AAMI TIR22:2007

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

Association for the Advancement of Medical Instrumentation , 03/20/2007

Pages: 53

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This AAMI Technical Information Report (TIR) provides interpretive guidance for the application ofANSI/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/ISO11607-2:2006, Packaging for terminally sterilized medical devices-Part 2: Validation andrequirements for forming, sealing, and assembly processes.