YY/T 1987-2025Brain-computer interface medical device - Vocabulary (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part

1.Structure and Drafting Rules of Standardization Documents". Drafting. Please note that some content in this document may involve patents. This document is published. The organization is not responsible for identifying patents. This document was proposed by the National Medical Products Administration. This document is under the jurisdiction of the Technical Committee on Standardization of Medical Electrical Appliances (SAC/TC 10). The main drafting units of this document are. Shanghai Institute for Medical Device Testing, Nanhu Brain-Computer Interaction Research Institute, Lingang National Laboratory, and National Pharmaceutical Research Institute. Medical Device Evaluation Center of the State Food and Drug Administration, China National Institutes for Food and Drug Control, Huashan Hospital Affiliated to Fudan University, Capital Medical University Xuanwu Hospital, Beijing Tiantan Hospital affiliated to Capital Medical University, Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Brain-Computer Interaction and Human... The Haihe Laboratory for Machine-Machine Collaboration, Beijing Institute of Brain Science and Brain-Inspired Intelligence, Shanghai Institute of Microsystem and Information Technology, Chinese Academy of Sciences, and Tsinghua University. The main drafters of this document are. Hu Sheng, Liu Xun, Yu Hongyi, Wang Yueming, Zhou Sishu, Li Chengyu, Xie Yang, Liang Hong, Jin Ruonan, Li Shu, and Han Qianqian. Mao Ying, Chen Liang, Zhao Guoguang, Shan Yongzhi, Jia Wang, Zhou Wenjianlong, Zhao Zhengtuo, Li Xue, Ming Dong, Xu Minpeng, Luo Minmin, Zhang Lei, Tao Hu, Zhou Zhitao Hongbo. Medical device terminology using brain-computer interface technology

1 Scope

YY/T 1987 is the vocabulary the whole Chinese brain-computer interface framework is built on. It defines the terms and definitions for medical devices employing brain-computer interface technology, abbreviated in the standards themselves to BCI medical devices. A terminology standard sounds like the least consequential document in a series until you notice that the test method standards cite it normatively: YY/T 1996, on closed-loop implantable neurostimulators, takes its terms from here, so the two are read together. It was issued in September 2025 and took effect on 1 January 2026, ahead of the test method standards that depend on it. For any company developing implanted or non-invasive BCI devices for China, this is the document that fixes what the regulator means by each term, and the place where a submission's language has to align.

This document defines the terminology and definitions for medical devices that employ brain-computer interface technology (hereinafter referred to as brain-computer interface medical devices). This document applies to brain-computer interface medical devices.

2 Normative references

This document has no normative references.

3 Terms and Definitions

The following terms and definitions apply to this document.