Biological evaluation of medical devices - Tests for genotoxicity, carcinogenicity and reproductive toxicity

Biological evaluation of medical devices - Tests for genotoxicity, carcinogenicity and reproductive toxicity

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1   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.