SOURCE RECORD / S0221

Medical devices using brain-computer interface technology—Implantable neurostimulators with closed-loop function—Sensing and response performance test methods

Evidence A

Medical devices using brain-computer interface technology—Implantable neurostimulators with closed-loop function—Sensing and response performance test methods

Authors or organization

National Medical Products Administration

Published date

2025-10-22

Source type

industry_standard_announcement

Technology route

brain-computer interface medical devices

Function or setting

closed-loop implantable neurostimulator testing

Rights status

manual_review

Evidence summary

Evidence: Recommended industry test-method standard. Key figures: YY/T 1996-2025; NMPA 2025 No. 94; signed 2025-09-25; effective 2027-10-01. Limitations: 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.

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