CE认证标准清单新颖完整

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1、可下载优质参赛文档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欧盟有源医疗器械指令ENISO13485:2003/AC:2007Medicaldevices–Qualitymanagementsystems–Requirementsforreg

2、ulatorypurposesQualitysystem质量体系法规ENISO14971:2007Medicaldevices–ApplicationofriskmanagementtomedicaldevicesRiskManagement风险管理标准EN60601-1:2006+A1:2013Medicalelectricalequipment–Part1:GeneralrequirementsforbasicsafetyandessentialperformanceGeneralrequirements:elec

3、tricalsafetyandessentialperformance医疗电子产品通用标准EN60601-1-2:2014Medicaldevicespart1-2:Generalrequirementsforsafetyandessentialperformance–Collateralstandards:electromagneticcompatibility–TestandrequirementsGeneralrequirements:EMC医疗电子产品并列标准：EMCISO15233-1:2012Medical

4、devices—Symbolstobeusedwithmedicaldevicelabels,labelingandinformationtobesupplied—Part1:GeneralrequirementsGeneralrequirements:MarkingsAppliedinLabels医疗器械标签、作标记和提供信息的符号EN1041:2008Terminology,symbolsandinformationprovidedwithmedicaldevicesGeneralrequirements:Term

5、inology医疗器械常用术语、标记ENISO10993-1:2009Biologicalevaluationofmedicaldevices–Part1:EvaluationandtestingBiologicalEvaluation生物相容性标准ENISO10993-5:2009BiologicalEvaluationofMedicalDevices–Part5:TestsforInVitroCytotoxicityBiologicalEvaluationENISO10993-10:2010BiologicalEv

6、aluationofMedicalDevices–Part10:TestsforIrritationandDelayed-TypeHypersensitivityBiologicalEvaluationEN14155:2011Clinicalinvestigationofmedicaldevicesforhumansubjects-Goodclinicalpractice(ISO14155:2011)医学研究受验者用医疗器械的临床试验MEDDEV2.7.1GuidelinesonmedicaldevicesEvalua

7、tionofclinicaldata:AguideformanufacturersandNotifiedBody医疗器械临床评价4可下载优质参赛文档二.监护仪系列产品适用标准：SerialNumber/VersionStandardandDescriptionScope备注EN60601-1-6:2010Medicalelectricalequipment–Part1-6:Generalrequirementsforbasicsafetyandessentialperformance–CollateralStandar

8、d:Usability.Generalrequirements:Usability医疗电子产品并列标准：可用性EN60601-1-8:2007Medicalelectricalequipment–Part1-8:Generalrequirementsforbasicsafetyandessentialperformance–Col