为具有直接书写设备的心电图（ECG）系统建立最低安全和性能要求，该设备用于分析复杂心脏复合体的节律和详细形态。根据本标准，心电图系统的所有部分都是从患者身体表面获取信号、放大该信号并以适合于诊断心脏电活动的形式显示该信号所必需的。本标准规定了从输入电极到输出显示器的心电图记录系统的要求。

Establishes minimum safety and performance requirements for electrocardiographic (ECG) systems with direct writing devices which are intended for use in the analysis of rhythm and of detailed morphology of complex cardiac complexes. Subject to this standard are all parts of the electrocardiographic system necessary to obtain the signal from the surface of the patient's body, to amplify this signal, and to display it in a form suitable for diagnosing the heart's electrical activity. This standard defines requirements for the electrocardiographic recording system, from the input electrodes to the output display.