ISO/TR 10993-33:2015

Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3

Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3

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ISO/TR 10993-33:2015

Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3

Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3

There are differences between the views of regulatory bodies on the subject of genotoxicity testing. The purpose of this ISO/TR 10993-33: 2015 is to provide background information to facilitate the selection of tests and guidance on the performance of tests.

Edition2015
Standard Part No33
Published Date2015
Published ByInternational Standardization Organisation/Technical Reference
Page Count47