BS EN 60601-2-25:2015适用于车辆的基本安全和基本性能 201.3.63中定义的心电图机，其本身或其组成部分 ME系统，用于生成诊断用ECG报告，以下简称 作为我的设备。不包括在本特定标准范围内的是:医用电气设备中提供心电向量图环路的部分；IEC 60601-2-47涵盖的动态心电图医用电气设备 用于获取用于诊断目的的ECG报告；IEC 60601-2-27规定的心脏监护仪，不用于获取ECG 用于诊断目的的报告。例如，注1。医用电气设备包括:直写式心电图机；为诊断目的生成ECG报告的其他医用电气设备，例如患者监护仪、除颤器、运动 测试设备；显示器远离患者的心电图机（例如。 g、 通过电话线、网络或存储介质）。这些医用电气设备或医用电气系统在本特定标准的范围内，不包括传输介质。注2:在诊断和监控功能之间提供选择的医用电气设备应满足以下要求: 为该功能配置时的相应标准要求。在极端或不受控环境条件下使用的医用电气设备 在医院环境或医生办公室之外，如救护车和空中 运输应符合本特殊标准。其他标准可能适用于 适用于这些使用环境的医用电气设备。交叉引用:IEC 60601-1-2:2007EN 60601-1-2:2007EN 60601-1-2:2007/勘误1:2010IEC 60601-2-2:2009EN 60601-2-2:2009EN 60601-2-2:2009+A11:201193/42/EECIEC 60601-2-27EN 60601-2-27IEC 60601-2-47EN 60601-2-47BS EN 60601-2- 25:1996和BS EN 60601-2-51:2003仍然有效。购买本文件时可获得的所有现行修订均包含在购买本文件中。

BS EN 60601-2-25:2015 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHS as defined in 201.3.63 intended by themselves or as a part of an ME SYSTEM, for the production of ECG REPORTS for diagnostic purposes, hereinafter referred to as ME EQUIPMENT.Not included within the scope of this particular standard are:the part of ME EQUIPMENT that provides vectorcardiographic loops;ambulatory electrocardiographic ME EQUIPMENT covered by IEC 60601-2-47 where not intended for obtaining ECG REPORTS for diagnostic purposes;cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining ECG REPORTS for diagnostic purposes.NOTE 1 For example. ME EQUIPMENT includes:direct-writing ELECTROCARDIOGRAPHS;other ME EQUIPMENT that produce ECG REPORTS for diagnostic purposes, e.g. patient monitors, defibrillators, exercise testing devices;ELECTROCARDIOGRAPHS having a display that is remote from the PATIENT (e.g. via phone lines, networks or storage media).These ME EQUIPMENT or ME SYSTEMS are within the scope of this particular standard excluding transmission media.NOTE 2 ME EQUIPMENT that provide selection between diagnostic and monitoring functions shall meet the requirements of the appropriate standard when configured for that function.ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to ME EQUIPMENT for those environments of use.Cross References:IEC 60601-1-2:2007EN 60601-1-2:2007EN 60601-1-2:2007/Corrigendum 1:2010IEC 60601-2-2:2009EN 60601-2-2:2009EN 60601-2-2:2009+A11:201193/42/EECIEC 60601-2-27EN 60601-2-27IEC 60601-2-47EN 60601-2-47Replaces BS EN 60601-2-25:1996 and BS EN 60601-2-51:2003 which remain currentAll current amendments available at time of purchase are included with the purchase of this document.