BS EN ISO 11607-1:2020+A11:2022
Packaging for terminally sterilized medical devices-Requirements for materials, sterile barrier systems and packaging systems
standard by British Standard / European Standard / International Organization for Standardization, 09/16/2022
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About This Item
Full Description
This standard 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
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BS EN ISO 11607-1:2020+A11:2022
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Packaging for terminally sterilized medical devices-Requirements for materials, sterile barrier systems and packaging systems- Most Recent
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BS EN ISO 11607-1:2020
Packaging for terminally sterilized medical devices-Requirements for materials, sterile barrier systems and packaging systems- Historical Version
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BS EN ISO 11607-1:2020 Draft
Draft -- Packaging for terminally sterilized medical devices-Requirements for materials, sterile barrier systems and packaging systems- Historical Version
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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
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BS EN ISO 11607-1:2017
Packaging for terminally sterilized medical devices-Requirements for materials, sterile barrier systems and packaging systems- Historical Version
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BS EN ISO 11607-1:2009+A1:2014
Packaging for terminally sterilized medical devices-Requirements for materials, sterile barrier systems and packaging systems- Historical Version
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BS EN ISO 11607-1:2009
Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems- Historical Version
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BS EN ISO 11607-1:2006
Packaging for terminally sterilized medical devices-Requirements for materials, sterile barrier systems and packaging systems- Historical Version
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BS EN 868-1:1997
Packaging materials and systems for medical devices which are to be sterilized-General requirements and test methods- Historical Version
