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About This Item

 

Full Description

Identical versions for sale:
Outside United States: BS EN ISO 11607-1:2006
German: DIN EN ISO 11607-1:2006
Spanish: UNE EN ISO 11607-1:2007


ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.

ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.

ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.

 

Document History

  1. ISO 11607-1:2019


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

    • Most Recent
  2. ISO 11607-1:2006

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

    • Historical Version
  3. ISO 11607:2003


    Packaging for terminally sterilized medical devices

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO 11607-1:2006/Amd1:2014


    - Amendment 1