ISO 11607-2:2019
International Standard
Current Edition
·
Approved on
31 January 2019
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11607-2:2019 Files
English
13 Pages
Current Edition
OMR
48.18
ISO 11607-2:2019 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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