There’s a new updated standard, (EN) ISO 17665:2024, sterilization of healthcare products using moist heat.

This document provides requirements for the development, validation, and routine control of moist heat sterilization processes for medical devices. Of course it includes Annex ZA, relationship between the standard and the GSPR requirements of the MDR 2017/745.

This sterilization method is primarily used in hospitals, including CSSD Departments, for the sterilization and re-sterilization of medical devices consisting of hard polymers and metals such as PEEK, Titanium and stainless steel. It will also be used for the upcoming EU new classification, class Ir, for the re-sterilization of reusable surgical instruments.