Abstract:Objective To analyze the need for quality evaluation of artificial intelligence AI medical device and design the standard
system. Methods This artical conducted literature study on the update of regulation policy and standardization of AI medical device
in China and other countries丨 analyzed the orientation and direction of AI medical device standards, in combination with experience
from AI medical device product testing. Results The standard system of artificial intelligence medical devices should be oriented to
the needs of product life-cycle supervision and quality management, coordinate and promote the formulation and revision of basic
standards and method standards, and further develop product standards and management standards when the time is ripe.
Conclusion The strategy in this paper may promote the development of AI medical device standards and improve the technology
system to evaluate AI medical device products.
王浩,唐桥虹,郝烨,孟祥峰,李佳戈,李静莉. 人工智能医疗器械标准体系设计探索[J]. 中国医疗设备, 2021, 36(12): 15-18.
WANG Hao, TANG Qiaohong, HAO Ye, MENG Xiangfeng, LI Jiage, LI Jingli. Design of Standard System for Artificial Intelligence Medical Device. China Medical Devices, 2021, 36(12): 15-18.