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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This standard is superseded by: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 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)

    EN ISO 13408-6:2011

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

    Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

    EN 556-1:2001/AC:2006

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

    Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

    EN 556-2:2015

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

    Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

    EN ISO 10993-1:2009/AC:2010

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

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

    EN ISO 10993-3:2014

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

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:...

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