AAMI 11607-2
Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing, and assembly processes
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| Organization: | AAMI |
| Publication Date: | 1 January 2019 |
| Status: | active |
| Page Count: | 26 |
scope:
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
Document History
AAMI 11607-2
January 1, 2019
Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing, and assembly processes
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and...
January 1, 2006
Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing, and assembly processes
This part of ISO 11607 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing,...
January 1, 2006
Packaging for terminally sterilized medical devices-Part 2: Validation requirements for forming, sealing, and assembly processes
This part of ISO 11607 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing,...
January 1, 2006
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
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