ISO 10993-3
Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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| Organization: | ISO |
| Publication Date: | 15 October 2003 |
| Status: | inactive |
| Page Count: | 24 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
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 developmental toxicity.
This part of ISO 10993 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.
NOTE Guidance on selection of tests is provided in ISO 10993-1.
Document History
October 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...
ISO 10993-3
October 15, 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, 1992
Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity; (CEN EN 30993-3: 1993)
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