ISO 11607-1 Amendment 1:2023: Packaging Risk Management
When specifying packaging for terminally sterilised medical devices, identify the full document designation. A base standard, a separate amendment and a consolidated national publication are different purchasing and reference options. What the amendment addresses ISO 11607-1:2019/Amd 1:2023 adds risk-management application to the Part 1 requirements for materials, sterile barrier systems and packaging systems. ISO records its publication in September 2023. A national adoption can have a different publication date. The EVS record for EN ISO 11607-1:2020/A1:2023 identifies an amendment publication. It should not be described as a new standalone edition containing the entire base standard. Check what your copy contains Confirm the base standard and all applicable amendments. Check whether the supplied document is amendment-only or consolidated. Distinguish European additions, such as an A11 amendment, from the international Amd 1. Record the publication actually used in the assessment a...