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AAMI 11607-2
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AAMI 11607-2 6th Edition, 2014 Packaging for terminally sterilized medical devices-Part 2: Validation requirements for forming, sealing, and assembly processes
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Description / Abstract:
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.
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.