EN60601及对应国标医疗器械通用、专用要求.pdf

序号标准号标准名称对应国内标准标准中文名称一EN60601-1系列标准1BSIBSEN60601-1-2006MedicalelectricalequipmentPart1GeneralrequirementsforbasicsafetyandessentialperformanceGB9706.1医用电气设备：安全性的一般技术要求1BSIBSEN60601-1-1-2007MedicalelectricalequipmentPart1GeneralrequirementsforsafetyCollateralstandardSafetyrequirementsformedicalelectricalsystemsGB9706.15医用电气设备：第1-1部分：医疗电气系统的安全性要求2BSIBSEN60601-1-2-2007MedicalelectricalequipmentPart1-2GeneralrequirementsforbasicsafetyandessentialperformanceCollateralstandardElectromagneticcompatibilityRequirementsandtestsYY0505医用电气设备：第1-2部分：电磁相容性技术要求和测试3BSIBSEN60601-1-3-1998MedicalelectricalequipmentPart1-3:GeneralrequirementsforsafetyCollateralstandard:GeneralrequirementsforradiationprotectionindiagnosticX-rayequipmentGB9706.12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4BSIBSEN60601-1-4-2000MedicalelectricalequipmentPart1-4GeneralrequirementsforsafetyCollateralstandardProgrammableelectricalmedicalsystemsYY/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5IEC60601-1-5MedicalelectricalequipmentPart1-5:GeneralrequirementsforsafetyCollateralstandard:ImagequalityanddoseforX-rayequipment医用电气设备：第1-5部分：安全通用要求：并行标准:X射线设备成像质量与剂量安全通用要求6IEC60601-1-62006MedicalelectricalequipmentPart1-6:GeneralrequirementsforbasicsafetyandessentialperformanceCollateralStandard:Usability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7IEC60601-1-7MedicalelectricalequipmentPart1-7:Generalrequirementsformultiparametermonitors医用电气设备：第1-7部分：多参数显示器的安全通用要求8IEC60601-1-82006MedicalelectricalequipmentPart1-8: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9EN60601-1-9-2007MedicalelectricalequipmentPart1-9Generalrequirements医用电气设备.第1-9部分:安全的一般要求.并行标forbasicsafetyandessentialperformanceCollateralStandardRequirementsforenvironmentallyconscious准：环境意识基本安全和性能通用要求10IEC-60601-1-102007MedicalelectricalequipmentPart1-10:GeneralrequirementsforbasicsafetyandessentialperformanceCollateralStandard:Requirementsforthedevelopmentofphysiologicclosed-loopcontrollers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二EN60601-2系列标准1BSIBSEN60601-2-1-1998MedicalelectricalequipmentPart2-1Particularrequirementsforthesafetyofelectronacceleratorsintherange1MeVto50MeVGB9706.5医用电气设备第2-1部分:能量为1MeV至50MeV医用电子加速器安全专用要求2BSIBSEN60601-2-2-2009MedicalelectricalequipmentPart2-2ParticularrequirementsforthesafetyofhighfrequencysurgicalequipmentGB9706.4医用电气设备第2-2部分：高频手术设备安全专用要求3BSIBSEN60601-2-3-1993MedicalelectricalequipmentPart2-3Particularrequirementsforthesafetyofshort-wavetherapyequipmentYY91086YY91087医用电气设备第2-3部分：超短波治疗设备安全专用要求4BSIBSEN60601-2-4-2003MedicalelectricalequipmentPart2-4ParticularrequirementsforthesafetyofcardiacdefibrillatorsGB9706.8医用电气设备第2-4部分：心脏除颤器安全专用要求5BSIBSEN60601-2-5-2001MedicalelectricalequipmentPart2-5ParticularrequirementsforthesafetyofultrasonicphysiotherapyequipmentGB9706.7医用电气设备第2-5部分:超声治疗设备安全专用要求6IEC60601-2-6-1984,MedicalelectricalequipmentPart2-6ParticularrequirementsforthesafetyofmicrowavetherapyequipmentGB9706.6医用电气设备第2-6部分:微波治疗设备安全专用要求7BSIBSEN60601-2-7-1998MedicalelectricalequipmentPart2-7ParticularrequirementsforsafetySpecificationforhighvoltagegeneratorsofdiagnosticX-raygeneratorsGB9706.3医用电气设备第2-7部分:诊断X射线发生装置的高压发生器安全专用要求8BSIBSEN60601-2-8-1998MedicalelectricalequipmentPart2-8ParticularrequirementsforsafetySectionSpecificationfortherapeuticX-rayequipmentoperatingintherange10kVto1MVGB9706.10医用电气设备第2-8部分:在10kV1MV治疗X射线发生装置安全专用要求9BSIBSEN60601-2-9-1997MedicalelectricalequipmentPart2ParticularrequirementsforsafetySection2.9SpecificationforpatientcontactdosemetersusedinradiotherapywithelectricallyconnectedradiationdetectorsGB9706.21医用电气设备第2-9部分：放射治疗中与患者接触的剂量仪与辐射探测器连接的安全专用要求10BSIBSENMedicalelectricalequipmentPart2.10ParticularrequirementsYY0607医用电气设备第2-10部分:神经和肌肉刺激器安全60601-2-10-2001forthesafetyofnerveandmusclestimulators专用要求11BSIBSEN60601-2-11-1998MedicalelectricalequipmentPart2ParticularrequirementsforsafetySection2.11SpecificationforgammabeamtherapyequipmentGB9706.17医用电气设备第2-11部分:射束治疗设备安全专用要求12BSIBSEN60601-2-12-2006MedicalelectricalequipmentPart2-12ParticularrequirementsforthesafetyoflungventilatorsCriticalcareventilatorsGB9706.28医用电气设备第2-12部分：呼吸机安全专用要求治疗呼吸机13BSIBSEN60601-2-13-2006MedicalelectricalequipmentPart2-13ParticularrequirementsforthesafetyandessentialperformanceofanaestheticsystemsGB9706.29医用电气设备第2-13部分:麻醉系统安全和基本性能专用要求14IEC60601-2-14-1989Medicalelectricalequipment-Part2:Particularrequirementsforthesafetyofelectroconvulsivetherapyequipment医用电气设备第2-14部分：电痉挛治疗设备安全的特殊要求15IEC60601-2-15-1988Medicalelectricalequipment-Part2:Particularrequirementsforthesafetyofcapacitordischargex-raygenerators医用电气设备第2-15部分：电容放电式X射线发生装置安全的特殊要求16BSIBSEN60601-2-16-1998MedicalelectricalequipmentPart2Particularrequirementsforthesafetyofhaemodialysis,haemodiafiltrationandhaemofiltrationequipmentGB9706.2医用电气设备第2-16部分:血液透析、血红素设备的基本安全和主要性能专门要求。17BSIBSEN60601-2-17-2004MedicalelectricalequipmentPart2-17Particularrequirementsforthesa