两种方法对导管医疗器具无菌检查的比较  

Comparison of Two Methods for the Medical Instrument Sterility Tests of Catheters

作　　者：黄结 王涛 

机构地区：[1]广西壮族自治区食品药品检验所,南宁530021

出　　处：《中国药事》2015年第11期1189-1191,共3页Chinese Pharmaceutical Affairs

摘　　要：目的:探讨两种方法对导管医疗器具无菌检查的适用性,给同行提供参考。方法:分别采用《中国药典》2010年版二部规定的洗脱-收集-薄膜过滤法和改进后的直接接种法,对市场抽检及企业委托送检的导管医疗器具59批进行无菌检查。结果:两种方法检测样品结果均符合《中国药典》的规定。结论:两种方法均可选用,但改进后的直接接种法操作更简单、更方便,能提高工作效率,节约实验成本。Objective： To investigate the applicability of two methods for medical instrument sterility tests of catheters, so as to provide references to peers. Methods： The method of elution, collection and membrane filteration specified in the second part of 2010 edition of Chinese Pharmacopoeia and the improved method of direct inoculation were employed for sterility tests. Samples of spot check in the market and 59 batches of catheter medical instruments entrusted by enterprises were analyzed. Results： The results of the two methods are consistent with the regulations specified in Chinese Pharmacopoeia. Conclusion： Both of the two kinds of methods can be used, but the improved method is easy to be operated and more efficient.

关 键 词：医疗器具 无菌检查 一次性使用输液(血)器 薄膜过滤法 直接接种法 

分 类 号：R197.39[医药卫生—卫生事业管理]