12导联心电图机自动诊断功能临床评价规范  

Clinical Evaluation Criteria for Automatic Diagnosis of 12-lead Electrocardiograph

作　　者：全军心血管专业委员会心脏无创检测学组 12导联心电图机自动诊断功能验评规范编写专家组 陈韵岱[2] Cardiovascular Non-invasive Testing Group,Cardiovascular Professional Committee;Expert Group for the Compilation of 12-Lead ECG Automatic Diagnosis Function Evaluation Specification

机构地区：[1]不详 [2]解放军总医院第一医学中心

出　　处：《中国医疗器械杂志》2021年第5期563-567,共5页Chinese Journal of Medical Instrumentation

基　　金：北京市科委课题(Z181100009518010)。

摘　　要：心电图机自动诊断功能直接影响设备的临床应用.而目前缺乏统一的12导联心电图机自动诊断功能临床评价规范。从规范适用范围、自动诊断功能判断规则、试验方法和条件及心电图数据输入等方面建立12导联心电图机自动诊断功能临床验评规范。重点阐述自动诊断功能判断规则,包括心电图特征值的准确性.自动诊断结果的解释与判断。本规范旨在为12导联心电图机自动诊断功能临床评价提供完整的技术依据。The automatic diagnosis function of the electrocardiograph(ECG)machine directly affects the clinical application of the device.However,there is currently no unified criteria for the evaluation of the automatic diagnosis function of the 12-lead ECG machine in clinic.We established a 12-lead ECG automatic diagnostic function clinical evaluation specification from the scope of the specification,the automatic diagnostic function judgment rules,general technical measurement requirements,test methods and conditions,and ECG data input.Emphasis is given to the judgment rules of the automatic diagnosis function,including the accuracy of ECG feature values,the interpretation and judgment of automatic diagnosis results.This specification aims to provide technical basis for the clinical evaluation for automatic diagnosis function of the 12-lead ECG.

关 键 词：心电图机 自动诊断功能 临床评价 规范 

分 类 号：F203[经济管理—国民经济]