ISO 11607-3:2026 / Packaging for terminally sterilized medical devices - Requirements
ID 27217 | 03.10.2026 / Allegato Preview
ISO 11607-3:2026
Packaging for terminally sterilized medical devices - Part 3: Requirements for process development for forming, sealing and assembly
Published (Edition 1, Sett. 2026)
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This document specifies requirements for process development for forming, sealing and assembly of packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies.
This document recommends minimum heat sealing equipment features to support subsequent validation, process control [...]