ISO17664《制造商提供的可重复灭菌的医疗器械的处理信息》标准解读

Interpretation of ISO17664 Sterilization of Medical Devices——Information to be provided by the manufacturer for the processing of re-sterilizable medical devices

ISO17664:2004标准《制造商提供的可重复灭菌的医疗器械的处理信息》为制造重复使用医疗器械或非灭菌但由用户完成灭菌的医疗器械的制造商,提供了指南。制造商应提供处理的信息,以指导用户对以上的医疗器械正确地清洗,消毒,干燥,检验,灭菌,贮存,以达到无菌的效果和避免医疗器械的损坏。

The ISO17664 standard： Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of re-sterilizable medical devices, provide the guidance for the manufacturers who makes medical devices claimed to be re-sterilizable and medical devices intended to be sterilized by the processor. The manufacturers shall provide and specify the information to the users / processors, to guide the correct cleaning, disinfection, drying, sterlization, and storage, for the result of sterile and avoiding the damage of medical devices.