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AAMI TIR22:2007

Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices- Part 1 and Part 2: 2006

This AAMI Technical Information Report (TIR) provides interpretive guidance for the application of ANSI/AAMI/ISO 11607-1:2006, Packaging for terminally sterilized medical devices- Part 1: Requirements for materials, sterile barrier systems, and packaging as well as for ANSI/AAMI/ISO 11607-2:2006, Packaging for terminally sterilized medical devices-Part 2: Validation and requirements for forming, sealing, and assembly processes.

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Association for the Advancement of Medical Instrumentation [aami]

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