BS EN ISO 10993-3:2014 - Page 2

Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity | Status: Current, Under review

1 Scope This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:

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

This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

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