We are pleased to share that a new edition of ISO 10993-1, the cornerstone standard for the biological evaluation of medical devices, has reached the Final Draft International Standard (FDIS) stage. This means the updated version — ISO/FDIS 10993-1:2025 — is now out for a final vote among ISO member bodies.
The new edition includes significant revisions to the technical content, reflecting current scientific understanding and evolving regulatory expectations. Notable improvements have been made to sections on risk-based biological evaluation, chemical characterization, and the standard’s overall integration with ISO 14971 for risk management of medical devices. Key updates are expected in areas such as material selection, material characterization, toxicological risk assessment, and testing strategies.
The FDIS stage represents the final opportunity for member countries to vote and submit any last comments before the standard’s publication. If approved, ISO 10993-1:2025 is expected to be released later this year.
We’ll continue to monitor its progress and share insights on how the changes could impact medical device manufacturers and biological safety professionals.
Stay tuned for further updates as the standard moves toward official publication.
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