医疗器械灭菌方法、灭菌工艺验证及无菌检查

Sterilization Methods,Validation of Sterilization Process and Sterility Testing for Medical Devices

文章阐述了湿热灭菌、干热灭菌、环氧乙烷灭菌、辐射灭菌、低温等离子体灭菌等5种医疗器械灭菌方法,并介绍了灭菌工艺验证和无菌检查方面的内容。

This paper describes five sterilization methods for medical devices,such as moist heat sterilization,dry heat sterilization,EO sterilization,radiation sterilization,low-temperature plasmas sterilization etc.The method of validation of sterilization process and sterility testing are introduced.