ISO/TR 10993-33:2015

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

Publication date:   Mar 6, 2015

95.99   Withdrawal of Standard   Aug 6, 2026

General information

95.99   Withdrawal of Standard   Aug 6, 2026

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.

Life cycle

NOW

WITHDRAWN
ISO/TR 10993-33:2015
95.99 Withdrawal of Standard
Aug 6, 2026

REVISED BY

PUBLISHED
ISO 10993-3:2026