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ISO 11607-3:2026PublishedPackaging for terminally sterilized medical devices — Part 3: Requirements for process development for forming, sealing and assemblyInternational Standard · Published 18 Sep 2026 · ISO/TC 198ISO 11607-1:2019PublishedPackaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systemsInternational Standard · Published 31 Jan 2019 · ISO/TC 198ISO 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 198ISO/TS 16775:2021PublishedPackaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2Technical Specification · Published 5 Nov 2021 · ISO/TC 198ISO 21881:2019PublishedSterile packaged ready for filling glass cartridgesInternational Standard · Published 18 Oct 2019 · ISO/TC 76ISO 21882:2019PublishedSterile packaged ready for filling glass vialsInternational Standard · Published 18 Oct 2019 · ISO/TC 76ISO 11607-1:2006WithdrawnPackaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systemsInternational Standard · Published 7 Apr 2006 · ISO/TC 198ISO 11607-2:2006WithdrawnPackaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processesInternational Standard · Published 7 Apr 2006 · ISO/TC 198ISO 11607:2003WithdrawnPackaging for terminally sterilized medical devicesInternational Standard · Published 10 Feb 2003 · ISO/TC 198ISO 11607:1997WithdrawnPackaging for terminally sterilized medical devicesInternational Standard · Published 30 Jan 1997 · ISO/TC 198ISO/TS 16775:2014WithdrawnPackaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2Technical Specification · Published 9 May 2014 · ISO/TC 198