ISO 11607-2:2019
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
- Standard No.
- ISO 11607-2:2019
- Release Date
- 2019
- Published By
- International Organization for Standardization (ISO)
- Status
- 2019-02
- Replace By
- ISO 11607-2:2019/Amd 1:2023
- Latest
- ISO 11607-2:2019/Amd 1:2023
- 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.
ISO 11607-2:2019 history
- 2019 ISO 11607-2:2019/Amd 1:2023 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — AMENDMENT 1: Application of risk management
- 2019 ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
- 2014 ISO 11607-2:2006/Amd 1:2014 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
- 2006 ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
