ISO 10993-3:2026 Published: Updated Requirements for Biological Evaluation of Medical Devices
ISO 10993-3:2026 was officially published in August 2026 as the fourth edition of the standard. The updated standard addresses the biological evaluation of medical devices with respect to genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity. ISO 10993-3 provides manufacturers with strategies for evaluating these potential biological risks where they have been identified as relevant to ...

