Abstract：Artificial intelligence (AI) in medical devices, rehabilitation devices and general wellness
products is developing fast. It has great impact on the automation and intelligentization of medical
diagnostics, treatment and health service, and significantly improves service quality and efficiency. The
safety and effectiveness of the AI algorithm is an important factor that affects the safety and effectiveness
of medical devices, which poses a new challenge for the quality control of medical devices.Currently,
no standard has been established to test AI methods in medical devices. In this paper, the testing of AI
methods in common medical devices were divided and discussed separately, according to the application
scenarios. The summary provides reference for further development of methodology and platforms to
establish AI testing norms for medical devices.
王浩，孟祥峰，刘艳珍，任海萍. 医疗器械中人工智能方法检验策略的研究[J]. 中国医疗设备, 2016, 31(10): 67-70.
WANG Hao, MENG Xiang-feng,
LIU Yan-zhen, REN Hai-ping. Study of the Testing Strategy of Artificial Intelligence Methods in Medical Devices. China Medical Devices, 2016, 31(10): 67-70.