医用超声耦合剂技术审评关注点  

Key Points of Technical Review of Medical Ultrasonic Couplants

作　　者：李平 吴丹 熊磊 鄢峰 姜常胜 LI Ping;WU Dan;XIONG Lei;YAN Feng;JIANG Changsheng(Jiangxi Center for Drug Certification and Evaluation(Jiangxi Center for Medical Device Evaluation),Nanchang Jiangxi 330046,China)

机构地区：[1]江西省药品认证审评中心(江西省医疗器械技术审评中心),江西南昌330046

出　　处：《药品评价》2023年第6期665-667,共3页Drug Evaluation

摘　　要：随着超声影像技术在临床上的普遍应用,医用超声耦合剂作为一种常见的医疗器械在临床上广泛应用。本研究基于大量医用超声耦合剂技术审评的实践经验,对该类产品技术审评过程需要重点关注的适用范围、主要性能要求、生物相容性研究、临床评价研究、研究资料等内容进行总结,提出相关建议,为技术审评机构和企业提供借鉴。With the widespread application of ultrasonic imaging technology in clinic,medical ultrasonic coupler as a common medical instrument has been widely used in clinic.Based on a large number of practical experience in technical review of medical ultrasonic couplants,this paper summarized the application scope,main performance requirements,biocompatibility studies,clinical evaluation studies,research data and other contents that should be paid attention to during the technical evaluation process of this kind of product,and put forward relevant suggestions,so as to provide reference for technical evaluation institutions and enterprises.

关 键 词：超声检查 凝胶类 医用超声耦合剂 生物相容性 技术审评 

分 类 号：R95[医药卫生—药学]