Foreword

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This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of medical devices, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 206, Biological and clinical evaluation of medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

A list of all parts in the ISO 10993 series can be found on the ISO website.

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ISO 10993-12:2021/Amd 1:2025

Biological evaluation of medical devices - Sample preparation and reference materials

Current

Published:

13 Aug 2025