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ISO 11607-2:2006Withdrawn

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

Emballages des dispositifs médicaux stérilisés au stade terminal — Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage

This edition has been replaced by ISO 11607-2:2019.

Abstract / scope

ISO 11607-2:2006 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.

ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.

ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.

Life cycle

Amendments & corrigenda

ISO 11607-2:2006/Amd 1:2014WithdrawnPackaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1International Standard · Published 7 Jul 2014 · ISO/TC 198

Replaces

ISO 11607:2003WithdrawnPackaging for terminally sterilized medical devicesInternational Standard · Published 10 Feb 2003 · ISO/TC 198

Replaced by

ISO 11607-2:2019PublishedPackaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processesInternational Standard · Published 31 Jan 2019 · ISO/TC 198