CE-一次性醫(yī)用口罩風(fēng)險(xiǎn)管理計(jì)劃和報(bào)告范文(英文版)

RiskManagementplanandReport<Single-usemedicalfacemask(non-sterile)>FileNo.：VersionNo.：A/0EffectiveDate：Status:ControlledDraftedby:Reviewedby:Approvedby:Date:Date:Date:<ZHEJIANGINFOPHOTONICSTECHNOLOGYCO.,LTD>PAGEPAGE10RevisionhistoryRevisedRevisedchapterRevisedcontentRevisedreasonReviseddateRevisorcontentsRiskManagementplanandReport 1<Single-usemedicalfacemask(non-sterile)> 1CHAPTER1-RiskManagementPlan 4Purpose 4Range 4Intendeduse 4Relaventstandard 4Riskmanagersandresponsibilities 4Riskacceptabilitycriteria 4Riskacceptabilitydecisionprocess 4Estimateoftheseverityofthehazard 5ProbabilityofHazard(Unitofoccurrenceprobability:numberofevents/year/unitofproduct) Determinationofintendeduseandsafety-relatedcharacteristics 5Determineforeseeablehazards,hazardanalysisandinitialriskcontrolplan 5Riskassessment,riskcontrolandverificationofriskcontrolmeasures 5Riskandbenefitanalysis 6Comprehensiveresidualriskassessment 6Productionandpost-productioninformation 6CHAPTER2-RiskManagementReport 6Summary 6Productintroduction 6Productstructure 7Riskmanagementpurpose 7RiskManagementTeam 7Riskacceptabilitycriterion 7Riskseveritylevel 7Riskprobabilitygrade 7Riskevaluationcriteria 8Riskanalysisrecord 8Securityanalysis 8Primaryhazardanalysis(PHA),includespredictableeventssequence,hazardsituationandpossibledamage Riskcontrolmeasuresimplementationandrevaluationrecord 21Productionandpost-productioninformation 23Risk-benefitanalysis 24Risksarisingfromriskcontrolmeasures 26Conclusion 26Residualriskrequirestobeopened 26CHAPTER1-RiskManagementPlan1PurposePlanningofriskmanagementactivitiesforproducts.Theriskmanagementplandeterminesthescopeofriskmanagementactivities,theallocationofparticipantsandresponsibilitiesauthority,andriskacceptabilityRangeRiskmanagementappliestotheentirelifecycleoftheproductIntendeduseSingle-usemedicalfacemask(non-sterile)isusedforpatientsinordertoreducetheriskofthespreadofinfections，andthoseisnotintendedforusebyhealthcareprofessionalsinanoperatingroomorinothermedicalsettingswithsimilarrequirementsRelaventstandardISO14971-2019-ApplicationofriskmanagementtomedicaldevicesISO/TR24971-2019-MedicaldevicesGuidanceontheapplicationofISO14971RiskmanagersandresponsibilitiesRiskmanagementpersonnelandtheirdivisionofresponsibilities(SeeTable1).Name Departments/positions——QualitydepartmentTechnicalandDevelopmentdepartmentMarketingdepartmentProductiondepartment

DutyResponsiblefortheimplementationofriskanalysismanagementTeammember:estimatetheprobabilityoffailureandthedefectsfromthequalityperspectiveTeammember:estimatetheprobabilityoffailureandthedefectsfromthedesignperspectiveTeammember:estimatetheriskfromanapplicationperspectiveTeammember:estimatethefromamanufacturingperspectiveRiskacceptabilitycriteriaRiskacceptabilitydecisionprocessTherearethreedecisionpointsinthisprocessthatraisedifferentquestionsabouttheacceptabilityofrisk:a.Istherisksolowthatitdoesnotneedtobeconsidered?b.Istherenolongeranyreasontoconsidertherisk,ortheriskhasbeenreducedtoareasonablypracticablelowlevel,andtheriskhasbeenexceeded?c.Areallrisksacceptableforacomprehensivebalanceofallbenefits?EstimateoftheseverityofthehazardTheseverityofthehazardisdividedintothefollowing4levels：GradeGradenameCodeSystemriskdefinitionsMildModerateCriticalS1S2S3CatastrophicS4MildinjuryornoinjuryModerateinjuryOnepersondiedorsevereinjuryManypeoplediedorsevereinjuryProbabilityofHazard(Unitofoccurrenceprobability:numberofevents/year/unitofproduct)GradeGradeVeryrarelyVeryfewFewOccasionallySometimesFrequentlyCodeP1P2P3P4P5P6Frequency(per<10-610-4~10-610-2~10-410-1~10-21~10-1>1Determinationofintendeduseandsafety-relatedcharacteristicsBasedonAppendixAoftheISO14791:2019"ApplicationofMedicalDeviceRiskManagementtoMedicalDevices"standard,thecompanyhasdeterminedtheintendeduseandsafety-relatedcharacteristicsoftheproduct.Byaskingaseriesofquestionsabouttheintendeduseoftheproduct,reasonablyforeseeablemisuse,andfinaldisposal,astep-by-stepunderstandingoftheproduct'ssafetycharacteristicsisprovidedtolaythefoundationforfurtherriskanalysis.Foralistofproductsafetycharacteristics,seeRiskManagementreport.Determineforeseeablehazards,hazardanalysisandinitialcontrolplanThecompanyhasconsideredreasonablyforeseeablesituationsintheanalysisofhazards.Theyincludetheconsequencesordamagetohazardsundernormalandfaultconditions,including:hazardstopatients,hazardstooperators,hazardstomaintenancepersonnel,andnearbypersonnel.Hazards,environmentalhazards,etc.Product'sforeseeablehazardlistinriskmanagementreportRisk assessment, risk control and verification of risk measuresPerformriskassessmentofknownhazards,determinewhethertheriskofeachhazardreachesanacceptablelevelaccordingtotheriskacceptancecriteria,takecontrolmeasuresforreasonablyfeasibleandreducedrisks,unacceptablerisks,andverifyspecificmeasures.TheriskaftertakingmeasuresisevaluatedtoconfirmwhetherthelevelofriskisRiskandbenefitanalysisIfthecriteriaestablishedintheriskmanagementplanareusedtojudgetheresidualriskisunacceptable,andfurtherriskcontrolisimpractical,thetechnicaldepartmentcollectsandreviewsthemedicalbenefitdataandliteraturefortheintendeduseandpurpose,inordertodeterminewhetherthebenefitexceedstheresidualrisk.ComprehensiveresidualriskassessmentAftertakingriskreductionmeasures,thecompanyreducedtheriskofharmtoanacceptablelevel.Aftertakingmeasurestoreducerisks,confirmwhethernewrisksareintroducedandevaluatethecomprehensiveresidualrisks.Productionandpost-productioninformationThecompanyestablishesfeedbackcontrolprocedurestocollectandreviewinformationmedicaldevices(orsimilardevices)duringandafterproduction.Whenestablishingasystemforcollectingandreviewingmedicaldeviceinformation,companiesshouldespeciallyconsider:Amechanismforcollectingandprocessinginformationgeneratedbytheoperator,userorpersonresponsiblefortheinstallation,useandmaintenanceofthemedicaldevice;orNeworrevisedstandards.Theaboveproceduresshouldalsocollectandreviewpubliclyavailableinformationsimilarmedicaldevicesavailableonthemarket.Informationthatmayberelevanttosafetyshouldbeevaluated,especiallyinthefollowingareas:Whetherapreviouslyunrecognizedhazard(source)ordangeroussituationarises,orwhetheroneormoreoftheestimatedrisksresultingfromthedangeroussituationarenolongeracceptable.Ifanyoftheaboveoccur:Theimpactofpreviouslyimplementedriskmanagementactivitiesshouldbeevaluatedandfedbackintotheriskmanagementprocessasaninput,andTheriskmanagementdocumentsofmedicaldevicesshallbereviewed.Ifitispossiblethatoneormoreoftheremainingrisksortheiracceptabilityhaschanged,theimpactofpreviouslyimplementedriskcontrolmeasuresshouldbeevaluated.Theresultsoftheevaluationshallberecordedintheriskmanagementfile.CHAPTER2-RiskManagement1SummaryProductintroductionProductandtradename：Single-usemedicalfacemask(non-sterile)Intendeduse:Single-usemedicalfacemask(non-sterile)isusedforpatientsinordertoreducetheriskofthespreadofinfections，anditisnotintendedforusebyhealthcareprofessionalsinanoperatingroomorinothermedicalsettingswithsimilarrequirements.ProductstructureTheproductiscomposedofmaskbody,noseclipandmaskribbon.RiskmanagementpurposePossiblehazardandriskforSingle-usemedicalfacemask(non-sterile)producedbytheCompanyareanalyzedbasedonrequirementsofMDRandISO14971：2019,andmeasuresaretakenforvariousriskstogeneratereportbyevaluation,thusensuringthathazardsandriskarereducedtoacceptablerangeforsafeandeffectivelaunching.RiskNameHaoHu

Departments/positions——

DutyResponsiblefortheimplementationofriskanalysismanagementJianxiongShao QualitydepartmentJianhuiChen TechnicalandDevelopmentdepartment

Teammember:estimatetheprobabilityoffailureandthedefectsfromthequalityperspectiveTeammember:estimatetheprobabilityoffailureandthedefectsfromthedesignperspectiveJinzhangZhangJianhuiChenManagementTeamRiskacceptabilitycriterionGradenameCodeIgnorableS1MildModerateCriticalGradenameCodeIgnorableS1MildModerateCriticalS2S3S4CatastrophicS5SystemriskdefinitionsInconvenienceortemporarydiscomfortMildinjuryornoinjuryModerateinjuryOnepersondiedorsevereinjuryManypeoplediedorsevere

MarketingdepartmentProductiondepartment

Teammember:estimatetheriskfromanapplicationperspectiveTeammember:estimatethefromamanufacturingperspective2.2RiskprobabilitygradeinjuryGradenameCodeFrequency(peryear)VeryfewP1<10-6FewP2<10-5and≥10-6OccasionallyP3<10-4and≥10-5SometimesP4<10-3and≥10-4FrequentlyFrequentlyP5≥1-3FrequentlyP5RRUUUSometimesP4ARRUUOccasionallyP3ARRRUFewP2AARRRVeryfewP1AAAAR2.32.3RiskevaluationcriteriaProbabilityIgnorableS1MildS2SeverityModerateS3CriticalS4CatastrophicS5R:Reasonablyreducedrisk;U:unacceptableriskwithoutrisk/benefitanalysisisconsideredasunacceptablerisk.AccordingtoISO14971andMDR2017/745:Itisrequiredthatallrisksfound,whetherornottheyareinanacceptablearea,shouldbetakentoreduceoreliminatethemasmuchaspossible.Inselectingthemostappropriatemethod,themanufacturermustapplythefollowingprinciplesinorder:-Eliminateorreducehazardswherepossible(inherentsafetydesignandstructure)-For dangers that cannot be eliminated, appropriate protective measures, appropriatewarnings,shouldbetakenifnecessary.-Notifytheuseroftheremainingdangercausedbythedefectiveprotectivemeasures.RiskanalysisrecordA.2questionFeaturesjudgmentPossiblehazardSecurityA.2questionFeaturesjudgmentPossiblehazardA.2questionWhatistheintendeduseandhowisthemedicaldevicetobeused?Factorsthatshouldbeconsideredinclude:whatisthemedicaldevice'srolerelativetodiagnosis,prevention,monitoring,treatmentoralleviationofdisease,

Featuresjudgment Possiblehazardcompensationforinjuryorhandicapor Intendeduse:Basicreplacementormodificationofanatomy, protectionfororcontrolofconception? personnelorrelatedwhataretheindicationsforuse(e.g.patient personnelandprotectionpopulation)? againstthespreadofdoesthemedicaldevicesustainorsupport fluidsandspillagelife? invasiveoperations.isspecialinterventionnecessaryinthecase Seetheoffailureofthemedicaldevice?Isthemedicaldeviceintendedtoimplanted?Factorsthatshouldbeconsideredincludethelocationofimplantation,thecharacteristicsthepatientpopulation,age,weight,physicalactivity,theeffectofageingonimplantperformance,theexpectedlifetimeoftheimplant,thereversibilityoftheimplantation.Isthemedicaldeviceintendedtobeincontactwiththepatientorotherpersons?Factorsthatshouldbeconsideredincludethenatureoftheintendedcontact,i.e.surfacecontact,invasivecontact,orimplantationand,foreach,theperiodandfrequencyofcontact.Whatmaterialsorcomponentsareutilizedinthemedicaldeviceorarewith,orareincontactwith,themedicaldevice?Factorsthatshouldbeconsideredinclude:compatibilitywithrelevantsubstances;compatibilitywithtissuesorbodyfluids;whethercharacteristicsrelevanttosafetyknown;

NOYes.Expectedcontactwithmedicalpersonnelissurfacecontact.Yes,Theproductiscomposedofamaskbody,noseclip,amaskband,andaspongestrip(non-sterilearched),Noseclipismadeofaluminumstriporplasticandmetal;maskbandwithpolyesterandspandexbraidormadeofnon-woven

R1BiologicalHazard(Source)CauseskinirritationorviralinfectioninmedicalstaffR2BiologicalHazard(source)Contactofbio-incompatiblematerialswithusers;causeIrritation,allergicsymptoms,damagetotheuser'shealth,life-threateninginseverecases.A.2question Featuresjudgment Possiblehazardisthedevicemanufacturedutilizingmaterials fabricmaterials;spongeofanimalorigin? stripusingNOTESeeAnnexIandalsotheISO22442series foammaterials.ofstandards[19].Isenergydeliveredtoorextractedthepatient?Factorsthatshouldbeconsideredinclude:thetypeofenergytransferred;itscontrol,quality,quantity,intensityand NOduration;whetherenergylevelsarehigherthancurrentlyusedforsimilardevices.Aresubstancesdeliveredtoorextractedfromthepatient?Factorsthatshouldbeconsideredincludewhetherthesubstanceisdeliveredorextracted; NOwhetheritisasinglesubstanceorrangesubstances;themaximumandminimumtransferandcontrolthereof.Arebiologicalmaterialsprocessedbythemedicaldevicesubsequentre-use,transfusionortransplantation?NOFactorsthatshouldbeconsideredincludethetypeofprocessandsubstance(s)processed(e.g.auto-transfusion,dialysis,bloodcomponentorcelltherapyprocessing).Isthemedicaldevicesuppliedsterileorintendedtobesterilizedbytheuser,orareothermicrobiologicalcontrolsapplicable?Factorsthatshouldbeconsideredinclude NOwhetherthemedicaldeviceisintendedsingleuseorre-usepackaging;shelf-lifeissues;limitationonthenumberofre-usecycles;11A.2questionmethodofproductsterilization;theimpactofothersterilizationmethodsintendedbythemanufacturer.Isthemedicaldeviceintendedtoberoutinelycleanedanddisinfectedbytheuser?Factorsthatshouldbeconsideredincludethetypesofcleaningordisinfectingagentstobeusedandanylimitationsonthenumberofcleaningcycles.Thedesignofthemedicaldevicecaninfluencetheeffectivenessofroutinecleaninganddisinfection.Inaddition,considerationshouldbegiventotheeffectofcleaninganddisinfectingagentsonthesafetyorperformanceofthedevice.Isthemedicaldeviceintendedtomodifythepatientenvironment?Factorsthatshouldbeconsideredinclude:temperature;humidity;atmosphericgascomposition;pressure;light.Aremeasurementstaken?Factorsthatshouldbeconsideredincludethevariablesmeasuredandtheaccuracyandtheprecisionofthemeasurementresults.Isthemedicaldeviceinterpretative?Factorsthatshouldbeconsideredincludewhetherconclusionsarepresentedbythemedicaldevicefrominputoracquireddata,algorithmsused,andconfidencelimits.Specialattentionshouldbegiventounintendedapplicationsofthedataoralgorithm.Isthemedicaldeviceintendeduseinconjunctionwithothermedicaldevices,medicinesorothermedicaltechnologies?Factorsthatshouldbeconsideredincludeidentifyinganyothermedicaldevices,medicinesorothermedicaltechnologiesthatcanbeinvolvedandthepotentialproblemsassociatedwithsuchinteractions,as wellaspatientcompliancewiththetherapy.

Featuresjudgment PossiblehazardNONONONONOPAGEPAGE18A.2questionArethereunwantedoutputsofenergysubstances?Energy-relatedfactorsthatshouldbeconsideredincludenoiseandvibration,heat,radiation(includingionizing,non-ionizing,andultraviolet/visible/infraredradiation),contacttemperatures,leakagecurrents,andelectricormagneticfields.Substance-relatedfactorsthatshouldbeconsideredincludesubstancesusedinmanufacturing,cleaningortestinghavingunwantedphysiologicaleffectsiftheyremainintheproduct.Othersubstance-relatedfactorsthatshouldbeconsideredincludedischargeofchemicals,wasteproducts,andbodyfluids.Isthemedicaldevicesusceptibleenvironmentalinfluences?

Featuresjudgment PossiblehazardNOR3BiologicalHazard(source)TheproductisnotprotectedFactorsthatshouldbeconsideredincludetheoperational,transportandstorageenvironments.Theseincludelight,temperature,humidity,vibrations,spillage,susceptibilitytovariationspowerandcoolingsupplies,andelectromagneticinterference.Doesthemedicaldeviceinfluenceenvironment?Factorsthatshouldbeconsideredinclude:theeffectsonpowerandcoolingsupplies;emissionoftoxicmaterials;thegenerationofelectromagneticdisturbance.Arethereessentialconsumablesoraccessoriesassociatedwiththemedicaldevice?Factorsthatshouldbeconsideredincludespecificationsforsuchconsumablesoraccessoriesandanyrestrictionsplaceduponusersintheirselectionofthese.

Yes,itshouldbestoredinadry,Therelativehumidityshouldnotexceed80%,nocorrosivegas,coolanddry,wellventilated,fire-proofandrodent-proofNONO

accordingtotransportationandstoragerequirements,thepackagingisdamaged,andtheproductiscontaminated;Medicalstaffusedbacterialproducts,whichwereinfectedbybacteria.Atthesametime,theymayinfectpatients.Inseveretheyhadfeverandshock.A.2questionIsmaintenanceorcalibrationnecessary?Factorsthatshouldbeconsideredinclude:whethermaintenanceorcalibrationaretocarriedoutbytheoperatororuserorbyaspecialist;arespecialsubstancesorequipmentnecessaryforpropermaintenancecalibration?Doesthemedicaldevicecontainsoftware?Factorsthatshouldbeconsideredincludewhethersoftwareisintendedtobeinstalled,verified,modifiedorexchangedbytheoperatororuserorbyaspecialist.Doesthemedicaldevicehavearestrictedshelf-life?

Featuresjudgment PossiblehazardNONOR4InformationHazardFactorsthatshouldbeconsideredincludelabellingorindicatorsandthedisposalof medicaldeviceswhentheexpirationdateisreached.Arethereanydelayedorlong-termeffects?Factorsthatshouldbeconsideredincludeergonomicandcumulativeeffects.Examplescouldincludepumpsforsalinethatcorrodetime,mechanicalfatigue,looseningofstrapsandattachments,vibrationeffects,labelsthatwearorfalloff,longtermmaterialdegradation.Towhatmechanicalforceswillmedicaldevicebesubjected?Factorsthatshouldbeconsideredincludewhethertheforcestowhichthemedicaldevicewillbesubjectedareunderthecontroloftheuserorcontrolledbyinteractionwithotherpersons.Whatdeterminesthelifetimeofmedicaldevice?Factorsthatshouldbeconsideredincludeageingandbatterydepletion.

InvalidforTwoyearsNoNoPackagingmaterialorproductisaging.

R5BiologicalHazard(source)Beforetheexpirationdateoflabel,theagingofthepackagingmaterialcannolongerkeepsterility,ortheagingofthematerialsoftheproductcausestheproductperformancetodecline.A.2questionIsthemedicaldeviceintendedforsingleuse?Factorsthatshouldbeconsideredinclude:doesthemedicaldeviceself-destructafteruse?Isitobviousthatthedevicehasbeenused?Issafedecommissioningordisposalofmedicaldevicenecessary?Factorsthatshouldbeconsideredincludethewaste

Featuresjudgment PossiblehazardR6BiologicalHazard(Source)Productisreused;MedicalstaffusedbacterialSingleuseproducts,whichwereinfectedbybacteria.Atthesametime,theymayinfectpatients.Inseveretheyhadfeverandductsthataregeneratedduringthedisposalof themedicaldeviceitself.Forexample,doesitcontaintoxicorhazardousmaterial,oristhematerialrecyclable?Doesinstallationoruseofthemedicaldevicerequirespecialtrainingorspecialskills?Factorsthatshouldbeconsideredincludethenoveltyofthemedicaldeviceandthelikelyskillandtrainingofthepersoninstallingthedevice.Howwillinformationforsafeuseprovided?Factorsthatshouldbeconsideredinclude:whetherinformationwillbeprovideddirectlytotheenduserbythemanufacturerorwillitinvolvetheparticipationofthirdpartiessuchasinstallers,careproviders,healthcareprofessionalsorpharmacistswhetherthiswillhaveimplicationsfortraining;commissioningandhandingovertotheuserandwhetheritislikely/possiblethatinstallationcanbecarriedoutbypeoplewithoutthenecessaryskills;basedontheexpectedlifeofthedevice,whetherre-trainingorre-certificationofoperatorsorservicepersonnelwouldberequired.Willnewmanufacturingprocessestobeestablishedorintroduced?Factorsthatshouldbeconsideredincludenewtechnologyoranewscaleofproduction.

NoPackagingidentification,instructionmanualNo

R7InformationHazard(Source)Theproductlabeldoesnotmeetrequirements,aproductthatdoesnotmeettherequirementsisusedortheproductisnothandledproperlyThemedicalpersonnelusedareinfectedanddamagetheenvironment.A.2questionIssuccessfulapplicationofthemedicaldevicecriticallydependentonhumanfactorssuchastheuserinterface?Cantheuserinterfacedesignfeaturescontributetouseerror?Factorsthatshouldbeconsideredareuserinterfacedesignfeaturesthatcancontributetouseerror.Examplesofinterfacedesignfeaturesinclude:controlandindicators,symbolsused,ergonomicfeatures,physicaldesignandlayout,hierarchyofoperation,menusforsoftwaredrivendevices,visibilityofwarnings,audibilityofalarms,standardizationofcolourcoding.SeeIEC60601-1-6[25]foradditionalguidanceonusabilityandIEC60601-1-8[26]forguidanceonalarms.Isthemedicaldeviceusedinanenvironmentwheredistractionscancauseerror?Factorsthatshouldbeconsideredinclude:theconsequenceofuseerror;whetherthedistractionsarecommonplace;whethertheusercanbedisturbedbyinfrequentdistraction.Doesthemedicaldeviceconnectingpartsoraccessories?Factorsthatshouldbeconsideredincludethepossibilityofwrongconnections,similaritytootherproductonnections,connectionforce,feedbackonconnectionintegrity,andover-under-tightening.Doesthemedicaldevicehaveacontrolinterface?Factorsthatshouldbeconsideredincludespacing,coding,grouping,mapping,modesoffeedback,blunders,slips,controldifferentiation,visibility,directionofactivationorchange,whetherthecontrolsarecontinuousordiscrete,andthereversibilityofsettingsoractions.

Featuresjudgment PossiblehazardNoNONoNoA.2questionDoesthemedicaldevicedisplayinformation?Factorsthatshouldbeconsideredincludevisibilityinvariousenvironments,orientation,thevisualcapabilitiesoftheuser,populationsandperspectives,clarityofthepresentedinformation,units,colourcoding,andtheaccessibilityofcriticalinformation.Isthemedicaldevicecontrolledbyamenu?Factorsthatshouldbeconsideredincludecomplexityandnumberoflayers,awarenessofstate,locationofsettings,navigationmethod,numberofstepsperaction,sequenceclarityandmemorizationproblems,andimportanceofcontrolfunctionrelativetoitsaccessibilityandtheimpactofdeviatingfromspecifiedoperatingprocedures.Willthemedicaldevicebeusedpersonswithspecialneeds?Factorsthatshouldbeconsideredincludetheuser,theirmentalandphysicalabilities,skillandtraining,ergonomicaspects,theuseenvironment,installationrequirements,andthepatient'scapabilitytocontrolorinfluencetheuseofthemedicaldevice.Specialattentionshouldbepaidtouserswithspecialneeds,suchashandicappedpersons,theelderlyandchildren.Theirspecialneedsmightincludeassistancebyanotherpersontoenabletheuseamedicaldevice.Isthemedicaldeviceintendedtobeusedbyindividualswithvariousskilllevelsandculturalbackgrounds?Cantheuserinterfacebeusedinitiateuseractions?Factorsthatshouldbeconsideredincludethepossibilityofinitiatinigadeliberateactionfortheusertoenteracontrolledoperationmode,whichenlargestherisksforthepatientandwhichcreatesawarenessfortheuserforthiscondition.Cantheuserinterfacebeusedtoinitiateuseractions?

Featuresjudgment PossiblehazardNoNoNoNoNoA.2questionFactorsthatshouldbeconsideredincludethepossibilityofinitiatinigadeliberateactionfortheusertoenteracontrolledoperationmode,whichenlargestherisksforthepatientandwhichcreatesawarenessfortheuserforthiscondition.Inwhatway(s)mightthemedicaldevicebedeliberatelymisused?Factorsthatshouldbeconsideredareincorrectuseofconnectors,disablingsafetyfeaturesoralarms,neglectofmanufacturer'srecommendedmaintenance.Doesthemedicaldeviceholddatacriticaltopatientcare?Factorsthatshouldbeconsideredincludetheconsequenceofthedatabeingmodifiedorcorrupted.Isthemedicaldeviceintendedtomobileorportable?Factorsthatshouldbeconsideredarethenecessarygrips,handles,wheels,brakes,mechanicalstabilityanddurabilityDoestheuseofthemedicaldevicedependonessentialperformance?Factorsthatshouldbeconsideredare,forexample,thecharacteristicsoftheoutputof

Featuresjudgment PossiblehazardNoNoNolife-supportingdevicesortheoperationofan alarm.SeeIEC60601-1[23]foradiscussionofessentialperformanceofmedicalelectricalequipmentandmedicalelectricalsystems.Doesthemedicaldevicehaveadegreeofautonomy?Factorsthatshouldbeconsideredinclude:awarenessoftheuserwhenthemedicaldevicewithadegreeofautonomygeneratesanerror,alarmorfailure;awarenessoftheuserwheninterventioninan autonomouslyperformedactionisrequired;—theabilityoftheusertointerveneinortoabortanactionthatisperformedautonomously;and—theabilityoftheusertoselectandperformpropercorrectiveactions.A.2questionA.2questionSeeIECTR60601-4-19forfurtherguidancemedicaldeviceswithadegreeofautonomy.A.2.36Doesthemedicaldeviceproduceanoutputthatisusedasaninputindeterminingclinicalaction?Factorsthatshouldbeconsideredincludewhetherincorrectordelayedoutputscanresultindirectorindirectriskstopatients,e.g.anincorrectdiagnosisresultingindelayedoromittedtherapyforapatient.SeeAnnexHforguidanceoninvitro