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DIN EN ISO 11607-1:2024
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
This part of ISO 11607 specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterilebarrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
This Amendment 1 expands on the application of risk management throughout the phases of design and development, validation and production of the packaging system. The 2020 version will be extended to include, among other things, Annex F "Risk management" and Annex G "Risk management for medical device packaging – rationale for requirements".
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Deutsches Institut für Normung [din]