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  • Charlie Rivera

ISO 11607-1:2019, Packaging for terminally sterilized medical devices

The new revision of ISO 11607 Part 1, Requirements for materials, sterile

barrier systems and packaging systems, just got released. This second edition cancels and replaces the first edition (ISO 11607-1:2006), which has been technically

revised. It also incorporates the amendment ISO 11607-1:2006/Amd.1:2014.


As part of this revision, newer requirements for the evaluation of usability for aseptic packaging presentation in addition to inspection of sterile barrier system integrity prior to use, among other changes, have been added.


Mavajan Packaging Solutions, LLC can help and educate on these changes in addition to what's needed to comply with these new requirements.



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