ISO 10993-1 updated version now available

The International Standardisation Organisation (ISO) has now published a revised version of this cornerstone standard for biological evaluation of medical devices, which has been completely reorganized to align with the ISO 14971 on risk management for medical devices.

The new standard, ISO 10993-1:2025, ‘Biological evaluation of medical devices – Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process,‘ adds new guidance on exposure duration, materials characterization, and identification of biological hazards. Terminology has also been updated for clarity, and new annexes explain the rationale behind the changes.

The new standard defines the principles and requirements for assessing a device’s biological safety within the broader risk management framework established by ISO 14971, guiding manufacturers and evaluators through the process of identifying, assessing, and managing biological risks associated with materials, design choices, and tissue contact during a device’s intended use.