標準號：IEC 60601-2-31-2008
中文標準名稱：醫用電氣設備.第2-31部分:帶內部能源的體外心臟起搏器基本安全和基本性能的特殊要求
英文標準名稱：Medical electrical equipment - Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source
標準類型：C45
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：C45
國際標準分類號：11.040.01;11.040.60
引用標準：IEC 60601-1-2-2007;ISO 14708-2-2005;ANSI/AAMI PC69-2007
適用范圍：Replacement:This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofEXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referredto as ME EQUIPMENT.This standard applies to PATIENT CABLES as defined in 201.3. 109.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 within the scope ofthis standard are not covered by specific requirements in this standard except in 7.2.13 and8.4.1 of the general standard.NOTE See also 4.2 of the general standard.This standard does not apply to the implantable parts of active implantable medical devicescovered by ISO 14708-1 This standard does not apply to EXTERNAL PACEMAKERS which can beconnected directly or indirectly to a SUPPLY MAINS.This standard does not apply to transthoracic and oesophageal pacing ME EQUIPMENT andantitachycardia ME EQUIPMENT.