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AAMI/ISO 11607-2: 2019

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 2019

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Full Description

Specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized and maintain sterility to the point of use. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems, and packaging systems.
 

Product Details

Edition:
2nd
Published:
2019
ISBN(s):
9781570207204
ANSI:
ANSI Approved
Number of Pages:
26
File Size:
1 file , 510 KB
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. AAMI/ISO 11607-2: 2019

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    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

    • Most Recent

  2. AAMI/ISO 11607-2:2006/(R)2015


    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

    • Historical Version

  3. AAMI/ISO 11607:2000


    Packaging for terminally sterilized medical devices

    • Historical Version

  4. AAMI 11607:1997


    Packaging for terminally sterilized medical devices

    • Historical Version