GB/T 16886.5—2017中体外细胞毒性试验的比较与分析  

Comparison of several in vitro cytotoxicity assays in GB/T 16886.5 —2017

作　　者：徐玉茵 韩颖 田林奇 周静 魏聪 张丹丹 XU Yu-yin;HAN Ying;TIAN Lin-qi;ZHOU Jing;WEI Cong;ZHANG Dan-dan(Henan Province Medical Instrument Testing Institute, Henan Province Engineering Research Center for Medical Instrument Inspection and Testing, Zhengzhou 450000, China)

机构地区：[1]河南省医疗器械检验所河南省医疗器械检验检测工程技术研究中心

出　　处：《医疗卫生装备》2019年第7期74-77,93,共5页Chinese Medical Equipment Journal

摘　　要：介绍了GB 16886 系列标准中固体样品和液体样品的制备方法,分析了GB/T 16886.5—2017《医疗器械生物学评价第5部分:体外细胞毒性试验》中浸提液试验、琼脂扩散试验、直接接触试验3 种定性试验和MTT 试验、中性红摄取(neutral red uptake,NRU)试验、集落形成(clone forming assay,CFA)试验3 种定量试验的试验方法,比较了各试验方法的实验条件和判定标准。指出了选择合适的体外细胞毒性试验对正确评价样品潜在毒性的重要性。提出了应将体外细胞毒性试验结果与其他生物相容性试验结果结合,以获得对医疗器械更准确的生物风险评估。The preparation methods for solid and liquid samples were introduced according to GB 16886 series of standards. Biological evaluation of medical devices-part 5: tests for in vitro cytotoxicity had six tests involved analyzed, containing three qualitative tests including leaching test, agar diffusion test and direct contact test as well as three quantitative tests including MTT test, neutral red uptake (NRU) test and clone forming assay (CFA) test. All the tests had their experimental conditions and judgment standards compared. It's pointed out selecting in vitro cytotoxicity test was important for evaluating the potential toxicity of the sample. It's suggested in vitro cytotoxicity test be combined with other biocompatibility tests to execute bio-risks of the medical device accurately.

关 键 词：GB/T 16886.5-2017 医疗器械 细胞毒性试验 定性试验 定量试验 生物相容性 生物风险评估 

分 类 号：R318[医药卫生—生物医学工程] R197.39[医药卫生—基础医学]