CE認證準則清單

CE認證產(chǎn)品常用標準清單一.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:ParticularrequirementsforbasicsafetyandessentialperformanceofpulseoximeterequipmentSpO2:Performancerequirement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ISO80601-2-55:2011Medicalelectricalequipment–Part2-55:ParticularrequirementsforthebasicsafetyandessentialperformanceofrespiratorygasmonitorsRespiratorygasmonitoring:SafetyrequirementsPerformancerequirement.醫(yī)療電子產(chǎn)品專用標準：呼吸氣體監(jiān)護設備三.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:ParticularrequirementsforbasicsafetyandessentialperformanceofpulseoximeterequipmentSpO2:Performancerequirement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CE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:Generalrequirementsforbasicsafetyandessentialperformance–CollateralStandard:RequirementsformedicalelectricalequipmentandmedicalelectricalsystemsusedinthehomehealthcareenvironmentGeneralrequirements:Homehealthcare醫(yī)療電子產(chǎn)品并列標準：家用健康環(huán)境ISO80601-2-61:2011Medicalelectricalequipment–Part2-61:ParticularrequirementsforbasicsafetyandessentialperformanceofpulseoximeterequipmentSpO2:Performancerequirement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:Particularrequi