AAMI标准

Association for the Advancement of Medical Instrumentation

协会中文名称：

AAMI

；美国医疗器械促进协会

1 AAMI 7198-1998 (R 2004) CARDIOVASCULAR IMPLANTS - TUBUAL VASCULAR

PROSTHESES-FDA RECOGNIZED

2 AAMI

10993-1-2003 Biological

evaluation

of

medical

devices

-

Part

1:

Evaluation and testing-FDA RECOGNIZED

3 AAMI

10993-2-2006 Biological

evaluation

of

medical

devices

-

Part

2:

Animal welfare requirements

4 AAMI

10993-3-2003 Biological

Evaluation

of

Medical

Devices,

Part

3:

Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity

5 AAMI

10993-4-2002 Biological

evaluation

of

medical

devices

-

Part

4:

Selection of tests for interaction with blood-Incorporates Amendment 1:

2006

6 AAMI

10993-5-1999 BIOLOGICAL

EVALUATION

OF

MEDICAL

DEVICES,

PART

5:

TEST FOR IN VITRO CYTOTOXICITY-FDA RECOGNIZED

7 AAMI

10993-6-1995

(R

2001) BIOLOGICAL

EVALUATION

OF

MEDICAL

DEVICES,

PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION-FDA RECOGNIZED

8 AAMI

10993-7-1995

(R

2001) Biological

Evaluation

of

Medical

Devices,

Part 7: Ethylene Oxide Sterilization Residuals-Only FDA RECOGNIZED if

used

in

conjunction

to

AAMI

TIR19:

1988;

Replaces

AAMI

ST29:

1988

and

AAMI

ST30: 1989 [Use: AAMI TIR19 AMD 1]

9 AAMI

10993-9-1999

(R

2005) Biological

evaluation

of

medical

devices

-

Part

9:

for

identification

and

quantification

of

potential

degradation

products

10 AAMI

10993-11-2006 Biological

evaluation

of

medical

devices

-

Part

11: Tests for systemic toxicity

11 AAMI

10993-12-2002 Biological

evaluation

of

medical

devices

-

Part

12: Sample preparation and reference materials-FDA RECOGNIZED

12 AAMI 10993-13-1999 (R 2004) Biological evaluation of medical

devices, Part 13: Identification and quantification of degradation

products from polymeric devices.

13 AAMI 10993-14-2001 (R 2006) BIOLOGICAL EVALUATION OF MEDICAL

DEVICES, PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION

PRODUCT FROM CERAMICS

14 AAMI 10993-15-2000 (R 2006) Biological evaluation of medical

devices?Part 15: Identification and quantification of degradation

products from metals and alloys

15 AAMI 10993-16-1997 (R 2003) BIOLOGICAL EVALUATION OF MEDICAL

DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS

AND LEACHABLES FROM MEDICAL DEVICES

16 AAMI 10993-17-2002 BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART

17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES

17 AAMI 11135 ERTA-2005 Medical devices ?Validation and routine

control of ethylene oxide sterilization-Erratum issued: 20 January 1995

(print copy only) and Erratum issued: 6 April 2005 (PDF copy only)

18 AAMI

11135-1994 Medical

devices

-

Validation

and

routine

control

of

ethylene oxide sterilization-FDA RECGOGNIZED; esignations: AAMI OPEO,

AAMI ST27, and AAMI TIR1 [Refer to: AAMI TIR14, AAMI TIR15, AAMI TIR16,

AAMI TIR20, AAMI TIR28]

19 AAMI

11137-1-2006 Sterilization

of

health

care

products

-

Radiation

-

Part

1:

Requirements

for

the

development,

validation

and

routine

control

of a sterilization process for medical devices-Also replaces AAMI ST31,

AAMI ST32, AAMI TIR5

20 AAMI

11137-3-2006 Sterilization

of

health

care

products

-

Radiation

- Part 3: Guidance on dosimetric aspects-Also replaces AAMI ST31, AAMI

ST32, AAMI TIR5

21 AAMI 11138-1-2006 Sterilization of health care products -

Biological

indicators

-

Part

1:

General

requirements

[Refer

to:

AAMI

18472]

22 AAMI 11138-2-2006 Sterilization of health care products -

Biological

indicators

-

Part

2:

Biological

indicators

for

ethylene

oxide

sterilization processes [Refer to: AAMI 18472]

23 AAMI 11138-3-2006 Sterilization of health care products -

Biological indicators - Part 3: Biological indicators for moist heat

sterilization processes [Refer to: AAMI 18472]

24 AAMI 11138-4-2006 Sterilization of health care products -

Biological indicators - Part 4: Biological indicators for dry heat

sterilization processes [Refer to: AAMI 18472]

25 AAMI 11138-5-2006 Sterilization of health care products -

Biological

indicators

-

Part

5:

Biological

indicators

for

low-temperature

steam and aldehyde sterilization processes [Refer to: AAMI 18472]

26 AAMI 11607-2-2006 Packaging for terminally sterilized medical

devices - Part 2: Validation requirements for ing, sealing and assembly

processes

27 AAMI 11737-2-1998 Sterilization of Medical Devices -

Microbiological Methods - Part 2: Tests of Sterility Per ed in the

Validation of a Sterilization Process-FDA RECOGNIZED

28 AAMI 13485-2003 Medical devices - Quality management systems -

Requirements for regulatory purposes

29 AAMI 14155-1-2003 Clinical investigation of medical devices for

human subjects - Part 1: General requirements

30 AAMI 14155-2-2003 Clinical investigation of medical devices for

human subjects?Part 2: Clinical investigation plans

31 AAMI 14160-1998 Sterilization of Single-Use Medical Devices

Incorporating

Materials

of

Animal

Origin

-

Validation

and

Routine

Control

of Sterilization by Liquid Chemical Sterilants-FDA RECOGNIZED

32 AAMI 14161-2000 Sterilization of health care products?Biological

indicators?Guidance for the selection, use, and interpretation of

results-FDA RECOGNIZED

33 AAMI 14937-2000 Sterilization of health care products?General

requirements for characterization of a sterilizing agent and the

development, validation, and routine control of a sterilization process

for medical devices-FDA RECOGNIZED

34 AAMI 15223-2000 Medical Devices - Symbols to be used with medical

device labels, labeling and in ation to be supplied.-FDA RECOGNIZED;

Includes Amendment 1: 11/5/2001 and Amendment 2: 4/23/2004

35 AAMI 15225-2000 (R 2006) NOMENCLATURE - SPECIFICATION FOA A

NOMENCLATURE

SYSTEM

FOR

MEDICAL

DEVICES

FOR

THE

PURPOSE

OF

REGULATORY

DATA

EXCHANGE-Includes Amendment 1: 2004

36 AAMI 15674-2001 Cardiovascular implants and artificial organs

—

Hard

shell

cardiotomy/venous

reservoir

systems

(with/without

filter)

and

soft venous reservoir bags

37 AAMI 15675-2001 Cardiovascular implants and artificial

organs?Cardiopulmonary bypass systems?Arterial blood line filters

38 AAMI 15882-2003 Sterilization of health care products - Chemical

indicators - Guidance for selection, use, and interpretation of

results-FDA RECOGNIZED

39 AAMI

17665-1-2006 Sterilization

of

health

care

products

-

Moist

heat

-

Part

1

Requirements

for

the

development,

validation

and

routine

control

of

a

sterilization

process

for

medical

devices-

er

Designation:

AAMI

ST25

40 AAMI 25539-1 AMD 1-2005 Cardiovascular implants - Endovascular

devices - Part 1: Endovascular prostheses, Amendment 1: Test methods

41 AAMI 25539-1-2003 Cardiovascular implants?Endovascular

devices?Part 1: Endovascular prostheses

42 AAMI 60601-2-21-2000 Medical electrical equipment, Part 2:

Particular requirements for the safety of infant radiant warmers-FDA

RECOGNIZED; er Designation: AAMI II52; Incorporates Amendment 1: 2000

43 AAMI 62304-2006 Medical device software - Software life cycle

processes [Refer to: AAMI TIR32]

44 AAMI BE78-2002 BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 10:

TEST FOR IRRITATION AND DELAYED TYPE HYPERSENSITIVITY-In place of AAMI

10993-10; FDA RECOGNIZED

45 AAMI BE83-2006 Biological evaluation of medical devices - Part 18:

Chemical characterization of materials

46 AAMI BF7-1989 (R 2002) Blood Transfusion Micro- Filters-FDA

RECOGNIZED

47 AAMI BF64-2002 LEUKOCYTE REDUCTION FILTERS

48 AAMI 7199-1996 (R 2002) Cardiovascular implants and artificial

organs - Blood-ga* **changers (oxygenators)

49 AAMI

BP22-1994

(R

2006) Blood

Pressure

Transducers-FDA

RECOGNIZED;

Incorporates Errata: 08/05/2004