摘要
以柔性电子与神经调控技术为核心的活体神经电子器件,目前正逐步从动物实验阶段迈向临床转化应用,但该领域至今仍缺少统一的接口定义与测试评价标准。本研究系统梳理了记录类、刺激类及电化学类器件的接口特性,创新性提出由通用技术规范、计量用设备类技术规范和参数校准类计量技术规范组成的3层级标准体系框架,同时明确了关键性能指标、测试评价方法与专用检测装置的一一对应关系,并构建了从离体验证到在体评估的全流程验证方案。研究成果可为活体神经电子器件的标准制定与质量控制提供重要理论依据和实践参考。
In vivo neuroelectronic devices with flexible electronics and neural regulation technology as the core are gradually moving from animal experimental stage to clinical translational application,but there is a lack of unified interface definition and test evaluation criteria in this field.This research systematically combed the interface characteristics of recording,stimulating and electrochemical devices,and innovatively proposed a three-level standard system framework consisting of general specifications,equipment specifications and parameter measurement specifications.In addition,the one-to-one correspondence between key performance indicators,test and evaluation methods and special detection devices was clarified,and the whole process validation scheme from in vitro validation to in vivo evaluation was constructed.The research results can provide important theoretical basis and practical reference for the standard development and quality control of in vivo neuroelectronic devices.
作者
刘泉志
孙添财
LIU Quanzhi;SUN Tiancai
出处
《质量与标准化》
2026年第1期37-40,共4页
Quality and Standardization
关键词
神经电子器件
神经接口
标准化
安全可靠性
Neural electronic device
Neural interface
Standardization
Safety and reliability
