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EN ISO 10993-18:2020 Standard

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  Keywords:

#amendment #main #medical #text #can

This standard can be totally or partially supervised by:
  •   EN ISO 10993-18:2020/A1:2023
  •   Directive

    Medical devices Regulation ((EU) 2017/745)

      Last Official Journal reference

    Wednesday 1st of April 2026

      Description:

    Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

      Purpose

    The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history. EN ISO 10993-18:2020/A1:2023 modifies the European standard EN ISO 10993-18:2020. In this amendment, you can find the relationship between EN ISO 10993-18:2020 and the General Safety and Performance Requirements of Regulation (EU) 2017/745.

      Publication

    Friday 8th of March 2024

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