环氧乙烷灭菌产品的无菌放行

Sterile Medical Device Release from Sterilization with Ethylene Oxide

依据《中华人民共和国医疗器械监管法规》《中华人民共和国药典》、国家标准GB 14233.2以及GB 18279.1,探讨医疗器械环氧乙烷灭菌后的几种无菌放行程序,分析这几种无菌放行程序的关系以及优缺点,同时总结国际上欧美等发达国家环氧乙烷灭菌产品常用的无菌放行程序。按照GB 18279.1的传统放行或者参数放行可以避免无菌检查法的局限性,确保无菌的要求得到完全满足,提高产品流通效率,避免资源的浪费。

Based on the medical device regulatory regulations of the People.s Republic of China, the Chinese Pharmacopoeia, the national standard GB14233.2 and GB18279.1, this paper discusses several procedures of medical device release from sterilization with ethylene oxide, and analyzes the relationship, advantages and disadvantages of these release procedures, as well as the common procedures of medical device release from sterilization with ethylene oxide in developed countries such as Europe and the United States. According to the traditional release or parameter release of GB 18279.1, not only the limitations of the sterility inspection method can be avoided, but also the SAL can be completely satisfied, the product circulation efficiency can be improved, and the waste of resources can be avoided.