摘要
肺是医疗器械全身毒性试验中重要的检查器官,在安全性评价中具有重要的意义。结合作者对医疗器械的理解,就医疗器械全身毒性试验中肺的检查及常见问题做浅要的分析,为医疗器械产品的临床前安全性评价提供参考。但针对具体医疗器械产品,还是要综合评估后作出合理的风险评估。
The lung is an important organ in systemic toxicity test of medical devices and is significant in safety evaluation.Based on the authors’understanding of medical devices,this study provides a brief analysis of the lung examination and common problems in systemic toxicity,so as to provide references for the pre-clinical safety evaluation of medical devices.It should be noted that a reasonable risk assessment should be made after comprehensive assessment for specific medical device products.
作者
王涵
许建霞
杨柳
何牧野
孙聪慧
赵纪兰
王春仁
WANG Han;XU Jianxia;YANG Liu;HE Muye;SUN Conghui;ZHAO Jilan;WANG Chunren(National Institute for Food and Drug Control,Beijing,102629;Yantai University,Yantai,264005)
出处
《中国医疗器械杂志》
2021年第4期446-449,共4页
Chinese Journal of Medical Instrumentation
基金
国家重点研发项目“全降解聚合物支架检测与评价体系的建立”(2016YFC1102304)。
关键词
肺
医疗器械
全身毒性
lung
medical device
systemic toxicity