IEC 60601 标准信息.docx

IEC 60601 标准信息（红色的为不再使用的信息）2011.11.08整理序号标准号标准名称对应国内标准标准中文名称备注一IEC 60601-1系列1IEC 3.060601-1-2005Medical electrical equipmentPart1 General requirements for basic safety and essential performanceGB9706.1医用电气设备：安全性的一般技术要求现行第二版（2012.6.1失效）1IEC 2.060601-1-1-2000Medicalelectricalequipmentpart1generalrequirementsforsafetycollateralstandardsafetyrequirementsformedicalelectricalsystemsGB9706.15医用电气设备：第1-1部分：医疗电气系统的安全性要求2IEC 3.060601-1-2-2007MedicalelectricalequipmentPart1-2GeneralrequirementsforbasicsafetyandessentialperformancecollateralstandardelectromagneticcompatibilityRequirements and testsYY0505医用电气设备：第1-2部分：电磁相容性技术要求和测试现行第二版（2012.6.1失效）3IEC 3.060601-1-3-2008MedicalelectricalequipmentPart1-3:GeneralrequirementsforsafetyCollateralstandard:generalrequirementsforradiationprotectionindiagnosticx-ray equipmentGB9706.12医用电气设备第1-3部分：通用安全要求并行标准：诊断用X射线设备辐射保护通用要求现行第三版（2012.6.1失效）4IEC 1.160601-1-4-2000MedicalelectricalequipmentPart1-4GeneralrequirementsforsafetycollateralstandardprogrammableelectricalmedicalsystemsYY/T0708医用电气设备第1-4部分：安全的一般要求并行的标准：可程序化的医用电气设备5IEC 60601-1-5MedicalelectricalequipmentPart1-5:Generalrequirementsforbasicsafety-Collateral standard: image quality and dose for x-ray equipment医用电气设备第1-5部分：通用安全要求并行标准：X射线设备成像质量与剂量安全通用要求不再使用6IEC3.0 60601-1-6-2010MedicalelectricalequipmentPart1-6:Generalrequirementsforbasicsafetyandessentialperformancecollateralstandard:UsabilityGBT 21051医用电气设备.第1-6部分:安全的通用要求.附属标准:使用性现行第二版（2012.6.1失效7IEC 60601-1-7MedicalelectricalequipmentPart1-7:Generalrequirementsformultiparameter monitors医用电气设备.第1-7部分:多参数显示器的安全通用要求不再使用8IEC2.060601-1-8-2006MedicalelectricalequipmentPart1-8:Generalrequirementsforbasicsafetyandessentialperformancecollateralstandard:Generalrequirements,testsandguidanceforalarmsystemsinmedicalelectricalequipmentandmedicalelectricalsystemYY0709医用电气设备.第1-8部分:安全的一般要求.并列标准.医疗电气设备和医疗电气系统中警报系统的一般要求、试验和指南现行第二版（2012.6.1失效9IEC1.060601-1-9-2007MedicalelectricalequipmentPart1-9Generalrequirementsforbasicsafetyandessentialperformancecollateralstandardrequirementsforenvironmentallyconscious医用电气设备.第1-9部分:安全的一般要求.并行标准：环境意识基本安全和性能通用要求10IEC1.060601-1-10-2007MedicalelectricalequipmentPart1-10:Generalrequirements forbasicsafetyandessentialperformancecollateralstandard: Requirementsforthedevelopmentofphysiologicclosed-loop controllers医用电气设备：第1-10部分：基本安全和性能通用要求并行标准:生理闭环控制器开发要求11IEC1.060601-1-11-2010Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment医用电气设备：第1-11部分：基本安全和性能通用要求并行标准:家庭健康护理使用医用电气系统要求二IEC 60601-2系列1IEC3.060601-2-1-2009Medical electrical equipment - part 2-1: particular requirements for the safety of electron accelerators in the range 1 mev to 50 mev GB9706.5医用电气设备 第2部分：能量为1MeV至50 MeV电子加速器安全专用要求2IEC5.060601-2-2-2009Medical electrical equipment - part 2-2: particular requirements for the safety of high frequency surgical equipment GB9706.4医用电气设备 第2-2部分：高频手术设备安全专用要求现行第五版（2012.4.1失效3IEC2.060601-2-3-1998 amdMedical electrical equipment part 2-3: particular requirements for the safety of short-wave therapy equipment YY91086 YY91087已于2011.7.1失效4IEC3.060601-2-4-2010Medical electrical equipment - part 2-4: particular requirements for the basic safety and essential performance of cardiac defibrillatorsGB9706.8医用电气设备第2-4部分：心脏除颤器安全专用要求5IEC3.060601-2-5-2009Medical electrical equipment - part 2-5: particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipmentGB9706.7医用电气设备 第2-5部分：超声理疗设备安全专用要求6IEC1.060601-2-6-1984Medical electrical equipment - part 2: particular requirements for the safety of microwave therapy equipment GB9706.6医用电气设备 第二部分：微波治疗设备安全专用要求不再使用？7IEC2.060601-2-7-1998Medical electrical equipment - part 2-7: particular requirements for the safety of high-voltage generators of diagnostic x-ray generators GB9706.3医用电气设备 第2部分:诊断X射线发生装置的高压发生器安全专用要求8IEC2.060601-2-8-2010Medical electrical equipment - part 2-8: particular requirements for the basic safety and essential performance of therapeutic x-ray equipment operating in the range 10 kv to 1 mvGB9706.10医用电气设备 第二部分:治疗X射线发生装置安全专用要求9IEC1.060601-2-9-1996Medical electrical equipment - part 2-9: particular requirements for the safety of patient contact dosemeters used in radiotherapy withelectrically connected radiation detectors GB9706.21医用电气设备 第2部分:用于放射治疗与患者接触且具有电气连接辐射探测器的剂量计的安全专用要求不再使用10IEC1.060601-2-10-2001 am1Medical electrical equipment part 2-10: particular requirements for the safety of nerve and muscle stimulators YY0607医用电气设备 第2部分：神经和肌肉刺激器安全专用要求已于2004.11.1失效11IEC2.060601-2-11-2004 am1Medical electrical equipment part 2-11: particular requirements for the safety of gamma beam therapy equipment GB9706.17医用电气设备 第2部分：射束治疗设备安全专用要求12IEC2.060601-2-12-2001Medical electrical equipment - part 2-12: particular requirements for the safety of lung ventilators for medical use GB9706.28医用电气设备 第2部分: 呼吸机安全专用要求 治疗呼吸机13 IEC3.160601-2-13-2009Medical electrical equipment - part 2-13: particular requirements for the safety of anaesthetic workstations GB9706.29医用电气设备 第2-13部分：麻醉系统的安全和基本性能专用要求14IEC1.060601-2-14-1989Medical electrical equipment - part 2-14: particular requirements for the safety of electroconvulsive therapy equipment 不再使用15IEC1.060601-2-15-1988Medical electrical equipment - part 2-15: particular requirements for the safety of capacitor discharge x-ray generators 不再使用16IEC3.060601-2-16-2008Medical electrical equipment - part 2-16: particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipmentGB9706.2医用电气设备 第2-16部分:血液透析、血液透析滤过和血液滤过设备的安全专用要求17IEC2.060601-2-17-2004Medical electrical equipment - part 2-17: particular requirements forthe safety of remote-controlled automatically driven gamma-ray after-loading equipment GB9706.13医用电气设备 第2-17部分：自动控制式近距离治疗后装设备安全专用要求已于2007.3.1失效18IEC3.060601-2-18-2009Medical electrical equipment part 2-18: particular requirements for the safety of endoscopic equipment GB9706.19医用电气设备 第2-18部分:内窥镜设备安全专用要求19IEC2.060601-2-19-2009Medical electrical equipment - part 2-19: particular requirements of safety of baby incubators GB11243医用电气设备 第2-19部分：婴儿培养箱安全专用要求2012.4.1失效20IEC2.060601-2-20-2009Medical electrical equipment - part 2-20: particular requirements for the safety of infant transport incubators 医用电气设备 第2-20部分：婴儿运输培养箱安全专用要求2012.9.1失效21IEC2.060601-2-21-2009Medical electrical equipment part 2-21: particular requirements for the safety of infant radiant warmers YY0455医用电气设备第2-21部分：婴儿辐射保暖台安全专用要求2012.4.1失效22IEC3.060601-2-22-2007Medical electrical equipment - part 2-22: particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipmentGB9706.20医用电气设备 第2-22部分:诊断和治疗激光设备安全专用要求23IEC3.060601-2-23-2011Medical electrical equipment - part 2-23: particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment 24IEC1.060601-2-24-1998Medical electrical equipment - part 2-24: particular requirements for the safety of infusion pumps and controllers GB9706.27医用电气设备 第2-24部分:输液泵和输液控制器安全专用要求25IEC2.060601-2-25-2011Medical electrical equipment - part 2-25: particular requirements for the safety of electrocardiographs GB10793医用电气设备第2部分：心电图机安全专用要求26IEC2.060601-2-26-2002Medical electrical equipment part 2-26: particular requirements for the safety of electroencephalographs GB9706.26医用电气设备 第2部分:脑电图机安全专用要求已于2006.3.1失效27IEC3.060601-2-27-2011Medical electrical equipment - part 2-27: particular requirements for the safety of electrocardiographic monitoring equipment GB9706.25医用电气设备 第2部分:心电监护设备安全专用要求28IEC2.060601-2-28-2010Medical electrical equipment - part 2-28: particular requirements for the basic safety and essential performance of x-ray tube assemblies for medical diagnosisGB9706.11医用电气设备 第2部分:医用诊断X射线源组件和X射线管组件安全专用要求2013.4.1失效29IEC3.060601-2-29-2008Medical electrical equipment - part 2-29: particular requirements for the basic safety and essential performance of radiotherapy simulatorsGB9706.16医用电气设备 第2部分:放射治疗模拟机安全专用要求已于2011.11.1失效30IEC2.060601-2-30-1999Medical electrical equipment - part 2-30: particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipmentYY0667医用电气设备 第2部分:自动循环无创血压监护设备的安全和基本性能专用要求已于2003.2.1失效31IEC2.160601-2-31-2011Medical electrical equipment - part 2-31: particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source32IEC1.060601-2-32-1994Medical electrical equipment part 2-32: particular requirements for the safety of associated equipment of x-ray equipment GB9706.14医用电气设备 第2部分:X射线设备附属设备安全专用要求33IEC3.060601-2-33-2010Medical electrical equipment - part 2-33: particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosisYY0319医用电气设备 第2-33部分：医疗诊断用磁共振设备安全专用要求34IEC3.060601-2-34-2011Medical electrical equipment - part 2-34: particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipmentYY0783医用电气设备 第2-34部分：有创血压监测设备的安全和基本性能专用要求35IEC1.060601-2-35-1996Medical electrical equipment - part 2-35: particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use 电热毯、衬垫、褥垫不再使用？36IEC1.060601-2-36-1997Medical electrical equipment - part 2-36: particular requirements forthe safety of equipment for extracorporeally induced lithotripsy GB9706.22医用电气设备 第2-36部分: 体外引发碎石设备安全专用要求37IEC2.060601-2-37-2007Medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipmentGB9706.9医用电气设备 第2-37部分：超声诊断和监护设备安全专用要求已于2010.10.1失效38IEC1.060601-2-38-1999Medical electrical equipment - part 2-38: particular requirements for the safety of electrically operated hospital bedsYY0571医用电气设备 第2部分：医院电动床安全专用要求已于2003.1.1失效39IEC2.060601-2-39-2007Medical electrical equipment - part 2-39: particular requirements for basic safety and essential performance of peritoneal dialysis equipmentGB9706.39医用电气设备 第2-39部分：腹膜透析设备的安全专用要求已于2011.3.1失效40IEC1.060601-2-40-1998Medical electrical equipment - part 2-40: particular requirements for the safety of eletromyographs and evoked response equipment 肌电图及激发响应设备41IEC2.060601-2-41-2009Medical electrical equipment - part 2-41: particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosisYY0627医用电气设备第2部分：手术无影灯和诊断用照明灯安全专用要求2012.11.1失效4260601-2-42Medical electrical equipment - part 2-42: particular requirements for the safety of automatic or advisory external defibrillators.外部除颤器不再使用43IEC2.060601-2-43-2010Medical electrical equipment - part 2-43: particular requirements for the basic safety and essential performance of x-ray equipment for interventional proceduresGB9706.23医用电气设备 第2-43部分:介入操作 X射线设备安全专用要求2013.6.1失效44IEC3.060601-2-44-2009Medical electrical equipment - part 2-44: particular requirements for the basic safety and essential performance of x-ray equipment for computed tomographyGB9706.18医用电气设备 第2部分：X射线计算机体层摄影设备安全专用要求2012.5.1失效45IEC3.060601-2-45-2011Medical electrical equipment - part 2-45: particular requirements for the basic safety and essential performance of mammographic x-ray equipment and mammographic stereotactic devicesGB9706.24医用电气设备 第2-45部分:乳腺X射线摄影设备及乳腺摄影立体定位装置 安全专用要求46IEC2.060601-2-46-2010Medical electrical equipment - part 2-46: particular requirements for the basic safety and essential performance of operating tablesYY0570医用电气设备 第2部分：手术台安全专用要求47IEC1.060601-2-47-2001Medical electrical equipment - part 2-47: particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems移动心电图48 60601-2-48 Medical electrical equipment - part 2-48: particular requirements for the safety of radiation therapy treatment planning sy