AAMI 10993-3
Biological evaluation of medical devices-Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
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| Organization: | AAMI |
| Publication Date: | 1 January 2014 |
| Status: | active |
| Page Count: | 50 |
scope:
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:
- genotoxicity;
- carcinogenicity;
- reproductive and developmental toxicity.
This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.
NOTE Guidance on selection of tests is provided in ISO 10993-1.
Document History
AAMI 10993-3
January 1, 2014
Biological evaluation of medical devices-Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially...
January 1, 2014
Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially...
January 1, 2003
Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the following biological aspects:
— genotoxicity,
— carcinogenicity, and
— reproductive and...
January 1, 2003
Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
A description is not available for this item.
January 1, 2003
Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the following biological aspects:
— genotoxicity,
— carcinogenicity, and
— reproductive and...
January 1, 1993
Biological evaluation of medical devices-Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
A description is not available for this item.