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EN ISO 10993-7:2008 Standard

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  Keywords:

#corrigendum #devices #residuals #sterilization #oxide

This standard can be totally or partially supervised by:
  •   EN ISO 10993-7:2008/AC:2009
  •   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 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

      Purpose

    Corrigendum to EN ISO 10993-7:2008.

      Publication

    Friday 17th of November 2017

      Related Standards

    EN 60601-1:2006/A1:2013

    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 10993-1:2009

    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 10993-17:2009

    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 10993-16:2010

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

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-...

    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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