医疗器械风险管理报告英文版模板

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