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Full Description

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.
 

Document History

  1. AAMI/ISO TIR16775:2023


    Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2

    • Most Recent
  2. AAMI/ISO TIR16775:2014


    Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2

    • Historical Version
  3. AAMI TIR22:2007 and TIR22:2007/A1:2008

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    Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices - Part 1 and Part 2:2006, (now includes 2008 amendment)

    • Historical Version
  4. AAMI TIR22:2007/A1:2008


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

    • Historical Version
  5. AAMI TIR22:2007


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

    • Historical Version
  6. AAMI/ISO TIR 22:1998 + Amendment 1


    Guidance for ANSI/AAMI/ISO 11607, Packaging for Terminally Sterilized Medical Devices

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. AAMI TIR22:2007/A1:2008

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