IEC 6060114 检查表 中英文版.docx

IEC 6060114 检查表 中英文版.docx

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IEC6060114检查表中英文版

TESTREPORT

IEC60601-14

Medicalelectricequipment

Part1-4:

Generalrequirementsforsafety

CollateralStandard:

Programmableelectricalmedicalsystems

ReportreferenceNo.:

×××

Compiledby（+signature）:

Reviewedby（+signature）:

Dateofissue:

Jan18,2010

Applicant:

Address:

Standard:

601-1-4

TestReportFormNo.:

I601-1_C/97-04

TRFOriginator:

UnderwritersLaboratoriesInc.

MasterTRF:

dated97-04

Copyrightblanktestreport:

ThebodiesparticipatingintheCommitteeofCertificationBodies（CCB）.ThisreportisbasedonablanktestreportthatwaspreparedbyKEMAusinginformationobtainedfromtheTRForiginator.

Testprocedure:

Testreportonly

Proceduredeviation:

N/A

Non-standardtestmethod:

N/A

Typeoftestobject:

Trademark:

Model/typereference:

Manufacturer:

Address:

Rating:

Copyofmarkingplate

GENERALINFORMATION

Testitemparticulars（seealsoclause5）:

Classificationofinstallationanduse:

Transportableandportable

Supplyconnection:

Non-detachablecord

Accessoriesanddetachablespartsincludedintheevaluation:

---

Optionsincluded:

---

Possibletestcaseverdicts:

-testcasedoesnotapplytothetestobject:

N/A

-testobjectdoesmeettherequirement:

Yes

-testobjectdoesnotmeettherequirement:

No

Abbreviationsusedinthereport:

-normalcondition:

N.C.

-singlefaultcondition:

S.F.C.

-operationalinsulation:

OP

-basicinsulation:

BI

-basicinsulationbetweenpartsofoppositepolarity:

BOP

-supplementaryinsulation:

SI

-doubleinsulation:

DI

-reinforcedinsulation:

RI

Generalremarks:

"ThisreportisnotvalidasaCBTestReportunlessappendedtoaCBTestCertificateissuedbyaNCB,inaccordancewithIECEE02".

"（seeAttachment#）"referstoadditionalinformationappendedtothereport.

"（seeappendedtable）"referstoatableappendedtothereport.

Throughoutthisreportapointisusedasthedecimalseparator.

Thetestsresultspresentedinthisreportrelateonlytotheobjecttested.

Thisreportshallnotbereproducedexceptinfullwithoutthewrittenapprovalofthetestinglaboratory.

Listoftestequipmentmustbekeptonfileandavailableforreview.

Summaryofcontentsprovidedonthelastpageofthisreport.

Generalproductinformationandconsiderations:

TheA&J-POCB01OxygenConcentratorisintendedforuseasanoxygenconcentratortoprovidesupplementallowflowoxygentherapyinthehome,nursinghomes,patientcarefacilities,etc.TheA&J-POCB01isavailablebyprescriptiononlyunderthesupervisionofaphysician,andisnotintendedtosupportorsustainlife.

SECTION

REQUIREMENT

Comment/Observation

Compliance（YES/NO/N/A）

6.

Identification,markinganddocuments

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6.8

Accompanyingdocuments

/

/

6.8.201

AllrelevantinformationregardingsignificantRESIDUALRiskincludingdescriptionsoftheHAZARDSandanyactionsbytheOPERATORortheUSERnecessarytoavoid/mitigatethemshallbeplacedinboththeINSTRUCTIONSFORUSEandtheRISKMANAGEMENTFILE.

“UseManual”and“RiskManagementReport”includealltherelevantinformationregardingsignificantRESIDUALRiskincludingdescriptionsoftheHAZARDSandanyactionsbytheOPERATORortheUSERnecessarytoavoid/mitigatethem.

YES

6.8.202

ACCOMPANYINGDOCUMENTSforthePEMSshallidentify,asaminimum,theMANUFACTURERandauniqueidentifiersuchasrevisionlevelanddateofrelease/issue.

“UseManual””identifiestheMANUFACTURERandauniqueidentifiersuchasrevisionlevelanddateofrelease/issue.

YES

52

Abnormaloperationandfaultconditions

/

/

52.201

Documentation

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/

52.201.1

DocumentsproducedfromapplicationofthisstandardshallbemaintainedandTheprocedureforDeviceriskanalysisshallformpartofthequalityrecords;seefigure201.Thisshouldbedoneinaccordancewith6.3ofISO9000-3.

Documentsproducedfromapplicationofthisstandardmaintainedaccordingto“DocumentManagementRequirementsofR&DDepartment”andtheprocedureforDeviceriskanalysishasformedapartofthequalityrecordsinthe“RiskManagementReport”accordingto6.3ofISO9000-3

YES

52.201.2

Thesedocuments,hereinreferredtoastheRISKMANAGEMENTFILE,shallbeapproved,issuedandchangedinaccordancewithaformalconfigurationmanagementsystem.Thisshouldbedoneinaccordancewith6.2ofISO9000-3

“NewProductDesignChangeRegulation”definesaformalconfigurationmanagementsystemfortheRISKMANAGEMENTFILEtobeapproved,issuedandchangedinaccordancewith6.2ofISO9000-3.

YES

52.201.3

ARISKMANAGEMENTSUMMARYshallbedevelopedthroughouttheDEVELOPMENTLIFECYCLEaspartoftheRISKMANAGEMENTFILE.itshallcontain:

“RiskManagementReport”containsfollowings

YES

a）identifiedHAZARDSandtheirinitiatingcauses

identifiedHAZARDSandtheirinitiatingcauses;

YES

b）estimationofRISK;

hasanestimationofRISK;

YES

c）referencetotheSAFETYmeasures,usedtoeliminateorcontroltheRISKoftheHAZARD;

GiveareferencetotheSAFETYmeasures,usedtoeliminateorcontroltheRISKoftheHAZARD.

YES

d）evaluationofeffectivenessofRISKcontrol;

GiveanevaluationofeffectivenessofRISKcontrol.

YES

e）referencetoVERIFICATION

Giveareferencetoverification.

YES

52.202

RISKmanagementplan

/

/

52.202.1

TheMANUFACTURERshallprepareaRISKmanagementplan

“IntegratedDevelopmentPlan”hasbeenprepared.

YES

52.202.2

Thisplanshallincludethefollowing:

a）scopeoftheplan,definingtheprojectorproductandtheDEVELOPMENTLIFE-CYCLEphasesforwhichtheplanisapplicable;

b）theDEVELOPMENTLIFE-CYCLEtobeapplied（see52.203）,includingaVERIFICATIONplanandaVALIDATIONplan;

c）managementresponsibilitiesinaccordancewith4.1oflS09001;

d）RISKmanagementprocess;

e）Requirementsforreviews.

“IntegratedDevelopmentPlan”includesthefollowing:

a）scopeoftheplan,definingtheprojectorproductandtheDEVELOPMENTLIFE-CYCLEphasesforwhichtheplanisapplicable;

b）theDEVELOPMENTLIFE-CYCLEtobeapplied（see52.203）,includingaVERIFICATIONplanandaVALIDATIONplan;

c）managementresponsibilitiesinaccordancewith4.1oflS09001;

d）RISKmanagementprocess;

e）Requirementsforreviews.

YES

52.202.3

Iftheplanchangesduringthecourseofdevelopment,arecordofthe

changesshallbekept.ComplianceischeckedbyinspectionoftheRISKMANAGEMENTFILE.

IntegratedDevelopmentPlan”regulatesthatiftheplanchangesduringthecourseofdevelopment,therecordshallbekept.Andtheplandidnotchange.

YES

52.203

DEVELOPMENTLIFE-CYCLE

/

/

52.203.1

ADEVELOPMENTLIFE-CYCLEshallbedefinedforthedesignanddevelopmentofthePEMS.

Dueto“IntegratedDevelopmentPlan”thedevelopmentlifecycleconsistsof:

-ProjectSchemeandEstablishmentphase;

-Requirementspecificationandanalysisphase;

-TechnicDesignphase;

-DevelopingPrototypemakeandVerificationphase;

-ProductVerificationandValidationphase;

YES

52.203.2

TheDEVELOPMENTLIFE-CYCLEshallbedividedintophasesandtasks,withawell-definedinputoutputandactivityforeach.

Dueto“IntegratedDevelopmentPlan”

-ProjectSchemeandEstablishmentphase:

carryoutsurveyandresearchintermsofmarketandtechnologyandraiseapplicationforestablishingproject.

-Requirementspecificationandanalysisphase:

defineproductquality,performance,functionandappliedstandardsandregulationsandproductspecificationsbasedonintendeduses.

-TechnicDesignphase:

finishthetechnologydevelopmentandtestoftheproduct,andarchiverelevantdevelopmentdocuments.

-DevelopmentPrototypemakeandVerificationphase:

finishtheintegrationandverificationofthesubsystemandthewholemachine.

-ProductVerificationandValidationphase:

finishtheclinictestandconfirmthattheprototypedesigncomplieswiththeproductdesignrequirements,appliedregulationsandstandardsandthereforeitissafeandvalid.

YES

52.203.3

TheDEVELOPMENTLIFE-CYCLEshallincludeintegralprocessesforRISKmanagement.

IntegratedDevelopmentPlan”definestheriskmanagementprocess.

YES

52.203.4

TheDEVELOPMENTLIFE-CYCLEshallincludedocumentationrequirements.

IntegratedDevelopmentPlan”prescribestherequirementsforthedocumentswrittenduringeachphaseofthelifecycle.

YES

52.203.5

RiskmanagementactivitiesshallapplythroughouttheDEVELOPMENTLIFE-CYCLEasappropriate;see52.204.

Referenceto52.204.2

YES

52.203.6

Whereappropriate,adefinedsystemforproblemresolutionwithinandbetweenallphasesandtasksoftheDEVELOPMENTLIFECYCLEshallbedevelopedandmaintainedasPartoftheRISKMANAGEMENTFILE,Dependingupontheproblem,thesystemmayhavethefollowingcharacteristics:

Thedocumentof“Riskmanagementreport”hasbeendefinedasasystem.Ithasthefollowingcharacteristics

YES

bedefinedasapartoftheDEVELOPMENTLIFE-CYCLE;

beendefinedasapartoftheDEVELOPMENTLIFE-CYCLE

YES

-allowthereportingofpotentialorexistingSAFETYand/orperformanceproblems;

allowthereportingofpotentialorexistingSAFETYand/orperformanceproblems

YES

-includeanassessmentofeachproblemforassociatedRISKS;

includeaassessmentofeachproblemforassociatedRISKS

YES

-identifythecriteria（SAFETYand/orperformance）thathavetobemetfortheissuetobeclosed;

identifiedthecriteria（SAFETYand/orperformance）thathavetobemetfortheissuetobeclosed

YES

-identifytheactiontobetakentoresolveeachproblem;

identifiedeachactiontakentoresolveeachproblem;

YES

-identifyVALIDATIONmethodsforeachaction;

identifiedVALIDATIO