BH GSO ISO 11607-2:2022
ISO 11607-2:2019
Bahraini Standard
Current Edition
·
Approved on
28 April 2022
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
BH GSO ISO 11607-2:2022 Files
English
13 Pages
Current Edition
Reference Language
BHD
47.13
BH GSO ISO 11607-2:2022 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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