Page 66 - 《中国医疗器械杂志》2026年第1期

Chinese Journal of Medical Instrumentation 2026年 第50卷 第1期

综 合 评 述

发展。OBCI这一技术、新产品的日益发展，对相 Eng, 2021, 18(4): 0460d7.
应的医疗器械检测技术提出了更高的要求。目前国 [13] YUAN H W, LI Y, YANG J J, et al. State of the art of
non-invasive electrode materials for brain–computer
内外还缺乏相应的OBCI设备统一评定标准，检测
interface[J]. Micromachines, 2021, 12(12): 1521.
技术的发展也相对缓慢。本文基于OBCI技术基本 [14] ROY S, RATHEE D, CHOWDHURY A, et al. Assessing
原理，提出了未来医疗器械检测技术在安全性和有 impact of channel selection on decoding of motor and
效性方面可参考或借鉴的标准，并对检测技术发展 cognitive imagery from MEG data[J]. J Neural Eng, 2020,
17(5): 056037.
中需关注的重要指标进行了展望。本文为提升
[15] 盛兴, 赵汶鑫, 李丽珠, 等. 脑机接口技术的基础研究:
OBCI设备的安全可靠性能、遴选下一代更高效的 神经元与二极管[J]. 中国激光, 2023, 50(9): 181-192.
OBCI医疗器械技术，乃至推动专属行业标准制定 [16] STRANGMAN G, BOAS D A, SUTTON J P. Non-
与监管法规完善，提供了思路和支撑。相信随着检 invasive neuroimaging using near-infrared light[J]. Biol
Psychiatry, 2002, 52(7): 679-693.
测技术的不断发展，OBCI技术在医疗器械领域的
[17] PINTI P, TACHTSIDIS I, HAMILTON A, et al. The
应用将迈入新的阶段。 present and future use of functional near‐ infrared
spectroscopy (fNIRS) for cognitive neuroscience[J]. Ann
N Y Acad Sci, 2020, 1464(1): 5-29.
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