IEC 60601的本部分适用于外部设备的基本安全和基本性能 由内部电源供电的起搏器，以下简称 我的设备。 本文件适用于201.3.209中定义的患者电缆，但不适用于导线 如201.3.206所定义。 在以下范围内医用电气设备预期生理功能的固有危害: 除7.2外，本文件的具体要求不包括本文件。 13及 通用标准的第8.4.1条。交叉引用:IEC 60601-1:2005IEC 60601-1:2005/AMD1:2012EN 60601-1:2006/勘误表2010年3月ISO 14117:2019ISO 14708-2:2019EN 60601-1:2006EN 60601-1:2006/A12:2014IEC 60601-1-2:2014IEC 60601-2-2010/AMD1:2018IEC 60601-2-4:2010IEC 61000-4-2:2008EN 60086-1:2015EN 60086-2:2015EN 60086-2-2:2015EN 61000-4-2018EN 6008-1:2016IEC 60086-2-2-2:2016IEC 60086-2-2-2008目前所有修订版均可用本文件的购买包含了购买费用。

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206. HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.Cross References:IEC 60601-1:2005IEC 60601-1:2005/AMD1:2012EN 60601-1:2006/corrigendum Mar. 2010ISO 14117:2019ISO 14708-2:2019EN 60601-1:2006EN 60601-1:2006/A12:2014IEC 60601-1-2:2014IEC 60601-2-4:2010/AMD1:2018IEC 60601-2-4:2010IEC 61000-4-2:2008EN 60086-1:2015EN 60086-2:2016IEC 60086-2:2015EN 61000-4-2:2009ISO 14708-1:2014IEC 60086-1:2015EN 60601-2-4:2011All current amendments available at time of purchase are included with the purchase of this document.