摘要
该研究先对中医舌诊设备进行了简单介绍,然后从产品名称、性能指标参数、图像处理功能、产品使用方式、临床评价等方面对舌诊设备的技术审评要点进行了详细分析探讨,分析了舌诊设备的安全风险和有效性指标,以期能为舌诊设备的逐步规范和注册申报企业带来一定的帮助。
This study briefly introduces the tongue diagnostic equipment of traditional Chinese medicine.It analyzes and discusses the key points of technical evaluation of tongue diagnostic equipment from the aspects of product name,performance parameters,image processing functions,product use methods,clinical evaluation,etc.It analyzes the safety risks and effectiveness indicators of tongue diagnostic equipment,hoping to bring some help to the gradual standardization of tongue diagnostic equipment and the registration of enterprises.
作者
宓云軿
段世梅
付强
MI Yunping;DUAN Shimei;FU Qiang(Shanghai Medical Device and Cosmetics Evaluation and Verification Center,Shanghai,200020;Shanghai Institute of Medical Device Testing,Shanghai,201318;NMPA Key Laboratory for Respiratory and Anaesthetic Equipment,Shanghai,201318)
出处
《中国医疗器械杂志》
2023年第1期89-92,共4页
Chinese Journal of Medical Instrumentation
关键词
医疗器械
舌诊设备
审评要点
medical device
tongue diagnosis equipment
technical evaluation
