DIN EN ISO 11607-2:2017
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO/DIS 11607-2:2017); German and English version prEN ISO 11607-2:2017

Standard No.

DIN EN ISO 11607-2:2017

Release Date

2017

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 11607-2 E:2017-11

Latest

DIN EN ISO 11607-2:2024-02

Scope

This part of ISO 11607 specifies the requirements for 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. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.

DIN EN ISO 11607-2:2017 history

• 2024 DIN EN ISO 11607-2:2024-02 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019 + Amd 1:2023); German version EN ISO 11607-2:2020 + A1:2023
• 2022 DIN EN ISO 11607-2/A1:2022-08 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2019/DAM 1:2022); German and English version EN ISO 11607-2:2020/prA1:2022 / Note: Date of issu...
• 2022 DIN EN ISO 11607-2 A11:2022 Packaging for medical devices to be sterilized in final packaging – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020/A11:2022
• 2020 DIN EN ISO 11607-2:2020-05 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020 / Note: To be amended by DIN EN ISO 11607-2/A1 (2022-08).
• 2020 DIN EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
• 1970 DIN EN ISO 11607-2 E:2017-11 Packaging of terminally sterilized medical devices Part 2: Identification and requirements for composition, sealing and assembly processes (draft)
• 2017 DIN EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO/DIS 11607-2:2017); German and English version prEN ISO 11607-2:2017
• 2014 DIN EN ISO 11607-2:2014 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006 + Amd 1:2014); German version EN ISO 11607-2:2006 + A1:2014
• 2006 DIN EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) English version of DIN EN ISO 11607-2:2006-07
• 0000 DIN EN ISO 11607-2:2004