CE認證產(chǎn)品常用標準清單.CE認證適用的一般標準:SerialNumber/VersionStandardandDescriptionScope備注MDD93/42/EECMedicalDeviceDirective(93/42/EEC)(IncludingDirective2007/47/EC)EUregulation歐盟有源醫(yī)療器械指令ENISO13485:2003/AC:2007Medicaldevices-Qualitymanagementsystems-RequirementsforregulatorypurposesQualitysystem質(zhì)量體系法規(guī)ENISO14971:2007Medicaldevices-ApplicationofriskmanagementtomedicaldevicesRiskManagement風險管理標準EN60601-1:2006+A1:2013Medicalelectricalequipment-Part1:GeneralrequirementsforbasicsafetyandessentialperformanceGeneralrequirements:electricalsafetyandessentialperformance醫(yī)療電子產(chǎn)品通用標準EN60601-1-2:2014Medicaldevicespart1-2:Generalrequirementsforsafetyandessentialperformance-Collateralstandards:electromagneticcompatibility-TestandrequirementsGeneralrequirements:EMC醫(yī)療電子產(chǎn)品并列標準：EMCISO15233-1:2012Medicaldevices—Symbolstobeusedwithmedicaldevicelabels,labelingandinformationtobesupplied—Part1:GeneralrequirementsGeneralrequirements:MarkingsAppliedinLabels醫(yī)療器械標簽、作標記和提供信息的符號EN1041:2008Terminology,symbolsandinformationprovidedwithmedicaldevicesGeneralrequirements:Terminology醫(yī)療器械常用術語、標記ENISO10993-1:2009Biologicalevaluationofmedicaldevices-Part1:EvaluationandtestingBiologicalEvaluation生物相容性標準ENISO10993-5:2009BiologicalEvaluationofMedicalDevices-Part5:TestsforInVitroCytotoxicityBiologicalEvaluationENISO10993-10:2010BiologicalEvaluationofMedicalDevices-Part10:TestsforIrritationandDelayed-TypeHypersensitivityBiologicalEvaluationEN14155:2011Clinicalinvestigationofmedicaldevicesforhumansubjects-Goodclinicalpractice(ISO14155:2011)醫(yī)學研究受驗者用醫(yī)療器械的臨床試驗精品

SerialNumber/VersionStandardandDescriptionScope備注MEDDEV2.7.1GuidelinesonmedicaldevicesEvaluationofclinicaldata:AguideformanufacturersandNotifiedBody醫(yī)療器械臨床評價二.監(jiān)護儀系列產(chǎn)品適用標準:SerialNumber/VersionStandardandDescriptionScope備注EN60601-1-6:2010Medicalelectricalequipment-Part1-6:Generalrequirementsforbasicsafetyandessentialperformance-CollateralStandard:Usability.Generalrequirements:Usability醫(yī)療電子產(chǎn)品并列標準：可用性EN60601-1-8:2007Medicalelectricalequipment-Part1-8:Generalrequirementsforbasicsafetyandessentialperformance-Collateralstandard:Generalrequirements,testsandguidanceforalarmsystemsinmedicalelectricalequipmentandmedicalelectricalsystemsGeneralrequirements：Alarmsystem醫(yī)療電子產(chǎn)品并列標準：報警系統(tǒng)EN60601-2-49:2011MedicalElectricalEquipmentPart2-49:ParticularrequirementsforthebasicsafetyandessentialperformanceofmultifunctionpatientmonitoringequipmentGeneralrequirements:Patientmonitoring醫(yī)療電子產(chǎn)品專用標準：多參數(shù)監(jiān)護儀IEC60601-2-27:2011Medicalelectricalequipment-Part2-27:ParticularrequirementsforthebasicsafetyandessentialperformanceofelectrocardiographicmonitoringequipmentECGmonitoring:Safetyrequirements醫(yī)療電子產(chǎn)品專用標準：心電監(jiān)護儀EN60601-2-30:2009MedicalElectricalEquipmentPart2-30:Particularrequirementsforthesafetyandessentialperformanceofautomatednon-invasivesphygmomanometersBloodpressuremonitoring:Safetyrequirements醫(yī)療電子產(chǎn)品專用標準：無創(chuàng)血壓計ISO80601-2-61:2011Medicalelectricalequipment-Part2-61:ParticularrequirementsforbasicsafetyandessentialperformanceofpulseoximeterequipmentSpO9:2Performancerequirement醫(yī)療電子產(chǎn)品專用標準：血氧設備ISO80601-2-56:2009Medicalelectricalequipment-Part2-56:ParticularrequirementsforbasicsafetyandessentialperformanceofclinicalthermometersforbodytemperaturemeasurementTemperature:Performancerequirement醫(yī)療電子產(chǎn)品專用標準：臨床體溫計ISO80601-2-55Medicalelectricalequipment-PartRespiratorygas醫(yī)療電子產(chǎn)品專用標精品

SerialNumber/VersionStandardandDescriptionScope備注2-55:monitoring:準:呼吸氣體監(jiān)護設備精品

SerialNumber/VersionStandardandDescriptionScope備注:2011ParticularrequirementsforthebasicsafetyandessentialperformanceofrespiratorygasmonitorsSafetyrequirementsPerformancerequirement.三.生理參數(shù)檢測儀適用標準:SerialNumber/VersionStandardandDescriptionScope備注IEC60601-1-11:2010Medicalelectricalequipment-Part1-11:Generalrequirementsforbasicsafetyandessentialperformance-CollateralStandard:RequirementsformedicalelectricalequipmentandmedicalelectricalsystemsusedinthehomehealthcareenvironmentGeneralrequirements:Homehealthcare醫(yī)療電子產(chǎn)品并列標準：家用健康環(huán)境EN60601-2-30:2009MedicalElectricalEquipmentPart2-30:Particularrequirementsforthesafetyandessentialperformanceofautomatednon-invasivesphygmomanometersBloodpressuremonitoring:Safetyrequirements醫(yī)療電子產(chǎn)品專用標準：無創(chuàng)血壓計ISO80601-2-61:2011Medicalelectricalequipment-Part2-61:ParticularrequirementsforbasicsafetyandessentialperformanceofpulseoximeterequipmentSpO9:2Performancerequirement醫(yī)療電子產(chǎn)品專用標準：血氧設備ISO80601-2-56:2009Medicalelectricalequipment-Part2-56:ParticularrequirementsforbasicsafetyandessentialperformanceofclinicalthermometersforbodytemperaturemeasurementTemperature:Performancerequirement醫(yī)療電子產(chǎn)品專用標準：臨床體溫計注：生理參數(shù)檢測含有的心電、血糖、無線傳輸功能并沒有隨產(chǎn)品做E認證。四.血氧系列產(chǎn)品（含血氧探頭）適用標準:SerialNumber/VersionStandardandDescriptionScope備注IEC60601-1-11:2010Medicalelectricalequipment-Part1-11:GeneralGeneralrequirements:醫(yī)療電子產(chǎn)品并列標準：家用健康環(huán)境精品

SerialNumber/VersionStandardandDescriptionScope備注requirementsforbasicsafetyandessentialperformance-CollateralStandard:RequirementsformedicalelectricalequipmentandmedicalelectricalsystemsusedinthehomehealthcareenvironmentHomehealthcareISO80601-2-61:2011Medicalelectricalequipment-Part2-61:ParticularrequirementsforbasicsafetyandessentialperformanceofpulseoximeterequipmentSpO9:2Performancerequirement醫(yī)療電子產(chǎn)品專用標準：血氧設備注：血氧探頭沒有IEC60601-1-11:2010標準。五.多普勒胎心儀適用標準:SerialNumber/VersionStandardandDescriptionScope備注IEC60601-1-11:2010Medicalelectricalequipment-Part1-11:Generalrequirementsforbasicsafetyandessentialperformance-CollateralStandard:RequirementsformedicalelectricalequipmentandmedicalelectricalsystemsusedinthehomehealthcareenvironmentGeneralrequirements:Homehealthcare醫(yī)療電子產(chǎn)品并列標準：家用健康環(huán)境IEC60601-2-37:2007MedicalelectricalequipmentPart2-37:Particularrequirementsforthebasicsafetyandessentialperform