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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This standard is superseded by: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    This standard has been withdrawn on 2021-04-14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

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    EN ISO 13408-4:2011

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    CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 11607-2:2006 STANDARD

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