BS EN ISO 10993-3:2009

Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity | Status: Superseded, Withdrawn

1 Scope This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the following biological aspects:

• — genotoxicity,
• — carcinogenicity, and
• — reproductive and developmental toxicity.

This part of ISO 10993 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.

NOTE Guidance on selection of tests is provided in ISO 10993-1.