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EN ISO 11607-1:2009 Standard

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  Keywords:

#systems #amendment #packaging #barrier #sterile

This standard is superseded by:
  •   EN ISO 11607-1:2020
  •   Directive

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

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

      Purpose

    Amendment for EN ISO 11607-1:2009.

      Publication

    Friday 17th of November 2017

      Reference

    This standard supersedes the "EN ISO 11607-1:2006"

    Anyway is still possible use the "EN ISO 11607-1:2006" until March 21st, 2010

      Related Standards

    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 10993-12:2012

    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 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 62304:2006/AC:2008

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

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

    EN 62304:2006

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

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

    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

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