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Publications of ISO/TC 198/WG 7

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DIN CEN ISO/TS 16775	2022-04	Technical Specification	Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021); German version CEN ISO/TS 16775:2021 More	Order from Beuth Verlag
DIN EN ISO 11607-1	2024-02	Standards	Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023); German version EN ISO 11607-1:2020 + A1:2023 More	Order from Beuth Verlag
DIN EN ISO 11607-2	2024-02	Standards	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 More	Order from Beuth Verlag
ISO/TS 16775	2021-11	Pre-standard	Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 More	Order from Beuth Verlag
ISO 11607-1	2019-02	Standards	Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems More	Order from Beuth Verlag
ISO 11607-1 AMD 1	2023-09	Standards	Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management More	Order from Beuth Verlag
ISO 11607-2	2019-02	Standards	Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes More	Order from Beuth Verlag
ISO 11607-2 AMD 1	2023-09	Standards	Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management More	Order from Beuth Verlag

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