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EN 62304:2006 Standard

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  Keywords:

#amendment #medical #device #software #software

This standard can be totally or partially supervised by:
  •   EN 62304:2006/AC:2008
  •   Directive

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

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

    Medical device software - Software life-cycle processesIEC 62304:2006

      Purpose

    Amendment for EN 62304:2006

      Publication

    Friday 17th of November 2017

      Related Standards

    EN ISO 14155:2011/AC:2011

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

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

    EN ISO 11607-1:2020

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

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

    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)

    EN ISO 10993-9:2009

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

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation produc...

    EN ISO 10993-7:2008/AC:2009

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

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

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