ISO TR 10993-33
Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
|Publication Date:||1 March 2015|
|ICS Code (Biological evaluation of medical devices):||11.100.20|
There are differences between the views of regulatory bodies on the subject of genotoxicity testing. The purpose of this Technical Report is to provide background information to facilitate the selection of tests and guidance on the performance of tests.