dnaSRPS EN ISO 10993-3:2024

Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity (ISO/FDIS 10993-3:2026)

Scope

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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.