文档介绍：: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–RequirementsforregulatorypurposesQualitysystem质量体系法规ENISO14971:2007Medicaldevices–ApplicationofriskmanagementtomedicaldevicesRiskManagement风险管理标准EN60601-1:2006+A1:2013Medicalelectricalequipment–Part1:GeneralrequirementsforbasicsafetyandessentialperformanceGeneralrequirements:electricalsafetyandessentialperformance医疗电子产品通用标准EN60601-1-2:2014Medicaldevicespart1-2:Generalrequirementsforsafetyandessentialperformance–Collateralstandards:patibility–TestandrequirementsGeneralrequirements:EMC医疗电子产品并列标准:EMCISO15233-1:2012Medicaldevices—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:Terminology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:TestsforInVitroCytotoxicityBiologicalEvaluationENISO10993-10:2010BiologicalEvaluationofMedicalDevices–Part10:TestsforIrritationandDelayed-TypeHypersensitivityBiologicalEvaluationEN14155:2011Clin