标准摘要
[中文适用范围]： 该国际标准适用于心脏除颤器（以下简称医疗设备）的基本安全和核心性能。如果某条款或子条款明确仅适用于医疗设备或仅适用于医疗系统，则该条款或子标题和内容将予以说明。否则，该条款或子条款既适用于医疗设备也适用于医疗系统（视情况而定）。本标准范围内医疗设备或医疗系统预期的生理功能内固有的危险，除在通用标准的7.2.13和8.4.1中另有规定外，不受本标准具体要求的覆盖。见通用标准4.2。本特定标准不适用于植入式除颤器、遥控除颤器、体外经皮起搏器或独立的独立心脏监护仪（由IEC 60601-2-27:2011标准化）。使用独立ECG监护电极的心脏监护仪不属于本标准的范围，除非它们作为除颤器自动除颤仪（AED）心律识别检测或同步电复律的搏动检测的唯一基础。如201.108所述的除颤器电极也可用于ECG监护；然而，由于电极面积较大，IEC 60601-2-27的要求不适用于除颤器电极。除颤波形技术正在迅速发展。已发表的研究表明，波形的有效性有所不同。特定波形的选择（包括波形形状、输送能量、疗效和安全性）已明确排除在本标准范围之外。然而，由于治疗波形至关重要，已添加评论以解决波形选择方面的考虑。 [外文原描述]： IEC 60601-2-4:2010+A1:2018 establishes particular basic safety and essential performance requirements for cardiac defibrillators. This third edition cancels and replaces the second edition published in 2002. This edition constitutes a technical revision, revised to structurally align it with IEC 60601-1:2005 and to implement the decision of IEC SC 62A that the clause numbering structure of particular standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. 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. This consolidated version consists of the third edition (2010) and its amendment 1 (2018). Therefore, no need to order amendment in addition to this publication.
英文名称Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators