Abstract：Datasets are important resources for the development, training, verification and optimization of artificial intelligence
medical device, which have important impact on the quality of AI products. In the beginning period of market translation, it is
important to regulate and guide companies, hospitals, academia and third party institutes to build and manage datasets for AI
correctly, which determines the safety, effectiveness and long-term success of AI medical device, and further impacts the utilization
of medical big data in China. However, there are no specific standards and clear methods for the management and assessment of
datasets for AI medical devices. With reference to practical experience on dataset development, we proposed detailed advice on the
quality management and evaluation of AI datasets, clarified working procedure and requirement, which might help industry recognize
the importance of dataset quality management and promote scientific quality management system, further ensure product quality.
王浩，孟祥峰，王权，任海萍. 人工智能医疗器械用数据集管理与评价方法研究[J]. 中国医疗设备, 2018, 33(12): 1-5.
WANG Hao, MENG Xiangfeng, WANG Quan, REN Haiping. Strategy for Management and Quality Control of Datasets in Artificial Intelligence Medical Device. China Medical Devices, 2018, 33(12): 1-5.