| 1. |
. |
AAMI 10993-1 |
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|
2003-JAN-01 现用
Biological evaluation of medical devices - Part 1: Evaluation and testing-FDA RECOGNIZED
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|
| 2. |
. |
AAMI 10993-2 |
|
|
2006-OCT-20 现用
Biological evaluation of medical devices - Part 2: Animal welfare requirements
|
|
| 3. |
. |
AAMI 10993-3 |
|
|
2003-JAN-01 现用
Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
|
|
| 4. |
. |
AAMI 10993-4 |
|
|
2002-JAN-01 现用
Biological evaluation of medical devices - Part 4: Selection of tests for interaction with blood-Incorporates Amendment 1: 2006
|
|
| 5. |
. |
AAMI 10993-5 |
|
|
2009-JAN-01 现用
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
|
|
| 6. |
. |
AAMI 10993-6 |
|
|
2007-JAN-01 现用
BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
|
|
| 7. |
. |
AAMI 10993-7 |
|
|
2008-JAN-01 现用
Biological evaluation of medical devices— Part 7: Ethylene oxide sterilization residuals
|
|
| 8. |
. |
AAMI 10993-8 |
|
|
2000-JAN-01 已撤销
Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
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|
| 9. |
. |
AAMI 10993-9 |
|
|
1999-JAN-01 现用
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
|
|
| 10. |
. |
AAMI 10993-11 |
|
|
2006-JAN-01 现用
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
|
|