This document specifies strategies for risk estimation and evaluation of biological harms with respect to:

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

This document is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity has been established.

This document is not applicable to active pharmaceutical ingredients of device-drug combination products or biological components of device-biologic combination products which are covered by regulations.

NOTE            Guidance on selecting relevant biological effects for medical devices is covered in ISO 10993-1.