OS GSO ISO 11607-2:2021
ISO 11607-2:2019
Omani Standard
Current Edition
·
Approved on
01 July 2021
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
OS GSO ISO 11607-2:2021 Files
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OS GSO ISO 11607-2:2021 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.
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