Release and Approval of Brain-Computer Interface Standards

Recently, the National Medical Products Administration (NMPA) has approved and issued the medical device industry standard YY/T 1987-2025 Medical Devices Adopting Brain-Computer Interface Technology-Terminology. This is China’s first standard for brain-computer interface (BCI) medical devices, laying a foundation for the high-quality development of the BCI medical device industry.

This standard systematically establishes a terminology system for BCI medical devices, defining more than 80 core terms. Its main contents fall into ten sections as follows:

1. Basic Concepts: Defines the core regulatory object “medical devices adopting brain-computer interface technology”, and classifies such devices into two basic categories: invasive and non-invasive.
2. Technical Terms: Standardizes definitions for core technical processes and principles such as neural encoding and decoding, Event-Related Potential (ERP), and Sensorimotor Rhythm (SMR).
3. Paradigms: Defines experimental methods and operation modes for human-computer interaction, including closed-loop control, feedback, motor imagery and others.
4. System Components: Covers terminology for hardware components including electrodes, channels, intracranial implants, electrode leads, and so forth.
5. Signal Processing: Defines key concepts in data processing such as artifact rejection and suppression, feature extraction, and phase-locking value.
6. Signal Morphology: Provides standardized descriptions of neural signals of different scales and origins, including Electroencephalography (EEG), Intracranial Electroencephalography (iEEG), Local Field Potential (LFP), and Spikes.
7. Applications: Specifies terminology for clinical application directions such as interface stability, cognitive/sensory restoration, emotion regulation, and brain-spinal cord interfaces.
8. Test Technology: Stipulates objective test indicators for evaluating electrical, mechanical and transmission performance of equipment, including information transfer rate, charge-injection capacity, and electrode insertion force.
9. Algorithms: Contains definitions related to software algorithms such as models, model validation, fault-injection testing, and latency.
10. Medical Safety: Establishes a comprehensive safety framework covering physical safety, functional safety, and innovative “neural safety”.

The issuance and implementation of this standard helps resolve fundamental industry-development bottlenecks such as inconsistent terminology and non-standardized concepts across the sector. It provides authoritative, unified common language and key technical basis for the R&D, production and scientific regulation of BCI medical devices, and bears great significance for standardizing industry order and advancing sound industrial development.

As of present, the published standards concerning brain-computer interfaces are listed below:

In addition, several standards are under steady development:

1. Medical Devices Adopting Brain-Computer Interface Technology — General Technical Conditions for Non-Invasive Equipment
2. Medical Devices Adopting Brain-Computer Interface Technology — Paradigm Design and Application Specification: Motor Function Reconstruction
3. Medical Devices Adopting Brain-Computer Interface Technology — Reliability Verification Methods for Invasive Equipment
4. Medical Devices Adopting Brain-Computer Interface Technology — Test Methods for RACA-Based Robotic Motion Intention Encoding-Decoding Performance

Information Sources

1. https://www.nmpa.gov.cn/ylqx/ylqxjgdt/20250916160619128.html
2. https://www.nidc.org.cn/zt/qxbzh2024/qxbzhtjshp24/20251014095304195.html
3. https://www.nidc.org.cn/bshff/ylqxbzhgl/qxggtzh/ggqt/202603131639401959082.html
4. https://www.nidc.org.cn/bshff/ylqxbzhgl/qxggtzh/ggqt/202602131153071921423.html
5. https://www.nidc.org.cn/gzdt/ywdt/202510101422521754103.html