摘要
目的:研究医疗器械微生物检测中影响生物负载修正系数的不同因素,以提高医疗器械微生物检测结果的准确性。方法:依据国家标准《医疗器械的灭菌微生物方法学第1部分:产品上微生物总数的测定》(GB/T19973.1-2015),对一次性使用无菌注射器进行微生物检测,选择不同菌种接种位置、不同洗脱液采集技术和不同微生物计数方法进行试验,计算生物负载的修正系数。结果:基于一次性使用无菌注射器生物负载的修正系数数据分析,选取锥头内部、管内壁、橡胶活塞3个不同菌种接种部位平板微生物生长情况比较,差异有统计学意义(F=36.575,P<0.05),回收率的修正系数分别为2.9、16.5和9.9;选取手工振摇20 s、机械振摇5和20 min(200 r/min)3种不同的微生物采集技术平板微生物生长情况比较,差异有统计学意义(F=119.460,P<0.05),回收率的修正系数分别为14.1、7.1和1.9;选取涂布法、倾注法、薄膜过滤法3种不同的微生物计数方法平板微生物生长情况比较,差异无统计学意义(F=0.529,P>0.05),回收率的修正系数分别为1.2、1.1和1.2。结论:在检测生物负载时,应选择多个部位同时染菌进行操作,并采用机械振摇的方式采集洗脱液,在医疗器械生物负载的检测中,染菌部位和微生物采集技术的选择是生物负载修正系数的重要因素。
Objective:To study the different factors that affected the correction coefficient of biological load in microorganism test of medical device,so as to improve the accuracy of testing microorganism of medical device.Methods:According to the national standard"Sterilization of medical devices-Microbiological methods-Part 1:Determination of a population of microorganisms on products"(GB/T 19973.1-2015),the microorganisms of disposable sterile syringes were tested.The vaccination locations of different bacterial strains,the collection techniques of different eluents and the different microorganism count methods were selected to conduct experiment.And then,the correction coefficient of biological load was calculated.Results:Based on the data analysis of the correction coefficient of the biological load of disposable sterile syringes,the difference of the microorganism growth status on plate among three different vaccination locations of bacterial strains(cone head interior,tube inner wall and rubber piston)was statistically significant(F=36.575,P<0.05),and the correction coefficients for recovery rate were respectively 2.9,16.5,and 9.9.The difference of the microorganism growth status on plate among three different microorganism collection techniques(manual shaking for 20 seconds,mechanical shaking for 5 and 20 minutes,200 r/min)was statistically significant(F=119.460,P<0.05),and the correction coefficients for recovery rate were respectively 14.1,7.1 and 1.9.The difference of the microorganism growth status on plate among three different microorganism count methods(coating method,pouring method and membrane filtration method)was not significant(F=0.529,P>0.05),and the correction coefficients for recovery rate were respectively 1.2,1.1 and 1.2.Conclusion:In testing biological load,multiple sites should be selected to conduct simultaneous infection of bacteria,and mechanical shaking should be used to collect eluent.In the test of biological load of medical device,the selection of the sites of bacterial infection and micr
作者
冯群
李婧
战玢
田光娟
李晓洋
Feng Qun;Li Jing;Zhan Bin;Tian Guangjuan;Li Xiaoyang(Department of Technique,Beijian Hengrun(Beijing)Measurement and Testing Technology Service Co.,Ltd,Beijing 100176,China;Department of Technique,Beijianruhe(Beijing)Technical Service Co.,Ltd,Beijing 100176,China;Department of Registration,Beijing Hongyi Runhe Management Consulting Co.,Ltd,Beijing 101318,China)
出处
《中国医学装备》
2024年第3期34-38,共5页
China Medical Equipment
关键词
医疗器械
微生物检测
修正系数
回收率
生物负载
Medical device
Microorganism testing
Correction coefficient
Recovery rate
Biological load
