BS EN 60601-2-47:2015适用于车辆的基本安全和基本性能 动态心电图系统，以下简称ME系统。如果某条款或子条款专门适用于医用电气设备，或 仅适用于ME系统，该条款或子条款的标题和内容将说明这一点。如果不是这样的话 在这种情况下，本条款或子条款适用于医用电气设备和医用电气系统（视情况而定）。 医用电气设备或医用电气系统预期生理功能中固有的危险 在本标准的范围内，本标准的具体要求不包括 通用标准7.2.13和8.4.1中的规定除外。在本标准的范围内，有以下类型的系统:提供ECG连续记录和连续分析的系统，允许完全 重新分析得出基本相似的结果。系统可能首先记录并存储 随后在单独的装置上记录和分析心电图，或同时记录和分析心电图。 使用的存储介质类型与本标准无关；提供连续分析且仅部分或有限记录的系统不允许 全面重新分析心电图。本标准的安全方面适用于上述任何一种系统的所有类型 类别。如果动态心电图系统提供自动心电图分析，则 测量和分析功能的性能要求适用。医用电气 IEC 60601-2-25和IEC 60601-2-27所涵盖的设备不在本协议范围内 这个标准。交叉引用:IEC 60601-1-2:2007EN 60601-1-2:200793/42/EECIEC 60601-2-25IEC 60601-2-27EN 60601-2-25EN 60601-2-27取代BS EN 60601-2-47: 2001年至今。购买本文件时可获得的所有当前修订均包含在购买本文件中。

BS EN 60601-2-47:2015 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS, hereafter referred to as ME SYSTEMS.If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.Within the scope of this standard are systems of the following types:systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard;systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.The safety aspects of this standard apply to all types of systems falling in one of the abovementioned categories.If the AMBULATORY ELECTROCARDIOGRAPHIC SYSTEM offers automatic ECG analysis, minimal performance requirements for measurement and analysis functions apply. MEDICAL ELECTRICAL EQUIPMENT covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this standard.Cross References:IEC 60601-1-2:2007EN 60601-1-2:200793/42/EECIEC 60601-2-25IEC 60601-2-27EN 60601-2-25EN 60601-2-27Replaces BS EN 60601-2-47:2001 which remains current.All current amendments available at time of purchase are included with the purchase of this document.