Cardiovascular Non-Invasive Testing Group, Cardiovascular Professional Committee, Expert Group For The Compilation Of-Lead Ecg Automatic Diagnosis Function Evaluation Specification
Zhongguo Yi Liao Qi Xie Za Zhi. 2021 Sep 30;45(5):563-567. doi: 10.3969/j.issn.1671-7104.2021.05.020.
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.
心电图机的自动诊断功能直接影响该设备的临床应用。然而，目前临床上对于12导联心电图机自动诊断功能的评估尚无统一标准。我们从规范范围、自动诊断功能判断规则、通用技术测量要求、测试方法与条件以及心电图数据输入等方面制定了一份12导联心电图自动诊断功能临床评估规范。重点阐述了自动诊断功能的判断规则，包括心电图特征值的准确性、自动诊断结果的解读与判断。本规范旨在为12导联心电图自动诊断功能的临床评估提供技术依据。
