標準號：IEC 60601-2-4-2010
中文標準名稱：醫用電氣設備.第2-4部分:心臟除顫器基本安全性和必要性能的詳細要求
英文標準名稱：Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators
標準類型：C46
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C46
國際標準分類號：11.040.10
引用標準：IEC 60601-1-2-2007;IEC 61000-4-2;ISO 15223-1-2007
適用范圍：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.