CE認(rèn)證準(zhǔn)則清單

CE認(rèn)證產(chǎn)品常用標(biāo)準(zhǔn)清單一.CE認(rèn)證適用的一般標(biāo)準(zhǔn)：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(fēng)險(xiǎn)管理標(biāo)準(zhǔn)EN60601-1:2006+A1:2013Medicalelectricalequipment–Part1:GeneralrequirementsforbasicsafetyandessentialperformanceGeneralrequirements:electricalsafetyandessentialperformance醫(yī)療電子產(chǎn)品通用標(biāo)準(zhǔn)EN60601-1-2:2014Medicaldevicespart1-2:Generalrequirementsforsafetyandessentialperformance–Collateralstandards:electromagneticcompatibility–TestandrequirementsGeneralrequirements:EMC醫(yī)療電子產(chǎn)品并列標(biāo)準(zhǔn)：EMCISO15233-1:2012Medicaldevices—Symbolstobeusedwithmedicaldevicelabels,labelingandinformationtobesupplied—Part1:GeneralrequirementsGeneralrequirements:MarkingsAppliedinLabels醫(yī)療器械標(biāo)簽、作標(biāo)記和提供信息的符號(hào)EN1041:2008Terminology,symbolsandinformationprovidedwithmedicaldevicesGeneralrequirements:Terminology醫(yī)療器械常用術(shù)語(yǔ)、標(biāo)記ENISO10993-1:2009Biologicalevaluationofmedicaldevices–Part1:EvaluationandtestingBiologicalEvaluation生物相容性標(biāo)準(zhǔn)ENISO10993-5:2009BiologicalEvaluationofMedicalDevices–Part5:TestsforInVitroCytotoxicityBiologicalEvaluationENISO10993-10:2010BiologicalEvaluationofMedicalDevices–Part10:TestsforIrritationandDelayed-TypeHypersensitivityBiologicalEvaluationEN14155:2011Clinicalinvestigationofmedicaldevicesforhumansubjects-Goodclinicalpractice(ISO14155:2011)醫(yī)學(xué)研究受驗(yàn)者用醫(yī)療器械的臨床試驗(yàn)MEDDEV2.7.1GuidelinesonmedicaldevicesEvaluationofclinicaldata:AguideformanufacturersandNotifiedBody醫(yī)療器械臨床評(píng)價(jià)二.監(jiān)護(hù)儀系列產(chǎn)品適用標(biāo)準(zhǔn)：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(biāo)準(zhǔn)：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(biāo)準(zhǔn)：報(bào)警系統(tǒng)EN60601-2-49:2011MedicalElectricalEquipmentPart2-49:ParticularrequirementsforthebasicsafetyandessentialperformanceofmultifunctionpatientmonitoringequipmentGeneralrequirements:Patientmonitoring醫(yī)療電子產(chǎn)品專用標(biāo)準(zhǔn)：多參數(shù)監(jiān)護(hù)儀IEC60601-2-27:2011Medicalelectricalequipment-Part2-27:ParticularrequirementsforthebasicsafetyandessentialperformanceofelectrocardiographicmonitoringequipmentECGmonitoring:Safetyrequirements醫(yī)療電子產(chǎn)品專用標(biāo)準(zhǔn)：心電監(jiān)護(hù)儀EN60601-2-30:2009MedicalElectricalEquipmentPart2-30:Particularrequirementsforthesafetyandessentialperformanceofautomatednon-invasivesphygmomanometersBloodpressuremonitoring:Safetyrequirements醫(yī)療電子產(chǎn)品專用標(biāo)準(zhǔn)：無(wú)創(chuàng)血壓計(jì)ISO80601-2-61:2011Medicalelectricalequipment–Part2-61:ParticularrequirementsforbasicsafetyandessentialperformanceofpulseoximeterequipmentSpO2:Performancerequirement醫(yī)療電子產(chǎn)品專用標(biāo)準(zhǔn)：血氧設(shè)備ISO80601-2-56:2009Medicalelectricalequipment–Part2-56:ParticularrequirementsforbasicsafetyandessentialperformanceofclinicalthermometersforbodytemperaturemeasurementTemperature:Performancerequirement醫(yī)療電子產(chǎn)品專用標(biāo)準(zhǔn)：臨床體溫計(jì)ISO80601-2-55:2011Medicalelectricalequipment–Part2-55:ParticularrequirementsforthebasicsafetyandessentialperformanceofrespiratorygasmonitorsRespiratorygasmonitoring:SafetyrequirementsPerformancerequirement.醫(yī)療電子產(chǎn)品專用標(biāo)準(zhǔn)：呼吸氣體監(jiān)護(hù)設(shè)備三.生理參數(shù)檢測(cè)儀適用標(biāo)準(zhǔn)：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(biāo)準(zhǔn)：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(biāo)準(zhǔn)：無(wú)創(chuàng)血壓計(jì)ISO80601-2-61:2011Medicalelectricalequipment–Part2-61:ParticularrequirementsforbasicsafetyandessentialperformanceofpulseoximeterequipmentSpO2:Performancerequirement醫(yī)療電子產(chǎn)品專用標(biāo)準(zhǔn)：血氧設(shè)備ISO80601-2-56:2009Medicalelectricalequipment–Part2-56:ParticularrequirementsforbasicsafetyandessentialperformanceofclinicalthermometersforbodytemperaturemeasurementTemperature:Performancerequirement醫(yī)療電子產(chǎn)品專用標(biāo)準(zhǔn)：臨床體溫計(jì)注：生理參數(shù)檢測(cè)含有的心電、血糖、無(wú)線傳輸功能并沒有隨產(chǎn)品做CE認(rèn)證。四.血氧系列產(chǎn)品（含血氧探頭）適用標(biāo)準(zhǔn)：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(biāo)準(zhǔn)：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(biāo)準(zhǔn)：血氧設(shè)備注：血氧探頭沒有IEC60601-1-11:2010標(biāo)準(zhǔn)。五.多普勒胎心儀適用標(biāo)準(zhǔn)：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(biāo)準(zhǔn)：家用健康環(huán)境IEC60601-2-37:2007MedicalelectricalequipmentPart2-37:Particularrequi