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智能化医疗设备测试方案探讨

Discussion about Testing Scheme of Intelligent Medical Devices
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摘要 智能化医疗设备随着现代信息技术和人工智能等技术与医疗的深度融合而呈现出蓬勃发展的局面。对智能化医疗设备开展测试是对其性能评价和质量控制的重要手段。相比于传统医疗设备,智能化医疗设备的测试方法和技术发展还不成熟,需要相关领域人员发挥积极作用。该文在概括论述智能化医疗设备发展局面的基础上,将智能化医疗设备按照特性分为软件形式的人工智能医疗器械、医疗机器人,并纳入了与智慧医院建设密切相关的医疗设备物联网系统。针对每类智能化医疗设备分别论述了测试指标和测试方案,并提出应进一步针对各种具体设备制定测试细则,引入复杂智能化系统的评价方法,同时注重运用真实世界数据进行评价。该文旨在加速推进智能化医疗设备测试工作的开展,为智能化医疗设备质量控制和性能评价奠定基础。 Intelligent medical devices are flourishing with the deep integration of modern information and artificial intelligence technologies into healthcare.Testing is an important means of performance evaluation and quality control for intelligent medical devices.Compared with traditional medical devices,the testing methods and technologies of intelligent medical devices are still immature,and need active research to promote the progress in this area.Intelligent medical devices are classified according to their characteristics as artificial intelligence medical devices in the form of software and medical robots based on a general discussion of their development.The medical-device Internet of Things(IoT)system has also been included due to its close relation to the construction of smart hospitals.For each type of intelligent medical device,testing indexes and testing plans are discussed.It is suggested that specific test rules should be further developed for various specific devices.Besides,the evaluation method of complex intelligent systems should be introduced and real-world data should be used for evaluation.This paper aims to accelerate the development of intelligent medical device testing,laying the foundation for quality control and performance evaluation of intelligent medical devices.
作者 张楠 李静 张杰 杨炯 张政波 何昆仑 ZHANG Nan;LI Jing;ZHANG Jie;YANG Jiong;ZHANG Zhengbo;HE Kunlun(Medical Supplies Center,Chinese PLA General Hospital,Beijing,100853;Medical Engineering Laboratory of Chinese PLA General Hospital,Beijing,100853;Department of Medical Innovation Research,Chinese PLA General Hospital,Beijing,100853)
出处 《中国医疗器械杂志》 2024年第6期699-705,共7页 Chinese Journal of Medical Instrumentation
基金 新一代人工智能国家科技重大专项课题(2021ZD0140403)。
关键词 智能化医疗设备 测试 人工智能医疗器械 医疗机器人 医疗设备物联网 Intelligent medical devices testing artificial intelligence medical devices medical robots medical device Internet of Things
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