iec62366b报告模板Word格式.docx

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iec62366b报告模板Word格式.docx

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iec62366b报告模板Word格式.docx

2010

Testprocedure:

CBScheme

Non-standardtestmethod…………..:

N/A

TestReportFormNo.:

IEC62366B

TestReportFormOriginator:

TÜ

VRheinlandNorthAmerica

MasterTRF:

Dated2011-07

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:

Testedby（name+signature）:

Approvedby（+signature）:

Testingprocedure:

TMP

WMT

Witnessedby（+signature）:

SMT

Supervisedby（+signature）:

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）:

Generalproductinformation:

PRINCIPLES

4.1.1

TheMANUFACTURERhasestablished,documentedandmaintainsaUSABILITYENGINEERINGPROCESSaddressingUSERinteractionswiththeMEDICALDEVICEaccordingtotheACCOMPANYINGDOCUMENT

4.1.2

TheUSABILITYENGINEERINGPROCESScomplieswiththisstandardandtheacceptancecriteriaintheUSABILITYVALIDATIONplanhavebeenmet

4.1.3

InformationforSAFETYusedasaRISKCONTROLmeasurehasbeenevaluatedaccordingtotheUSABILITYENGINEERINGPROCESS

4.2

TheresultsoftheUSABILITYENGINEERINGPROCESSarerecordedintheUSABILITYENGINEERINGFILE:

4.3

TheUSABILITYENGINEERINGPROCESSisscaled-uporscaled-downbasedonthesignificanceofthemodificationasdeterminedbytheresultsoftheRISKANALYSIS:

USABILITYENGINEERINGPROCESS

5.1

TheapplicationoftheMEDICALDEVICEisspecifiedintheUSABILITYENGINEERINGFILE:

DocumentReferenceNo.inusabilityengineeringfile:

–intendedmedicalindication

–intendedPATIENTpopulation

--intendedpartofthebodyortypeoftissueappliedtoorinteractedwith

–intendedUSERPROFILE

–intendedconditionsofuse

–operatingprinciple

5.2

ThefrequentlyusedfunctionsthatinvolveUSERinteractionwiththeMEDICALDEVICEarerecordedintheUSABILITYENGINEERINGFILE:

5.3.1

TheMANUFACTURERidentifiedcharacteristicsrelatedtoSAFETYthatfocusonUSABILITY

SeeTable5.3.1

5.3.2

TheMANUFACTURERidentifiedknownorforeseeableHAZARDSrelatedtoUSABILITY

SeeTable5.3.2

ReasonablyforeseeablesequencesorcombinationsofeventsinvolvingtheUSERINTERFACEthatcanresultinaHAZARDOUSSITUATIONassociatedwiththeMEDICALDEVICEareidentified

TheSEVERITYoftheresultingpossibleHARMwasdetermined

5.4

TheMANUFACTURERdeterminedthePRIMARYOPERATINGFUNCTIONSandrecordedthemintheusabilityfile

TheinputstothePRIMARYOPERATINGFUNCTIONSincludedfrequentlyusedfunctionsandfunctionsrelatedtoSAFETYoftheMEDICALDEVICE

5.5

TheMANUFACTURERdevelopedtheUSABILITYSPECIFICATION

SeeTable5.5

5.6

TheMANUFACTURERpreparedaUSABILITYVALIDATIONplan

SeeTable5.6

5.7

TheMANUFACTURERdesignedandimplementedtheUSERINTERFACEasdescribedintheUSABILITYSPECIFICATION:

See5.8and5.9

5.8

TheMANUFACTURERverifiedtheimplementationoftheMEDICALDEVICEUSERINTERFACEdesignagainsttherequirementsoftheUSABILITYSPECIFICATION

5.9

TheMANUFACTURERVALIDATEDUSABILITYoftheMEDICALDEVICEaccordingtotheUSABILITYVALIDATIONplan

Iftheacceptancecriteriaarenotmetandnofurtherimprovementsarepracticable,themedicalbenefitsoutweightherisk

ACCOMPANYINGDOCUMENT

Ifprovided,theACCOMPANYINGDOCUMENTincludesasummaryoftheapplicationspecification

Ifprovided,theACCOMPANYINGDOCUMENTincludesaconcisedescriptionoftheMEEQUIPMENT,itsoperatingprinciplesandsignificantphysicalandperformancecharacteristics,andintendeduserprofile

Referencetoinstructionsforuse_____/page____

Ifprovided,theACCOMPANYINGDOCUMENTiswrittenatalevelconsistentwiththeUSERPROFILE.

IftheACCOMPANYINGDOCUMENTisprovidedelectronically,theUSABILITYENGINEERINGPROCESSincludedconsiderationofwhichinformationalsoneedstobeprovidedashardcopyorasmarkingsontheMEDICALDEVICE

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

IdentificationofknownorforeseeableHAZARDSandHAZARDOUSSITUATIONS

IdentificationofknownorforeseeableHAZARDSrelatedtoUSABILITYaccordingtoISO14971:

2007,Cl.4.3

TheidentificationofHAZARDSconsidersHAZARDStoPATIENTS,USERSandotherpersons

ReasonablyforeseeablesequencesorcombinationsofeventsinvolvingtheuserinterfacethatcanresultinaHAZARDOUSSITUATIONassociatedwiththeMEDICALDEVICEareidentified

TheSEVERITYoftheresultingpossibleHARMwasdetermined

DuringtheidentificationofHAZARDSandHAZARDOUSSITUATIONS,thefollowingwasconsidered:

–applicationspe

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