摘要
文章介绍了POC超声的出现背景及其主要临床应用领域。分析了其设计特点,包括操作功能精简、结构紧凑、方便移动、方便清洁等。提出了相应的审评关注重点,包括适用的标准和审评指导原则、环境要求、可用性要求、图像质量评价等方面,为这类产品的技术审评搭建了框架。
This paper introduces the emergence of POC ultrasound and its main clinical applications.The design features are analyzed,including simplified operation and function,compact structure,mobility,easy cleaning and so on.This paper puts forward the technical review focus,including the standards and review guidelines,environmental requirements,usability requirements,image quality evaluation and other aspects,which establishes a framework for the technical review of such products.
作者
刘枭寅
刘菁
郭兆君
LIU Xiao-yin;LIU Jing;GUO Zhao-jun(Center for Medical Device Evaluation,NMPA,Beijing 100081)
出处
《中国医疗器械信息》
2021年第19期9-11,共3页
China Medical Device Information
关键词
POC超声
技术审评
环境试验
可用性
point-of-care ultrasound
technical review
environmental test
usability
