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Risk Managementplan andReportSingle-use medicalface masknon-sterile FileNo.Version No.A/0Effective DateStatus:ControlledDrafted by:Reviewed by:Date:Approved by:Date:Date:ZHEJIANG INFOPHOTONICS TECHNOLOGYCO.,LTD^^eatures judgmentfabric-is the device manufacturedutilizing materialsofmaterials;sponge stripanimaloriginusing polyurethanefoamNOTE See Annex Iand alsothe ISO22442seriesmaterials.of standards
[19].A.
2.5Is energydelivered toor extractedfrom thepatientFactors that should be considered include:—the typeof energytransferred;——its control,quality,quantity,intensity andduration;whether energylevels arehigher thanthose一currently used for similardevices.A.
2.6Are substancesdelivered toor extractedfrom thepatientwhether the substanceis deliveredor一extracted;NOFactors that should be considered includewhetherit isa singlesubstance orrange of一substances;—the maximumand minimumtransfer ratesandcontrol thereof.A.
2.7Are biologicalmaterials processedby the medicaldevice forsubsequentre-use,transfusion ortransplantationNOFactorsthat should be considered include thetype ofprocessand substancesprocessed e.g.autotransfusion,dialysis,blood componentor celltherapyprocessing.A.
2.8Is the medical devicesupplied sterileor intended tobe sterilizedby the user,or areother microbiologicalcontrolsapplicableNOFactors that should be considered includewhether the medical device is intended forsingle一use orre-use packaging;_shelf-life issues;limitation on the number of re-use cycles;method ofproduct sterilization;_the impactof othersterilization methodsnotintended by the manufacturer.A.
2.9Is the medical deviceintended to be routinelycleanedand disinfected by theuserFactorsthat should be considered include thetypesof cleaningor disinfectingagents to be usedand anyNOlimitationson thenumber ofcleaning cycles.Thedesign of the medical device caninfluence theeffectivenessof routinecleaning anddisinfection.Inaddition,consideration should be givento the effectof cleaningand disinfectingagents onthe safetyorperformance of thedevice.Factorsthat should be considered include:A.
2.10Is the medical deviceintended tomodify the-temperature;NOpatient environment-humidity;-atmospheric gascomposition;pressure;light.一A.
2.11Are measurementstakenFactors that should be considered include thevariables measuredand theaccuracy and theprecision of the measurementresults.A.
2.12Is the medical deviceinterpretativewhether conclusionsare presentedby the medicalFactors that should be considered includeNOdevice frominput oracquired data,the algorithmsused,and confidencelimits.Special attentionshouldbe givento unintendedapplications of the dataoralgorithm.A.
2.13Is the medical deviceintended for use inconjunctionwith other medical devices,medicines orother medical technologiesNOFactorsthat should be considered include identifyinganyothermedical devices,medicines or othermedical technologiesthat canbe involvedand thepotentialproblems associatedwith suchinteractions,as wellas patientcompliance with the therapy.A.2question Featuresjudgment PossiblehazardA.
2.14Are thereunwanted outputsof energyorsubstancesEnergy-related factorsthat should be consideredincludenoise andvibration,heat,radiation includingionizing,non-ionizing,and ultraviolet/visible/infraredradiation,contact temperatures,leakage currents,andNOelectric ormagnetic fields.Substance-related factorsthat should be consideredincludesubstances used in manufacturing,cleaning ortestinghaving unwantedphysiological effectsif theyremainin the product.Other substance-related factorsthat should beconsidered includedischarge ofchemicals,wasteR3Biological Hazardsource TheA.
2.15Is themedical devicesusceptible toenvironmentalproduct is not protectedaccording toinfluencesYes,it should be storedin adry,transportation andstorageFactors that should be considered include theThe relativehumidity shouldnotrequirements,the packagingisoperational,transport andstorage environments.exceed80%,no corrosivegas,damaged,and the product isTheseinclude light,temperature,humidity,vibrations,cool anddry,well ventilated,contaminated;spillage,susceptibility tovariations inpower andfire-proof androdent-proofMedical staff used bacterial products,cooling supplies,and electromagneticinterference.which wereinfected bybacteria.At thesametime,they mayinfect patients.InA.
2.16Does themedical deviceinfluence theenvironmentFactors that should be considered include:-the effectson powerand coolingsupplies;_emissionNOof toxicmaterials;the generationof electromagneticdisturbance.A.
2.17Are thereessential consumables or accessoriesassociatedwiththe medicaldeviceNOFactors that should be considered includespecificationsfor suchconsumablesoraccessoriesand anyrestrictions placedupon usersin theirselectionA.2question Featuresjudgment PossiblehazardA.
2.18Is maintenanceor calibrationnecessaryFactors that should be considered include:whether maintenanceor calibrationare to be carried一NOout by the operator or user or by a specialist;are specialsubstances orequipment necessaryfor一proper maintenanceor calibrationA.
2.19Does themedical devicecontain softwareFactorsthat should be considered include whetherNOsoftwareisintended to be installed,verified,modified orexchangedby the operatororuser orbyaspecialist.R4Information HazardA.
2.20Does themedical devicehave arestricted shelf-lifeFactors that should be considered includelabelling orInvalidfor Twoyearsindicators and the disposal of suchmedical deviceswhen the expiration date isreached.A.
2.21Are thereany delayed or long-term useeffectsFactors that should be considered includeergonomicand cumulativeeffects.Examples couldinclude pumpsNoforsaline thatcorrode overtime,mechanical fatigue,loosening ofstraps and attachments,vibration effects,labels thatwear orfall off,long termmaterialdegradation.A.
2.22To whatmechanical forceswill themedical devicebesubjectedFactors that should be considered includewhether theNoforces towhich themedical devicewill besubjected areunderthe controlof the user orcontrolled byinteractionA.
2.23What determines the lifetimeof themedical deviceR5Biological Hazardsource BeforeFactorsthat should be considered include ageingand the expiration dateof thelabel,thePackaging materialor productagingof the packaging materialcan nobatterydepletion.is aging.longer keepthe sterility,or the aging ofthe raw materialsof the product causesthe product performanceto decline.A.2question Featuresjudgment Possiblehazard1A.
2.24Is themedical deviceintended forsingle useR6Biological HazardSource ProductFactorsthat should be considered include:does theisreused;medical deviceself-destruct afteruse Isit obviousthatSingle useMedicalstaffusedbacterialproducts,the devicehas beenusedwhich wereinfectedbybacteria.At thesametime,they mayinfect patients.InA.
2.25Is safedecommissioning ordisposalof the medicaldevicenecessaryFactors thatshould beconsidered include the wasteNoproducts that aregenerated duringthe disposalof themedical device itself.For example,does itcontain toxicor hazardous material,or isthe materialrecyclableA.
2.26Does installationoruse of themedical devicerequirespecial training or specialskillsFactors thatshould beconsideredincludethe noveltyNoof themedical deviceand thelikely skill and trainingofthe personinstalling thedevice.A.
2.27How willinformation for safe usebe providedR7Information HazardSource TheFactorsthatshouldbeconsideredinclude:product label does notmeet the_whether informationwill beprovided directlyto the requirements,a product that does notend userby the manufacturer orwill itinvolve themeet therequirements is usedor theparticipationof thirdparties such as installers,product is not handledproperlycare providers,health care professionals orThe medical personnelused arepharmacistsand whetherthis willhaveinfected anddamage theenvironment.Packaging identification,implications fortraining;instruction manual_commissioning andhanding overto theend userandwhether it is likely/possible thatinstallation canbecarried outby peoplewithout thenecessary skills;_based onthe expectedlife of thedevice,whetherre-trainingorre-certification ofoperators orservicepersonnel wouldbe required.A.
2.28Will newmanufacturing processesneed tobeestablished or introducedNoFactors thatshouldbeconsideredincludenewtechnology ora newscale ofproduction.A.2question Featuresjudgment PossiblehazardA.
2.29Is successfulapplication of themedical devicecritically dependenton humanfactorssuch asthe userinterfaceA.
2.
29.1Can the user interface design featurescontributeto useerrorFactors thatshouldbeconsidered areuser interfaceNodesignfeatures thatcan contributeto useerror.Examples ofinterfacedesignfeatures include:controland indicators,symbols used,ergonomic features,physical design and layout,hierarchy ofoperation,menus forsoftware drivendevices,visibility ofwarnings,audibility of alarms,standardization ofcolourcoding.See IEC60601-1-6
[25]for additionalguidanceA.
2.
29.2Is themedical deviceusedin an environmentwheredistractions cancause useerrorFactors thatshouldbeconsideredinclude:NO-the consequenceof useerror;-whether thedistractions arecommonplace;_whether the user canbe disturbedby aninfrequentdistraction.A.
2.
29.3Does themedical devicehave connectingparts oraccessoriesFactorsthatshouldbeconsideredinclude theNopossibilityof wrongconnections,similarity tootherproductsc onnections,connection force,feedback onconnectionintegrity,and over-and under-tightening.A.
2.
2.
29.5Does themedical devicedisplay informationFactorsthatshouldbeconsideredinclude visibilityinvarious environments,orientation,the visualNocapabilitiesof the user,populations andperspectives,clarity of the presentedinformation,units,colourcoding,and theaccessibilityof criticalinformation.A.
2.
29.6Is themedical devicecontrolled bya menuFactorsthatshouldbeconsideredinclude complexityandnumber oflayers,awareness ofstate,location ofsettings,navigation method,number ofsteps perNoaction,sequence clarityandmemorization problems,and importanceof controlfunctionrelative toits accessibilityand the impact ofdeviatingfrom specifiedoperating procedures.A.
2.
29.7Will themedical devicebe usedby personswithspecial needsFactorsthatshouldbeconsideredincludethe user,their mentaland physicalabilities,skillandtraining,ergonomic aspects,theuseenvironment,installationrequirements,and the patients capabilityto controlorinfluence theuse of themedical device.SpecialNoattention shouldbe paidto userswith specialneeds,suchashandicapped persons,the elderlyand children.Their specialneeds mightinclude assistancebyanother personto enabletheuse ofamedical device.Is themedical deviceintended tobe usedbyindividuals withvarious skilllevels andculturalbackgroundsA.
2.
29.8Can the user interfacebe used to initiateuseractionsNoFactors thatshouldbeconsideredincludethewhich createsawareness for theuserfor thiscondition.A.
2.30Can theuser interfacebe usedto initiateuseractionsNoFactors thatshouldbeconsideredincludethepossibility ofinitiatinig adeliberate actionfor theuserto entera controlledoperation mode,which enlargesthe risks for thepatientand whichcreates awarenessfor theuserfor thiscondition.A.
2.31In whatways mightthemedical device bedeliberatelymisusedFactors thatshouldbeconsidered are incorrect useofconnectors,disabling safetyfeatures oralarms,Noneglect ofmanufacturers recommendedmaintenance.A.
2.32Does themedical devicehold datacritical topatientcareFactors thatshouldbeconsideredincludetheNoconsequence of the databeing modifiedor corrupted.A.
2.33Is themedical deviceintended tobe mobileorportableFactors thatshouldbeconsidered arethe necessaryNogrips,handles,wheels,brakes,mechanical stabihtyanddurabihtyA.
2.34Does theuseof themedicaldevice dependonessential performanceFactorsthatshouldbeconsideredare,for example,Nothe characteristicsof theoutput oflife-supportingdevices orthe operationof analarm.1See IEC60601-
[23]f ra discussionof essentialOperformanceof medicalelectrical equipmentandmedical electricalsystems.A.
2.35Does themedicaldevicehave a degree ofautonomyFactorsthatshouldbeconsideredinclude:—awareness of theuserwhenthemedicaldevicewith Noadegree of autonomy generatesan error,alarm orfailure;awareness of theuserwhen interventionin an一autonomously performedaction isrequired;—the abilityof theuser tointervene inor to abort anactionthat isperformed autonomously;and-the abilityoftheuserto selectand performproper correctiveactions.A.2question Featuresjudgment PossiblehazardSee IECTR60601-4-19for furtherguidance onmedical devices withadegreeofautonomy.A.
2.36Does themedicaldeviceproduce anoutput thatisused as an inputin determiningclinical actionFactorsthatshouldbeconsideredinclude whetherincorrector delayedoutputs canresult indirect orNoindirect risks to patients,e.g.an incorrectdiagnosisresulting indelayedoromitted therapyfor apatient.SeeAnnexH forguidance onin vitrodiagnostic
3.2Primary hazard analysis PHA,includes predictableevents sequence,hazard situationand possibledamagesessPredictable eventsand eventsRiskRisk asConsequencesor damagesHazardtype HazardsituationProNo.sequenceSeveri tybiliThe product materialsdo notThe productcontact a health Maycause skincomply with biocompatibilitycareprofessional or patientsensitization or viralBiologicalinfection bymedicalrequirementsR1S2P3hazardspersonnel.Biological Theproduct materialsdo notThemedical personnelContactof bio-incompatiblehazards comply with biocompatibilitymaterials withpatients orused are infected byrequirementsmedicalpersonnel bacteria,and mayinfectR2S2P4patients atthe sametime,causing fever and shockinsevere cases.Failure toprotect the product Themedical personnelIrregulartransportation S3P5in accordancewith used areinfectedbycauses productfailure.Biologicaltransportation andstorageR3bacteria,and mayinfecthazardsrequirements,packagingpatients atthe sametime,damage,and productcausing feverand shock inRevisionhistory contamination.Revised contentRevised reasonRevised dateRevisorRevised chapterIdentifiesthe productIncomplete instructions for Medicalpersonnel haveS3P2Information expiration date andhow touse;products beyondthe usedproductsthathaveR4deal withthe productexpirationdate cannot exceededtheir usefullife,hazardsexpiration.maintain effectiveprotection.posing ahazard tousers.Before theexpirationdateofProduct orraw materialS3P5theproductidentification,the Medicalpersonnel usedagingpackagingmaterials areaging ineffectiveproducts,BiologicalR5ortheraw materialsofthesubstandard products,hazardsproducts areaging,which resultingin ineffectiveuserleads tothe degradationof protection.product performance.ThemedicalpersonnelProduct isreused multipleProduct isreused S3P2usedareinfected byBiologicaltimes.R6bacteria,and mayinfecthazardspatients atthe sametime,causingfeverandshockinThe product labeldoesnotDispose atwill,People infectedS2P4meettherequirements,aInformationenvironmental pollutionDestroytheenvironmentR7productthat doesnotmeet thehazardsrequirementsis usedor theproduct is nothandledproperly.
3.3Risk control measures implementationand revaluation recordRisk re-evMeasuresRisk No.Primary control measures planHazardtype Measureverificationimplementation recordSeveri Protybill
1.Raw materialinspection
1.Incoming inspectionreportreportof raw materialsBiological Test result complies with
2.Biocompatibility testR1S2P
22.Biocompatibility test reporthazards ENISO10993standardreport
3.Product processinspection
3.Factory inspectionreportprocedures andtest reports
1.Raw materialinspection
1.Incoming inspectionreportreportBiological ofrawmaterialsTestresultcomplies with
2.Biocompatibility testR2S2P
22.Biocompatibility testreporthazards ENISO10993standardreport
3.Product processinspection
3.Factory inspectionreportprocedures andtest reportsClearlyidentify theproductSee product packaging orProduct instruction andInformationtransportation and storageinstructionslabels comply withR3S3P1hazards requirementsonthepackagerequirementsor instructionmanualProduct instruction andInformation Considerationfrom safetyProduct instruction andR4S3P1labels complywithinformation notificationabelinghazardsrequirementsThe rawmaterials usedin theSeeproduct acceleratedProduct instruction andproductshall beverified andagingtestreportProductlabels complywithInformationconfirmed bytheagingtest ofinstructionmanual andR5requirements S3P1hazardsthe validityperiod,and markedpackagingonthepackagingandinstructions.Use iconsor wordson theProductinstruction andSeeproductpackagingorBiologicalpackaging orinstructions tolabelscomply withR6S3P1instructions.hazardsmark theproduct forsinglerequirementsuse.Productinstruction andInformation Considerationfrom safetyProductinstruction andR7labelscomplywith S2P2information notificationlabelinghazardsrequirements
3.4Production andpost-production informationThe risk teamreviewed that the feedback control proceduresand thewarning systemcontrol procedurescan effectivelycollectand evaluatepublic informationof similar medicaldevices,which isusedtoevaluate risksthat werenot foundpreviously andone or morepreviously evaluatedacceptable risksare no longer acceptable.At present,above systemin ourcompany hasnot collectedrelated data,if yes,we willenter relateddata torisk managementforanalysis basedon Risk control procedure.And we will makereview forrisk management documents,if oneor morerisksacceptability changes,wewillmake evaluationfor influenceof control measures takenpreviously.
3.5Risk-benefit analysisNo.Hazard TypeHazard Measureverification Residual risk RisThis risk hasbMasks contactahealthcareTest resultcomplies withENcontrolling theR1Biological hazardsS2P2professionalorpatientISO10993standardand thebenefitthe risksBiological hazardsContact ofbio-incompatibleTest resultcomplieswithEN■■■■■■■一■・■■■■■■■•■■■■■■■■■R2materials withpatients orS2P2Thisrisk has bISO10993standard«medical personnelcontrollingtheand thebenefitFailure toprotect theproductThrough designthe risksin accordancewithprotection idemProductinstructionandlabelsInformation hazardsR3transportationandstorage S3P1complywithrequirements benefits of therequirements,packagingrisksdamage,and productIncompleteinstructionsforThrough designProductinstructionandlabelsuse;products beyondthe protectionidenInformationcomply with requirementsR4S3P1hazards expirationdatecannotbenefits ofthemaintain effectiveprotection.risksThrough testveProduct instructionand labelsBeforetheexpirationdate ofrelevantinformInformation hazardsR5complywithrequirements S3P1theproductidentification,theeffectively elimpackagingmaterials aretheproduct farNo.Hazard TypeHazard Measureverification ResidualriskRisaging ortherawmaterials ofthe products areaging,which leadsto thedegradationof productThroughdesignProduct isreused Productinstructionandlabelsprotection idencomplywithrequirementsR6BiologicalhazardsS3P1Can effectivelybenefitsof theTheproductlabeldoes notProductinstructionandlabels Throughdesignmeet therequirements,acomply withrequirementsprotection idenproductthatdoesnot meetInformationhazardsR7S2P2Can effectivelytherequirementsisused orbenefitsof thetheproduct isnot handledrisksproperly.As canbe seenfrom theabove table,the resultsofthe risk-benefit analysis oftheproducts showthatthebenefitsofthepronounacceptable risks.
3.6Risks arisingfrom risk control measuresNonew hazardsorhazardoussituations arisingfrom risk control measuresbecause allrisk control measures areinherentdesign inequipment beforeprocess of risk managementand resultof thesecontrolmeasuresare acceptable.
4.ConclusionIt canbe seenfrom
3.3Risk controlmeasures implementationand re-evaluationrecordthat thereisnonew riskafter riskcontrolmeasure istaken,and risksbefore and after controlare distributedas follows.Before measuresAfter measures的probabilityX^^x一x seventy1234512345probability55R3R544R2R733R1R1R22R4R62R7R3R411R5R6A:Acceptable riskR:Reasonably reducedriskU:unacceptable riskwithout risk/benefit analysisis consideredas unacceptable riskHazardous riskafter takingmeasures has been reduced to acceptabledegree;by risk/benefit analysis,theproductsbenefit isfargreater thanits risk,besides,the Companytakes measures,including intended use andproper handlingspecified in theinstructions for use,therefore,comprehensive residualrisk fortheproductis acceptable.
13.1Product introduction
13.2Product structure
14.1Risk severitylevel
815.2Primary hazardanalysis PHA,includes predictableevents sequence,hazard situationand possibledamage
1.Name Departments/positions Duty——Responsible forthe implementationofrisk analysismanagementQuality departmentTeam member:estimate theprobability of failure andthe riskdefects from the qualityperspectiveTechnical andDevelopment Team member:estimate thedepartmentprobability of failure andthe riskdefects from thedesign perspectiveTeam member:estimate therisk fromMarketingdepartmentan applicationperspectiveTeam member:estimate therisk fromProductiondepartmenta manufacturingperspective6Risk acceptabilitycriteria
6.1Risk acceptabilitydecision processThereare threedecision pointsin thisprocess thatraise differentquestions aboutthe acceptabilityofrisk:a.Is therisk solow thatit doesnot needtobeconsideredb.Is thereno longerany reasonto considertherisk,ortheriskhasbeen reducedtoareasonably practicablelow level,andthe riskhasbeenexceededc.Are all risks acceptablefor acomprehensive balanceof allbenefits
6.2Estimate ofthe severityofthehazardThe severityofthehazard isdivided into the following4levels Gradename Code System riskdefinitionsMild S1Mild injury or noinjuryModerate S2Moderate injuryCriticalS3ne persondied orsevere injuryCatastrophicS4Many peopledied orsevere injury
6.3Probability ofHazard Unitof occurrenceprobability:numberofevents/year/unit ofproductGrade nameCode Frequencyper yearVeryrarely P110-6Very few P210-4-10-6Few P310-2-10-4Occasionally P410-1-10-2Sometimes P51-10-1Frequently P617Determination ofintended use and safety-related characteristicsBasedon AppendixA ofthe ISO14791:2022Application ofMedical DeviceRisk Managementto MedicalDevices**standard,the company has determinedthe intendeduse andsafety-related characteristicsoftheproduct.By askinga seriesof questionsaboutthe intendeduseoftheproduct,reasonably foreseeablemisuse,and finaldisposal,a step-by-step understandingof theproductssafety characteristicsis providedto laythe foundationfor furtherrisk analysis.For alist ofproduct safetycharacteristics,see Risk Management report.8Determine foreseeablehazards,hazardanalysisand initialriskcontrol planThecompanyhasconsidered reasonablyforeseeable situationsin theanalysisofhazards.They includethe consequencesordamage tohazards undernormal andfault conditions,including:hazards topatients,hazards tooperators,hazards tomaintenancepersonnel,and nearbypersonnel.Hazards,environmental hazards,etc.Products foreseeablehazard listin risk9Risk assessment,riskcontroland verificationofriskcontrolmanagement reportmeasuresPerformrisk assessmentof knownhazards,determine whethertherisk of eachhazard reachesan acceptablelevel accordingtotheriskacceptance criteria,take controlmeasures forreasonably feasibleand reducedrisks,unacceptable risks,and verifyspecificmeasures.The riskafter takingmeasures isevaluated toconfirm whetherthe levelofrisk is acceptable.10Risk andbenefit analysisIfthe criteriaestablished in theriskmanagement planare usedto judgethe residualriskisunacceptable,and furtherrisk controlisimpractical,the technicaldepartment collectsand reviewsthemedicalbenefit dataand literatureforthe intendeduseandpurpose,inorder to determinewhetherthebenefit exceedsthe residualrisk.11Comprehensive residualrisk assessmentAfter taking riskreduction measures,the companyreduced therisk ofharm toan acceptablelevel.Aftertakingmeasures toreducerisks,confirm whethernew risksare introducedand evaluatethe comprehensiveresidual risks.12Production andpost-production informationThecompany establishesfeedbackcontrolprocedures tocollect and review information on medicaldevices orsimilar devicesduringandafterproduction.When establishinga systemfor collecting and reviewingmedicaldeviceinformation,companiesshould especiallyconsider:a Amechanism forcollectingandprocessing informationgenerated bytheoperator,userorperson responsiblefor theinstallation,useandmaintenance ofthemedicaldevice;orb Newor revisedstandards.The aboveprocedures shouldalso collectandreviewpublicly availableinformationonsimilarmedicaldevices availableonthe market.Information thatmay berelevant tosafety shouldbe evaluated,especially in the followingareas:Whether apreviously unrecognizedhazard sourceor dangeroussituation arises,or whetheroneor more oftheestimated risksresulting fromthe dangeroussituation arenolongeracceptable.If anyoftheabove occur:1The impactof previouslyimplemented riskmanagementactivitiesshouldbeevaluated andfed backintotheriskmanagement processasaninput,and2Theriskmanagementdocumentsof medicaldevices shallbe reviewed.If itis possiblethat oneormoreofthe remainingrisks ortheir acceptabilityhas changed,theimpactof previouslyimplemented riskcontrolmeasuresshouldbeevaluated.The resultsoftheevaluation shallbe recordedintheriskmanagementfile.CHAPTER2-RiskManagementReportSummary
11.1Product introductionProductand tradenameSingle-use medicalface masknon-sterileIntended use:Single-use medicalfacemasknon-sterile isusedforpatients inordertoreduce theriskofthe spreadofinfections,and itisnotintendedforusebyhealthcareprofessionalsinanoperatingroomorinothermedicalsettings withsimilarrequirements.
1.2Product structureTheproductiscomposed ofmask body,nose clipand maskribbon.
1.3RiskmanagementpurposePossible hazardand riskfor Single-use medicalfacemasknon-sterile producedbytheCompany areanalyzed basedonrequirements ofMDR andISO149712022,and measuresare takenfor variousriskstogenerate reportby evaluation,thusensuring thathazards andrisk arereducedtoacceptable rangeforsafeand effectivelaunching.
1.4RiskName Departments/positions DutyHaoHu——Responsible forthe implementationofrisk analysismanagementJianxiong ShaoQuality departmentTeammember:estimate theprobabilityoffailureandtheriskdefectsfromthe qualityperspectiveJianhui ChenTechnical andDevelopment Teammember:estimate thedepartmentprobabilityoffailureandtheriskdefectsfromthedesign perspectiveTeammember:estimate therisk fromJinzhangZhang Marketingdepartmentan applicationperspectiveTeammember:estimate therisk fromJianhuiChen Productiondepartmenta manufacturingperspectiveManagement Team
2.Risk acceptabilitycriterion
2.1Risk severitylevelGrade nameCodeSystemrisk definitionsInconvenienceor temporaryIgnorableS1discomfortMild S2Mild injuryor noinjuryModerate S3Moderate injuryCriticalS4One persondied orsevere injuryCatastrophicS5Many peopledied orsevere injury
2.2Risk probabilitygradeGrade nameCode Frequencyper yearVeryfewP110-6Few P210-5and10-6Occasionally P310-4and10-5Sometimes P410-3and10-4Frequently P
51032.3Risk evaluationcriteriaSeverityIgnorable MildModerate CriticalCatastrophicProbabilityS1S2S3S4S5u IuFrequently P5R RUu uP4A R RSometimesuP3A RR ROccasionallyFewP2A ARRRVery fewP1A A AARA:acceptablerisk;R:Reasonably reducedrisk;U:unacceptable riskwithout risk/benefit analysisis consideredas unacceptablerisk.According toISO14971and MDR2022/745:It isrequired thatallrisksfound,whether ornot theyareinan acceptablearea,shouldbetaken toreduce oreliminate themasmuch aspossible.In selectingthe mostappropriate method,themanufacturermust applythe followingprinciples inorder:-Eliminate orreduce hazardswhere possibleinherent safetydesignandstructure-For dangersthat cannotbe eliminated,appropriate protectivemeasures,including appropriatewarnings,should betakenif necessary.-Notify theuser oftheremainingdanger causedbythedefective protectivemeasures.
3.Risk analysisrecordA.2question Featuresjudgment Possiblehazard
3.1Security analysisA.2question Featuresjudgment PossiblehazardA.
2.1What isthe intendeduseandhow isthemedicaldevicetobeusedFactors thatshouldbeconsideredinclude:——what isthemedicaldevices rolerelative toIntendeduse:Basic protectiondiagnosis,prevention,monitoring,treatment or一alleviation ofdisease,for medicalpersonnel orrelated_compensation forinjuryorhandicap or_personnelandprotectionreplacement ormodification ofanatomy,or controlagainstthe spreadof bodyofconceptionfluids andspillage during-what arethe indicationsforusee.g.patientinvasive operations.populationSee theIFU.-does themedicaldevicesustain orsupport life-is specialintervention necessaryinthecase offailureof themedical deviceA.
2.2Is themedicaldeviceintendedtobe implantedFactorsthatshouldbeconsideredincludethelocationof implantation,the characteristicsofthepatientNOpopulation,age,weight,physical activity,theeffectofageing onimplant performance,the expectedlifetime oftheimplant,thereversibilityoftheimplantation.A.
2.3Is themedicaldeviceintendedtobein contact withR1Biological HazardSource CauseYes.Expected contactwiththe patientorotherpersonsskin irritationorviralinfection inmedicalmedical personnelis surfaceFactorsthatshouldbeconsideredincludethenature ofstaffcontact.theintendedcontact,i.e.surface contact,invasivecontact,or implantationand,for each,the periodandYes,Theproductis composedA.
2.4What materialsor componentsare utilizedintheR2Biological HazardsourceContactof amask body,a noseclip,amedical deviceor areused with,or areincontactwith,the ofbio-incompatible materialswithmask band,andasponge stripmedicaldevice users;cause Irritation,allergicnon-sterile arched,Nose clipFactorsthatshouldbeconsideredinclude:symptoms,damage tothe usershealth,is made of aluminumstrip or_compatibility withrelevant substances;and life-threatening insevere cases.plastic andmetal;mask band_compatibility withtissues orbody fluids;whetherwith polyesterand spandexcharacteristicsrelevant tosafety areknown;braid ormadeofnon-woven。