Notice of the Establishment of the Medical Device Industry Standard "Medical Devices Using Brain-Computer Interface Technology Quality Requirements and Evaluation Methods for EEG Data Sets Used in Artificial Intelligence Algorithms" by the Comprehensive Department of the State Drug Administration (SDA)
| 索引号 | FGWJ-2025-121 | 主题分类 | 法规文件 / 规范性文件 |
| 标题 | Notice of the Establishment of the Medical Device Industry Standard "Medical Devices Using Brain-Computer Interface Technology Quality Requirements and Evaluation Methods for EEG Data Sets Used in Artificial Intelligence Algorithms" by the Comprehensive Department of the State Drug Administration (SDA) | ||
| 发布日期 | 2025-02-25 | ||
中检院（器械标管中心）：
为满足监管急需，助推采用脑机接口技术的医疗器械高质量发展，经研究，国家药监局批准《采用脑机接口技术的医疗器械 用于人工智能算法的脑电数据集质量要求与评价方法》医疗器械行业标准制修订项目立项。
请按照《医疗器械标准制修订工作管理规范》有关要求，采用快速程序开展标准制订，做好标准的起草、验证、征求意见和技术审查等工作，保证标准质量和水平。
附件：医疗器械行业标准制修订项目
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