人类辅助生殖技术用医疗器械胚胎毒性检验  

Embryonic Toxicity Test of Medical Devices for Human Assisted Reproductive Technology

作　　者：史建峰[1] 王蕊 韩倩倩[1] SHI Jianfeng;WANG Rui;HAN Qianqian(National Institutes for Food and Drug Control,Beijing,102629)

机构地区：[1]中国食品药品检定研究院,北京市102629

出　　处：《中国医疗器械杂志》2021年第6期604-607,共4页Chinese Journal of Medical Instrumentation

基　　金：中国科学院“器官重建与制造”战略性先导专项(XDA16040602)。

摘　　要：目的介绍目前国内人类辅助生殖技术用医疗器械的胚胎毒性检验方法,为此类产品的安全性评价提供参考。方法对人类辅助生殖技术用医疗器械的胚胎毒性检验方法进行梳理,指出检验过程中的程序要点,探讨其安全性评价中面临的挑战。结果建立敏感、稳定的胚胎毒性检验体系对保障人类辅助生殖技术用医疗器械的安全性具有重要意义。结论胚胎毒性评价在样品制备优化、检验技术延伸和评价方法扩充等方面还具有较大的发展空间。Objective To introduce the test methods of embryo toxicity applied to medical devices for human assisted reproductive technology(ARTMD),and provide the evaluation reference.Methods The embryo toxicity test methods of ARTMD were summarized,and the key procedures and challenges in their safety evaluation were also discussed.Results Establishing sensitive and stable test system is important to guarantee the safety and efficacy of ARTMD.Conclusion It remains development opportunities in improving sample preparation,extending test technology and expending evaluation method.

关 键 词：人类辅助生殖技术用医疗器械 体外鼠胚试验 囊胚细胞染色和计数 生物学评价 

分 类 号：F203[经济管理—国民经济] R318[医药卫生—生物医学工程]