CE認(rèn)證標(biāo)準(zhǔn)清單

認(rèn)證產(chǎn)品常用準(zhǔn)清單一.CE認(rèn)適的般準(zhǔn)MDD93/42/EECENISOENISOEN2006+A1:2013

andMedicalDeviceDirective（Directive）Medicaldevices–Quality–RequirementsforMedicaldevices–ApplicationofmanagementtomedicaldevicesMedicalequipment–forsafetyperformance

EUregulationQualityelectricalessentialperformance

備歐盟有源醫(yī)療器械指令質(zhì)量體系法規(guī)風(fēng)險(xiǎn)管理標(biāo)準(zhǔn)醫(yī)療電子產(chǎn)品通用標(biāo)準(zhǔn)EN60601-1-2:

Medicaldevicespartrequirementsforsafety–CollateralGeneralelectromagneticcompatibility–EMCrequirementsMedicaldevices—beusedwithmedicallabelingandMarkingsAppliedinsupplied—requirements

醫(yī)療電子產(chǎn)品并列標(biāo)準(zhǔn)：EMC醫(yī)療器械標(biāo)簽記和提供信息的符號(hào)ENENISOENISO

symbolsandinformationwithmedicaldevicesBiologicalevaluationdevices–PartBiologicalEvaluationofDevices–TestsVitroCytotoxicity

TerminologyBiologicalEvaluationBiologicalEvaluation

醫(yī)療器械常用術(shù)語(yǔ)記生物相容性標(biāo)準(zhǔn)BiologicalEvaluationofDevices–ENISO10993-10:PartforIrritationClinicalofmedicalforENhuman-Goodclinical(ISO14155:2011)Evaluationof

BiologicalEvaluation

醫(yī)學(xué)研究受驗(yàn)者用醫(yī)療器械的臨床試驗(yàn)MEDDEV

data:AguideformanufacturersNotified

醫(yī)療器械臨床評(píng)價(jià)二.護(hù)系產(chǎn)適標(biāo)：

精選文庫(kù)

and

備Medicalequipment–1-6:EN60601-1-6:

requirementsforsafetyandessentialperformance–

醫(yī)療電子產(chǎn)品并列標(biāo)準(zhǔn)：可用性Usability.Medicalequipment–1-8:requirementsforsafetyandEN60601-1-8:

essentialperformance–standard:requirements,guidancefor

：

醫(yī)療電子產(chǎn)品并列標(biāo)準(zhǔn)：報(bào)警系統(tǒng)alarminmedicalequipmentelectricalMedicalElectricalEquipmentPart2-49:EN

Particularforbasicandessentialperformanceofmultifunction

Patient

醫(yī)療電子產(chǎn)品專(zhuān)用標(biāo)準(zhǔn)：多參數(shù)監(jiān)護(hù)儀equipmentMedicalequipment-IEC

Particularforbasicandessentialperformanceof

monitoring:Safetyrequirements

醫(yī)療電子產(chǎn)品專(zhuān)用標(biāo)準(zhǔn)：心電監(jiān)護(hù)儀equipmentEN:

MedicalElectricalEquipmentPart2-30:Particularforandessentialperformanceofnon-invasiveMedicalequipment–ParticularforsafetyessentialperformanceofMedicalequipment–ParticularforsafetyessentialperformanceofclinicalforbodymeasurementMedicalequipmentParticularforbasicandessentialperformanceofrespiratorygasmonitors

BloodSafetyrequirements:requirementTemperature:requirementRespiratory

醫(yī)療電子產(chǎn)品專(zhuān)用標(biāo)準(zhǔn)：無(wú)創(chuàng)血壓計(jì)醫(yī)療電子產(chǎn)品專(zhuān)用標(biāo)準(zhǔn)：血氧設(shè)備醫(yī)療電子產(chǎn)品專(zhuān)用標(biāo)準(zhǔn)：臨床體溫計(jì)醫(yī)療電子產(chǎn)品專(zhuān)用標(biāo)準(zhǔn)氣體監(jiān)護(hù)設(shè)備三.理數(shù)測(cè)適標(biāo)：—

2

22精選文庫(kù)22

and

備MedicalequipmentrequirementsforsafetyandIEC

essentialperformance–forelectrical

healthcare

醫(yī)療電子產(chǎn)品并列標(biāo)準(zhǔn)：家用健康環(huán)境electricalinhomehealthcareenvironmentEN

MedicalElectricalEquipmentPart2-30:Particularforandessentialperformanceofnon-invasiveMedicalequipment–ParticularforsafetyessentialperformanceofMedicalequipment–Particularforsafetyessentialperformanceofclinicalforbodymeasurement

BloodSafetyrequirements:requirementTemperature:requirement

醫(yī)療電子產(chǎn)品專(zhuān)用標(biāo)準(zhǔn)：無(wú)創(chuàng)血壓計(jì)醫(yī)療電子產(chǎn)品專(zhuān)用標(biāo)準(zhǔn)：血氧設(shè)備醫(yī)療電子產(chǎn)品專(zhuān)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(xiàn)傳輸功能并沒(méi)有隨產(chǎn)品CE證。四.氧列品含氧頭適標(biāo)：

and

備MedicalequipmentrequirementsforsafetyandIEC

essentialperformance–forelectrical

healthcare

醫(yī)療電子產(chǎn)品并列標(biāo)準(zhǔn)：家用健康環(huán)境electricalinhomehealthcareenvironment

Medicalequipment–Particularforsafetyessentialperformanceof

:requirement

醫(yī)療電子產(chǎn)品專(zhuān)用標(biāo)準(zhǔn)：血氧設(shè)備注：血氧探頭沒(méi)IEC標(biāo)準(zhǔn)。五.普胎儀用準(zhǔn)—

3

精選文庫(kù)

and

備MedicalequipmentrequirementsforsafetyandIEC

essentialperformance–forelectrical

healthcare

醫(yī)療電子產(chǎn)品并列標(biāo)準(zhǔn)：家用健康環(huán)境electricalinhomehealthcareenvironmentIEC

MedicalequipmentPartParticularforbasicandessentialperformanceofmedicaldiagnosticandequipment

monitoring:forsafetyperformance

醫(yī)療電子產(chǎn)品專(zhuān)用標(biāo)準(zhǔn)診斷和監(jiān)護(hù)設(shè)備六.速電測(cè)適標(biāo)：

and

備MedicalequipmentrequirementsforsafetyandIEC

essentialper