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Biological evaluation of medical devices -- Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity
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.
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