Standard ISO standard · ISO/TR 10993-33:2015

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

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Standard ISO standard · ISO/TR 10993-33:2015

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Scope

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.

Subjects

Biological evaluation of medical devices (11.100.20)

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

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