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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 understand the distribution of cytotoxicity of medical devices submitted by immigration agencies between 2012 and 2014. Methods According to the medical device biological evaluation ISO standard, the L929 cell line was used to evaluate the cytotoxicity of the sample extract directly or indirectly. The direct cells were exposed to different concentrations of leaching solution. The cell viability was measured by MTT as the end point. Indirect method Addition of agar on the cells, the wetting filter paper placed on the agar, microscopic examination of the toxicity of cells. Results 184 samples of medical devices were inspected, the number of qualified samples was 150, and the total qualified rate was 81.5%. The qualified rate of medical devices varied with different management categories and categories, and there was a big difference in the detected cytotoxicity. Conclusion The manufacturing enterprises and testing institutes should pay close attention to the medical devices with large cytotoxicity, especially the type III management products, and strictly control the production and export testing.