[Federal Register: July 12, 1999 (Volume 64, Number 132)]
[Notices]
[Page 37546-37551]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jy99-89]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0530]


FDA Modernization Act of 1997: Modifications to the List of
Recognized Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
publication of modifications to the list of standards that will be
recognized for use in the premarket review process. This will assist
manufacturers who elect to declare conformity with consensus standards
to meet certain requirements for medical devices.

DATES: This recognition of standards is effective on July 12, 1999;
however, written comments concerning this document may be submitted at
any time.

ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of ``Modifications to the List of Recognized Standards'' 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 listed contact
person. Comments should be identified with the docket number found in
brackets in the heading of this document. This document may also be
accessed via the Internet at FDA's web site ``http://www.fda.gov/cdrh/
fedregin.html''. See the
SUPPLEMENTARY INFORMATION section for electronic access to ``Guidance
on the Recognition and Use of Consensus Standards,'' the current list
of ``FDA Recognized Consensus Standards Appendix A,'' and other
standards related information.

FOR FURTHER INFORMATION CONTACT: To comment on this document and/or to
recommend additional standards for recognition: James J. McCue, Center
for Devices and Radiological Health (HFZ-84), Food and Drug
Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4766,
ext. 101.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d) to allow the
agency to recognize consensus standards established by international
and national standards development 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 document
entitled ``Recognition and Use of Consensus Standards,'' which
describes how FDA will implement that part of FDAMA. The February 1998
notice also provided the initial list of recognized standards.
    In a notice published in the Federal Register of October 16, 1998
(63 FR 55617), FDA made modifications to the initial list of recognized
standards. This October 1998 notice described the changes made in the
initial list and also provided a listing of the ``Modifications to the
List of Recognized Standards.''

II. Discussion of Modifications to the List of Recognized Standards

    Modifications to the list of consensus standards to be recognized
for use in premarket review and to meet other requirements are
presented in a listing at the end of this notice.
    Modifications identified in the listing include: (1) The initial
addition of certain recognized standards not previously identified by
FDA; (2) the addition of certain recognized standards in conjunction
with the withdrawal of other previously recognized standards and their
replacement by later, amended, or different standards; and (3) the
addition of certain recognized standards with revisions to the
supplementary information sheets for the standards, involving changes
in significant applications of the standards, e.g., changes in the
extent of recognition.
    The listing of modifications presented at the end of this document
does not include minor revisions which the agency is making in certain
previously recognized standards. These revisions are made for
editorial, corrective, or technical purposes, such as adding a
previously omitted date, or changing the contact person(s) in the
supplementary information sheet for a recognized standard. Particular
minor revisions in the specific recognition of standards are described
in the following paragraphs.
    As noted previously, FDA is making modifications to the list of
recognized standards that represent the initial addition of certain
standards not previously recognized by the agency. These additions are
identified in the listing presented at the end of this document and are
not otherwise described.
    Modifications that FDA is making, which represent the addition of
certain recognized standards in conjunction with the withdrawal of
other standards, or with changes in significant applications of the
standards, are also identified in the listing at the end of this
document. However, the agency is further describing the actions it is
taking in making these additions, and in sections II.A through H of
this document it is identifying the minor revisions it is making in
certain recognized standards.

A. Generally Applicable Standards

    1. ANSI/AAMI/ISO 10993-1 and ISO 10993-1 are withdrawn, under
previous items 1 and 3,\1\ respectively, from the list of recognized
consensus standards. The latest version of the standard ISO 10993-1
(1997) is added, under current

[[Page 37547]]

item 13, to the list of recognized standards.
---------------------------------------------------------------------------

    \1\ Item numbers identify entries in the ``FDA Recognized
Consensus Standards Appendix A.'' Within each grouping, entries
begin with item 1. Item numbers are not repeated if an entry is
withdrawn, replaced, or added.
---------------------------------------------------------------------------

    2. EN 1441 (1997) is withdrawn, under previous item 9, from the
list of recognized consensus standards. EN 1441 (1997) is added back,
under current item 21, to the list of recognized standards, with
changes to the extent of recognition and relevant guidances made in the
supplementary information sheet(s) for the recognized standard.

B. Anesthesia

    1. IEC 60601-2-13 (1998-05) is withdrawn, under previous item 10,
from the list of recognized consensus standards. This 1998 version of
the standard is not yet finalized. The latest version of the standard
IEC 60601-2-13 (1989) is added, under current item 30, to the list of
recognized standards.

C. Biocompatibility

    1. ANSI/AAMI/ISO 10993-12 (1996) is withdrawn, under previous item
22, from the list of recognized consensus standards. ANSI/AAMI/ISO
10993-12 (1996) is added back, under current item 28, with changes to
the extent of recognition made in the supplementary information
sheet(s) for the recognized standard.
    2. ANSI/AAMI/ISO 10993-5 (1993) is withdrawn, under previous item
17, from the list of recognized consensus standards. ANSI/AAMI/ISO
10993-5 (1998) is added, under current item 29, to the list of
recognized standards.
    3. ASTM F720-81 (r1996) is withdrawn, under previous item 8, from
the list of recognized consensus standards. ASTM F720-81 (r1996) is
added, under current item 30, to the list of recognized standards, with
changes to the extent of recognition made in the supplementary
information sheet(s) for the recognized standard.
    4. USP 23, ``Biological Reactivity Tests, In Vivo, Classification
of Plastics, Sample Preparation (88),'' is withdrawn, under previous
item 26, from the list of recognized consensus standards. USP 23,
``Biological Reactivity Tests, In Vivo, Classification of Plastics,
Sample Preparation (1988),'' is added back, under current item 31, to
the list of recognized standards, with changes to the extent of
recognition made in the supplementary information sheet(s) for the
recognized standard.
    5. ASTM F750 is withdrawn, under previous item 10, from the list of
recognized consensus standards. The latest version of the standard ASTM
F750-96 is added, under current item 32, to the list of recognized
standards.
    6. ASTM E1372-90 is withdrawn, under previous item 4, from the list
of recognized consensus standards. ASTM E1372-95 is added, under
current item 33, to the list of recognized standards.
    7. ASTM F749-87 (r1996) is withdrawn, under previous item 9, from
the list of recognized consensus standards. The latest version of the
standard ASTM F749-98 is added, under current item 34, to the list of
recognized standards.
    8. ASTM F763-87 is withdrawn, under previous item 11, from the list
of recognized consensus standards. ASTM F763-87 (1993) is added, under
current item 35, to the list of recognized standards.
    9. ASTM F1408-92 is withdrawn, under previous item 15, from the
list of recognized consensus standards. ASTM F1408-97 is added, under
current item 36, to the list of recognized standards.

D. Cardiovascular/Neurology

    1. ASTM F75-92 is withdrawn, under previous item 6, from the list
of recognized consensus standards. ASTM F75-98 is added, under current
item 21, to the list of recognized standards.
    2. ASTM F90-96 is withdrawn, under previous item 7, from the list
of recognized consensus standards. ASTM F90-97 is added, under current
item 22, to the list of recognized standards.
    3. ASTM F136-96 is withdrawn, under previous item 8, from the list
of recognized consensus standards. ASTM F136-98 is added, under current
item 23, to the list of recognized standards.
    4. ASTM F560-92 is withdrawn, under previous item 10, from the list
of recognized consensus standards. ASTM F560-98 is added, under current
item 24, to the list of recognized standards.

E. General Plastic Surgery/General Hospital

    1. IEC 60601-2-19 (1990-12) is withdrawn, under previous item 7,
from the list of recognized consensus standards. IEC 60601-2-19 (1996)
is added, under current item 29, to the list of recognized standards.
    2. IEC 60601-2-20 (1990-12) is withdrawn, under previous item 8,
from the list of recognized consensus standards. IEC 60601-2-20 (1996)
is added, under current item 32, to the list of recognized standards.
    3. USP 21, ``Absorbable Surgical Sutures,'' is withdrawn, under
previous item 22, from the list of recognized consensus standards. The
latest version of USP 23, ``Absorbable Surgical Sutures,'' is added,
under current item 40, to the list of recognized standards.
    4. USP 21, ``Nonabsorbable Surgical Sutures,'' is withdrawn, under
previous item 23, from the list of recognized consensus standards. The
latest version of USP 23, ``Nonabsorbable Surgical Sutures,'' is added,
under current item 41, to the list of recognized standards.
    5. USP 21, ``Sutures--Diameter <861>,'' is withdrawn, under
previous item 24, from the list of recommended consensus standards. USP
23, ``Sutures-- Diameter <861>,'' is added, under current item 42, to
the list of recognized standards.
    6. USP 21, ``Sutures Needle Attachment <871>,'' is withdrawn, under
previous item 25, from the list of recognized consensus standards. USP
23, ``Sutures Needle Attachment <871>,'' is added, under current item
43, to the list of recognized standards.
    7. USP 21, ``Tensile Strength <881>,'' is withdrawn, under previous
item 26, from the list of recognized consensus standards. USP 23,
``Tensile Strength <881>,'' is added, under current item 44, to the
list of recognized standards.

F. Ob-Gyn/Gastroenterology

    1. ASTM D3492-96 was inadvertently listed twice and is withdrawn,
under previous items 2 and 15, from the list of recognized consensus
standards. The latest version of the standard ASTM 3492-97 is added,
under current item 17, to the list of recognized standards, with
changes to the extent of recognition made in the supplementary sheet(s)
for the recognized standard.
    2. For ISO Standards for ``Rubber Condoms,'' Parts 1 through 9,
specifically: ISO 4074-1:1996(E), ISO 4074-2:1994(E), ISO 4074-
3:1994(E), ISO 4074-5:1996(E), ISO 4074-6:1996(E), ISO 4074-7:1996(E),
and ISO 4074-9:1996(E), which were identified under previous items 8
through 14, respectively, on the list of recognized consensus
standards, the FDA technical contact person has been changed on the
supplementary information sheets for the recognized standards. These
standards remain identified under current items 8 through 14 on the
list of recognized standards.

G. Ophthalmic

    1. For ISO 10942 listed, under previous item 13, on the list of
recognized consensus standards, the previously omitted publication date
of 1988 has been added. ISO 10942:1998 remains identified, under
current item 13, on the list of recognized standards.\2\
---------------------------------------------------------------------------

    \2\ These minor revisions are not identified in the listing of
``Modifications to the List of Recognized Standards,'' but are to be
included in the current list in the ``FDA Recognized Consensus
Standards Appendix A.''
---------------------------------------------------------------------------

H. Sterility

    1. ANSI/AAMI/ISO 10993-7:1995 is withdrawn, under previous item 23,
from the list of recognized consensus

[[Page 37548]]

standards. ANSI/AAMI/ISO 10993-7:1995 is added, under current item 37,
to the list of recognized standards, with changes to the extent of
recognition made in the supplementary information sheet(s) for the
recognized standard.

III. List of Recognized Standards

    The complete list of consensus standards to be recognized for use
in premarket review and to meet other requirements is contained in the
document, ``FDA Recognized Consensus Standards Appendix A.'' The
modifications and minor revisions to the list of recognized standards
set forth in this document are to be incorporated in that document,
which is maintained on the FDA World Wide Web (WWW) site, ``http://
www.fda.gov/cdrh/modact/ recstand.html''. Also posted on the WWW site
are supplementary information sheets for each recognized standard.
These information sheets list the address(es) where the standard can be
obtained, information on any limitations on the application of the
standard in medical device review or in satisfying other regulatory
requirements, and a list of devices for which declarations of
conformity with the recognized standard will be routinely accepted by
agency reviewers. In addition to these documents, the WWW site contains
answers to frequently asked questions regarding the use of recognized
standards.
    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 the guidance entitled ``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. At the first voice prompt press 1 to
access DSMA Facts, at the second voice prompt press 2, and then enter
the document number 321, followed by the pound sign (#). Then follow
the remaining voice prompts to complete your request. Persons
interested in obtaining a copy of the guidance may also do so by using
the WWW. CDRH maintains an entry on the WWW for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with access to the WWW. Updated on a regular
basis, the CDRH home page includes the ``Guidance on the Recognition
and Use of Consensus Standards,'' as well as the current list in the
``FDA Recognized Consensus Standards Appendix A,'' ``Supplementary
Information'' sheets for each recognized standard, and other device-
oriented information. The CDRH home page may be accessed at ``http://
www.fda.gov/cdrh''. The ``Guidance on the Recognition and Use of
Consensus Standards'' is available at ``http://www.fda.gov/cdrh/
modact/k982.html''. The ``FDA Recognized Consensus Standards Appendix
A'' may be accessed at ``http://fda.gov/cdrh/modact/recstand.html'' and
provides hyperlinks to the ``Supplementary Information'' sheets for
listed recognized standards.

VI. Comments

    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.''
    The listing of ``Modifications to the List of Recognized
Standards'' is set forth below:

----------------------------------------------------------------------------------------------------------------
 Item Number                  Title of Standard                             Reference Number and Date
----------------------------------------------------------------------------------------------------------------

                                         Generally Acceptable Standards

----------------------------------------------------------------------------------------------------------------
         10   Medical Devices--Risk Management--Part 1:         AAMI/ISO 14971-1 (1998)
               Application of Risk Analysis
         11   Sampling Procedures and Tables for Inspection by  ISO 2859 (1995)
               Attributes
         12   Quality Assurance Requirements for Measuring      ISO 10012 (1993)
               Equipment Part 1: Metrological Confirmation
               System for Measuring Equipment
         13   Biological Evaluation of Medical Devices Part 1:  ISO 10993-1 (1997)
               Evaluation and Testing
         14   Inspection by Attributes                          ANSI/ASQC Z1.4 (1993)
         15   Inspection by Variables                           ANSI/ASQC Z1.9 (1993)
         16   Test Methods for Peel or Stripping Strength of    ASTM D-903 (1993)
               Adhesive Bonds
         17   Standard Practice for Performance Testing of      ASTM D-4169 (1993)
               Shipping Containers and Systems
         18   Standard Practice for Conditioning Containers,    ASTM D-4332 (1991)
               Packages, or Packaging Components for Testing
         19   Standard Practice for Use of Statistics in the    ASTM E-876 (1995)
               Evaluation of Spectrometric Data
         20   Standard Test Method for Failure Resistance of    ASTM F-1140 (1988)
               Unrestrained and Nonrigid Packages for Medical
               Applications
         21   Medical Devices--Risk Management                  EN 1441 (1997)
----------------------------------------------------------------------------------------------------------------

[[Page 37549]]

                                                    Anesthesia

----------------------------------------------------------------------------------------------------------------
         23   Conical Fittings of 15 millimeters (mm) and 22    ASTM F 1054 (1987)
               mm Sizes
         24   Standard Specification for Capnometers            ASTM F 1456 (1992)
         25   Specification for Oxygen Analyzers                ASTM F 1462 (1993)
         26   Standard Color Marking of Compressed Gas          CGA C-9 (1988)
               Containers Intended for Medical Use
         27   Standard for Compressed Gas Cylinder Valve        CGA V-1 (1994)
               Outlets and Inlet Connection
         28   Diameter-Index Safety System                      CGA V-5 (1989)
         29   Standard Method of Determining Cylinder Valve     CGA V-7 (1997)
               Outlet Connections for Medical Gases
         30   Medical Electrical Equipment Part 2: Particular   IEC 60601-2-13 (1989)
               Requirements for the Safety of Anesthetic
               Machines
         31   Anesthetic and Respiratory Equipment--Conical     ISO 5356-1 (1996)
               Connectors
         32   Oxygen Monitors for Monitoring Patient Breathing  ISO 7767 (1997)
               Mixtures--Safety Requirements
         33   Capnometers for Use With Humans--Requirements     ISO 9918 (1993)
----------------------------------------------------------------------------------------------------------------

                                                Biocompatibility

----------------------------------------------------------------------------------------------------------------
         28   Biological Evaluation of Medical Devices--Part    ANSI/AAMI/ISO 10993-12 (1996)
               12: Sample Preparation and Reference Materials
         29   Biological Evaluation of Medical Devices--Part    ISO 10993-5 (1998)
               5: Tests for Cytotoxicity: In Vitro Methods
         30   Standard Practice for Testing Guinea Pigs for     ASTM F720-81 (r1996)
               Contact Allergens: Guinea Pig Maximization Test
         31   Biological Reactivity Tests, In Vivo,             USP 23 (1988)
               Classification of Plastics-Sample Preparation
         32   Standard Practice for Evaluating Material         ASTM F750 (1996)
               Extracts by Systemic Injection in the Mouse
         33   Standard Test Method for Conducting a 90-Day      ASTM E1372-95
               Oral Toxicity Study in Rats
         34   Standard Practice for Evaluating Material         ASTM F749-98
               Extracts by Intracutaneous Injection in the
               Rabbit
         35   Standard Practice for Short Term Screening for    ASTM F763-87 (1993)
               Implant Material
         36   Standard Practice for Subcutaneous Screening      ASTM F1408-97
               Test for Implant Materials
----------------------------------------------------------------------------------------------------------------

                                            Cardiovascular/Neurology

----------------------------------------------------------------------------------------------------------------
         21   Specification for Cobalt-28 Chromium-6 Molyb-     ASTM F75-98
               denum Casting Alloy and Cast Products for
               Surgical Implants (UNS R30075)
         22   Specification for Wrought Cobalt-20 Chromium-15   ASTM F90-97
               Tungsten-10 Nickel Alloy for Surgical Implant
               Applications (UNS R30605)
         23   Specification for Wrought Titanium-6 Aluminum-4   ASTM F136-98
               Vanadium ELI (Extra Low Interstitial) Alloy
               (UNS R56401) for Surgical Implant Applications
         24   Specification for Unalloyed Tantalum for          ASTM F560-98
               Surgical Implant Applications
----------------------------------------------------------------------------------------------------------------

                                                   Dental/ENT

----------------------------------------------------------------------------------------------------------------
         40   Specification for Audiometers                     ANSI S3.6 (1996)
         41   Specification of Hearing Aid Characteristics      ANSI S3.22 (1996)
         42   Dental Impression Compound                        ANSI/ADA Specification No. 3 (1994)
         43   Dental Casting Alloys                             ANSI/ADA Specification No. 5 (1988)
         44   Agar Impression Material                          ANSI/ADA Specification No. 11 (1968)
         45   Denture Cold-Curing Repair Resin                  ANSI/ADA Specification No. 13 (1981)
         46   Dental Base Metal Casting Alloys                  ANSI/ADA Specification No. 14 (1982)
         47   Synthetic Resin Teeth                             ANSI/ADA Specification No. 15a (1992)
         48   Dental Impression Paste Zinc Oxide-Eugenol Type   ANSI/ADA Specification No. 16 (1989)
         49   Denture Base Temporary Reclining Resin            ANSI/ADA Specification No. 17 (1983)
         50   Alginate Impression Materials                     ANSI/ADA Specification No. 18 (1992)
         51   Dental Duplicating Material                       ANSI/ADA Specification No. 20 (1968)
         52   Resin-Based Filling Materials                     ANSI/ADA Specification No. 27 (1993)
         53   Dental Zinc Oxide-Eugenol and Zinc Oxide Non-     ANSI/ADA Specification No. 30 (1990)
               Eugenol Cements
         54   Metal-Ceramic Systems                             ANSI/ADA Specification No. 38 (1991)
         55   Ultraviolet Activator and Disclosing Lights       ANSI/ADA Specification No. 48 (1983)

[[Page 37550]]

         56   Endodontic Sealing Materials                      ANSI/ADA Specification No. 57 (1993)
         57   Dental Ceramic                                    ANSI/ADA Specification No. 69 (1991)
         58   Endodontic Obturating Points                      ANSI/ADA Specification No. 78 (1994)
         59   Color Stability Test Procedure                    ANSI/ADA Specification No. 80 (1997)
         60   Dental Water-Based Cements                        ANSI/ADA Specification No.96 (1994)
         61   Dental Casting Gold Alloys                        ISO 1562 (1993)
         62   Dental Alginate Impression Material               ISO 1563 (1990)
         63   Dental Aqueous Impression Materials Based on      ISO 1564 (1995)
               Agar
         64   Dental Zinc Oxide/Eugenol Cements and Zinc Oxide  ISO 3107 (1988)
               Non-Eugenol Cements
         65   Dentistry--Synthetic Polymer Teeth                ISO 3336 (1993)
         66   Dentistry--Resin-Based Filling Materials          ISO 4049 (1988)
         67   Dental Base Metal Casting Alloys--Part 1: Cobalt- ISO 6871-1 (1994)
               Based Alloys
         68   Dental Base Metal Casting Alloys--Part 2: Nickel- ISO 6871-2 (1994)
               Based Alloys
         69   Dental Ceramic                                    ISO 6872 (1995) Amendment 1 (1997)
         70   Dental Resin-Based Pit and Fissure Sealants       ISO 6874 (1988)
         71   Dental Root Canal Sealing Materials               ISO 6876 (1986)
         72   Dental Root-Canal Obturating Points               ISO 6877 (1995)
         73   Dentistry--Preclinical Evaluation of              ISO 7405 (1997)
               Biocompatibility of Medical Devices Used in
               Dentistry--Test Methods for Dental Materials
         74   Dental Units                                      ISO 7494 (1996)
         75   Part 1: High-Speed Air Turbine Handpieces         ISO 7785-1 (1997)
         76   Part 2: Straight and Geared Angle Handpieces      ISO 7785-2 (1995)
         77   Dental Casting Alloys With Noble Metal Content    ISO 8891(1993)
               of 25% Up to but Not Including 75%
         78   Dental Handpieces--Hose Connectors                ISO 9168 (1991)
         79   Dental Ceramic Fused to Metal Restorative         ISO 9693 (1991)
               Material
         80   Dental Water-Based Cements                        ISO 9917 (1991)
         81   Dentistry--Resilient Lining Materials for         ISO 10139-1 (1991)
               Removable Dentures--Part 1: Short Term
               Materials
         82   Dentistry--Polymer-Based Crown and Bridge         ISO 10477 (1998)
               Materials
         83   Dental Handpieces: Dental Low Voltage Electrical  ISO 11498 (1997)
               Motors
         84   Dental Handpieces--Dental Air-Motors              ISO 13294 (1997)
----------------------------------------------------------------------------------------------------------------

                                    General Plastic Surgery/General Hospital

----------------------------------------------------------------------------------------------------------------
         29   Medical Electrical Equipment--Part 2: Particular  IEC 60601-2-19 (1996)
               Requirements for Safety of Baby Incubators
         30   Standard Specification for Rubber Surgical        ASTM D3577 (1998)
               Gloves
         31   Standard Specification for Rubber Examination     ASTM D3578 (1995)
               Gloves
         32   Medical Electrical Equipment--Part 2: Particular  IEC 60601-2-20 (1996)
               Requirements for the Safety of Transport
               Incubators
         33   Standard Specification for Rubber Finger Cots     ASTM D3772 (1997)
         34   Standard Test Method for Detection of Holes in    ASTM D5151 (1992)
               Medical Gloves
         35   Standard Specification for Poly (vinyl chloride)  ASTM D5250 (1992)
               Gloves for Medical Application
         36   Standard Test Method for Resistance of Medical    ASTM F862 (1998)
               Face Masks to Penetration by Synthetic Blood
               (Horizontal Projection of Fixed Volume at a
               Known Velocity)
         37   Standard Specification for Conical Fittings of    ASTM F1054 (1987)
               15-mm and 22-mm Sizes
         38   Standard Test Method for Resistance of Materials  ASTM F1671 (1997b)
               Used in Protective Clothing to Penetration by
               Blood-Borne Pathogens Using Phi-X174 Bacterio-
               phage Penetration as Test System
         39   Standard Test Method for Resistance of Materials  ASTM F1670 (1997)
               Used in Protective Clothing to Penetration by
               Synthetic Blood
         40   Absorbable Surgical Sutures                       USP 23
         41   Nonabsorbable Surgical Sutures                    USP 23
         42   Sutures--Diameters <861>                          USP 23
         43   Sutures Needle Attachment <871>                   USP 23
         44   Tensile Strength <881>                            USP 23
         45   Standard Test Method for Residual Powder on       ASTM D6124-97
               Medical Gloves
----------------------------------------------------------------------------------------------------------------

                                                In Vitro Devices

----------------------------------------------------------------------------------------------------------------
         49   Performance Goals for the Internal Quality        NCCLS H26-A (1996)
               Control of Multichannel Hematology Analyzers;
               Approved Standard
         50   Glossary and Guidelines for Immunodiagnostic      NCCLS D11-A2
               Procedures, Reagents, and Reference Materials--
               Second Edition; Approved Guideline

[[Page 37551]]

         51   Using Proficiency Testing (PT) to Improve the     NCCLS GP27-A
               Clinical Laboratory; Approved Guideline
         52   Terminology and Definition for Use in NCCLS       NRSCL 8-A
               Documents; Approved Standard
         53   Continuous Quality Improvement: Essential         NCCLS GP22-A
               Management Approaches; Approved Guideline
----------------------------------------------------------------------------------------------------------------

                                             OB-GYN/Gastroenterology

----------------------------------------------------------------------------------------------------------------
         16   Enteral Feeding Set Connectors and Adapters       ANSI/AAMI ID54 (1996)
         17   Standard Specifications for Rubber                ASTM D3492-97
               Contraceptives (Male Condoms)
         18   Electrosurgical Device                            ANSI/AAMI HF-18 (1993)
----------------------------------------------------------------------------------------------------------------

                                                   Ophthalmic

----------------------------------------------------------------------------------------------------------------
         14   Ophthalmics--Contact Lenses--Standard             ANSI Z80.20-1998
               Terminology, Tolerances, Measurements, and
               Physicochemical Properties
----------------------------------------------------------------------------------------------------------------

                                                    Radiology

----------------------------------------------------------------------------------------------------------------
         44   Acoustic Output Measurement Standard for          AIUM (1998)
               Diagnostic Ultrasound Equipment
         45   Standard for Real-Time Display of Thermal         AIUM RTD (1998)
               andMechanical Acoustic Output Indices on
               Diagnostic Ultrasound Equipment. Revision 1.
         46   Acoustic Output Labeling Standard for Diagnostic  AIUM AOL (1998)
               Ultrasound Equipment: A Standard for How
               Manufacturers Should Specify Acoustic Output
               Data
         47   Medical Electrical Equipment: Radionuclide        IEC 61303 (1994-10)
               Calibrators B Particular Methods for Describing
               Performance
         48   Calibration and Usage of ``Dose Calibrator''      ANSI N42.13 (1986)
               Ionization Chambers for the Assay of
               Radionuclides
         49   Calibration and Usage of Ionization Chamber       IEC 61145 (1992-05)
               Systems for Assay of Radionuclides
----------------------------------------------------------------------------------------------------------------

                                                    Software

----------------------------------------------------------------------------------------------------------------
          2   Standard for Developing Software Life Cycle       IEEE 1074 (1997)
               Processes
          3   Industry Implementation of International          IEEE/EIA 12207.0 (1996)
               Standard ISO/IEC 12207: 1995 (ISO/IEC 12207)
               Standard for Information Technology--Software
               Life Cycle Processes
----------------------------------------------------------------------------------------------------------------

                                                    Sterility

----------------------------------------------------------------------------------------------------------------
         37   Biological Evaluation of Medical Devices--Part    ANSI/AAMI/ISO 10993-7 (1995)
               7: Ethylene Oxide Sterilization Residuals
----------------------------------------------------------------------------------------------------------------

    Dated: June 30, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy.
[FR Doc. 99-17429 Filed 7-9-99; 8:45 am]
BILLING CODE 4160-01-F