对动物源性医疗器械免疫毒理学评价的思考  

Thoughts on the Evaluation of Immunotoxicology of Animal-Derived Medical Devices

作　　者：翁旭 奚晓青 陆佳骏 黄仁良 赵金川 WENG Xu;XI Xiao-qing;LU Jia-jun;HUANG Ren-liang;ZHAO Jin-chuan(Zhejiang Medical Device Inspection and Research Institute,Zhejiang Hangzhou 310018)

机构地区：[1]浙江省医疗器械检验研究院,浙江杭州310018

出　　处：《中国医疗器械信息》2021年第3期1-3,9,共4页China Medical Device Information

基　　金：浙江省省属科研院所扶持经费项目(项目编号:304017-2018-1043);浙江省医疗器械检验研究院自立项项目(项目名称:动物源性医疗器械对机体自然杀伤细胞的影响,项目编号:20180002)。

摘　　要：阐述了对于动物源性医疗器械免疫毒理学评价的思考。主要介绍了动物源性医疗器械的种类以及关于动物源性医疗器械的国内外法规,同时详细介绍分析了动物源性医疗器械免疫毒理学评价的具体检测方法,同时对动物源性医疗器械免疫学评价进行总结和展望。This article elaborates the thoughts on the evaluation of immunotoxicology of animal-derived medical devices.It mainly introduces the types of animal-derived medical devices and the domestic and foreign regulations on animal-derived medical devices.It also introduces and analyzes the specific detection methods for the evaluation of immunotoxicology of animal-derived medical devices.The evaluation has been summarized and prospected.

关 键 词：动物源性医疗器械 免疫毒理 DNA残留量 α-Gal抗原残留 

分 类 号：TH789[机械工程—仪器科学与技术]