YY/T 1996-2025Brain-computer interface medical device - Closed-loop implantable neurostimulator - Test methods for sensing and response performance (English PDF)
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
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 25, 2025
Implementation date
October 1, 2027
Scope
YY/T 1996-2025 is the English-translated version of 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.
YY/T 1996-2025 is the Chinese standard "Brain-computer interface medical device - Closed-loop implantable neurostimulator - Test methods for sensing and response performance".
Its scope clause reads: This document describes an implantable neurostimulator with closed-loop functionality that utilizes brain-computer interface technology, based on the perception and response of neural signals.
Performance testing methods. This document applies to implantable neurostimulators with closed-loop functionality that utilize brain-computer interface technology.
Note. For implantable neurostimulators that do not have closed-loop functionality, their ability to sense neural signals (if any) shall be tested in accordance with the relevant clauses of this document. method. Its clauses include terms and definitions.
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Document preview — YY/T 1996-2025
National Standard of the People's Republic of China
- ICS
- 11.40.040
- Classification
- C31
Issued by: National Medical Products Administration
Contents
- Preface
- 1.Scope
- 2 Normative References
- 3.Terms and Definitions
- 4.Test Method
- 4.1 Test Data Requirements
- 4.2 Perceived Performance Test
- 4.3 Closed-loop control stimulus-response test
- 4.4 EEG signal acquisition and processing algorithm test
- Appendix A (Informative) Correspondence between different states of test signals and stimulus protocol modulation
1 Scope
This document describes an implantable neurostimulator with closed-loop functionality that utilizes brain-computer interface technology, based on the perception and response of neural signals.
Performance testing methods.
This document applies to implantable neurostimulators with closed-loop functionality that utilize brain-computer interface technology.
Note. For implantable neurostimulators that do not have closed-loop functionality, their ability to sense neural signals (if any) shall be tested in accordance with the relevant clauses of this document.
method.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are listed below.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
document.
YY/T 1987 Terminology for Medical Devices Employing Brain-Computer Interface Technology
3 Terms and Definitions
The terms and definitions defined in YY/T 1987 and the following terms and definitions apply to this document.
3.1 Brain-computer interface implanted neurostimulator
Brain-computer interface technology is used to implant medical devices that provide electrical stimulation to the central nervous system.
3.2 Algorithm performance
The efficiency and effectiveness of an algorithm when performing a specific task.
Note. This typically includes the time required for the algorithm to execute, the memory or storage space required for the algorithm to execute, and the correctness of the algorithm in solving the problem.
Rate or accuracy, stability and reliability of the algorithm when handling abnormal or noisy data, performance of the algorithm when handling datasets of different sizes, and computational efficiency.
The speed of response and processing capabilities of the method in real-time applications.
3.3 stimulation threshold
The critical value of electrical stimulation intensity that can control symptoms.
Note. Generally includes a lower threshold and an upper threshold. The lower threshold refers to the minimum electrical stimulation intensity that can control symptoms, while the upper threshold refers to the intensity that can control symptoms while stimulating related accessory pathways.
The maximum safe electrical stimulation intensity that minimizes the effect.
3.4 electrical stimulation strategy
Electrical stimulation parameters and methods are developed and applied during treatment to optimize therapeutic effects and patient comfort.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 13 pages — is available in the English PDF.
Referenced standards
Normative references
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