规定了心电图（ECG）监测设备的基本安全要求和基本性能。适用于医院环境中使用的心电监护设备。如果在医院外环境中使用，如救护车和空运，ECG监测设备应符合本标准。本标准不适用于家用心电监护仪和心电遥测系统。然而，制造商应考虑使用本标准的相关条款作为其预期用途/预期目的。动态（“Holter”）监护仪、胎儿心率监护仪、脉搏容积描记仪和其他ECG记录设备不在本特定标准的范围内。

Specifies basic safety requirements and essential performance for electrocardiographic (ECG) monitoring equipment. It is applicable to ECG monitoring equipment used in a hospital environment. If it is used outside the hospital environment, such as in ambulances and air transport, the ECG monitoring equipment shall comply with this standard. This standard is not applicable to electrocardiographic monitors for home use and ECG telemetry systems. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use/intended purpose. Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard.