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RiskManagementreport
ProductName
XXX
Type/Model
XXX-XXX
Issuedate
5/11/2019
Release
Name
Occupation
Releasedate
Issued/changedby
Engineeringdepartment
10/11/2019
Checked/Approvedby
Qualitydepartment
20/11/2019
Checked/Approvedby
Engineeringdepartment
30/11/2019
Generalreleaseby
Engineeringdepartment
5/12/2019
Contents
1.Introduction
3
2.Scope
3
3.Applicationinformation
3
3.1Policy,directiveandstandard
3
3.2Theinformationofproduct
4
3.3Othersourceofinformation
4
3.4Teamofriskmanagement
4
3.5Instructionofproduct
4
4.Riskanalysis
4
4.1Riskanalysisprocedure
4
4.2Intendeduse/intendedpurposeandidentificationofcharacteristicsrelatedtothesafety
5-7
4.3IdentificationofknownorforeseeablehazardsandEstimationoftherisk(s)foreachhazard
7-10
5.RiskevaluationandRiskcontrol
11-18
6.Usageofinformationfromin/afterproductionandfollowup
6.1Risksarisingfromriskcontrolmeasures
6.2Completenessofriskevaluation
6.3Overallresidualriskevaluation
7.Evaluationofoverallriskacceptability
8.Annex
TABLE:Intendeduseandidentificationofcharacteristicsrelatedtothesafetyofthe
medicaldevicefromIEC60601-1
19
20
20
20
20
21-24
1.Introduction
ThisriskanalysiswasmadeinaccordancewithENISO14971:2012–Applicationofriskmanagementtomedicaldevices.
ThisriskanalysisreportispreparedforaBiteReliefdeviceorasimilarproduct.Theriskevaluationwasbasedonthefeedbackfromthemarketforsimilarproduct,andalsotheoverallexperiencesofourdevelopmentheadquarter–PerfectSteamAppliancesLimited,andalsotheopinionandexperiencefromthecustomer(s).
Allpossiblerisksareexamined,reducedandratedinthisriskanalysisreport.
Thisriskanalysiswillbereviewedannuallyorwheneveritisnecessarybecauseofe.g.newinformationfromthemarket,newriskdiscovered,functionupdate,etc.RefertoriskmanagementplanRM-1711-01fordetails.
2.Scope
ThisreportisapplicabletotheproductofXXXwhichincludingthefollowingparts:
1. PCB
2. Ceramicheater
3. Alkalinebattery
4. Plasticenclosure
5. Useroperationmanual
3.Applicationinformation:
3.1Policy,directiveandstandard
1)93/42/EEC(MDD)MedicalDevicesDirective
2)Regulation(EU)2017/745(MDR)MedicalDeviceRegulation
3)ISO13485:2016Medicaldevice-Qualitymanagementsystem-requirementsforregulatory
4)ENISO14971:2016Medicaldevices-Applicationofriskmanagementtomedicaldevices
5)IEC60601-1:2005+A1:2012/EN60601-1:2006Medicalelectricalequipment-Part1:Generalrequirementsforbasicsafetyandessentialperformance
6)IEC60601-1-2:2007/EN60601-1-2:2007Medicalelectricalequipment-Part1-2:Generalrequirementsforsafety-Collateralstandard:Electromagneticcompatibility-Requirementsandtests
7)IEC60601-1-11:2015Medicalelectricalequipment--Part1-11:Generalrequirementsforbasicsafetyandessentialperformance--Collateralstandard:Requirementsformedicalelectricalequipmentandmedicalelectricalsystemsusedinthehomehealthcareenvironment
3.2Theinformationofproduct
-Designprogram
-Schematic
-Standardofproduct
-PCBlayout
-OperationInstruction
3.3Othersourceofinformation
-Customersuggestion
-Recordofaccident
-Professionaldocumentary
-Internet
3.4Teamofriskmanagement:
Name
Title
Thedutyintheriskmanagement
ManagementDirector
Providetheresourcesneeded;approvetheplansandthereportsofriskmanagement
ManagementRepresentative
Supervise,organizeandimplementtheriskmanagementactivities;participateintheriskanalysisandevaluation.
HeadofEngineeringDepartment
Responsibleforproducttechnicalandqualityriskmanagement;participateintheriskanalysisandevaluation.Organizetomaketheriskmanagementplanandreport.
HeadofProductDepartment
Provideinformationrelatedtoriskduringproductionprocess;implementriskcontrolmeasuresintheprocessofproduction,reduceoreliminatetherisk;participateintheriskanalysisandevaluation.
HeadofQualityDepartment
Validatetheresultsofriskcontrolmeasures;participateintheriskanalysisandevaluation.
HeadofMarketingDepartment
Responsiblefortrackingthequalityofproductssold,andcollecttherelatedinformation;participateintheriskanalysisandevaluation.
3.5Instructionofproduct
RefertoUserOperationManual
4.Riskanalysis
4.1Riskanalysisprocedure
RefertoRiskManagementPlan(DocumentNo.:RM-1711-01Version:A0)
4.2Intendeduse/intendedpurposeandidentificationofcharacteristicsrelatedtothesafety(AnnexCofENISO14971:2016)
NO
Items
Thespecialtyofcharacter
Result
Applicable(A)/Notapplicable(NA)
C.2.1
Whatistheintendeduseandhowisthemedicaldevicetobeused?
Thedeviceissuitableforalleviatingitching,swellingorinflammationcausedbyinsectbites.Whenused,itmakesuseoftheeffectofheatatthetreatmentsite,whichcanhaveapositiveinfluenceonthehealingprocess.
A
C.2.2
Isthemedicaldeviceintendedtobeimplanted?
Thedeviceisnotintendedtobeimplanted.
NA
C.2.3
Isthemedicaldeviceintendedtobeincontactwiththepatientorotherpersons?
Theheatingplateisintendedtobeincontactwiththeuser’sskin.
A
C.2.4
Whatmaterialsorcomponentsareutilizedinthemedicaldeviceorareusedwith,orareincontactwith,themedicaldevice?
Thematerials&componentsusedandtherelevantcharacteristicsarelistedinBOM(BillofMaterial).Theheatingplateofthedeviceisinintendedcontactwiththeuser’sskin.ThematerialoftheheatingplatehasbeencertifiedtomeettherequirementsofENISO10993biocompatibilitystandards.
A
C.2.5
Isenergydeliveredtoorextractedfromthepatient?
Thereisenergydeliveredtoorextractedfromthepatient.
A
C.2.6
Aresubstancesdeliveredtoorextractedfromthepatient?
Therearenosubstancesdeliveredtoorextractedfromthepatient.
NA
C.2.7
Arebiologicalmaterialsprocessedbythemedicaldeviceforsubsequentre-use,transfusionortransplantation?
Therearenobiologicalmaterialsprocessedbythemedicaldevice.
NA
C.2.8
Isthemedicaldevicesuppliedsterileorintendedtobesterilizedbytheuser,orareothermicrobiologicalcontrolsapplicable?
Thedeviceisnotsuppliedsterileandisnotintendedtobesterilizedbytheuser.
Therearenoothermicrobiologicalcontrolsapplicable.
NA
C.2.9
Isthemedicaldeviceintendedtoberoutinelycleanedanddisinfectedbytheuser?
Ifnecessary,cleanthedeviceandheatingplatecarefullyonlywithaslightlymoistenedcloth.
Neveruseabrasive,corrosiveorsolvent-basedcleaningproducts.
Noroutinelydisinfectionforeseen.
A
C.2.10
Isthemedicaldeviceintendedtomodifythepatientenvironment?
Thedeviceisnotmodifyingthepatientenvironment.
NA
C.2.11
Aremeasurementstaken?
Thedevicedoesnottakeanymeasurements.
NA
C.2.12
Isthemedicaldeviceinterpretative?
Thedevicedoesnotdeliveranyinterpretations.
NA
C.2.13
Isthemedicaldeviceintendedforuseinconjunctionwithothermedicaldevices,medicinesorothermedicaltechnologies?
Themedicaldeviceisnotintendedforuseinconjunctionwithothermedicaldevices,medicinesorothermedicaltechnologies.
NA
C.2.14
Arethereunwantedoutputsofenergyorsubstances?
Unpleasantcurrentwillnotoccur
NA
C.2.15
Isthemedicaldevicesusceptibletoenvironmentalinfluences?
Extremeoperating,storageandtransportconditionsmaydamagethemedicaldevice.
Theenvironmentconditions,liketemperature,humidity,pressure,altitude,ifapplicablearefixedintheproductspecificinstructionforuse
A
C.2.16
Doesthemedicaldeviceinfluencetheenvironment?
Besidethedisposalofwaste,themedicaldevicedoesnotinfluencetheenvironment.
Theelectromagneticinterferencegeneratedbythemedicaldevicemayadverselyaffectthenormaloperationofotherelectricdevicesnearby.
TheproductmeetstherequirementsofIEC/EN60601-1-2.
NA
C.2.17
Arethereessentialconsumablesoraccessoriesassociatedwiththemedicaldevice?
Yes,2xAAA1,5Vbatteriesareincludedtothegiftbox.
Ifthedevicerequiresbatteriesforapplication,thesebatteriesareconsumables.
A
C.2.18
Ismaintenanceorcalibrationnecessary?
Calibrationandmaintenancearenotnecessary.Cleaningwhichisdescribedintheinstructionforuseissufficient.
NA
C.2.19
Doesthemedicaldevicecontainsoftware?
Thedevicecontainsnosoftware.
NA
C.2.20
Doesthemedicaldevicehavearestrictedshelf-life?
Themedicaldevicedoesnothavearestrictedshelflife.
Thisproductseriesisguaranteedforatleast5yearsagainstmaterialandmanufacturingdefects.(C.2.23)
NA
C.2.21
Arethereanydelayedorlong-termuseeffects?
Therearenodelayedorlong-termuseeffects.
NA
C.2.22
Towhatmechanicalforceswillthemedicaldevicebesubjected?
Therearenospecialmechanicalforcesinadditiontotheforceswhicharenecessaryinnormaluse.
NA
C.2.23
Whatdeterminesthelifetimeofthemedicaldevice?
Agingofcomponentdeterminesthelifetimeofthedevice.
Thisproductseriesisguaranteedforatleast5yearsagainstmaterialandmanufacturingdefects.
A
C.2.24
Isthemedicaldeviceintendedforsingleuse?
Thedeviceisintendedforre-use.
NA
C.2.25
Issafedecommissioningordisposalofthemedicaldevicenecessary?
DisposalhastobedoneinconformitywithWEEEand/ornational/localrequirements.Refertotheinstructionforuse.
A
C.2.26
Doesinstallationoruseofthemedicaldevicerequirespecialtrainingorspecialskills?
Thedevicedoesnotneedspecialskillandtraining.
NA
C.2.27
Howwillinformationforsafeusebeprovided?
Safetyinformation(instructionforuse)willbeenclosedwiththepackagewhenmanufactured.
Notraining,re-trainingorre-certificationofoperatorsorservicepersonnelwouldberequired.
A
C.2.28
Willnewmanufacturingprocessesneedtobeestablishedorintroduced?
Thereisnoneedfornewmanufacturingprocesses.
NA
C.2.29
Issuccessfulapplicationofthemedicaldevicecriticallydependentonhumanfactorssuchastheuserinterface?
Asfollowingconsiderationlistedin29.1~29.8andUsabilityEngineeringfileinaccordancewithIEC/EN60601-1-6&IEC/EN62366.
A
C.2.29.1
Cantheuserinterfacedesignfeaturescontributetouseerror?
No,thepatientinterfacecancontributetouseerror.
NA
C.2.29.2
Isthemedicaldeviceusedinanenvironmentwheredistractionscancauseuseerror?
Therearenousererrorspossiblerelatedtodistractionsfromenvironment.
NA
C.2.29.3
Doesthemedicaldevicehaveconnectingpartsoraccessories?
No,themedicaldevicedoesnothaveconnectingpartsoraccessories.
NA
C.2.29.4
Doesthemedicaldevicehaveacontrolinterface?
Therearebuttonstooperatethedevice,thereisnospecialcontrolinterfaceforexternalcontrols.
NA
C.2.29.5
Doesthemedicaldevicedisplayinformation?
ThedeviceshowsahiddenLEDasreadyindicatorandalightringasopticalfunctioninformationthatthetreatmentisrunning.Thereisnodisplaywithinformationdetails.
NA
C.2.29.6
Isthemedicaldevicecontrolledbyamenu?
Thedeviceisnotcontrolledbyamenu.
NA
C.2.29.7
Willthemedicaldevicebeusedbypersonswithspecialneeds?
Anypersonusingitonthemselvesmustbeover12yearsold.Theproductshouldonlybeusedonchildrenunder12yearsoldifsupervisedorassistedbyanadult.Thedeviceshouldnotbeusedonchildrenyoungerthan3years.
A
C.2.29.8
Cantheuserinterfacebeusedtoinitiateuseractions?
Inadditiontotheintuitiveuserinterface,allusagestepsareexplainedintheinstructionmanual.
NA
C.2.30
Doesthemedicaldeviceuseanalarmsystem?
Themedicaldevicedoesn’thaveanalarmsystem.
NA
C.2.31
Inwhatway(s)mightthemedicaldevicebedeliberatelymisused?
Necessaryconsiderationconcerningusabilityhasbeenperformedtoavoidmisuse.Potentialmisusesare:
-Inthecaseofdiabetics,astheymayhavereducedsensitivitytopainandmayburnthemselves
-Neartotheeyes,ontheeyelids,mouthoronmucousmembranes
-Useondisease-relatedskinchangesorscarredskinareas
-Applicationonacutelyorchronicallydiseased(injuredorinflamed)skin(e.g.painfulandpainlessinflammations,redness,skinrashes(e.g.allergies),burns,bruises,swellingsandopenwoundsaswellaswoundsinthehealingprocess,onsurgicalscarswhichareintheprocessofhealing)
-Ifyouhaveanysensoryimpairmentthatreducesthefeelingofpain(e.g.metabolicdisorders)
-Useincaseoffever
-Ifyousufferfrompersistentlyirritatedskinduetolong-termheatapplicationonthesameareaofskin
-Onsensitiveareasofskin
Ifyouareusinglotions,creamsandgelslocallyatthesametime
-Youhaveanyskinconditions
-Yousufferfromaseriousillness,inparticularifyouhaveapropensitytothromboembolicconditionsorrecurrentmalignantgrowths
-Youhaveunexplainedchronicpaininanypartofthebody
A
C.2.32
Doesthemedicaldeviceholddatacriticaltopatientcare?
Thedevicedoesnotholdcriticaldata.
NA
C.2.33
Isthemedicaldeviceintendedtobemobileorportable?
Thedeviceisdesignedtobeportable.
A
C.2.34
Doestheuseofthemedicaldevicedependonessentialperformance?
Themedicaldeviceisnotlife-supporting.
NA
4.3IdentificationofknownorforeseeablehazardsandEstimationoftherisk(s)foreachhazard.KnownorforeseeablehazardsinbothnormalandsinglefaultconditionsareidentifiedbasedonAnnexEofENISO14971:2016
Item
Possiblehazards
Comments
RiskevaluationYes/No
1.General
Thisannexprovidesanon-exhaustivelistofpossiblehazardstogetherwithcontributingfactorswhichmaybeassociatedwithdifferentmedicaldevices.Thislistcanbeusedtoaidintheidentificationofhazardsassociatedwithaparticularmedicaldevice.
A:Energyhazards
A.1
Electromagneticenergy
1.Linevoltage
Thedevicesuseinternalpowersource
(2x1.5VAAAbatteries).
Yes
2.Leakagecurrent
enclosureleakagecurrent
Dueto1.5Vbatteryoperation,leakagecurrentsofthedevicearenegligible.
Yes
earthleakagecurrent
Yes
patientleakagecurrent
Yes
3.Electricfields
Theoccurrenceofelectricfieldsmayoccur.
Yes
4.Magneticfields
Theoccurrenceofmagneticfieldsmayoccur.
Yes
A.2
Radiationenergy
1.Ionizingradiation
No
2.Non-ionizingradiation
No
A.3
Thermalenergy
1.Hightemperature
Thetemperatureoftheceramicheatingplatecouldbehigher50°C+/-2°Cbecauseofamalfunctionorenvironmentalinfluences.
Yes
2.Lowtemperature
No
A.4
Mechanicalenergy
1.Gravity
-falling
Theonlyeffectsofthedroptestsarethoseregardingtheexternalcaseofthedevice,whichhasproventobehighlyresistant.Thedevicewasdesignedinshapesandsizesoptimizedtobehandledeasilyandtopreventthedamagesfromcrashesasmuchaspossible.Alsothematerialschosenhavebeenstudiedtothispurpose.
Yes
-suspendedmasses
No
2.Vibration
No
3.Storedenergy
No
4.Movingparts
No
5.Torsion,shearandtensileforce
No
6.Movingandpositioningofpatient
Movingofthepatientduringusageofunitcouldresultintouchingsensitiveskinareas,whichcouldbepainfulbutharmlessforthepatient.
Yes
7.Acousticenergy
-ultrasonicenergy
No
-infrasoundenergy
No
-Sound
Acousticalsignalduringuseofthedevice.
No
8.Highpressurefluidinjection
No
B:Biologicalandchemicalhazards
B.1
Biologicalhazards
1.Bacteria
No
2.Viruses
No
3.Otheragents(e.g.prions)
No
4.Re-orcross-infection
Re-useofthedevicebyanotheruserwithoutcleaningtheheatingelementmightcausecross-infectionofskindiseases.
Yes
B.2
Chemicalhazards
Exposureofairway,tissues,environmentorproperty,e.g.toforeignmaterials:
acidsoralkalis
Batteriesmayleak.
Yes
residues
No
contaminates
No
additivesorprocessingaids
No
cleaning,disinfectingortestingagents
No
degradationproducts
No
medicalgasses
No
anaestheticproducts
No
B.3
Biocompatibility
Toxicityofchemicalconstituents,e.g.:
allergenicity/irritancy
pyrogenicity
ThemedicaldevicepartswhichareincontactwiththehumanskinshouldcomplywiththerequirementsofENISO10993toavoidtheimpacttohumanbody.
Includewarningsandinformationoncorrecthandlingwiththedeviceintheinstructionsforuse,e.g.
Thedeviceisnotasubstituteformedicalconsultationandtreatment.Alwaysconsultyourdoctorifyouareexperiencinganypainoraresufferingfromanillness.
Seekprofessionaladviceimmediatelyif:
-ThesymptomspersistdespiteusingtheinsectXXX.Stopuse.
-ThesymptomsworsenwhilstorafterusingtheinsectXXX.Stopuse.
-Itisatickbite.Thebitemayresultintransmissionofpathogenssuchastick-borneencephalitis(TBE)orborreliosis.
-Thefirstsignsofincreaseditching,skinredness,swelling,dizziness,nausea,shortnessofbreath,formationofwhealsoradroporincreaseinbloodpressureoccur.
Yes
C:Operationhazards
C.1
Function
1.Incorrectorinappropriateoutputorfunctionality
Thetemperatureofthedevicecouldbetoohighbecauseofamalfunction.
Yes
2.Incorrectmeasurement
Thedevicenotdeliversanymeasurements.
No
3.Erroneousdatatransfer
Theunithasnodatatransfer.
No
4.Lossordeteriorationoffunction
1)Itispossiblethatagingofcomponentdeterminesthelifetimeofthedevice.
2)Depletionofbatteriesmaycausethedevicetoloseitsintendedfunction.Replacethedepletedbatterieswithnewoneswillre-coverthesystem.
Yes
C.2
Useerror
1.Attentionalfailure
Theusageiseasyandnearlyautomatically,forthatreasontherearenoharmsexpectedbecauseoflossofattention.
No
2.Memoryfailure
Thenecessaryinformationismentionedintheinstructionforuse.
No
3.Rule-basedfailure
Thenecessaryrulesaregivenintheinstructionsforuse.Instructionsforusemaybelostormisremembered.
No
4.Knowledge-basedfailure
Thenecessaryknowledgeofusingthemedicalproductwillbegivenwithinstructionforuse.Instructionsforusemaybelostormisremembered.
No
5.Routineviolation
Theusageiseasyandnearlyautomatically,forthatreasontherearenoharmsexpectedbe-causeofroutineviolation.
Yes
D:Informationhazards
D.1
Labeling
1.Incompleteinstructionsforuse
Instructionforuse,descriptionofperformancecharacteristics,specificationofintendeduseanddisclosureoflimitationsshallbepartofthedevicepackaging.
Yes
2.Inadequatedescriptionofperformancecharacteristics
Yes
3.Inadequatespecificationofintendeduse
Yes
4.Inadequatedisclosureoflimitations
Yes
D.2
Operatinginstructions
1.Inadequatespecificationofaccessoriestobeusedwiththemedicaldevice
Specificationofaccessories,specificationofpre-usechecks,simpleoperationinstructionandtrouble-shootinginformationshallbepartofthedevicepackaging.
Yes
2.Inadequatespecificationofpre-usechecks
Yes
3.Over-complicatedoperatinginstructions
Yes
D.3
Warnings
1.ofsideeffects
Ifthedeviceisusedaccordingtotheinstructionforusetherearenosideeffects.
No
2.ofhazardslikelywithre-useofsingle-usemedicaldevices
Thedeviceisnotasingle-usemedicaldevice.
No
D.4
Specificationofserviceandmaintenance
Theserviceandmaintenancespecificationsarelistedintheinstructionforuse.
Yes
E.Additionalhazards(please,stateatleasthazardsspecifictoyourequipment.Youshouldidentifymorethan2additionalforeseeablehazards)
E.1
Incompatibilitywithconsumables/accessories/othermedicaldevices
Rechargeablebatteriescouldbeused;Correctaccessorieswhichshouldbeusedarelistedininstructionforuse.
Yes
E.2
Sharpedgesorpoints
Theouter/touchableappearanceofthedevicecan’thaveanysharpedgesorpointsasthesearebasicdesignrequirementsofthecompany.Thedevelopmentteamwillfollowthisrequirement,andthemedicaldeviceshallmeettherequirementsoftheapplicablesafetystandards.
Yes
E.3
Unintendedmotion
Thereisnounintendedmotionwiththedevice.
No
E.4
Storageoroperationoutsideprescribedenvironmentalconditions
Ifthedeviceisunderabnormalstorageconditionsinlongterm,e.g.extremehighorlowtemperature,itmaycausethecomponentstobedamaged.
Ifthedeviceisusedoutsidetheoperatingenvironmentalconditions,itmaygetinaccuratetemperatures.
Thestorageandoperatingconditionsarelistedintheinstructionmanualandongiftbox
Thestorageconditionsareprintedonthemasterandtheshippingcarton.
Therearenospecialrequirementsfortransportation.Transportationisnotconsideredasalongtermcondition.
Yes
E.5
Incompatibilitywithotherdeviceswithwhichitisintendedtobeused
Thedeviceisastand-alonedevice.
No
E.6
Usebyunskilled/untrainedpersonnel
UseofthedevicedoesNOTneedspecialskillortraining.
No
E.7
FailureofpatientSupportDevice
Thedeviceisnotapatientsupportdevice.
No
E.8
Burnsonskin
IftheuserapplicatethedeviceagainandagainononeskinareaORifuserlettoolesspacebetweenthetreatmentstheskinmaygetsomeburns.
Yes
E.9
Hazardsofothersurroundingobjects
Ifuserputthedeviceintothebagwithoutturningitoffinbeforethetreatmentcouldstartbymistakeandcanheatupotherparts(e.g.lighters)
Yes
5.RiskevaluationandRiskControl
RiskEvaluationaccordingtoENISO14971:2012;AnnexD–Riskconceptsformedicaldevices
D.3.4.2Semiquantitativeanalysis-5x5matrixpictureD5
Probability(Likelihoodofeventoccurrence)
Definition
Commonterm
Rank(1=lowest)
Frequent
5
≥10-3(≥1:1000)
Probable
4
<10-3and≥10-4(<1:1000and≥1:10000)
Occasional
3
<10-4and≥10-5(<1:10000and≥1:100000)
Remote
2
<10-5and≥10-6(<1:100000and≥1:1000000)
Incredible
1
<10-6(<1:1000000)
Severity(Impactofeventoccurrence)
Definition
Commonterm
Rank(1=lowest)
Catastrophic
5
Resultsinpatientdeath
Serious
4
Resultsinpermanentimpairmentorlife-threateninginjury
Moderate
3
Resultsininjuryorimpairmentrequiringprofessionalmedicalintervention
Minor
2
Resultsintemporaryinjuryorimpairmentnotrequiringprofessionalmedicalinterventionordeviceloseintendedmedicalfunction.Oritmaycausethepatientsdelaythetimingtoseeadoctor.OrItmaybeaccumulatedtoimpairpatients’healthinlong-term.
Negligible
1
Inconvenienceortemporarydiscomfort
RiskIndexMatrix
Severityrank
Probabilityrank
1Negligible
2Minor
3Moderate
4Serious
5Catastrophic
5Frequent
NAC
NAC
NAC
NAC
NAC
4Probable
NAC
NAC
NAC
NAC
NAC
3Occasional
AC
AC
NAC
NAC
NAC
2Remote
AC
AC
AC
NAC
NAC
1Incredible
AC
AC
AC
AC
AC
Result
AC
Acceptablerisk
NAC
Notacceptablerisk
Risk
No.
Potentialhazard
Rootcause
Riskestimation
Risk
acceptable
Yes/No
Riskreductionmeasures(RRM)/Remarks(Rem)
Newrisk
Yes/No
**)
Affects
otherrisk
Yes/No
***)
Newriskestimation
Risk
acceptable
Yes/No
Prob
Sev
RI*)
Prob
Sev
RI*)
R1
A.1.1
Linevoltage
Usercangetanelectricalshock.
1
2
2
Yes
RRM
Includewarningsandinformationoncorrectoperationofthedeviceintheinstructionsforuse,e.g.
•Keeptheunitinadryplace(indooruseonly).Inordertoavoidtheriskoffireand/orelectricshock,theunitmustbeprotectedagainsthighhumidityandwater.
No
No
1
2
2
Yes
Rem
ThedevicecomplieswiththerequirementsaccordingtoIEC/EN60601-1.
R2
A.1.2
Leakagecurrent
Usercangetaslightelectricalshock.
1
2
2
Yes
RRM
Includewarningsandinformationoncorrectoperationof
thedeviceintheinstructionsforuse,e.g.
•Keeptheunitinadryplace(indooruseonly).Inordertoavoidtheriskoffireand/orelectricshock,theunitmustbeprotectedagainsthighhumidityandwater.
No
No
1
2
2
Yes
Rem
ThedevicecomplieswiththerequirementsaccordingtoIEC/EN60601-1.
R3
A.1.3
Electricfields
Electricfieldsareharmfultohealth.
Electricfieldscanleadtoelectromagneticinterferenceswithotherdevices.
1
2
2
Yes
Rem
ThedevicecomplieswiththerequirementaccordingtoIEC/EN60601-1-2.
No
No
1
2
2
Yes
R4
A.1.4
Magneticfields
Magneticfieldsareharmfultohealth.
1
4
4
Yes
Rem
ThedevicecomplieswiththerequirementaccordingtoIEC/EN60601-1-2.
No
No
2
1
2
Yes
R5
A.3.1
ThermalEnergy
Thetemperatureoftheceramicheatingplatecouldbehigher50°C+/-2°Cbecauseofamalfunctionorenvironmentalinfluences.
2
3
6
Yes
Rem
Theoutputlevelwillbecontrolledatproductionstage.
No
No
2
2
4
Yes
RRM
Setupnecessaryinformationininstructionforuse,e.g.
•Usethedeviceinthespecific“permissibleoperatingand
storageconditions.
•“Youshouldprotectthedevicefromimpact,moisture,dirt,
majortemperaturefluctuationsanddirectexposuretothe
sun’srays.
R6
A.4.1
Gravityfalling
Themedicaldevicemaybedamagedafterdrop.Asresultitgetsharpedgesand
usercangethurt.
2
2
4
Yes
RRM
ThereisasafetyremarkintheIM:
“Beforeuse,ensurethatthereisnovisibledamagetothedevice
oraccessories.”
No
No
1
2
2
Yes
Rem
Thedeviceisconstructedandproducedaccordingto
IEC/EN60601-1.
R7
A.4.6
Movingandpositioningofpatient
Movingofthepatientduringusageoftheunitcouldresultintouchingsensitiveskinareas,whichcouldbepainfulbutharmlessforthepatient.
1
2
2
Yes
RRM
Includewarningsandinformationoncorrectoperationof
thedeviceintheinstructionsforuse,e.g.
Notmovetheunitduringuse
Taketheunitofftheskinifyoudetecttheheatisinconvenient
hot
No
No
2
2
4
Yes
R8
B.1.4
Biologicalhazard–re-orcross-infection
Re-useofthedevice
byanotheruserwithoutcleaningmightcausecross-infectionofskindiseases.
3
2
6
Yes
RRM
Warningininstructionforuse:
-Thedeviceisintendedformultipleuses.
-Thedeviceshouldonlybeusedbyoneperson;usebymultiplepeopleisnotrecommended.
-Itisrecommendedtocleanthedevicebeforefirstuseandbeforeanyfurtheruse.
-Thedeviceshouldonlybeusedbyoneperson.Theuseofvariouspeopleisnotrecommended.
-Ifthedeviceisusedonseveralinjectionsites,itisrecommendedtocleantheheatingplateeverytime.Thisreducesthepossibilityofcrossinfectionfromonepl
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