IEC 60601-2-4-2010 医用电气设备.第2-4部分:心脏除颤器基本安全性和必要性能的详细要求

标准号：IEC 60601-2-4-2010
中文标准名称：医用电气设备.第2-4部分:心脏除颤器基本安全性和必要性能的详细要求
英文标准名称：Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators
标准类型：C46
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C46
国际标准分类号：11.040.10
引用标准：IEC 60601-1-2-2007;IEC 61000-4-2;ISO 15223-1-2007
适用范围：This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofCARDIAC DEFIBRILLATORS, hereafter referred to as ME EQUIPMENT.If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or toME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not thecase, 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 SYSTEMSwithin the scope of this standard are not covered by specific requirements in this standardexcept in 7.2.13 and 8.4.1 of the general standard.NOTE See also 4.2 of the general standard.This particular standard does not apply to implantable defibrillators, remote controlDEFIBRILLATORS, external transcutaneous pacemakers, or separate stand-alone cardiacmonitors (which are standardized by IEC 60601-2-27 [2]2). Cardiac monitors which useseparate ECG monitoring electrodes are not within the scope of this standard unless they areused as the sole basis for AED rhythm recognition detection or beat detection forsynchronized cardioversion.Defibrillation waveform technology is evolving rapidly. Published studies indicate that theeffectiveness of waveforms varies. The choice of a particular waveform including waveshape,delivered energy, efficacy, and safety has been specifically excluded from the scope of thisstandard.However, due to the critical importance of the therapeutic waveform, comments have beenadded to the rationale which addresses considerations in waveform selection.