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About This Item
Full Description
This document 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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DANSK DS/EN ISO 11607-1
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Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)- Most Recent
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DANSK DS/EN ISO 11607-1
Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)- Historical Version
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DANSK DS/EN ISO 11607-1
Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems- Historical Version
Amendments, rulings, supplements, and errata
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DANSK DSF/EN ISO 11607-1/PRA1
Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) -
DANSK DS/EN ISO 11607-1/A11
Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) -
DANSK DS/EN ISO 11607-1/A1
Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems – Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)