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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 ISO/TR 10993-33:2015

Publication date:   Mar 6, 2015

General information

60.60 Standard published   Mar 6, 2015

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

Technical Report

11.100.20   Biological evaluation of medical devices

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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.

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PUBLISHED
ISO/TR 10993-33:2015
60.60 Standard published
Mar 6, 2015