Technical Evaluation Standard Analysis of Medical Wearable Electroencephalogram Devices
LI Guoyong1, XIA Wenlong1, XIAO Jie1, CHEN Ou2, GENG Youjun1
1. Shandong Center for Food and Drug Evaluation & Inspection, Jinan Shandong 250014, China;
2. School of Nursing and Rehabilitation, Shandong University, Jinan Shandong 250012, China
Abstract：The medical wearable electroencephalogram (EEG) devices with high integration, high intelligence, good portability,
long-term and real-time monitoring and other characteristics has become a research hot spot at home and abroad. But this product is
very different from the traditional EEG devices, because it is short of the corresponding standards and norms, resulting in product
registration and marketing, quality control are difficult. From the perspective of technical evaluation, this paper focused on the main
concerns of technical review, such as product structure, main risks, performance requirements, clinical evaluation, etc. to carry out
detailed elaboration and analysis, in order to provide guidance for the design and development, production, registration, use and postmarket
supervision of the devices.
