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Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
Description
Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processesWhat is this standard about? 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. Who is this standard for? This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical
so it has to be tested on its own
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