AAMI TIR22:2007 and TIR22:2007/A1:2008 PDF
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.