Βιολογική αξιολόγηση προϊόντων για ιατρική χρήση - Μέρος 3: Αποτίμηση γονοτοξικότητας, ικανότητας καρκινογένεσης, τοξικότητας στο αναπαραγωγικό σύστημα και τοξικότητας στην ανάπτυξη

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.