RMTABLES-rev07(有源医疗设备CE认证RM表)

ATTENTION:-ThistablelistcontainstheRMtablesfromtheIEC60601-1:2005trfversiong.-ThisRMtablelistisintendedtobeusedinthefollowingway:a)ManufacturerwillfilloutONLYTHEFIRSTCOLUMN„DocumentRefinRMF“andsendbacktheworddocumenttothetestengineer.b)Thetestengineerwillverifythecorrectnessofthe“DocumentRefinRMF”andtransferitintheIEC60601-1trf.c)ThenthetestengineerwillevaluatetheRMFand“verdict”theresults.Pleasefinda“wrong”and“right”filledoutsampleofasingleRM-tableasguidancehowtofillouttheRM-tablescorrectly:4.2“WRONG”exampleoffilledoutRMRESULTSTABLE:ClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict3.3aSeeRM-file3.5eSeeRM-file4.1SeeRM-file4.2SeeRM-file4.3SeeRM-file4.4SeeRM-file5SeeRM-file6.1SeeRM-file6.2SeeRM-file6.3SeeRM-file6.4SeeRM-file6.5SeeRM-file6.6SeeRM-file6.7SeeRM-file7SeeRM-file4.2“RIGHT”exampleoffilledoutRMRESULTSTABLE:ClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict3.3a9806400000_RMFchapter4page233.5e9806400000_RMFchapter5page344.19806400000_RMFchapter2page084.29806400000_RMFchapter3page14ff4.39806400000_AR01_001RAref#1.00a4.49806400000_AR02_001RMSRAref#1.00a4.2“RIGHT”exampleoffilledoutRMRESULTSTABLE:ClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict59806400000_AR02_001RMSRAref#1.00a6.1See6.2to6.76.29806400000_AR02_001RMSRAref#1.00a6.39806400000_VA01_001Checklist6.49806400000_AR02_001RMSRAref#1.00a6.59806400000_AR02_001RMSRAref#1.00a6.69806400000_AR02_001RMSRAref#1.00a6.79806400000_RMFchapter11page10479806400000_RMFchapter12page107STARTtofilloutbythemanufacturer:Manufacturer:DeviceunderTest:Dateofcompletionoffirstcolumn:4.2RMRESULTSTABLE:RiskManagementProcessforMEEquipmentorMESystemsClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict3.3a3.5e4.14.24.34.456.16.26.36.44.2RMRESULTSTABLE:RiskManagementProcessforMEEquipmentorMESystemsClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict6.56.66.774.3RMRESULTSTABLE:EssentialPerformanceClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.456.26.36.4Note:6.2to6.4notpartofIECEETRFversionG,butrequiredbyISO14971.4.5RMRESULTSTABLE:EquivalentSafetyforMEEquipmentofMESystemClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.456.26.36.46.5Notapplicableforequivalentsafety.N/A4.6RMRESULTSTABLE:MEEquipmentorsystempartscontactingthepatientClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.456.26.34.6RMRESULTSTABLE:MEEquipmentorsystempartscontactingthepatientClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict6.46.54.7RMRESULTSTABLE:SingleFaultConditionforMEEquipmentClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.44.8RMRESULTSTABLE:ComponentsofMEEquipmentClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.456.26.36.46.54.9RMRESULTSTABLE:Useofcomponentswithhigh-integritycharacteristicsClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.456.26.36.46.5N/A5.1RMRESULTSTABLE:TypeTestsClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.45.4a)RMRESULTSTABLE:OtherConditionsClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.45.7RMRESULTSTABLE:HumiditypreconditioningtreatmentClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.456.26.36.46.55.9.2.3RMRESULTSTABLE:ActuatingmechanismsClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.456.26.36.46.57.2.2RMRESULTSTABLE:IdentificationClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.456.47.2.5RMRESULTSTABLE:MEEQUIPMENTpoweredfromotherequipmentClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.456.47.2.13RMRESULTSTABLE:Physiologicaleffects(safetysignsandwarning)ClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.456.37.2.17RMRESULTSTABLE:ProtectivepackagingClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.456.36.47.3.3RMRESULTSTABLE:BatteriesClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.456.37.3.7RMRESULTSTABLE:SupplyterminalsClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.37.4.2RMRESULTSTABLE:ControldevicesClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.456.26.3Note:Ifapredefinedstandardcountermeasure“e.g.instrumentorscaleorindicationofdirection...”hasbeenappliedtheRMisN/A.7.5RMRESULTSTABLE:SafetysignsClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict4.24.34.457.5RMRESULTSTABLE:SafetysignsClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerdict6.37.9.1RMRESULTSTABLE:Generalaccompanyingdocuments(SeeTableC.4)ClauseofISO14971DocumentRef.inRMF(DocumentNo.¶graph)Result-RemarksVerd