161>USP 24: 2000
Start Signature

Dated: October 31, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center for Devices and Radiological Health.

End Signature End Supplemental Information

[FR Doc. 00-29165 Filed 11-14-00; 8:45 am]

BILLING CODE 4160-01-F