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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 ISO 17665-1:2006

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

    Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a...

    EN ISO 13408-4:2011

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

    Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

    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 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 13485:2016/AC:2018

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

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

    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)

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