ISO/TR 10993-33:2015Withdrawn

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

Évaluation biologique des dispositifs médicaux — Partie 33: Directives sur les essais pour évaluer la génotoxicité — Supplément à l'ISO 10993-3

This edition has been replaced by ISO 10993-3:2026.

Abstract / 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.

Life cycle

Replaced by

ISO 10993-3:2026PublishedBiological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicityInternational Standard · Published 6 Aug 2026 · ISO/TC 194