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医疗器械全身毒性试验中肺的检查

Lung Examination in Systemic Toxicitytest of Medical Devices
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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 医疗器械 全身毒性 lung medical device systemic toxicity
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