Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
|Publication Date:||15 October 2003|
|ICS Code (Biological evaluation of medical devices):||11.100.20|
This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the following biological aspects:
- 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.