ISO 11607-2
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
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| Organization: | ISO |
| Publication Date: | 1 February 2019 |
| Status: | active |
| Page Count: | 20 |
| ICS Code (Sterilized packaging): | 11.080.30 |
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
September 1, 2023
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes AMENDMENT 1: Application of risk management
A description is not available for this item.
ISO 11607-2
February 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...
July 15, 2014
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes AMENDMENT 1
A description is not available for this item.
April 15, 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,...