DS/EN ISO 11607-2:2006
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

Standard No.

DS/EN ISO 11607-2:2006

Release Date

2006

Published By

Danish Standards Foundation

Latest

DS/EN ISO 11607-2:2006

Replace

DS/ISO 11607:2003

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.

DS/EN ISO 11607-2:2006 history

• 2006 DS/EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
• 0000 DS/ISO 11607:2003