2024年4月16日发(作者：英正平)
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
2024年4月16日发(作者：英正平)
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