医疗电器设备.安全的特殊要求.具有内部功率源的外部心脏起搏器

BS EN 60601-2-31-2008

医疗电器设备.安全的特殊要求.具有内部功率源的外部心脏起搏器

Medical electrical equipment. Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

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适用范围：Clause 1 of the general standard applies, except as follows: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 to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, 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 of his standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 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 be connected directly or indirectly to a SUPPLY MAINS.This standard does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and antitachycardia ME EQUIPMENT.

实施日期： 2009-07-31

ICS分类号： 11.040.01,11.040.40 - 医药卫生技术

标准组织： BS - 英国标准学会标准

全文来源： WF

中文关键词：调整设备组装蓄电池组运河电路清洁处理燃料元部件团料连接连接器的连接件恒电流缺陷定义(术语) 测定放电消毒电力系统电击电气设备电气工程医用电气设备电气安全性电磁兼容性电医学电子电源电磁兼容性(EMC) 环境条件环境测试外部特点频率高温防护点火输入电流使用说明书内部中断液体作标记测量测量不确定度医疗设备医疗技术学潮气示波器引出端溢水口起搏器纸患者辅助电流功率消耗精密度脉冲发生器辐射辐射防护安全性安全性要求规范(验收) 灭菌指示器温度测试工作数据

语种：汉语

页数： 40

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医疗电器设备.安全的特殊要求.具有内部功率源的外部心脏起搏器

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