Biological evaluation of medical devices - Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3

Biological evaluation of medical devices - Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3

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1   Scope

There are differences between the views of regulatory bodies on the subject of genotoxicity testing. The purpose of this Technical Report is to provide background information to facilitate the selection of tests and guidance on the performance of tests.