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EN ISO 10993-1:2009 Standard

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  Keywords:

#corrigendum #process #management #risk #testing

This standard can be totally or partially supervised by:
  •   EN ISO 10993-1:2009/AC:2010
  •   Directive

    Active implantable medical devices Directive (90/385/EEC)

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

      Purpose

    Corrigendum to EN ISO 10993-1:2009.

      Publication

    Friday 17th of November 2017

      Related Standards

    EN 556-1:2001

    Active implantable medical devices Directive (90/385/EEC)

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    EN ISO 11607-1:2020

    Active implantable medical devices Directive (90/385/EEC)

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

    EN ISO 10993-18:2020

    Active implantable medical devices Directive (90/385/EEC)

    Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management...

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