Найдено: 9
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…
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 11607-1:2019 sets the internationally recognized requirements for the materials, sterile barrier systems, and packaging systems used for terminally sterilized medical devices. Published…
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…