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ANSI/AAMI/ISO 11607-2:2019

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

This standard specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized and maintain sterility to the point of use. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems, and packaging systems.

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Association for the Advancement of Medical Instrumentation [aami]

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