医用电气设备.第2-47部分:移动式心电描记系统基础安全(主要性能)的特殊要求

[中文适用范围]： 替换：本国际标准适用于流动心电图系统@以下简称ME系统的基本安全和基本性能 如果某个条款或子条款专门旨在仅适用于ME设备@或仅适用于ME系统@标题和内容该条款或子条款的内容将如此说明。如果情况并非如此@，则该条款或子条款同时适用于 ME 设备和相关的 ME 系统@。除通用标准 7.2.13 和 8.4.1 之外，本标准中的具体要求不涵盖本标准范围内 ME 设备或 ME 系统的预期生理功能所固有的危险。注：另见通用标准4.2。本标准的范围包括以下类型的系统： a) 提供心电图连续记录和连续分析的系统，允许完全重新分析，给出基本相似的结果。系统可以首先记录和存储心电图，然后在单独的单元上对其进行分析，或者同时记录和分析心电图。所使用的存储介质类型与本标准无关； b) 提供连续分析和仅部分或有限记录的系统，不允许对心电图进行完全重新分析。本标准的安全方面适用于属于上述类别之一的所有类型的系统。如果动态心电图系统提供自动心电图分析，则适用测量和分析功能的最低性能要求。 IEC 60601-2-25 和 IEC 60601-2-27 涵盖的医疗电气设备不包括在本标准的范围内。本标准不适用于不连续记录和分析心电图的系统（例如@间歇性事件记录仪）。 [外文原描述]： IEC 60601-2-47:2012 concerns the basic safety and essential performance of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS. It amends and supplements the general standard IEC 60601-1 (third edition 2005). The requirements of this particular standard take priority over those of the general standard. Within the scope of this standard are systems of the following types: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. b) 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 above- mentioned 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. This standard does not apply to systems that do not continuously record and analyse the ECG (for example, 'intermittent event recorders'). This second edition cancels and replaces the first edition published in 2001. It constitutes a technical revision. This edition was revised to align structurally with the 2005 edition of IEC 60601-1.