心电类医用电子仪器综合验证评价方案设计的探讨  

Discussion on Design of Comprehensive Verification and Evaluation Schemes for Electrocardiogram Medical Electronic Instruments

作　　者：石亚君[1] 王晋丽[1] 郜玲[1] 梁振士 王茜 但晴 董颖[1] 陈韵岱[3] SHI Yajun;WANG Jinli;GAO Ling;LIANG Zhenshi;WANG Qian;DAN Qing;DONG Ying;CHEN Yundai(Department of Cardiology,First Medical Center,Chinese PLA General Hospital,Beijing,100142;Beijing Institute of Medical Device Testing,Beijing,101111;Senior Department of Cardiology,the Sixth Medical Center of PLA General Hospital,Beijing,100142)

机构地区：[1]解放军总医院第一医学中心心血管内科,北京市100142 [2]北京市医疗器械检验所,北京市101111 [3]解放军总医院第六医学中心心血管病医学部,北京市100142

出　　处：《中国医疗器械杂志》2022年第2期225-229,共5页Chinese Journal of Medical Instrumentation

基　　金：北京市科委课题(Z181100009518010)。

摘　　要：该研究介绍了现行的心电类医用电子仪器的检测内容和标准,结合临床实际需求,探讨了心电类医用电子仪器综合验证评价方案,主要包括硬件性能检测、自动诊断功能检测和临床应用评价,强调了综合验证评价方案在临床的实用性和重要性,为方案涉及机构提供参考。This study introduced the current testing content and standards of ECG medical electronic instruments,combined with actual clinical needs,and discussed the comprehensive verification and evaluation protocol for ECG medical electronic instruments.The protocol mainly includes hardware performance testing,automatic diagnostic function testing and clinical application evaluation.The protocol emphasizes the clinical practicality and importance of the comprehensive verification and evaluation program,and provides a reference for the institutions involved in the program.

关 键 词：心电图机 医疗器械 验证评价 方案设计 

分 类 号：TH776[机械工程—仪器科学与技术]