摘要
目的:对人类辅助生殖技术用液体类医疗器械的细菌回复突变试验进行优化研究。方法:以该类医疗器械的典型代表—囊胚培养液为研究对象,根据其特点对其细菌回复突变试验的剂量水平选择、结果判定方式等进行优化,分析经优化后的细菌回复突变试验结果。结果:在经优化的试验条件下,细菌回复突变试验系统有效,试验结果为阴性且具有可重复性。结论:通过对细菌回复突变试验剂量水平选择、结果判定方式的优化,可获得更准确、可靠的测试结果。
Objective:Perform the optimization study for bacterial reverse mutation assay of liquid medical devices for human assisted reproductive technology.Methods:Blastocyst Culture Medium(a typical representative)was used as the research object.According to the characteristics of them,the selection of dose level and results evaluation method for bacterial reverse mutation assay were optimized,then the results of the optimized study were analyzed.Results:Under the conditions of the optimized study,the bacterial reverse mutation assay was considered valid and the result was assessed as a reproducible negative.Conclusion:Accurate and reliable results can be obtained by optimizing the selection of dose level and results evaluation method of bacterial reverse mutation assay.
作者
孙国伟
王丽洁
朱飞冀
胡彩珍
孙金陆
苏静娜
方菁嶷
SUN Guo-wei;WANG Li-jie;ZHU Fei-ji;HU Cai-zhen;SUN Jin-lu;SU Jing-na;FANG Jing-yi(Sanitation&Environment Technology Institute of Soochow University Ltd,Jiangsu Suzhou 215000;Suzhou Medical College of Soochow University,Jiangsu Suzhou 215000)
出处
《中国医疗器械信息》
2022年第15期21-24,共4页
China Medical Device Information
关键词
辅助生殖技术
液体类医疗器械
细菌回复突变试验
优化
assisted reproductive technology
liquid medical devices
bacterial reverse mutation assay
optimization
