The NMPA recently released the industry standard YY/T 1987—2025, titled “Brain-Computer Interface Medical Equipment—Terminology”. This represents China’s first official standard dedicated to brain-computer interface (BCI) medical devices, providing a structured framework that will guide research, development, regulation, and application of BCI technologies in healthcare.
Referenced to FDA guidance of “0Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation -Non-clinical Testing and Clinical Considerations”, the standard establishes a comprehensive terminology system for BCI medical equipment. It clearly defines foundational concepts, paradigm classifications, signal modalities, signal processing methods, and application scenarios.
BCI technology holds transformative potential in medical fields such as neurorehabilitation, communication aids for patients with severe motor impairments, and next-generation neural prosthetics. However, the absence of standardized language has often posed difficulties in aligning interdisciplinary efforts. The YY/T 1987—2025 standard directly addresses this gap, creating a foundation that will accelerate progress across multiple application areas.
Brain-computer interface, together with other high-end medical equipment such as surgical robots, devices, radiation therapy equipment, and advanced imaging devices, will be given priority in the review and approval process. Click HERE to learn more
Core terminology
- Action potential (AP): Rapid changes in neuron membrane potential.
- Artifacts, artifact rejection, and artifact removal: Handling non-neural interference signals.
- Biofeedback: Using feedback mechanisms to regulate physiological functions.
- Brain implants: Devices interfacing with brain tissue.
- BCI medical equipment (BCI-ME): Active medical devices directly connecting with the central nervous system for functional restoration or replacement.
System Components
- Electrodes, electrode arrays, coatings, contacts, and leads.
- Properties such as charge storage capacity, charge injection capacity, rigidity, puncture force, and electrode stability.
Signal Processing and Morphology
- Neural coding and decoding
- Feature extraction methods
- Event-related potentials (ERP), event-related synchronization/desynchronization, spike trains, and local field potentials (LFP)
- Signal modalities including intracranial EEG and electrocorticography (ECoG)
Applications and Therapeutic Uses
- Cognitive recovery, perceptual recovery, and movement recovery
- Emotional regulation and neurofeedback
- Closed-loop systems for real-time feedback and control
Safety
- Functional safety: ensuring reliable device operation
- Neurological safety: preventing harmful neural effects
- Physical safety: avoiding injury from hardware or procedures
The standard also provides classification tables in Annex B, grouping terms into categories such as:
- Basic concepts
- Technical terms
- Paradigms (motor imagery, mental imagery, auditory imagery, etc.)
- System components
- Signal processing and morphology
- Applications
- Testing technologies and performance measures (e.g., spike count rate, flexural fatigue, wireless transmission rates).
- Algorithms and medical safety