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

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.

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\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.

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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 ,'' is withdrawn, under

previous item 24, from the list of recommended consensus standards. USP

23, ``Sutures-- Diameter ,'' is added, under current item 42, to

the list of recognized standards.

6. USP 21, ``Sutures Needle Attachment ,'' is withdrawn, under

previous item 25, from the list of recognized consensus standards. USP

23, ``Sutures Needle Attachment ,'' is added, under current item

43, to the list of recognized standards.

7. USP 21, ``Tensile Strength ,'' is withdrawn, under previous

item 26, from the list of recognized consensus standards. USP 23,

``Tensile Strength ,'' 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\

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\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.''

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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:

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Item Number Title of Standard Reference Number and Date

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Generally Acceptable Standards

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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)

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[[Page 37549]]

Anesthesia

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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)

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Biocompatibility

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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

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Cardiovascular/Neurology

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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

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Dental/ENT

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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)

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General Plastic Surgery/General Hospital

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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 USP 23

43 Sutures Needle Attachment USP 23

44 Tensile Strength USP 23

45 Standard Test Method for Residual Powder on ASTM D6124-97

Medical Gloves

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In Vitro Devices

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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

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OB-GYN/Gastroenterology

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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)

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Ophthalmic

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14 Ophthalmics--Contact Lenses--Standard ANSI Z80.20-1998

Terminology, Tolerances, Measurements, and

Physicochemical Properties

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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

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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

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Sterility

----------------------------------------------------------------------------------------------------------------

37 Biological Evaluation of Medical Devices--Part ANSI/AAMI/ISO 10993-7 (1995)

7: Ethylene Oxide Sterilization Residuals

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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