选RMTABLESrev07有源医疗设备CE认证RM表 ln.docx
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选RMTABLESrev07有源医疗设备CE认证RM表 ln.docx
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选RMTABLESrev07有源医疗设备CE认证RM表ln
RMTABLES-rev07(有源医疗设备CE认证RM表)
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
5
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
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
5
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
7
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
5
6.1
6.2
6.3
6.4
6.5
6.6
6.7
7
4.3
RMRESULTSTABLE:
EssentialPerformance
ClauseofISO14971
DocumentRef.inRMF(DocumentNo.¶graph)
Result-Remarks
Verdict
4.2
4.3
4.4
5
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
5
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
5
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
5
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
5
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
5
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
5
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
5
6.4
7.2.5
RMRESULTSTABLE:
MEEQUIPMENTpoweredfromotherequipment
ClauseofISO14971
DocumentRef.inRMF(DocumentNo.¶graph)
Result-Remarks
Verdict
4.2
4.3
4.4
5
6.4
7.2.13
RMRESULTSTABLE:
Physiologicaleffects(safetysignsandwarning)
ClauseofISO14971
DocumentRef.inRMF(DocumentNo.¶graph)
Result-Remarks
Verdict
4.2
4.3
4.4
5
6.3
7.2.17
RMRESULTSTABLE:
Protectivepackaging
ClauseofISO14971
DocumentRef.inRMF(DocumentNo.¶graph)
Result-Remarks
Verdict
4.2
4.3
4.4
5
6.3
6.4
7.3.3
RMRESULTSTABLE:
Batteries
ClauseofISO14971
DocumentRef.inRMF(DocumentNo.¶graph)
Result-Remarks
Verdict
4.2
4.3
4.4
5
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
5
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
5
6.3
7.9.1
RMRESULTSTABLE:
Generalaccompanyingdocuments(SeeTableC.4)
ClauseofISO14971
DocumentRef.inRMF(DocumentNo.¶graph)
Result-Remarks
Verdict
4.2
4.3
4.4
5
6.2
6.3
7.9.2.4
RMRESULTSTABLE:
Electricalpowersource
ClauseofISO14971
DocumentRef.inRMF(DocumentNo.¶graph)
Result-Remarks
Verdict
4.2
4.3
4.4
5
6.3
7.9.3.2
RMRESULTSTABLE:
Replacementoffuses,powersupplycords,otherparts
ClauseofISO14971
DocumentRef.inRMF(DocumentNo.¶graph)
Result-Remarks
Verdict
4.2
4.3
4.4
5
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
5
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
5
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
5
8.5.2.3
RMRESULTSTABLE:
PATIENTLeads
ClauseofISO14971
DocumentRef.inRMF(DocumentNo.¶graph)
Result-Remarks
Verdict
4.2
4.3
4.4
5
8.6.3
RMRESULTSTABLE:
Protectiveearthingofmovingparts
ClauseofISO14971
DocumentRef.inRMF(DocumentNo.¶graph)
Result-Remarks
Verdict
4.2
4.3
4.4
5
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
5
6.2
6.3
6.4
6.5
8.10.1
RMRESULTSTABLE:
Fixingofcomponents
ClauseofISO14971
D
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