医疗器械灭菌

Sterilization of Medical Devices

本文阐述了医疗器械灭菌的方法和进展。同时介绍了六个有关灭菌的标准 :(1)工业湿热灭菌的确认和常规控制要求。(2)环氧乙烷灭菌的确认和常规控制要求。(3)灭菌用生物指示剂。(4)灭菌用化学指示剂。(5)环氧乙烷残留量的测试。(6)

This describes the methods of sterilization on medical devices and the headway of sterilization. Six standard of sterilization on medical devices isintroduced: (1) Sterilization of healthcare products requirements for validation and routine controlindustrial moist heat sterilization. (2) Medical devicesvalidation and routine control of ethylene oxide sterilization. (3) Sterilization of healthcare products biological indicators. (4) Sterilization of healthcare products chemical indicators. (5) Ethylene oxide sterilization residuals. (6) Microbial assays.