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CSA ISO 11607-2:21

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Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (Adopted ISO 11607-2:2019, second edition, 2019-02)

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Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (Adopted ISO 11607-2:2019, second edition, 2019-02)

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.


SDO CSA: Canadian Standards Association
Document Number
Publication Date Jan. 1, 2021
Language en - English
Page Count
Revision Level
Supercedes
Committee
Publish Date Document Id Type View
Jan. 1, 2021 CSA ISO 11607-2:21 Revision
Jan. 1, 2021 CSA ISO 11607-2:F21 Revision