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EN ISO 10993-1:2009 Standard

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  Keywords:

#corrigendum #process #management #risk #testing

This standard is superseded by:
  •   EN ISO 10993-1:2009 from: 2010-03-21
  • 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 60601-1:2006/AC:2010

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

    Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

    EN ISO 11607-2:2020

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

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

    EN ISO 10993-18:2009

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

    Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

    EN ISO 10993-17:2009

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

    Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

    EN ISO 10993-13:2010

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

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

    EN ISO 10993-12:2012

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

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

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