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AAMI/ISO TIR16775:2014

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

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 07/27/2014

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Full Description

This technical report contains guidance on the application of ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2006, Packaging for terminally sterilized medical device - Part 2: Validation requirements for forming, sealing, and assembly processes. Possible options for compliance with the requirements of Parts 1 and 2 will be addressed as special concerns that may require attention due to regional or local conditions, practices or regulations.
 

Product Details

Published:
07/27/2014
ISBN(s):
1570205590
File Size:
1 file , 980 KB
Same As:
ISO/TS 16775:2014
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

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

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    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


    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