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About This Item

 

Full Description

BS EN ISO 11607-1:2020 specifies 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.

It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.

It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

It does not describe a quality assurance system for control of all stages of manufacture.

It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
 

Document History

  1. BS EN ISO 11607-1:2020

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    Packaging for terminally sterilized medical devices

    • Most Recent
  2. BS EN ISO 11607-1:2017 - TC


    Tracked Changes. Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems

    • Historical Version
  3. BS EN ISO 11607-1:2017


    Packaging for terminally sterilized medical devices

    • Historical Version
  4. BS EN ISO 11607-1:2009+A1:2014


    Packaging for terminally sterilized medical devices

    • Historical Version
  5. BS EN ISO 11607-1:2009


    Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems

    • Historical Version
  6. BS EN ISO 11607-1:2006


    Packaging for terminally sterilized medical devices

    • Historical Version
  7. BS EN 868-1:1997


    Packaging materials and systems for medical devices which are to be sterilized. General requirements and test methods

    • Historical Version