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EN ISO 10993-12:2021 Standard

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  Keywords:

#selection #test #device #sample #methods

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Wednesday 1st of April 2026

  Description:

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

  Purpose

ISO 10993-12 specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing. Sample preparation methods must be appropriate for both the biological evaluation methods and the materials being evaluated. Each biological test method requires the selection of materials, extraction solvents and conditions. ISO 10993-12 is based on existing national and international standards and regulations, wherever possible. ISO 10993-12 addresses: — test sample selection,— selection of representative portions from a medical device,— test sample preparation,— experimental controls,— selection of, and— reference materials, preparation of extracts. The text of ISO 10993-12:2021 has been approved in Europe as EN ISO 10993-12:2021 without any changes.

  Publication

Wednesday 5th of January 2022

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