EVS-EN ISO 10993-3:2026

ISO 10993-3 specifies strategies for risk estimation and evaluation of biological harms with respect to:

— genotoxicity,
— carcinogenicity,
— reproductive toxicity and
— developmental toxicity.

The basis for biological evaluation of medical devices is often empirical and driven by relevant concerns for human safety. The risk of serious and irreversible effects, such as cancer or second-generation abnormalities, is of particular public concern. It is inherent in the provision of safe medical devices that such risks be minimised to the greatest extent feasible.

ISO 10993-3 can be applied when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity has been established.  This standard cannot be applied to active pharmaceutical ingredients of device-drug combination products or biological components of device-biologic combination products which are covered by regulations.

ISO 10993-3:2026 text has been approved in Europe as EN ISO 10993-3:2026 without any changes.