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About This Item
Full Description
This document specifies requirements for the 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.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
Document History
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ISO 11607-2:2019
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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes- Most Recent
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ISO 11607-2:2006/Amd1:2014
- Amendment 1- Historical Version
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ISO 11607-2:2006
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes- Historical Version
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ISO 11607:2003
Packaging for terminally sterilized medical devices- Historical Version