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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

    Medical devices Directive (93/42/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 ISO 11607-1:2020

    Medical devices Directive (93/42/EEC)

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

    EN ISO 11138-2:2009

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    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization pro...

    EN ISO 10993-4:2009

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd...

    EN ISO 10993-7:2008/AC:2009

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

    EN ISO 10993-12:2012

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

    EN ISO 10993-13:2010

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medic...

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