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Overview ISO 11607-2:2019/Amd 1:2023 is an important amendment to the international standard ISO 11607-2:2019, which specifies the validation requirements for forming, sealing, and assembly processes…
Overview EN ISO 11607-2:2020/A1:2023 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of…
Overview EN ISO 11607-2:2020/A11:2022 (Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes) is a CEN-adopted amendment to…
Overview CEN ISO/TS 16775:2021 - "Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2" - is an informative Technical Specification that ex…
Overview EN ISO 11607-2:2020 (ISO 11607-2:2019) - "Packaging for terminally sterilized medical devices - Part 2" defines the validation requirements for forming, sealing and assembly processes used t…
1 Scope This Technical Specification provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, the requirements of I…
Overview ISO/TS 16775:2021 - Packaging for terminally sterilized medical devices - is an informative technical specification that provides guidance on applying ISO 11607‑1 and ISO 11607‑2. It clarifi…
Overview ISO 11607-2:2019 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - specifies requirements for the developm…