北京地区生产的三种外科植入物初始污染水平的检测分析  

Testing of Initial Contamination for Three Kinds of Surgical Implants Producted in Beijing

作　　者：胡洋[1] 张悦[1] 胡金慧[1] 

机构地区：[1]北京市射线应用研究中心,北京100012

出　　处：《中国医疗器械杂志》2010年第5期370-373,388,共5页Chinese Journal of Medical Instrumentation

摘　　要：对北京地区7个厂家生产的股骨头、股骨柄和股骨髁的初始污染水平进行了检测,得到这3种外科植入物的初始污染检测数据共计580个。之后,对这些数据进行了统计学分析,结果显示:3种产品初始污染值符合正态分布;同一厂家生产的股骨头和股骨髁的初始污染值之间没有显著性差异;北京地区不同季节股骨柄的初始污染值之间也没有显著性差异。根据正态分布曲线可看出,每种产品的初始污染水平存在一定的波动性,所以生产厂家应对产品的初始污染进行严格控制,保持初始污染值的稳定性。The initial contamination of femoral head,femoral stem and femoral component producted by seven factories in Beijing is tested,all of the initial contamination values are 580 in total. Then these data is analyzed on statistics. The result indicates that the initial contamination values of three kinds of products according with normal distribution; The initial contamination values have not significant difference between femoral head and femoral component of the same factory; and the season has not significant effect on initial contamination in Beijing. According to the experimental data,the level of initial contamination is undulatory,so the factories should control the initial contamination and maintain the stability of initial contamination.

关 键 词：初始污染 正态分布 方差分析 

分 类 号：R318.1[医药卫生—生物医学工程]