GSO ISO 11607-2:2007
ISO 11607-2:2006
Gulf Standard
Historical
·
Approved on
26 September 2007
Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
GSO ISO 11607-2:2007 Files
English
11 Pages
Historical
Reference Language
29.11 BHD
GSO ISO 11607-2:2007 Scope
This part of ISO 11607 specifies the requirements for 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.
This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are
packaged and sterilized.
This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured
aseptically. Additional requirements may also be necessary for drug/device combinations.
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