浅析影响医疗器械检验机构检测数据准确性的几种因素  

Analysis of the Several Factors Influencing the Accuracy of Medical Device Testing Data

作　　者：张成[1] 杨海燕 陈卓玥[1] 

机构地区：[1]陕西省医疗器械检测中心,西安710075 [2]陕西省食品药品检验所,西安710065

出　　处：《中国医疗器械信息》2015年第12期62-65,75,共5页China Medical Device Information

摘　　要：医疗器械检验机构检测数据的准确性直接关系到一个检验机构的生存与发展,而影响医疗器械检验机构检测数据准确性的因素又是十分复杂的。本文从检测人员的素质、检测仪器设备及计量器具、样品的抽取和制备、检验方法、环境和设施条件、检验过程、标准物质与试剂、数据处理等方面对影响医疗器械检验机构检测数据准确性的因素进行了分析。The survival and development of an inspection institution relate to the accuracy of the testing data. Meanwhile, it is complex that the factors of medical device testing influence the accuracy of the data. In this paper, personnel quality, testing equipment and measuring instrument, preparation of sample, testing methods, environment and facilities, inspection process, reference material and reagent, data processing etc. that influence the accuracy of medical device testing data are analyzed.

关 键 词：医疗器械检验机构 检测数据 准确性 因素 

分 类 号：R197.32[医药卫生—卫生事业管理]