[Federal Register Volume 65, Number 221 (Wednesday, November 15, 2000)]
[Notices]
[Pages 69022-69030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29165]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0530]
FDA Modernization Act of 1997: Modifications to the List of
Recognized Standards, Recognition List Number: 004
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the agency is making to the list
of standards FDA will recognize for use in premarket reviews (FDA
Recognized Consensus Standards). This publication entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 004'' (Recognition List Number: 004) will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Written comments concerning this document may be submitted at
any time. See section VI of this document for the effective date of the
recognition of standards announced in this document.
ADDRESSES: Submit written requests for single copies on a 3.5' diskette
of ``Modifications to the List of Recognized Standards, Recognition
List Number:
[[Page 69023]]
004,'' to the Division of Small Manufacturers Assistance (DSMA), Center
for Devices and Radiological Health (HFZ-220), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-
addressed adhesive labels to assist that office in processing your
requests, or fax your request to 301-443-8818. Written comments
concerning this document must be submitted to the contact person
(address below). Comments should be identified with the docket number
found in brackets in the heading of this document. This document may
also be accessed on FDA's Internet site at http://www.fda.gov/cdrh/fedregin.html. See section V of this document for electronic access to
the searchable data base for the current list of ``FDA Recognized
Consensus Standards,'' including Recognition List Number: 004
modifications, and other standards related information.
FOR FURTHER INFORMATION CONTACT: To comment on this document and/or to
recommend additional standards for recognition: Donald E. Marlowe,
Center for Devices and Radiological Health (HFZ-100), Food and Drug
Administration, 12725 Twinbrook Pkwy., Rockville, MD 20852, 301-827-
4777.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards, developed by
international and national organizations, for use in satisfying
portions of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' This notice described
how FDA will implement its standards program recognizing the use of
certain standards and provided the initial list of recognized
standards.
In Federal Register notices published on October 16, 1998 (63 FR
55617) and July 12, 1999 (64 FR 37546), FDA modified its initial list
of recognized standards. These notices described the addition,
withdrawal, and revision of certain standards recognized by FDA. When
these notices were published, the agency maintained ``html'' and
``pdf'' versions of the list of ``FDA Recognized Consensus Standards.''
Both versions were publicly accessible at the agency's Internet site.
The agency maintains the current list in a searchable data base
accessible to the public. See section V of this document for electronic
access information.
II. Discussion of Modifications to the List of Recognized
Standards, Recognition List Number: 004
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the agency will recognize for
use in satisfying premarket reviews for devices. FDA will incorporate
these modifications in the list of ``FDA Recognized Consensus
Standards'' in the agency's searchable data base. FDA will use the term
``Recognition List Number: 004'' to identify supplementary information
sheets for standards added to the list for the first time, standards
added to replace withdrawn standards, and still recognized standards
for which minor revisions are made to clarify the application of the
standards.
At the end of this notice, FDA lists modifications the agency is
making that involve: (1) The initial addition of standards not
previously recognized by FDA and (2) the addition of standards in
conjunction with the withdrawal of other standards that are replaced by
these later, or amended, or different standards.
Under headings ``A'' through ``L'' below, FDA describes
modifications that involve: (1) The withdrawal of standards and their
replacement by others (``replacement'' standards are included in the
list at the end of this notice, but not ``withdrawn'' standards); (2)
the correction of errors made in previously recognized standards, e.g.,
the name of the standard; (3) the withdrawal of standards not replaced;
and (4) the minor revision of supplementary information sheets for
standards that FDA still recognizes, e.g., to clarify the extent of
recognition, or applicable devices.
Item numbers discussed below identify entries in the searchable
data base list of ``FDA Recognized Consensus Standards.'' ``Previous
item'' refers to entries in the list after modification on July 12,
1999 (64 FR 37546). ``Current item'' refers to entries in the list
after Recognition List Number: 004 modifications are included. Within
each category of standards, entries begin (or began) with item 1. Item
numbers are not repeated if an entry is withdrawn, replaced, or added.
A. Biocompatibility
1. ASTM E1397-91 is withdrawn under previous item 5. ASTM E1397-91
(1998) is added under current item 37.
2. ASTM E1398-91 is withdrawn under previous item 6. ASTM E1398-91
(1998) is added under current item 38.
3. ASTM F763-87 (1993) is withdrawn under previous item 35. ASTM
F763-99 is added under current item 40.
4. ASTM F981-93 is withdrawn under previous item 14. ASTM F981-99
is added under current item 41.
5. USP 23, ``Biological Reactivity Tests, In Vitro-Direct Contact
Test (87),'' is withdrawn under previous item 23. The USP 24 version,
Biological Tests 87>, is added under current item 46.
6. USP 23, ``Biological Reactivity Tests, In Vitro-Elution Test
(87),'' is withdrawn under previous item 24. The USP 24 version,
Biological Tests 87> is added under current item 47.
7. USP 23 (1988), ``Biological Reactivity Tests, In Vivo,
Classification of Plastics Sample Preparation,'' is withdrawn under
previous item 31. The USP 24 version, Biological Tests 88>, is added
under current item 48.
8. USP 23, ``Biological Reactivity Test, In Vivo, Classification of
Plastics-Intracutaneous Test (88),'' is withdrawn under previous item
25. The USP 24 version, Biological Tests 88>, is added under current
item 49.
9. USP 23, ``Biological Reactivity Tests, In Vivo-Systemic
Injection Test (88),'' is withdrawn under previous item 27. The USP 24
version, Biological Tests 88>, is added under current item 50.
B. Cardiovascular/Neurology
1. ASTM F1058-91 is withdrawn under previous item 13. ASTM F1058-97
is added under current item 28.
2. IEC 60601-2-30 (1995-03) is withdrawn, under previous item 19.
IEC 60601-2-30: 1999-12 is added under current item 29.
3. IEC 60601-2-25 (1993-03) is withdrawn under previous item 17.
IEC 60601-2-25 Amendment 1 (1999) is added under current item 30.
C. Dental/ENT
1. ANSI/ADA Specification No.15a (1992) is withdrawn under previous
item 47. ANSI/ADA Specification No. 15: 1999 is added under current
item 85.
2. ANSI/ADA Specification No. 38 (1991) is withdrawn under previous
item 54. ANSI/ADA Specification No. 38: 2000 is added under current
item 86.
3. ANSI/ADA Specification No. 69 (1991) is withdrawn under previous
item 57. ANSI/ADA Specification No. 69: 1999 is added under current
item 87.
[[Page 69024]]
4. ANSI/ADA Specification No. 78 (1994) is withdrawn under previous
item 58. ANSI/ADA Specification No. 78: 2000 is added under current
item 88.
D. General (General Applicability)
1. ANSI/AAMI/ISO 10993-1 (1997) is withdrawn under previous item
13. ANSI/AAMI/ISO 10993-1 (1997) is added back to the list as current
item 51 under the Biocompatibility category of standards.
E. General Plastic Surgery/General Hospital
1. ASTM D6124-97 is withdrawn under previous item 45. ASTM D6124-00
is added under current item 51.
2. ASTM D5250 (1992) is withdrawn under previous item 35. ASTM
D5250-00 is added under current item 52.
3. ASTM D5151 (1992) is withdrawn under previous item 34. ASTM
D5151-99 is added under current item 53.
4. ASTM D3578 (1995) is withdrawn under previous item 31. ASTM
D3578-00 is added under current item 54.
5. ASTM D3577 (1998) is withdrawn under previous item 30. ASTM
D3577-00 is added under current item 55.
6. USP 23 11>, ``Sterile Sodium Chloride for Injection,'' is
withdrawn. The USP 24 11> version of this standard is added under
current item 56.
7. USP 23 11>, ``Sterile Water for Injection,'' is withdrawn under
previous item 28. The USP 24 11> version of this standard is added
under current item 57.
8. USP 23, ``Absorbable Surgical Sutures,'' is withdrawn under
previous item 40. The USP 24 version of this standard is added under
current item 58.
9. USP 23, ``Tensile Strength,'' is withdrawn under previous item
44. The USP 24 version of this standard is added under current item 59.
10. USP 23, ``Sutures-Diameter 861>,'' is withdrawn under previous
item 42. The USP 24 861> version of this standard is added under
current item 60.
11. USP 23, ``Suture Needle Attachment 871>,'' is withdrawn under
previous item 43. The USP 24 871> version of this standard is added,
under current item 61.
F. In Vitro Devices
1. NCCLS standard M11-A3 (1993) is withdrawn under previous item 9.
FDA intended to replace this standard with NCCLS standard M11-A4
(1997), which it added to the list on July 12, 1999 (64 FR 37546) and
which remains as current item 45.
G. OB GYN/Gastroenterology
1. In the supplementary information sheet(s) for IEC 60601-2-18:
1996, which was identified under previous item 5, minor revisions are
made to the devices affected, related Code of Federal Regulations (CFR)
citation(s) and procode(s), and relevant guidance. This standard
remains recognized and identified under current item 5.
H. Ophthalmic
1. ISO 9394: 1994 is withdrawn under previous item 6, from the list
of recognized consensus standards. ISO 9394: 1998 is added under
current item 15.
I. Orthopaedics
1. ASTM F75-92 is withdrawn under previous item 2. ASTM F75-98 is
added under current item 86.
2. ASTM F90-96 is withdrawn under previous item 4. ASTM F90-97 is
added under current item 87.
3. ASTM F136-96 is withdrawn under previous item 5. ASTM F136-98 is
added under current item 88.
4. ASTM F138-92 is withdrawn under previous item 6. ASTM F138-97 is
added under current item 89.
5. ASTM F560-92 is withdrawn under previous item 9. ASTM F560-98 is
added under current item 90.
6. ASTM F561-87 is withdrawn under previous item 10. ASTM F561-97
is added under current item 91.
7. ASTM F565-85 (R1996) is withdrawn under previous item 12. ASTM
F565-85 (1996)(e1) is added under current item 92.
8. ASTM F601-86 (1992) is withdrawn under previous item 13. ASTM
F601-98 is added under current item 93.
9. ASTM F603-83 is withdrawn under previous item 14. ASTM F603-83
(1995) is added under current item 94.
10. ASTM F620-96 is withdrawn under previous item 16. ASTM F620-97
is added under current item 96.
11. ASTM F621-92 is withdrawn under previous item 17. ASTM F621-97
is added under current item 97.
12. ASTM F629-86 is withdrawn under previous item 18. ASTM F629-97
is added under current item 98.
13. ASTM F648-84 is withdrawn under previous item 19. ASTM F648-98
is added under current item 99, with changes to the extent of
recognition made in the supplementary information sheet(s).
14. ASTM F746-87 is withdrawn under previous item 22. ASTM F746-87
(1994) is added under current item 100.
15. ASTM F786-82 is withdrawn under previous item 23. It is not
replaced.
16. ASTM F787-82, is withdrawn under previous item 24. It is not
replaced.
17. ASTM F897-84 (R1993) is withdrawn under previous item 26. ASTM
F897-84 (1997) is added under current item 101.
18. The title of ASTM F961-96, identified under previous item 28,
is corrected to read ``Standard Specification for Cobalt-35 Nickel-20
Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (R30035).''
It remains identified as current item 28.
19. ASTM F983-86 is withdrawn under previous item 29. ASTM F983-86
(1996) is added under current item 102.
20. ASTM F1089-87 is withdrawn under previous item 32. ASTM F1089-
87 (1994) is added, under current item 104.
21. ASTM F1091-91 (R1996) is withdrawn under previous item 33. ASTM
F1091-91 (1996) E01 is added under current item 105.
22. ASTM F1147-95 is withdrawn under previous item 35. ASTM F1147-
99 is added under current item 107.
23. ASTM F1160-91 is withdrawn under previous item 36. ASTM F1160-
98 is added under current item 108.
24. ASTM F1185-88 (1993) is withdrawn under previous item 37. ASTM
F1185-88 (1993) E01 is added under current item 109.
25. ASTM F1264-96a is withdrawn under previous item 38. ASTM F1264-
99 is added under current item 110.
26. ASTM F1350-96 is withdrawn under previous item 42. ASTM F1350-
91 (1996) E01 is added under current item 112.
27. ASTM F1377-92 is withdrawn under previous item 43. ASTM F1377-
98a is added under current item 113.
28. In the supplementary information sheet(s) for ASTM F1672-95,
identified under previous item 55, minor changes are made to the extent
of recognition, devices affected, and related CFR citation(s) and
procode(s). This standard remains recognized and identified under
current item 55.
29. ASTM F1798 is withdrawn under previous item 59. ASTM F1798-97
is added under current item 114.
30. ASTM F1800 is withdrawn under previous item 60. ASTM F1800-97
is added under current item 115.
31. ASTM F1801 is withdrawn under previous item 61. ASTM F1801-97
is added under current item 116.
32. ISO 5832-2: 1993 is withdrawn under previous item 63. ISO 5832-
2:1999 is added under current item 117.
33. ISO 5832-9: 1992 is withdrawn under previous item 68. ISO 5832-
9:1995 is added under current item 118.
[[Page 69025]]
34. ISO 5832-10: 1996 is withdrawn under previous item 69. It is
not replaced.
35. ISO 5834-2: 1985 is withdrawn under previous item 72. ISO 5834-
2: 1998 is added under current item 119.
36. In the supplementary information sheets for ISO 7206-4: 1989
and ISO 7206-8: 1995, which were identified under previous items 78 and
79, respectively, minor changes are made to the devices affected,
processes impacted, type of standards, and related CFR citations and
procodes. They remain recognized and identified under current items 78
and 79.
J. Radiology
1. UL-122 is withdrawn under previous item 30. UL-122 (Fourth
Edition) is added under current item 50.
2. UL-187 is withdrawn under previous item 31. UL-187 (Seventh
Edition) is added under current item 51.
3. UL-544 (Third Edition) is withdrawn under previous item 32. UL-
544 (Fourth Edition) is added under current item 52.
4. IEC 60601-2-8 (1987-04) is withdrawn under previous item 35. IEC
60601-2-8 (1999-04) is added under current item 54.
5. IEC 60601-2-29 (1993-04) is withdrawn under previous item 41.
IEC 60601 2-9 (1999-01) is added under current item 55.
K. Software
1. In the supplementary information sheets for ISO/IEC 12207 and
IEEE/EIA 12207.0-1996, which were identified under previous items 1 and
3, respectively, minor changes are made to the identities of
organizations associated with the standards and the extent of
recognition. These standards remain recognized and identified under
current items 1 and 3.
L. Sterility
1. ANSI/AAMI ST24: 1992 is withdrawn under previous item 13. ANSI/
AAMI ST24: 1999 is added under current item 38.
2. USP 23: 1995, is withdrawn under previous item 29. USP 24: 2000
is added under current item 39.
3. USP 23: 1995, ``Biological Indicator for Dry-Heat Sterilization,
Paper Strip,'' is withdrawn under previous item 30. The USP 24: 2000
version of this standard is added under current item 40.
4. USP 23: 1995, ``Biological Indicator for Ethylene Oxide
Sterilization, Paper Strip,'' is withdrawn under previous item 31. The
USP 24: 2000 version of this standard is added under current item 41.
5. USP 23: 1995, ``Microbial Limits Test 61>,'' is withdrawn under
previous item 32. The USP 24: 2000 61> version of this standard is
added under current item 42.
6. USP 23: 1995, ``Microbiological Tests, Sterility Tests 71>,'' is
withdrawn under previous item 33. The USP 24: 2000 71> version of this
standard is added under current item 43.
7. USP 23: 1995, ``Biological Tests and Assays, Bacterial Endotoxin
Test (LAL) 85>,'' is withdrawn under previous item 34. The USP 24: 2000
85> version of this standard is added under current item 44.
8. USP 23: 1995, ``Pyrogen Test (USP Rabbit Test) 151>,'' is
withdrawn under previous item 35. The USP 24: 2000 151> version of this
standard is added under current item 45.
9. USP 23: 1995, ``Sterilization and Sterility Assurance of
Compendial Articles 1211>,'' is withdrawn under previous item 36. The
USP 24: 2000 1211> version of this standard is added under current item
46.
III. List of Recognized Standards
FDA maintains the agency's current list of ``FDA Recognized
Consensus Standards'' in a searchable data base that may be accessed
directly at FDA's Intranet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. The modifications and minor
revisions described in this notice will be incorporated into the data
base and, upon publication in the Federal Register, this recognition of
consensus standards will be effective.
Additional modifications and minor revisions as needed, to the list
of recognized consensus standards, will be announced in the Federal
Register once a year, or more often, if necessary.
IV. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under the new provision of section 514 of the act by
submitting such recommendations, with reasons for the recommendation,
to the contact person (address above). To be properly considered, such
recommendations should contain, at a minimum, the following
information: (1) Title of standard, (2) any reference number and date,
(3) name and address of the national or international standards
development organization, (4) a proposed list of devices for which a
declaration of conformity to this standard should routinely apply, and
(5) a brief identification of the testing or performance or other
characteristics of the device(s) that would be addressed by a
declaration of conformity.
V. Electronic Access
In order to receive ``Guidance on the Recognition and Use of
Consensus Standards'' via your fax machine, call the CDRH Facts-On-
Demand (FOD) system at 800-899-0381 or 301-827-0111 from a touch-tone
telephone. Press 1 to enter the system. At the second voice prompt
press 1 to order a document. Enter the document number 321 followed by
the pound sign (#). Follow the remaining voice prompts to complete your
request.
Persons interested in obtaining a copy of ``Guidance on the
Recognition and Use of Consensus Standards'' may also do so by using
the Internet. CDRH maintains a site on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with access to the Internet. Updated on a
regular basis, the CDRH home page includes this guidance as well as the
current list of recognized standards and other standards related
documents. After publication in the Federal Register, this notice
announcing ``Modifications to the List of Recognized Standards,
Recognition List Number: 004'' will be available on the CDRH home page.
The CDRH home page may be accessed at http://www.fda.gov/cdrh. The
``Guidance on the Recognition and Use of Consensus Standards,'' and the
searchable data base for ``FDA Recognized Consensus Standards,'' may be
accessed through hyper links at http://www.fda.gov/cdrh/stdsprog.html.
This Federal Register notice of modifications in FDA's recognition of
consensus standards will be available, upon publication, at http://www.fda.gov/cdrh/fedregin.html.
VI. Submission of Comments and Effective Date
Interested persons may, at any time, submit to the contact person
(address above) written comments regarding this document. Two copies of
any comments are to be submitted, except that individuals may submit
one copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. Received comments will be
considered in determining whether to amend the current listing of
``Modifications to the List of Recognized Standards, Recognition list:
004.''
The recognition of standards announced in this notice of
modifications will become effective on
[[Page 69026]]
[insert date of publication in the Federal Register].
VII. Listing of New Entries
The list of new entries and consensus standards added as
``Modifications to the List of Recognized Standards,'' under
Recognition List Number: 004, is as follows:
----------------------------------------------------------------------------------------------------------------
Item Number Title of Standard Reference Number and Date
----------------------------------------------------------------------------------------------------------------
Biocompatibility
----------------------------------------------------------------------------------------------------------------
Standard Practice for the In Vitro Rat ASTM E1397-91 (1998)
Hepatocyte DNA Repair Assay
38 Standard Practice for the In Vivo Rat Hepatocyte ASTM E1398-91 (1998)
DNA Repair Assay
39 Standard Practice for Selecting Generic ASTM F748-98
Biological Test Methods for Materials and
Devices
40 Standard Practice for Short-Term Screening of ASTM F763-99
Implant Materials
41 Standard Practice for Assessment of ASTM F981-99
Compatibility of Biomaterials for Surgical
Implants with Respect to Effect of Materials on
Muscle and Bone
42 Standard Practice for Testing for Whole ASTM F1984-99
Complement Activation in Serum by Solid
Materials
43 Standard Practice for Testing for Biological ASTM F1903-98
Responses to Particles In Vitro
44 Standard Practice for Testing for Biological ASTM F1904-98
Responses to Particles In Vivo
45 Standard Practice for Assessment of ASTM F1983-99
Compatibility of Absorbable/Resorbable
Biomaterials for Implant Applications
46 Biological Reactivity Test, In Vitro--Direct USP 24 Biological Tests 87>
Contact Test
47 Biological Reactivity Test, In Vitro--Elution USP 24 Biological Tests 87>
Test
48 Biological Reactivity Test, In Vivo--Procedure-- USP 24 Biological Test 88>
Preparation of Sample
49 Biological Reactivity Test, In Vivo-- USP 24 Biological Tests 88>
Intracutaneous Test
50 Biological Reactivity Tests, In Vivo--Systemic USP 24 Biological Test 88>
Injection Test
51 Biological Evaluation of Medical Devices--Part ANSI/AAMI/ISO 10993-1 (1997)
1: Evaluation and Testing
----------------------------------------------------------------------------------------------------------------
Cardiovascular/ Neurology
----------------------------------------------------------------------------------------------------------------
25 Cardiac Defibrillators--Connector Assembly for ISO 11318-93/Amendment 1:1996 (E)
Implantable Defibrillators-Dimensional and Test
Requirements
26 Medical Electrical Equipment, Part 2: Particular IEC 60601-2-23: 1993
Requirements for the Safety of Transcutaneous
Partial Pressure Monitoring Equipment
27 Medical Electrical Equipment, Part 2: Particular IEC 60601-2-34 (1994-12)
Requirements for the Safety of Direct Blood
Pressure Monitoring Equipment
28 Standard Specification for Wrought Cobalt- ASTM F1058-97
Chromium-Nickel-Molybdenum-Iron Alloys for
Surgical Implant Applications (UNS R30003 and
UNS R30008)
29 Medical Electrical Equipment, Part 2: Particular IEC 60601-2-30: 1999-12
Requirements for the Safety, Including
Essential Performance, of Automatic Cycling Non-
Invasive Blood Pressure Monitoring Equipment
30 Medical Electrical Equipment, Part 2: Particular IEC 60601-2-25 Amendment 1 (1999)
Requirements for the Safety of
Electrocardiographs
----------------------------------------------------------------------------------------------------------------
Dental/ ENT
----------------------------------------------------------------------------------------------------------------
85 Synthetic Resin Teeth ANSI/ADA Specification No. 15: 1999
86 Metal-Ceramic Systems ANSI/ADA Specification No. 38: 2000
87 Dental Ceramic ANSI/ADA Specification No. 69: 1999
88 Endodontic Obturating Points ANSI/ADA Specification No. 78: 2000
89 Polymer-Based Crown and Bridge Resins ANSI/ADA Specification No. 53: 1999
90 Specifications for Instruments to Measure Aural ANSI/ASA S3.39: 1996
Acoustic Impedance and Admittance (Aural
Acoustic Immittance)
----------------------------------------------------------------------------------------------------------------
General (Generally Applicable)
----------------------------------------------------------------------------------------------------------------
22 General Tolerances--Part 1: Tolerances for ISO 2768-1 (1989)
Linear and Angular Dimensions Without
Individual Tolerance Indications
23 General Tolerances--Part 2: Geometrical ISO 2768-2 (1989)
Tolerances for Features Without Individual
Tolerance Indications
24 Analysis Techniques for System Reliability-- IEC 60812 (1985)
Procedure for Failure Modes and Effects
Analysis (FMEA)
----------------------------------------------------------------------------------------------------------------
[[Page 69027]]
General Plastic Surgery/ General Hospital
----------------------------------------------------------------------------------------------------------------
46 Medical Electrical Equipment--Part 2: Particular IEC 60601-2-2: Third Edition 1998-09
Requirements for the Safety of High Frequency
Surgical Equipment
47 Standard Test Method for Analysis of Protein in ASTM D5712-99
Natural Rubber and its Products Using the
Modified Lowry Method
48 Standard Test Method for the Immunological ASTM D6499-00
Measurement of Antigenic Protein in Natural
Rubber and its Products
49 Standard Test Method for Human Repeat Insult ASTM D6355-98
Patch Testing or Medical Gloves
50 Standard Specification for Nitrile Examination ASTM D6319-00
Gloves for Medical Application
51 Standard Test Method for Residual Powder on ASTM D6124-00
Medical Gloves
52 Standard Specification for Poly (Vinyl Chloride) ASTM D5250-00
Gloves for Medical Application
53 Standard Test Method for Detection of Holes in ASTM D5151-99
Medical Gloves
54 Standard Specification for Rubber Examination ASTM D3578-00
Gloves
55 Standard Specification for Rubber Surgical ASTM D3577-00
Gloves
56 Sterile Sodium Chloride For Irrigation USP 24 11>
57 Sterile Water for Injection USP 24 11>
58 Absorbable Surgical Sutures USP 24
59 Tensile Strength USP 24
60 Sutures--Diameters USP 24 861>
61 Sutures Needle Attachment USP 24 871>
----------------------------------------------------------------------------------------------------------------
OB GYN/ Gastroenterology
----------------------------------------------------------------------------------------------------------------
19 Optical and Optical Instruments--Medical ISO 8600-1: 1997
Endoscopes and Endoscopic Accessories--Part 1:
General Requirements
20 Optical and Optical Instruments--Medical ISO 8600-3: 1997
Endoscopes and Endoscopic Accessories--Part 3:
Determination of Field of View and Direction of
View of Endoscopes with Optics
21 Optical and Optical Instruments--Medical ISO 8600-4: 1997
Endoscopes and Certain Accessories--Part 4:
Determination of Maximum Width of Insertion
Portion
22 Standard Practice for Cleaning and Disinfecting ASTM F1518-94
of Flexible Fiberoptic and Video Endoscopes
Used in the Examination of Hollow Viscera
----------------------------------------------------------------------------------------------------------------
Ophthalmic
----------------------------------------------------------------------------------------------------------------
15 Optics and Optical Instruments--Determination of ISO 9394-1998
Biological Compatibility of Contact Lens
Material--Testing of the Contact Lens System by
Ocular Study with Rabbit Eyes
16 Optics and Optical Instruments--Contact Lenses-- ISO 9913-2: 2000
Part 2: Determination of Oxygen Permeability
and Transmissibility by the Coulometeric Method
17 Optics and Optical Instruments--Ophthalmic ISO 10939: 1998
Instruments--Slit-Lamp Microscopes
18 Optics and Optical Instruments--Ophthalmic ISO 10943: 1999
Instruments--Indirect Ophthalmoscopes
19 Ophthalmic Optics--Contact Lenses-- ISO 11539: 1999
Classification of Contact Lenses and Contact
Lens Materials
20 Ophthalmic Implants--Intraocular Lenses--Part 1: ISO 11979-1: 1999
Vocabulary
21 Ophthalmic Implants--Intraocular Lenses--Part 2: ISO 11979-2: 2000
Optical Properties and Tests Methods
22 Ophthalmic Implants--Intraocular Lenses--Part 3: ISO 11979-3: 1999
Mechanical Properties and Test Methods
23 Ophthalmic Optics--Contact Lenses and Contact ISO 11981-1999
Lens Care Products--Determination of Physical
Compatibility of Contact Lens Care Products
with Contact Lenses
24 Ophthalmic Optics--Contact Lenses and Contact ISO 11986: 1999
Lens Care Products--Guidelines for
Determination of Preservative Uptake and
Release
25 Optics and Optical Instruments--Ophthalmic ISO 12865: 1998
Instruments--Retinoscopes
26 Ophthalmic Optics--Contact Lens Care Products-- ISO 13212: 1999
Guidelines for Determination of Shelf-Life
----------------------------------------------------------------------------------------------------------------
[[Page 69028]]
Orthopaedics
----------------------------------------------------------------------------------------------------------------
86 Standard Specification for Cobalt-28 Chromium-6 ASTM F75-98
Molybdenum Casting Alloy and Cast Products for
Surgical Implants (UNS R30075)
87 Standard Specification for Wrought Cobalt-20 ASTM F90-97
Chromium-15 Tungsten-10 Nickel Alloy for
Surgical Implant Applications (UNS R30605)
88 Standard Specification for Wrought Titanium-6 ASTM F136-98
Aluminum-4 Vanadium ELI (Extra Low
Interstitial) Alloy (R56401) for Surgical
Implant Applications
89 Standard Specification for Wrought 18 Chromium- ASTM F138-97
14 Nickel-2.5 Molybdenum Stainless Steel Bar
and Wire For Surgical Implants (UNS S31673)
90 Standard Specification for Unalloyed Tantalum ASTM F560-98
for Surgical Implant Applications (UNS R 05200,
UNS R05400)
91 Recommended Practice for Retrieval and Analysis ASTM F561-97
of Implanted Medical Devices, and Associated
Tissues
92 Standard Practice for Care and Handling of ASTM F 565-85 (1996) (e1)
Orthopedic Implants and Instruments
93 Standard Practice for Fluorescent Penetrant ASTM F601-98
Inspection of Metallic Surgical Implants
94 Standard Specification for High-Purity Dense ASTM F603-83 (1995)
Aluminum Oxide for Surgical Implant Application
95 Standard Test Method for Constant Amplitude ASTM F1539-95
Bending Fatigue Tests of Metallic Bone Staples
96 Standard Specification for Titanium-6 Aluminum-4 ASTM F620-97
Vanadium ELI Alloy Forgings for Surgical
Implants (UNS R56401)
97 Standard Specification for Stainless Steel ASTM F621-97
Forgings for Surgical Implants
98 Standard Practice for Radiography of Cast ASTM F629-97
Metallic Surgical Implants
99 Standard Specification for Ultra-High-Molecular- ASTM F648-98
Weight Polyethylene Powder and Fabricated Form
for Surgical Implants
100 Standard Test Method for Pitting or Crevice ASTM F746-87 (1994)
Corrosion of Metallic Surgical Implant
Materials
101 Standard Test Method for Measuring Fretting ASTM F897-84 (1997)
Corrosion of Osteosynthesis Plates and Screws
102 Standard Practice for Permanent Marking of ASTM F983-86 (1996)
Orthopaedic Implant Components
103 Standard Test Method for Pull-Out Fixation ASTM F1540-95
Strength of Metallic Bone Staples
104 Standard Test Method for Corrosion of Surgical ASTM F1089-87 (1994)
Instruments
105 Standard Specification for Wrought Cobalt- ASTM F1091-91 (1996) E01
Chromium Alloy Surgical Fixation Wire
106 Standard Test Method for Determining Axial Pull- ASTM F1691-96
Out Strength of Medical Bone Screws
107 Standard Test Method for Tension Testing of ASTM F1147-99
Calcium Phosphate and Metallic Coatings
108 Standard Test Method for Shear and Bending ASTM F1160-98
Fatigue Testing of Calcium Phosphate and
Metallic Medical Coatings
109 Standard Specification for Composition of ASTM F1185-88 (1993) E01
Ceramic Hydroxylapatite for Surgical Implants
110 Standard Specification and Test Methods for ASTM F1264-99
Intramedullary Fixation Devices
111 Standard Guide for Evaluating Modular Hip and ASTM F1814-97a
Knee Joint Components
112 Standard Specification for Stainless Steel ASTM F1350-91 (1996) E01
Surgical Fixation Wire
113 Standard Specification for Cobalt-28 Chromium-6 ASTM F1377-98a
Molybdenum Powder for Coating of Orthopedic
Implants (UNS R30075)
114 Standard Guide for Evaluating the Static and ASTM F1798-97
Fatigue Properties of Interconnection
Mechanisms and Subassemblies Used in Spinal
Arthrodesis Implants
115 Standard Test Method for Cyclic Fatigue Testing ASTM F1800-97
of Metal Tibial Tray Components of Total Knee
Joint Replacements
116 Standard Practice for Corrosion Fatigue Testing ASTM F1801-97
of Metallic Implant Materials
117 Implants for Surgery--Metallic Materials--Part ISO 5832-2:1999
2: Unalloyed Titanium
[[Page 69029]]
118 Implants for Surgery--Metallic Materials--Part ISO 5832-9: 1995
9: Wrought High Nitrogen Stainless Steel
119 Implants for Surgery--Ultra-high-Molecular- ISO 5834-2: 1998
Weight Polyethylene--Part 2: Moulded Forms
120 Standard Specification and Test Method for ASTM F0382-99
Metallic Bone Plates
121 Implants for Surgery--Femoral and Tibial ISO 7207-1: 1994
Components for Partial and Total Knee Joint
Prosthesis--Part 1: Classification, Definitions
and Designation of Dimensions--Second Edition
122 Implants for Surgery--Components for Partial and ISO 7207-2: 1994
Total Knee Joint Prosthesis--Part 2:
Articulating Surfaces Made of Metal, Ceramic
and Plastics Materials
----------------------------------------------------------------------------------------------------------------
Radiology
----------------------------------------------------------------------------------------------------------------
50 Standard for Safety of Photographic Equipment-- UL-122
Fourth Edition
51 Standard for Safety: X-ray Equipment--Seventh UL-187
Edition
52 Standard for Safety: Medical and Dental UL-544
Equipment--Fourth Edition
53 Radiation Protection--Sealed Radioactive ISO 2919 (1999)
Sources--General Requirements and
Classification
54 Medical Electrical Equipment--Part 2: Particular IEC 60601-2-8 (1999-04)
Requirements for the Safety of Therapeutic X-
ray Equipment Operating in the Range 10kV to
1MV
55 Medical Electrical Equipment--Part 2: Particular IEC 60601-2-29 (1999-01)
Requirements for the Safety of Radiotherapy
Simulators
56 Medical Electrical Equipment--Dosimeters with IEC 61674-1997
Ionization Chambers and/or Semi-Conductor
Detectors as used in X-ray Diagnostic Imaging
57 Medical Electrical Equipment--Dosimeters with IEC 60731-1997
Ionization Chambers as used in Radiotherapy
58 Classification of Sealed Radioactive Sources ANSI/HPS N43.6-1997
59 Radiotherapy Simulators--Functional Performance IEC 61168: 1993
Characteristics--First Edition
60 Radiotherapy Equipment--Coordinates, Movements, IEC 1217-1996
and Scales
----------------------------------------------------------------------------------------------------------------
Software
----------------------------------------------------------------------------------------------------------------
4 Software in Programmable Components ANSI/UL 1998
5 Standard for Developing Software Life Cycle IEEE 1074: 1997
Processes
6 Standard for Software Verification and IEEE 1012: 1998
Validation
----------------------------------------------------------------------------------------------------------------
Sterility
----------------------------------------------------------------------------------------------------------------
38 Automatic General Purpose Ethylene Oxide ANSI/AAMI ST 24: 1999
Sterilizers and Ethylene Oxide Sterilant
Sources Intended for Use in Health Care
Facilities, Third Edition
39 Biological Indicator for Dry-Heat Sterilization, USP 24: 2000
Paper Strip
40 Biological Indicator for Ethylene Oxide USP 24: 2000
Sterilization, Paper Strip
41 Biological Indicator for Steam Sterilization, USP 24: 2000
Paper Strip
42 Microbial Limits Test 61> USP 24: 2000
43 Microbiological Tests, Sterility Tests 71> USP 24: 2000
44 Biological Tests and Assays, Bacterial Endotoxin USP 24: 2000
Test (LAL) 85>
45 Pyrogen Test (USP Rabbit Test) 151> USP 24: 2000
46 Sterilization and Sterility Assurance of USP 24: 2000
Compendial Articles 1211>
47 Flash Sterilization: Steam Sterilization of ANSI/AAMI ST37: 1996
Patient Care Items for Immediate Use
48 Table-Top Dry Heat (Heated Air) Sterilization ANSI/AAMI ST40: 1992/(R) 1998
and Sterility Assurance in Dental and Medical
Facilities
49 Ethylene Oxide Sterilization in Health Care ANSI/AAMI ST41: 1999
Facilities: Safety and Effectiveness
50 Steam Sterilization and Sterility Assurance ANSI/AAMI ST42: 1998
Using Table-Top Sterilizers in Office-Based,
Ambulatory-Care Medical, Surgical, and Dental
Facilities
51 Safe Use and Handling of Glutaraldehyde-Based ANSI/AAMI ST58: 1996
Products in Health Care Facilities
52 Biological Indicators Part 1: General ANSI/AAMI ST59: 1999
Requirements Sterilization of Health Care
Products
[[Page 69030]]
53 Sterilization of Health Care Products--Chemical ANSI/AAMI ST66: 1999
Indicators--Part 2: Class 2 Indicators for Air
Removal Test Sheets and Packs
54 Sterilization of Medical Devices-- ANSI/AAMI/ISO 11737-2: 1998
Microbiological Methods--Part 2: Tests of
Sterility Performed in the Validation of a
Sterilization Process
55 Sterilization of Single-Use Medical Devices ANSI/AAMI/ISO 14160: 1998
Incorporating Materials of Animal Origin--
Validation and Routine Control of Sterilization
by Liquid Chemical Sterilants
56 Standard Test Method for Determination of Leaks ASTM D3078: 1994
in Flexible Packaging by Bubble Emission
57 Standard Practice for Performance Testing of ASTM D4169: 1999
Shipping Containers and Systems
58 Standard Test Method for Seal Strength of ASTM F88: 1999
Flexible Barrier Materials
59 Standard Test Methods for Failure Resistance of ASTM F1140: 1996
Unrestrained and Nonrigid Packages for Medical
Applications
60 Standard Terminology Relating to Barrier ASTM F1327: 1998
Materials for Medical Packaging
61 Standard Guide for Integrity Testing of Porous ASTM F1585: 1995
Barrier Medical Packages
62 Standard Test Method for Microbial Ranking of ASTM F1608: 1995
Porous Packaging Materials (Exposure Chamber
Method)
63 Standard Test Method for Determining Integrity ASTM F1886: 1998
of Seals for Medical Packaging by Visual
Inspection
64 Standard Test Method for Detecting Seal Leaks in ASTM F1929: 1998
Porous Medical Packaging by Dye Penetration
65 Standard Guide for Accelerated Aging of Sterile ASTM F1980: 1999
Medical Device Packages
66 Transfusion and Infusion Assemblies and Similar USP 24: 2000
Medical Devices 161>
----------------------------------------------------------------------------------------------------------------
Dated: October 31, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 00-29165 Filed 11-14-00; 8:45 am]
BILLING CODE 4160-01-F