BS EN ISO 11607-2:2020+A11:2022 Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
1 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.
BS EN ISO 11607-2:2020+A11:2022 history
2023BS EN ISO 11607-2:2020+A1:2023 Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
2022BS EN ISO 11607-2:2020+A11:2022 Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
1970BS EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
1970BS EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
2014BS EN ISO 11607-2:2006+A1:2014 Packaging for terminally sterilized medical devices-Validation requirements for forming, sealing and assembly processes
2006BS EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes