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.
EN ISO 10993-3:2009 history
2014EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
2009EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity@ carcinogenicity and reproductive toxicity
2003EN ISO 10993-3:2003 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Supersedes EN 30993-3: 1999; ISO 10993-3: 2003