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

Interpretation of Sectoral Standard Artificial Intelligence Medical DeviceSpecific Requirement for Datasets: Color Fundus Images of Diabetic Retinopathy

  • 摘要: 近年来, 随着人工智能医疗器械产业的迅猛发展, 监管部门对数据集的质量控制也在不断加强。2024年, 国家药品监督管理局发布的重要行业标准YY/T 1949-2024《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》, 是我国首个针对特定疾病领域人工智能医疗器械数据集质量评价的专项标准。该标准在既有的人工智能医疗器械通用标准框架下, 重点围绕糖尿病视网膜病变眼底彩照数据集, 系统性地提出了专业化的质量要求与测试方法。该标准的实施将为数据集制造责任方提供明确的技术指导, 有助于提升糖尿病视网膜病变人工智能辅助诊断软件的研发质量, 推动行业规范化发展。

     

    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 DevicesParticular Requirements for Datasets: Color Fundus Photographs of Diabetic 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 specialized 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 diabeticretinopathy, and promote standardized industry advancement.

     

/

返回文章
返回