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EN ISO 11607-2:2006 Standard

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  Keywords:

#systems #packaging #barrier #sterile #include

This standard is superseded by:
  •   EN ISO 11607-2:2020
  •   This standard is no longer addressed in the last official Journal publication of the "2021-04-14 ". This standard is addressed for the last time in the official journal publication of the "2020-03-25"

      Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 25th of March 2020

      Description:

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)

      Purpose

    This part of ISO 11607 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

      Publication

    Friday 17th of November 2017

      Cessation

    This standard has been withdrawn on 2021-04-14

      Related Standards

    EN 60601-2-46:1998

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment -- Part 2-46: Particular requirements for the safety of operating tablesIEC 60601-2-46:1998

    EN ISO 7396-1:2007/A2:2010

    Medical devices Directive (93/42/EEC)

    Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)

    EN ISO 11607-1:2020

    Medical devices Directive (93/42/EEC)

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

    EN ISO 10993-18:2020

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management...

    EN 1789:2020

    Medical devices Directive (93/42/EEC)

    Medical vehicles and their equipment - Road ambulances

    EN ISO 8835-5:2009

    Medical devices Directive (93/42/EEC)

    Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)

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