医疗器械全身毒性试验中肺的检查

Lung Examination in Systemic Toxicitytest of Medical Devices

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。

Abstract: 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.