人类辅助生殖技术用医疗器械精子毒性检验  

Spermic Toxicity Test of Medical Devices for Human Assisted Reproductive Technology

作　　者：连环 陈虹[1] 韩倩倩[1] LIAN Huan;CHEN Hong;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608-611,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：通过对辅助生殖用医疗器械相关的精子毒性检验方法进行了全面总结与分析,并对其发展方向做出预估。同时对现有人精子相关检测方法及其评价指标进行阐述,进一步分析其漏洞及风险点,并提出可能的改进方法。In order to provide a thorough summary and analysis over sperm toxicity evaluation of medical devices for human in vitro assisted reproductive technology,as well as to forecast its future direction,currently available test methods and evaluation indicators related to human sperm were elaborated here.Furthermore,their weakness and risk points were analyzed and possible ways for further improvement were also provided.

关 键 词：人类辅助生殖技术 医疗器械 人精子存活试验 人精子替代试验 

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