SOURCE RECORD / S0221
采用脑机接口技术的医疗器械 具备闭环功能的植入式神经刺激器 感知与响应性能测试方法
Medical devices using brain-computer interface technology—Implantable neurostimulators with closed-loop function—Sensing and response performance test methods
- 作者或机构
- National Medical Products Administration
- 发布日期
- 2025-10-22
- 来源类型
- industry_standard_announcement
- 技术路线
- brain-computer interface medical devices
- 功能场景
- closed-loop implantable neurostimulator testing
- 权利状态
- manual_review
证据摘要
证据支持：YY/T 1996-2025，国家药监局2025年第94号。关键日期：2025-09-25 签署，2027-10-01 实施。局限：仅适用于具备闭环功能的植入式神经刺激器感知与响应性能测试，不是通用四项定义。
关键数字
YY/T 1996-2025; NMPA 2025 No. 94; signed 2025-09-25; effective 2027-10-01
局限
YY/T is a recommended industry standard; only for sensing and response performance tests of closed-loop implantable neurostimulators, not a general four-condition definition