医用电气设备.第2-27部分:心电图监护设备的基本安全性和必要性能用详细要求

[中文适用范围]： 本部分标准适用于心电图（ECG）监护设备的基本安全和主要性能，该设备在医院环境以及医院环境之外（如救护车和航空运输）使用。本部分标准也适用于在医院环境中使用的ECG遥测系统。旨在在极端或不受控的环境条件下（如救护车和航空运输）使用的医疗设备应符合本部分标准。其他标准可能适用于这些使用环境的医疗设备。本标准不适用于家用心电图监护仪。然而，制造商应考虑在预期用途中适当使用本标准的有关条款。动态（Holter）监护仪、胎儿心率监护仪、脉搏容积描记装置和其他心电图记录设备不在本部分标准的范围内。 [外文原描述]： IEC 60601-2-27:2011 applies to electrocardiographic monitoring equipments used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment. Electrocardiographic monitoring equipments intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use. Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes. The contents of the corrigendum of May 2012 have been included in this copy.