医疗器械环氧乙烷灭菌的主要考量因素

摘要

Ethylene Oxide is a widely used sterilant with demonstrated strong effectiveness to bacteria, virus, fungi and spores. Ethylene oxide sterilization is one of the major methods of sterilizing medical devices and about half of the medical device sterilization market is occupied by ethylene oxide. This paper summarizes the major factors to be considered in ethylene oxide sterilization for medical devices, including processing parameters, product releases, sterilization residues, and product design.%环氧乙烷是一种运用广泛的灭菌剂，对细菌、病毒、真菌、芽胞等都具有良好的灭菌效果。环氧乙烷灭菌是目前医疗器械灭菌的主要方式之一，目前全球医疗器械灭菌的市场份额，环氧乙烷占据了约一半左右。本文对医疗器械环氧乙烷灭菌相关的主要因素，如灭菌参数、放行方式、灭菌残留、产品设计等做了简要归纳。