口岸医疗器械产品体外细胞毒性结果分析

Analysis of the vitro cytotoxicity detection results in medical devices at port

目的了解2012年-2014年出入境检测机构送检医疗器械细胞毒性的分布状况。方法参考医疗器械生物学评价ISO标准,采用L929细胞系对样品浸提液进行直接或间接细胞毒性评价,直接法细胞暴露于不同浓度浸提液,采用MTT测量细胞活力作为终点。间接法在细胞上添加琼脂,浸提液湿润的滤纸置于琼脂上,镜检细胞的毒性反应。结果送检的184份医疗器械样品,合格样品数为150份,总合格率为81.5%,不同管理分类和目录分类的医疗器械合格率不一,检出细胞毒性大小存在较大差异。结论生产企业和检测机构应重点关注细胞毒性大的医疗器械,尤其是Ⅲ类管理类别产品,在生产和出口检测环节给予严格把关。

Objective To investigate the cytotoxicity distribution status of medical devices from entry inspection agency from2012 to 2014. Methods According to biological evaluation of medical devices ISO standard,samples were evaluated by direct or indirect contract cytotoxicity test by using L929 cell line. In direct contract method,cells were exposed in leaching liquor with different concentrations,and cell viability was determined by MTT. In the indirect method,sample was added in filter paper,then put onto the surface of the agar which covered the cell monolayer. The morphology of cell reaction was observed by microscope. Results 150 samples were qualified out of the 184 medical devices samples for test,with the qualified rate of 81. 5%.There were great differences on the qualified rates of medical devices in different management classification and different menu classification,so was the difference on the cytotoxicity. Conclusion Medical devices with high cytotoxicity should be paid more attention by industries and test institutes,especially for Ⅲ type product. Quality control should be strengthened in manufacturing and entry- exit testing.