Interpretation of Sectoral Standard Artificial Intelligence Medical Device—Specific Requirement for Datasets:Color Fundus Images of Diabetic Retinopathy
10.12290/xhyxzz.2025-0420
- VernacularTitle:行业标准《人工智能医疗器械数据集专用要求:糖尿病视网膜病变眼底彩照》解析
- Author:
Yanli ZHANG
1
;
Jing LI
;
Xiangfeng MENG
;
Shu LI
;
Hao WANG
Author Information
1. 中国食品药品检定研究院,北京 100050
- Publication Type:Journal Article
- Keywords:
YY/T 1949-2024;
artificial intelligence;
medical device;
diabetic retinopathy;
data quality;
dataset
- From:
Medical Journal of Peking Union Medical College Hospital
2025;16(4):916-921
- CountryChina
- Language:Chinese
-
Abstract:
In recent years,with the rapid development of the artificial intelligence(AI)medical device industry,regulatory authorities have been continuously strengthening quality control over datasets.In 2024,the National Medical Products Administration(NMPA)issued the significant industry standard YY/T 1949-2024 Artificial Intelligence Medical Devices—Particular Requirements for Datasets:Color Fundus Photographs of Dia-betic Retinopathy,which is China's first specialized standard for evaluating dataset quality in AI medical devices targeting a specific disease area.Under the existing general standards framework for AI medical devices,this standard focuses specifically on diabetic retinopathy fundus photograph datasets,systematically proposing spe-cialized quality requirements and testing methods.Its implementation will provide clear technical guidance for dataset manufacturers,help improve the development quality of AI-assisted diagnostic software for diabetic retinopathy,and promote standardized industry advancement.
