CE认证标准清单

1、v1.0可编辑可修改CE认证产品常用标准清单一.CE认证适用的一般标准:SerialNumber/VersionStandardandDescriptionScope备注MDD93/42/EECMedicalDeviceDirective(93/42/EEC)(IncludingDirective2007/47/EC)EUregulation欧盟有源医疔器械指令ENISO13485:2003/AC:2007Medicaldevices-Qualitymanagementsystems-RequirementsforregulatorypurposesQualitysystem质量体系法规ENI

2、SO14971:2007Medicaldevices-ApplicationofriskmanagementtomedicaldevicesRiskManagement风险管理标准EN60601-1:2006+A1:2013Medicalelectricalequipment-Part1:GeneralrequirementsforbasicsafetyandessentialperformanceGeneralrequirements:electricalsafetyandessentialperformance医疗电子产品通用标准EN60601-1-2:2014Medicaldevices

3、part1-2:Generalrequirementsforsafetyandessentialperformance-Collateralstandards:electromagneticcompatibility-TestandrequirementsGeneralrequirements:EMC医疗电子产品并列标准：EMCISO15233-1:2012Medicaldevices-Symbolstobeusedwithmedicaldevicelabels,labelingandinformationtobesupplied-Part1:GeneralrequirementsGenera

4、lrequirements:MarkingsAppliedinLabels医疔器械标签、作标记和提供信息的符号EN1041:2008Terminology,symbolsandinformationGeneral医疔器械常用术语、标iiv1.0可编辑可修改SerialNumber/VersionStandardandDescriptionScope备注providedwithmedicaldevicesrequirements:Terminology记ENISO10993-1:2009Biologicalevaluationofmedicaldevices-Part1:Evaluationan

5、dtestingBiologicalEvaluation生物相容性标准ENISO10993-5:2009BiologicalEvaluationofMedicalDevices-Part5:TestsforInVitroCytotoxicityBiologicalEvaluationENISO10993-10:2010BiologicalEvaluationofMedicalDevices-Part10:TestsforIrritationandDelayed-TypeHypersensitivityBiologicalEvaluationEN14155:2011Clinicalinvesti

6、gationofmedicaldevicesforhumansubjects-Goodclinicalpractice(ISO14155:2011)医学研究受验者用医疗命械的岛床试3巫MEDDEV2.7.1GuidelinesonmedicaldevicesEvaluationofclinicaldata:AguideformanufacturersandNotifiedBody医疔器械临床评价监护仪系列产品适用标准:SerialNumber/VersionStandardandDescriptionScope备注EN60601-1-6:2010Medicalelectricalequipme

7、nt-Part1-6:Generalrequirementsforbasicsafetyandessentialperformance-CollateralStandard:Usability.Generalrequirements:Usability医疗电子产品并列标准：可用性22v1.0可编辑可修改SerialNumber/VersionStandardandDescriptionScope备注EN60601-1-8:2007Medicalelectricalequipment-Part1-8:Generalrequirementsforbasicsafetyandessentialper

8、formance-Collateralstandard:Generalrequirements,testsandguidanceforalarmsystemsinmedicalelectricalequipmentandmedicalelectricalsystemsGeneralrequirements:Alarmsystem医疗电子产品并列标准：报警系统EN60601-2-49:2011MedicalElectricalEquipmentPart2-49:Particularrequirementsforthebasicsafetyandessentialperformanceofmult

9、ifunctionpatientmonitoringequipmentGeneralrequirements:Patientmonitoring医疗电子产品专用标准：多参数监护仪IEC60601-2-27:2011Medicalelectricalequipment-Part2-27:ParticularrequirementsforthebasicsafetyandessentialperformanceofelectrocardiographicmonitoringequipmentECGmonitoring:Safetyrequirements医疗电子产品专用标准：心电监护仪EN6060

10、1-2-30:2009MedicalElectricalEquipmentPart2-30:Particularrequirementsforthesafetyandessentialperformanceofautomatednon-invasivesphygmomanometersBloodpressuremonitoring:Safetyrequirements医疗电子产品专用标准：无创血压计ISO80601-2-61:2011Medicalelectricalequipment-Part2-61:Particularrequirementsforbasicsafetyandessent

11、ialperformanceofpulseoximeterequipmentSpO:Performancerequirement医疗电子产品专用标准：血氧设备33v1.0可编辑可修改SerialNumber/VersionStandardandDescriptionScope备注ISO80601-2-56:2009Medicalelectricalequipment-Part2-56:Particularrequirementsforbasicsafetyandessentialperformanceofclinicalthermometersforbodytemperaturemeasure

12、mentTemperature:Performancerequirement医疗电子产品专用标准：临床体温计ISO80601-2-55:2011Medicalelectricalequipment-Part2-55:ParticularrequirementsforthebasicsafetyandessentialperformanceofrespiratorygasmonitorsRespiratorygasmonitoring:SafetyrequirementsPerformancerequirement.医疗电子产品专用标准：呼吸气体监护设备三.生理参数检测仪适用标准:SerialN

13、umber/VersionStandardandDescriptionScope备注IEC60601-1-11:2010Medicalelectricalequipment-Part1-11:Generalrequirementsforbasicsafetyandessentialperformance-CollateralStandard:RequirementsformedicalelectricalequipmentandmedicalelectricalsystemsusedinthehomehealthcareenvironmentGeneralrequirements:Homehe

14、althcare医疗电子产品并列标准：家用健康环境44v1.0可编辑可修改SerialNumber/VersionStandardandDescriptionScope备注EN60601-2-30:2009MedicalElectricalEquipmentPart2-30:Particularrequirementsforthesafetyandessentialperformanceofautomatednon-invasivesphygmomanometersBloodpressuremonitoring:Safetyrequirements医疗电子产品专用标准：无创血压计ISO8060

15、1-2-61:2011Medicalelectricalequipment-Part2-61:ParticularrequirementsforbasicsafetyandessentialperformanceofpulseoximeterequipmentSpO:Performancerequirement医疗电子产品专用标准：血氧设备ISO80601-2-56:2009Medicalelectricalequipment-Part2-56:Particularrequirementsforbasicsafetyandessentialperformanceofclinicalthermo

16、metersforbodytemperaturemeasurementTemperature:Performancerequirement医疗电子产品专用标准：临床体温计注：生理参数检测含有的心电、血糖、无线传输功能并没有随产品做C以证。四.血氧系列产品（含血氧探头）适用标准:SerialNumber/VersionStandardandDescriptionScope备注IEC60601-1-11:2010Medicalelectricalequipment-Part1-11:Generalrequirementsforbasicsafetyandessentialperformance-C

17、ollateralStandard:RequirementsformedicalelectricalequipmentandmedicalelectricalsystemsusedinthehomeGeneralrequirements:Homehealthcare医疗电子产品并列标准：家用健康环境55v1.0可编辑可修改SerialNumber/VersionStandardandDescriptionScope备注healthcareenvironmentISO80601-2-61:2011Medicalelectricalequipment-Part2-61:Particularrequ

18、irementsforbasicsafetyandessentialperformanceofpulseoximeterequipmentSpO:Performancerequirement医疗电子产品专用标准：血氧设备注：血氧探头没有IEC60601-1-11:2010标准。五.多普勒胎心仪适用标准:SerialNumber/VersionStandardandDescriptionScope备注IEC60601-1-11:2010Medicalelectricalequipment-Part1-11:Generalrequirementsforbasicsafetyandessentialperformance-CollateralStandard:RequirementsformedicalelectricalequipmentandmedicalelectricalsystemsusedinthehomehealthcareenvironmentGeneralrequirements:Homehealthcare医疗电子产品并列标准：家用健康环境IEC60601-2-37:2007MedicalelectricalequipmentPart2-37:Part