Sterilisation of Vat-Printed Photopolymers: Dimensional Evidence and Qualification Gaps
Segurola, Juan
2026-08-21 · Informe · Versión 1.2
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Two primary studies evaluate dimensional accuracy of printed surgical guides or templates after defined sterilisation/disinfection workflows. No source in the retained set reports mechanical, thermal or extractables change as a function of a sterilisation cycle. Those outcomes are therefore qualification requirements, not reviewed findings. Current process anchors are ISO 17665:2024 for moist heat, ISO 11135:2014+A1:2018 for ethylene oxide and ISO 11137-1:2025 for radiation. Biological evaluation belongs to the finished processed and sterilised article within ISO 10993-1:2025 risk management. RP-02 defines the shared qualification method.