产品策划设计开发控制程序指南性文件风险管理报告打印

-1-Projectname:HomecareMuti-parameterRecorder(H10)Documentname:RiskmanagementreportWritten:Date:Auditor:Date:Approved:Date:RevisionRecordVer.RevisiondescriptionReviserDate-2-TableofContentsTableofContents.................................................................................................................................................-2-Chapter1Summary..............................................................................................................................................-3-Chapter2Category...............................................................................................................................................-4-Chapter3GeneralIntroduction...........................................................................................................................-6-3.1ProductOverview..................................................................................................................................-6-3.2IntendedUse.........................................................................................................................................-6-3.3Composition..........................................................................................................................................-6-Chapter4MembersandResponsibilityofRiskManagement.............................................................................-7-Chapter5DeterminationofSafetyCharacteristics.............................................................................................-8-Chapter6SummarizationoftheRiskManagement..........................................................................................-12-Chapter7EvaluationoftheResidualRisk..........................................................................................................-30-Chapter8CompletenessEvaluationofRisk........................................................................................................-31-Chapter9Informationupdatingandriskmanagementaftermanufacturing...................................................-32-AppendixA.Analysismethod............................................................................................................................-33-A.1Harmanalysismethod..........................................................................................................................-33-A.2Riskestimatemethod..........................................................................................................................-33-AppendixB.AnalysisMethod............................................................................................................................-34-B.1Estimationoftheseverityofeachhazard...........................................................................................-34-B.2.Estimationofthelikelihoodofeachhazard........................................................................................-35-B.3.Estimationoftheacceptabilityofeachrisk........................................................................................-36-AppendixCAbbreviationsused..........................................................................................................................-37-AppendixDContentsofTables..........................................................................................................................-38--3-Chapter1SummaryStandardinformationStandardISO14971:2012NameMedicaldevices-ApplicationofriskmanagementtomedicaldevicesTestproductinformationNameHomecareMuti-parameterRecorderModelH8ConfigurationMainframe,BPcuff,SpO2sensor,ECGcableandelectrodes,AndroidPadPhotoH8ConclusionAllknownorforeseeablehazardshavebeenanalyzed.Aftercarryingoutcorrespondingriskcontrolmeasures,havenotintroducedanynewhazards,andtherearenoALARPorN/ACCrisk,sotherisk/benefitanalysisisnotnecessary.FailitemNothingRemarkNothing-4-Chapter2Category2.1CategoryThisdocumentisestablishedaccordingtostandardISO14971:2012theriskmanagementformedicaldevices.Thegoalistosystematicallycarryouttheeffectivemanagementofthevariousriskprocessesforthecompany’sR&DandmanufactureofHomecaremulti-parameterrecorder,Thedocumentistheinstructivedirectionfordesign,confirmation,productionandsales,andforCEauthentication,FDAauthenticationandSFDAauthenticationconstituent.2.2RelativesupportingdocumentItemStandardDescription1MDD93/42/EECMedicalDevicesDirective:COUNCILDIRECTIVE2007/47/ECof5September2007concerningmedicaldevices2ISO780:1997Packaging─Pictorialmarkingforhandingofgoods3EN980:2008Terminology,symbolsandinformationprovidedwithmedicaldevices-Graphicalsymbolsforuseinthelabelingofmedicaldevices4EN1041:2008Terminology,symbolsandinformationprovidedwithmedicaldevices-Informationsuppliedbythemanufacturerwithmedicaldevices5IEC/TR60878:2015Graphicalsymbolsforelectricalequipmentinmedicalpractice6ENISO13485:2012Medicaldevices─QualityManagementSystems─RequirementsforRegulatoryPurposes7ENISO14971:2012Medicaldevices-Applicationofriskmanagementtomedicaldev