iec62366b报告模板.docx
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iec62366b报告模板.docx
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iec62366b报告模板
12
TestReportissuedundertheresponsibilityof:
TESTREPORT
IEC62366
Medicaldevices–Applicationofusabilityengineeringtomedicaldevices
ReportReferenceNo.:
Dateofissue:
Totalnumberofpages:
CBTestingLaboratory:
Address:
Applicant’sname:
Address:
Testspecification:
Standards:
IEC62366:
2007(FirstEdition)foruseinconjunctionwithIEC60601-1-6:
2010
Testprocedure:
CBScheme
Non-standardtestmethod…………..:
N/A
TestReportFormNo.:
IEC62366B
TestReportFormOriginator:
TÜVRheinlandNorthAmerica
MasterTRF:
Dated2011-07
Copyright©2011IECSystemforConformityTestingandCertificationofElectricalEquipment(IECEE),Geneva,Switzerland.Allrightsreserved.
Thispublicationmaybereproducedinwholeorinpartfornon-commercialpurposesaslongastheIECEEisacknowledgedascopyrightownerandsourceofthematerial.IECEEtakesnoresponsibilityforandwillnotassumeliabilityfordamagesresultingfromthereader'sinterpretationofthereproducedmaterialduetoitsplacementandcontext.
IfthisTestReportFormisusedbynon-IECEEmembers,theIECEE/IEClogoshallberemoved.
ThisreportisnotvalidasaCBTestReportunlesssignedbyanapprovedCBTestingLaboratoryandappendedtoaCBTestCertificateissuedbyanNCBinaccordancewithIECEE02.
Testitemdescription:
TradeMark:
Manufacturer:
Model/Typereference:
Ratings:
Testingprocedureandtestinglocation:
CBTestingLaboratory:
Testinglocation/address:
AssociatedCBTestLaboratory:
Testinglocation/address:
Testedby(name+signature):
Approvedby(+signature):
Testingprocedure:
TMP
Testedby(name+signature):
Approvedby(+signature):
Testinglocation/address:
Testingprocedure:
WMT
Testedby(name+signature):
Witnessedby(+signature):
Approvedby(+signature):
Testinglocation/address:
Testingprocedure:
SMT
Testedby(name+signature):
Approvedby(+signature):
Supervisedby(+signature):
Testinglocation/address:
ListofAttachments(includingatotalnumberofpagesineachattachment):
Summaryoftesting
Testsperformed(nameoftestandtestclause):
Testinglocation:
SummaryofcompliancewithNationalDifferences
Listofcountriesaddressed:
Theproductfulfilstherequirementsof_________(insertstandardnumberandeditionanddeletethetextinparenthesisordeletethewholesentenceifnotapplicable)
Copyofmarkingplate
Theartworkbelowmaybeonlyadraft.TheuseofcertificationmarksonaproductmustbeauthorizedbytherespectiveNCBsthatownthesemarks.
SeePart1Report
Testitemparticulars:
Classificationofinstallationanduse:
SeeIEC60601-1TestReport
Clinicalapplication:
Modeofoperation:
Surfacetemperatureofappliedpart:
Possibletestcaseverdicts:
-testcasedoesnotapplytothetestobject:
N/A(Notapplicable)
-testobjectdoesmeettherequirement:
P(Pass)
-testobjectdoesnotmeettherequirement:
F(Fail)
Testing:
Dateofreceiptoftestitems:
Date(s)ofperformanceoftests:
Abbreviationsusedinthereport:
-normalcondition:
N.C.
-Singlefaultcondition:
S.F.C.
-meansofOperatorprotection:
MOOP
-MeansofPatientprotection:
MOPP
Generalremarks:
"(seeAttachment#)"referstoadditionalinformationappendedtothereport.
"(seeappendedtable)"referstoatableappendedtothereport.
Throughoutthisreportapointisusedasthedecimalseparator.
Thetestsresultspresentedinthisreportrelateonlytotheobjecttested.
Thisreportshallnotbereproducedexceptinfullwithoutthewrittenapprovalofthetestinglaboratory.
Listoftestequipmentmustbekeptonfileandavailableforreview.
Additionaltestdataand/orinformationprovidedintheattachmentstothisreport.
Throughoutthisreportacomma/pointisusedasthedecimalseparator.
ThisTestReportcontainsthegeneralsafetyrequirementsasrelatedtotheusabilityofMedicalElectricalEquipment.ItcanonlybeusedtogetherwithIEC60601-1TestReportandIEC60601-1-6TestReport.
Nameandaddressoffactory(ies):
SeePart1Report
Generalproductinformation:
4
PRINCIPLES
4.1.1
TheMANUFACTURERhasestablished,documentedandmaintainsaUSABILITYENGINEERINGPROCESSaddressingUSERinteractionswiththeMEDICALDEVICEaccordingtotheACCOMPANYINGDOCUMENT
4.1.2
TheUSABILITYENGINEERINGPROCESScomplieswiththisstandardandtheacceptancecriteriaintheUSABILITYVALIDATIONplanhavebeenmet
4.1.3
InformationforSAFETYusedasaRISKCONTROLmeasurehasbeenevaluatedaccordingtotheUSABILITYENGINEERINGPROCESS
4.2
TheresultsoftheUSABILITYENGINEERINGPROCESSarerecordedintheUSABILITYENGINEERINGFILE:
4.3
TheUSABILITYENGINEERINGPROCESSisscaled-uporscaled-downbasedonthesignificanceofthemodificationasdeterminedbytheresultsoftheRISKANALYSIS:
5
USABILITYENGINEERINGPROCESS
5.1
TheapplicationoftheMEDICALDEVICEisspecifiedintheUSABILITYENGINEERINGFILE:
DocumentReferenceNo.inusabilityengineeringfile:
–intendedmedicalindication
–intendedPATIENTpopulation
--intendedpartofthebodyortypeoftissueappliedtoorinteractedwith
–intendedUSERPROFILE
–intendedconditionsofuse
–operatingprinciple
5.2
ThefrequentlyusedfunctionsthatinvolveUSERinteractionwiththeMEDICALDEVICEarerecordedintheUSABILITYENGINEERINGFILE:
DocumentReferenceNo.inusabilityengineeringfile:
5.3.1
TheMANUFACTURERidentifiedcharacteristicsrelatedtoSAFETYthatfocusonUSABILITY
SeeTable5.3.1
5.3.2
TheMANUFACTURERidentifiedknownorforeseeableHAZARDSrelatedtoUSABILITY
SeeTable5.3.2
ReasonablyforeseeablesequencesorcombinationsofeventsinvolvingtheUSERINTERFACEthatcanresultinaHAZARDOUSSITUATIONassociatedwiththeMEDICALDEVICEareidentified
TheSEVERITYoftheresultingpossibleHARMwasdetermined
5.4
TheMANUFACTURERdeterminedthePRIMARYOPERATINGFUNCTIONSandrecordedthemintheusabilityfile
DocumentReferenceNo.inusabilityengineeringfile:
TheinputstothePRIMARYOPERATINGFUNCTIONSincludedfrequentlyusedfunctionsandfunctionsrelatedtoSAFETYoftheMEDICALDEVICE
5.5
TheMANUFACTURERdevelopedtheUSABILITYSPECIFICATION
SeeTable5.5
5.6
TheMANUFACTURERpreparedaUSABILITYVALIDATIONplan
SeeTable5.6
5.7
TheMANUFACTURERdesignedandimplementedtheUSERINTERFACEasdescribedintheUSABILITYSPECIFICATION:
See5.8and5.9
__
5.8
TheMANUFACTURERverifiedtheimplementationoftheMEDICALDEVICEUSERINTERFACEdesignagainsttherequirementsoftheUSABILITYSPECIFICATION
DocumentReferenceNo.inusabilityengineeringfile:
5.9
TheMANUFACTURERVALIDATEDUSABILITYoftheMEDICALDEVICEaccordingtotheUSABILITYVALIDATIONplan
DocumentReferenceNo.inusabilityengineeringfile:
Iftheacceptancecriteriaarenotmetandnofurtherimprovementsarepracticable,themedicalbenefitsoutweightherisk
DocumentReferenceNo.inusabilityengineeringfile:
6
ACCOMPANYINGDOCUMENT
Ifprovided,theACCOMPANYINGDOCUMENTincludesasummaryoftheapplicationspecification
Ifprovided,theACCOMPANYINGDOCUMENTincludesaconcisedescriptionoftheMEEQUIPMENT,itsoperatingprinciplesandsignificantphysicalandperformancecharacteristics,andintendeduserprofile
Referencetoinstructionsforuse_____/page____
Ifprovided,theACCOMPANYINGDOCUMENTiswrittenatalevelconsistentwiththeUSERPROFILE.
IftheACCOMPANYINGDOCUMENTisprovidedelectronically,theUSABILITYENGINEERINGPROCESSincludedconsiderationofwhichinformationalsoneedstobeprovidedashardcopyorasmarkingsontheMEDICALDEVICE
7
Trainingandmaterialsfortraining
Whentrainingisrequiredforthesafeandeffectiveuseofprimaryoperatingfunctions,theACCOMPANYINGDOCUMENTdescribestheavailabletrainingoptions
Whentrainingisrequired,theINTENDEDUSEandUSERPROFILE(S)arethebasisfortrainingandtrainingmaterial
Table5.3.1
usabilityengineeringfileRESULTSTABLE:
CharacteristicsrelatedtoSAFETY
DocumentRef.inusabilityengineeringfile
Result-Remarks
Verdict
AnidentificationofcharacteristicsrelatedtoSAFETYthatfocusedonUSABILITYwasperformedaccordingtoISO14971:
2007,Clause4.2
DuringtheidentificationofcharacteristicsrelatedtoSAFETY,thefollowingwasconsidered:
—
–applicationspecification,includingUSERPROFILE(S)
–frequentlyusedfunctions
Table5.3.2
usabilityengineeringfileRESULTSTABLE:
IdentificationofknownorforeseeableHAZARDSandHAZARDOUSSITUATIONS
DocumentRef.inusabilityengineeringfile
Result-Remarks
Verdict
IdentificationofknownorforeseeableHAZARDSrelatedtoUSABILITYaccordingtoISO14971:
2007,Cl.4.3
TheidentificationofHAZARDSconsidersHAZARDStoPATIENTS,USERSandotherpersons
ReasonablyforeseeablesequencesorcombinationsofeventsinvolvingtheuserinterfacethatcanresultinaHAZARDOUSSITUATIONassociatedwiththeMEDICALDEVICEareidentified
TheSEVERITYoftheresultingpossibleHARMwasdetermined
DuringtheidentificationofHAZARDSandHAZARDOUSSITUATIONS,thefollowingwasconsidered:
—
–applicationspe
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