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Biological evaluation of medical devices - Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3 Ingestion-build-48024 By adopting BS EN 15342

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By adopting BS EN 15342

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Biological evaluation of medical devices - Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3 Ingestion-build-48024 By adopting BS EN 153421 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.

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