RMTABLES-rev07(有源医疗设备CE认证RM表)

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文档简介

ATTENTION:

-ThistablelistcontainstheRMtablesfromtheIEC60601-1:2005trfversiong.

-ThisRMtablelistisintendedtobeusedinthefollowingway:

a)ManufacturerwillfilloutONLYTHEFIRSTCOLUMN„DocumentRefinRMF“andsendbacktheworddocumenttothetestengineer.

b)Thetestengineerwillverifythecorrectnessofthe“DocumentRefinRMF”andtransferitintheIEC60601-1trf.

c)ThenthetestengineerwillevaluatetheRMFand“verdict”theresults.

Pleasefinda“wrong”and“right”filledoutsampleofasingleRM-tableasguidancehowtofillouttheRM-tablescorrectly:

4.2

“WRONG”exampleoffilledoutRMRESULTSTABLE:

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

3.3a

SeeRM-file

3.5e

SeeRM-file

4.1

SeeRM-file

4.2

SeeRM-file

4.3

SeeRM-file

4.4

SeeRM-file

6.1

SeeRM-file

6.2

SeeRM-file

6.3

SeeRM-file

6.4

SeeRM-file

6.5

SeeRM-file

6.6

SeeRM-file

6.7

SeeRM-file

4.2

“RIGHT”exampleoffilledoutRMRESULTSTABLE:

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

3.3a

9806400000_RMFchapter4page23

3.5e

9806400000_RMFchapter5page34

4.1

9806400000_RMFchapter2page08

4.2

9806400000_RMFchapter3page14ff

4.3

9806400000_AR01_001

RAref#1.00a

4.4

9806400000_AR02_001RMS

RAref#1.00a

9806400000_AR02_001RMS

RAref#1.00a

6.1

See6.2to6.7

6.2

9806400000_AR02_001RMS

RAref#1.00a

6.3

9806400000_VA01_001Checklist

6.4

9806400000_AR02_001RMS

RAref#1.00a

6.5

9806400000_AR02_001RMS

RAref#1.00a

6.6

9806400000_AR02_001RMS

RAref#1.00a

6.7

9806400000_RMFchapter11page104

9806400000_RMFchapter12page107

STARTtofilloutbythemanufacturer:

Manufacturer:

DeviceunderTest:

Dateofcompletionoffirstcolumn:

4.2

RMRESULTSTABLE:RiskManagementProcessforMEEquipmentorMESystems

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

3.3a

3.5e

4.1

4.2

4.3

4.4

6.1

6.2

6.3

6.4

6.5

6.6

6.7

4.3

RMRESULTSTABLE:EssentialPerformance

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

Note:6.2to6.4notpartofIECEETRFversionG,butrequiredbyISO14971.

4.5

RMRESULTSTABLE:EquivalentSafetyforMEEquipmentofMESystem

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

Notapplicableforequivalentsafety.

N/A

4.6

RMRESULTSTABLE:MEEquipmentorsystempartscontactingthepatient

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

4.7

RMRESULTSTABLE:SingleFaultConditionforMEEquipment

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

4.8

RMRESULTSTABLE:ComponentsofMEEquipment

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

4.9

RMRESULTSTABLE:Useofcomponentswithhigh-integritycharacteristics

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

N/A

5.1

RMRESULTSTABLE:TypeTests

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

5.4a)

RMRESULTSTABLE:OtherConditions

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

5.7

RMRESULTSTABLE:Humiditypreconditioningtreatment

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

5.9.2.3

RMRESULTSTABLE:Actuatingmechanisms

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

7.2.2

RMRESULTSTABLE:Identification

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.4

7.2.5

RMRESULTSTABLE:MEEQUIPMENTpoweredfromotherequipment

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.4

7.2.13

RMRESULTSTABLE:Physiologicaleffects(safetysignsandwarning)

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.3

7.2.17

RMRESULTSTABLE:Protectivepackaging

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.3

6.4

7.3.3

RMRESULTSTABLE:Batteries

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.3

7.3.7

RMRESULTSTABLE:Supplyterminals

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

7.4.2

RMRESULTSTABLE:Controldevices

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

Note:Ifapredefinedstandardcountermeasure“e.g.instrumentorscaleorindicationofdirection...”hasbeenappliedtheRMisN/A.

7.5

RMRESULTSTABLE:Safetysigns

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.3

7.9.1

RMRESULTSTABLE:Generalaccompanyingdocuments(SeeTableC.4)

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

7.9.2.4

RMRESULTSTABLE:Electricalpowersource

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.3

7.9.3.2

RMRESULTSTABLE:Replacementoffuses,powersupplycords,otherparts

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

8.1b(1)

RMRESULTSTABLE:Fundamentalruleofprotectionagainstelectricshock

-interruptionofanyonepower-carryingconductor

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

4.4

8.1b(2)

RMRESULTSTABLE:Fundamentalruleofprotectionagainstelectricshock

-unintendedmovementofacomponent

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

8.1b(3)

RMRESULTSTABLE:Fundamentalruleofprotectionagainstelectricshock

-accidentaldetachmentofconductorsandconnectors

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

8.2.2

RMRESULTSTABLE:Connectiontoanexternald.c.powersources

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

8.3d

RMRESULTSTABLE:RequirementsofTypeBForCFAppliedParts

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

6.2

SeealsoRMTablefor4.6

8.4.2c

RMRESULTSTABLE:Accessiblepartsincludingappliedparts

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

8.5.2.2

RMRESULTSTABLE:TypeBappliedparts

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

8.5.2.3

RMRESULTSTABLE:PATIENTLeads

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

8.6.3

RMRESULTSTABLE:Protectiveearthingofmovingparts

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

8.8.4.1

RMRESULTSTABLE:Mechanicalstrengthandresistancetoheat

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

8.10.1

RMRESULTSTABLE:Fixingofcomponents

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

8.10.2

RMRESULTSTABLE:Fixingofwiring

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

4.4

6.2

6.3

6.4

6.5

8.10.5

RMRESULTSTABLE:Mechanicalprotectionofwiring

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

4.4

6.2

6.3

6.4

6.5

8.11.5

RMRESULTSTABLE:Mainsfusesandover-currentreleases

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

4.4

6.2

6.3

6.4

6.5

9.2.1

RMRESULTSTABLE:HAZARDSassociatedwithmovingparts-General

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

9.2.2.4.3

RMRESULTSTABLE:Movableguards

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

9.2.2.4.4

RMRESULTSTABLE:Protectivemeasures

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

9.2.2.5c)

RMRESULTSTABLE:Continuousactivation

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

9.2.2.6

RMRESULTSTABLE:Speedofmovement(s)

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

9.2.3.2

RMRESULTSTABLE:Overtravel

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

9.2.4

RMRESULTSTABLE:Emergencystoppingdevices

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

6.6

9.2.5

RMRESULTSTABLE:Releaseofpatient

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

9.3

RMRESULTSTABLE:Hazardsassociatedwithsurfaces,cornersandedges

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

4.4

6.2

6.3

6.4

6.5

9.4.2.4.3

RMRESULTSTABLE:Movementoverathreshold

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

NOTE:Ifthemanufacturerhasnotconductedownpretestingpriortotesthousetesting,themanufacturercan’tknowinadvancetheexacttestresultspriortotesthousetesting.ThereforethemanufacturersRMFshouldaddressthisRM-clausebasedonhisbestassumption,whatthemanufacturerthinkswhattheoutcomeofthetestingwillprobablybe.IflaterthetesthouserealtestresultdifferfromthemanufacturersassumptionasmadeinadvanceintheRMF,thenaccordingthenoteinclause5.1theRMFneedstoundergoanupdatebasedonthetestresults.

9.5.1

RMRESULTSTABLE:Protectivemeans

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

4.4

6.2

6.3

6.4

6.5

9.6.1

RMRESULTSTABLE:Acousticenergy-General

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

9.6.2.2

RMRESULTSTABLE:Infrasoundandultrasoundenergy

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

9.7.2

RMRESULTSTABLE:Pneumaticandhydraulicparts

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

4.4

6.2

6.3

6.4

6.5

9.7.4

RMRESULTSTABLE:PressureratingofMEequipmentparts

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

4.4

6.2

6.3

6.4

6.5

9.7.6

RMRESULTSTABLE:Pressure-controldevice

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

4.4

6.2

6.3

6.4

6.5

9.7.7

RMRESULTSTABLE:Pressure-reliefdevice

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

4.4

6.2

6.3

6.4

6.5

9.8.1

RMRESULTSTABLE:Hazardsassociatedwithsupportsystems-General

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

9.8.2

RMRESULTSTABLE:Tensilesafetyfactor

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

4.4

6.2

6.3

6.4

6.5

9.8.3.1

RMRESULTSTABLE:Strengthofpatientoroperatorsupportorsuspensionsystems-General

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

9.8.3.2a,b

RMRESULTSTABLE:Staticforcesduetoloadingfrompersons

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

4.4

6.2

6.3

6.4

6.5

9.8.4.1

RMRESULTSTABLE:Systemswithmechanicalprotectivedevices-General

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

4.4

6.2

6.3

6.4

6.5

9.8.4.3

RMRESULTSTABLE:Mechanicalprotectivedeviceforsingleactivation

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

4.4

6.2

6.3

6.4

6.5

9.8.5

RMRESULTSTABLE:Systemswithoutmechanicalprotectivedevices

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

4.4

6.2

6.3

6.4

6.5

10.1.2

RMRESULTSTABLE:MEequipmentintendedtoproducediagnosticortherapeuticX-radiation

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

10.2

RMRESULTSTABLE:Alpha,beta,gamma,neutron&otherparticleradiation

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

10.3

RMRESULTSTABLE:Microwaveradiation

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

10.5

RMRESULTSTABLE:Othervisibleelectromagneticradiation

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

10.6

RMRESULTSTABLE:Riskassociatedwithinfraredradiationotherthanemittedbylasersandleds

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

10.7

RMRESULTSTABLE:Riskassociatedwithultravioletradiationotherthanemittedbylasersandleds

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

11.1.1

RMRESULTSTABLE:Maximumtemperatureduringnormaluse

(Table23or24)

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

11.1.2.1

RMRESULTSTABLE:Appliedpartsintendedtosupplyheattopatient

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

11.1.2.2

RMRESULTSTABLE:Appliedpartsnotintendedtosupplyheattopatient

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

11.1.3

RMRESULTSTABLE:Measurements

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

11.2.2.1

RMRESULTSTABLE:Riskoffireinanoxygenrichenvironment

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

11.3

RMRESULTSTABLE:ConstructionalrequirementsforfireenclosuresofMEequipment

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

11.5

RMRESULTSTABLE:MEequipmentandMEsystemsintendedforuseinconjunctionwithflammableagents

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

11.6.2

RMRESULTSTABLE:OverflowinMEequipment

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

11.6.3

RMRESULTSTABLE:SpillageonMEequipmentandMEsystem

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

11.6.5

RMRESULTSTABLE:IngressofwaterorparticulatematterintoMEEQUIPMENTandMESYSTEMS

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

11.6.6

RMRESULTSTABLE:CleaninganddisinfectionofMEequipmentandMEsystems

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

11.6.7

RMRESULTSTABLE:SterilizationofMEequipmentandMEsystems

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

11.6.8

RMRESULTSTABLE:Compatibilitywithsubstancesused

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

12.1

RMRESULTSTABLE:Accuracyofcontrolsandequipment

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

12.3

RMRESULTSTABLE:Alarmsystems

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

12.4.1

RMRESULTSTABLE:Intentionalexceedingofsafetylimits

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

12.4.2

RMRESULTSTABLE:Indicationofparametersrelevanttosafety

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

12.4.3

RMRESULTSTABLE:Accidentalselectionofexcessiveoutputvalues

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

12.4.4

RMRESULTSTABLE:Incorrectoutput

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

12.4.5.2

RMRESULTSTABLE:DiagnosticX-rayequipment

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

12.4.5.3

RMRESULTSTABLE:Radiotherapyequipment

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

12.4.5.4

RMRESULTSTABLE:OtherMEequipmentproducingdiagnosticortherapeuticradiation

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

12.4.6

RMRESULTSTABLE:Diagnosticortherapeuticacousticpressure

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

13.2.6

RMRESULTSTABLE:Leakageofliquid

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

14.1

RMRESULTSTABLE:Programmableelectricalmedicalsystems-General

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

14.6.1

RMRESULTSTABLE:Identificationofknownandforeseeablehazards

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.3

14.6.2

RMRESULTSTABLE:Riskcontrol

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

6.1

14.7

RMRESULTSTABLE:Requirementspecification

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

6.3

14.8

RMRESULTSTABLE:Architecture

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

6.3

14.9

RMRESULTSTABLE:DesignandImplementation

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

6.2

6.3

14.10

RMRESULTSTABLE:Verification

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

6.3

14.11

RMRESULTSTABLE:PEMSvalidation

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

6.3

14.13

RMRESULTSTABLE:ConnectionofPEMSbyNETWORK/DATACOUPLINGtootherequipment

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

15.1

RMRESULTSTABLE:ConstructionofMEequipment–ArrangementsofcontrolsandindicatorsofMEequipment

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

6.2

6.3

6.4

6.5

15.3.2

RMRESULTSTABLE:Pushtest

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

15.3.3

RMRESULTSTABLE:Impacttest

ClauseofISO14971

DocumentRef.inRMF(DocumentNo.¶graph)

Result-Remarks

Verdict

4.2

4.3

4.4

NOTE:Ifthemanufacturerhasnotconductedownpretesti

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RMTABLES-rev07(有源医疗设备CE认证RM表)

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