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

Standard No.

DIN EN ISO 11607-2:2006

Release Date

2006

Published By

German Institute for Standardization

Status

Withdraw

Replace By

DIN EN ISO 11607-2:2014

DIN EN ISO 11607-2 A1 E:2013-04

Latest

DIN EN ISO 11607-2:2024-02

Replace

DIN EN ISO 11607-2:2004

Scope

This standard 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.

DIN EN ISO 11607-2:2006 Referenced Document

• ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1*， 2009-12-01 Update

DIN EN ISO 11607-2:2006 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