1、INTERNATIONAL STANDARD IEC 6122334 Firstedition 200003 Evaluationandroutinetestinginmedical imagingdepartments Part34: Acceptancetests ImagingperformanceofdentalXrayequipment Essaisdvaluationetderoutinedanslesservices dimageriemdicale Partie34: Essaisdacceptation Performancedimageriedesappareils der
2、adiographiedentaire Referencenumber IEC6122334:2000(E)Numbering Asfrom1January1997allIECpublicationsareissuedwithadesignationinthe 60000series. Consolidatedpublications ConsolidatedversionsofsomeIECpublicationsincludingamendmentsare available.Forexample,editionnumbers1.0,1.1and1.2refer,respectively,
3、tothe basepublication,thebasepublicationincorporatingamendment1andthebase publicationincorporatingamendments1and2. Validityofthispublication ThetechnicalcontentofIECpublicationsiskeptunderconstantreviewbytheIEC, thusensuringthatthecontentreflectscurrenttechnology. Informationrelatingtothedateofthere
4、confirmationofthepublicationisavailable intheIECcatalogue. Informationonthesubjectsunderconsiderationandworkinprogressundertaken bythetechnicalcommitteewhichhaspreparedthispublication,aswellasthelist ofpublicationsissued,istobefoundatthefollowingIECsources: IECwebsite* CatalogueofIECpublications Pub
5、lishedyearlywithregularupdates (Onlinecatalogue)* IECBulletin AvailablebothattheIECwebsite*andasaprintedperiodical Terminology,graphicalandlettersymbols Forgeneralterminology,readersarereferredtoIEC 60050: International ElectrotechnicalVocabulary (IEV). Forgraphicalsymbols,andlettersymbolsandsignsap
6、provedbytheIECfor generaluse,readersarereferredtopublicationsIEC60027: Lettersymbolstobe usedinelectricaltechnology,IEC60417:Graphicalsymbolsforuseonequipment. Index,surveyandcompilationofthesinglesheets andIEC60617: Graphicalsymbols fordiagrams. * Seewebsiteaddressontitlepage.INTERNATIONAL STANDARD
7、 IEC 6122334 Firstedition 200003 Evaluationandroutinetestinginmedical imagingdepartments Part34: Acceptancetests ImagingperformanceofdentalXrayequipment Essaisdvaluationetderoutinedanslesservices dimageriemdicale Partie34: Essaisdacceptation Performancedimageriedesappareils deradiographiedentaire PR
8、ICECODE IEC2000 Copyrightallrightsreserved Nopartofthispublicationmaybereproducedorutilizedinanyformorbyanymeans,electronicor mechanical,includingphotocopyingandmicrofilm,withoutpermissioninwritingfromthepublisher. InternationalElectrotechnicalCommission 3,ruedeVarembGeneva,Switzerland Telefax:+4122
9、9190300 email:inmailiec.ch IECwebsitehttp:/www.iec.ch Q Forprice,seecurrentcatalogue Commission Electrotechnique Internationale InternationalElectrotechnicalCommission2 6122334IEC:2000(E) CONTENTS Page FOREWORD4 INTRODUCTION6 Clause 1 Scopeandobject . 7 1.1 Scope . 7 1.2 Object . 7 2 Normativerefere
10、nces . 8 3 Terminology . 8 3.1 Degreeofrequirements . 8 3.2 Useofterms . 9 3.3 Definedterms . 9 4 Generalaspectsof ACCEPTANCETESTS . 9 4.1 Generalconditionstobeconsideredintestprocedures . 9 4.2 Documentsanddataforthetests10 4.3 Testconditions10 4.4 Scopeoftests . 11 4.5 Testequipmentincluding PHANT
11、OMSand TESTDEVICES11 4.6 Evaluatingthetestresults . 13 5 TestmethodsfordentalX RAYEQUIPMENT withintraoralX RAYIMAGERECEPTOR . 13 5.1 Visualandfunctionaltests . 13 5.2 *X RAYTUBEVOLTAGE13 5.3 *TOTALFILTRATION . 14 5.4 *FOCALSPOT oftheX RAYTUBE14 5.5 LimitationandalignmentoftheX RAYBEAM . 15 5.6 FOCAL
12、SPOTTOSKINDISTANCE15 5.7 *Reproducibilityof RADIATIONOUTPUT . 16 5.8 LINEPAIRRESOLUTION16 5.9 LOWCONTRASTRESOLUTION . 16 6 TestmethodsfordentalpanoramicX RAYEQUIPMENT withextraoralX RAYIMAGE RECEPTOR . 17 6.1 Visualandfunctionaltests . 17 6.2 X RAYTUBEVOLTAGE17 6.3 TOTALFILTRATION17 6.4 FOCALSPOT of
13、theX RAYTUBE . 17 6.5 LimitationandalignmentoftheX RAYBEAM . 17 6.6 FOCALSPOTTOSKINDISTANCE18 6.7 Reproducibilityof RADIATIONOUTPUT18 6.8 LINEPAIRRESOLUTION19 6.9 LOWCONTRASTRESOLUTION . 19 6.10 RADIOGRAPHICFILM cassetteswith INTENSIFYINGSCREENS . 19 6.11 Imagehomogeneity . 19 6.12 Indicatorsforpati
14、entspositioning . 20 6.13 Panoramiclayer206122334IEC:2000(E) 3 Clause Page 7 TestmethodsfordentalcephalometricX RAYEQUIPMENT withextraoralX RAYIMAGE RECEPTOR . 20 7.1 Visualandfunctionaltests . 20 7.2 X RAYTUBEVOLTAGE20 7.3 TOTALFILTRATION20 7.4 FOCALSPOT oftheX RAYTUBE . 20 7.5 Limitationandalignme
15、ntoftheX RAYBEAM . 20 7.6 FOCALSPOTTOSKINDISTANCE21 7.7 Reproducibilityof RADIATIONOUTPUT21 7.8 LINEPAIRRESOLUTION21 7.9 LOWCONTRASTRESOLUTION . 21 7.10 RADIOGRAPHICFILM cassetteswith INTENSIFYINGSCREENS . 21 8 Testreportandstatementofcompliance21 AnnexA(normative)TerminologyIndexofdefinedterms30 An
16、nexB(informative)Examplesofrequirements(accuracy,tolerances,discrepancies) accordingtoactualIECstandardsorstateoftheart . 32 AnnexC(informative)A CCEPTANCETEST forprocessingofnonscreendentalXrayfilms (nonscreenfilm)34 Bibliography . 35 Figure1DentalX RAYEQUIPMENT withintraoralX RAYIMAGERECEPTOR meas
17、uring arrangementfor AIRKERMA andresolution . 23 Figure2DentalX RAYEQUIPMENT withintraoralX RAYIMAGERECEPTOR measuring arrangementfor AIRKERMA andresolution . 24 Figure3DentalpanoramicX RAYEQUIPMENT withextraoralX RAYIMAGERECEPTOR measuringarrangementfor AIRKERMA andresolution25 Figure4Exampleofaden
18、talpanoramicX RAYEQUIPMENT withextraoraldigitalX RAY IMAGERECEPTOR measuringarrangementfor AIRKERMA ,resolution,imagehomogenity andpanoramiclayer . 26 Figure5ExampleofacephalometricX RAYEQUIPMENT withextraoralX RAY IMAGERECEPTOR measuringarrangementfor AIRKERMA andresolution27 Figure6Dental PHANTOM(
19、example) . 28 Figure7Dental PHANTOMfordigitalimageacquisitionorprocessingparts(example)29 TableB.1Typicalvaluesof FOCALSPOT dimensionsfor NOMINALFOCALSPOTVALUES324 6122334IEC:2000(E) INTERNATIONALELECTROTECHNICALCOMMISSION _ EVALUATIONANDROUTINETESTING INMEDICALIMAGINGDEPARTMENTS Part34:Acceptancete
20、sts ImagingperformanceofdentalXrayequipment FOREWORD 1) TheIEC(InternationalElectrotechnicalCommission)isaworldwideorganizationforstandardizationcomprising allnationalelectrotechnicalcommittees(IECNationalCommittees).TheobjectoftheIECistopromote internationalcooperationonallquestionsconcerningstanda
21、rdizationintheelectricalandelectronicfields.To thisendandinadditiontootheractivities,theIECpublishesInternationalStandards.Theirpreparationis entrustedtotechnicalcommittees;anyIECNationalCommitteeinterestedinthesubjectdealtwithmay participateinthispreparatorywork.International,governmentalandnongove
22、rnmentalorganizationsliaising withtheIECalsoparticipateinthispreparation.TheIECcollaboratescloselywiththeInternationalOrganization forStandardization(ISO)inaccordancewithconditionsdeterminedbyagreementbetweenthetwo organizations. 2) TheformaldecisionsoragreementsoftheIEContechnicalmattersexpress,asn
23、earlyaspossible,an internationalconsensusofopinionontherelevantsubjectssinceeachtechnicalcommitteehasrepresentation fromallinterestedNationalCommittees. 3) Thedocumentsproducedhavetheformofrecommendationsforinternationaluseandarepublishedintheform ofstandards,technicalspecifications,technicalreports
24、orguidesandtheyareacceptedbytheNational Committeesinthatsense. 4)Inordertopromoteinternationalunification,IECNationalCommitteesundertaketoapplyIECInternational Standardstransparentlytothemaximumextentpossibleintheirnationalandregionalstandards.Any divergencebetweentheIECStandardandthecorrespondingna
25、tionalorregionalstandardshallbeclearly indicatedinthelatter. 5)TheIECprovidesnomarkingproceduretoindicateitsapprovalandcannotberenderedresponsibleforany equipmentdeclaredtobeinconformitywithoneofitsstandards. 6)AttentionisdrawntothepossibilitythatsomeoftheelementsofthisInternationalStandardmaybethes
26、ubject ofpatentrights.TheIECshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights. InternationalStandardIEC6122334hasbeenpreparedbysubcommittee62B:Diagnostic imagingequipment,ofIECtechnicalcommittee62:Electricalequipmentinmedicalpractice. Thetextofthisstandardisbasedonthefollowingdocuments
27、 FDIS Reportonvoting 62B/393/FDIS 62B/402/RVD Fullinformationonthevotingfortheapprovalofthisstandardcanbefoundinthereporton votingindicatedintheabovetable. ThispublicationhasbeendraftedinaccordancewiththeISO/IECDirectives,Part3. AnnexAformsanintegralpartofthisstandard. AnnexesBandCareforinformation
28、only.6122334IEC:2000(E) 5 Inthisstandard,thefollowingprinttypesareused: requirements,compliancewithwhichcanbetested,anddefinitions:romantype; explanations,advice,notes,generalstatements,exceptionsandreferences:smallertype; testspecifications:italictype; TERMSDEFINEDINIEC606011,INIEC60788,INIEC612231
29、ORINOTHERIECPUBLICATIONS REFERENCEDINANNEXA : SMALLCAPITALS . Thecommitteehasdecidedthatthecontentsofthispublicationwillremainunchanged until2005.Atthisdate,thepublicationwillbe reconfirmed; withdrawn; replacedbyarevisededition,or amended. Abilingualversionofthisstandardmaybeissuedatalaterdate.6 612
30、2334IEC:2000(E) INTRODUCTION ThispartofIEC61223ispartofaseriesofInternationalStandardswhichgivesmethodsof acceptancetestingandconstancytestingforsubsystemsandsystems(forexample,diagnostic X RAYEQUIPMENT )includingfilmprocessing. Someprovisionsorstatementsinthisstandardrequireadditionalinformation.Su
31、chinformation ispresentedinannexB.Anasteriskintheleftmarginofaclauseorsubclauseindicatesthe presenceofsuchadditionalinformation.6122334IEC:2000(E) 7 EVALUATIONANDROUTINETESTING INMEDICALIMAGINGDEPARTMENTS Part34:Acceptancetests ImagingperformanceofdentalXrayequipment 1 Scopeandobject 1.1Scope Thispa
32、rtofIEC61223appliestothosecomponentsofdentalX RAYEQUIPMENTusing radiographicimagingsystemswhichinfluencetheimagequalityand PATIENTdose. Thisstandardappliestotheperformanceofthe ACCEPTANCETESTondentalX RAYEQUIPMENT withintraoralX RAYIMAGERECEPTOR anddentalX RAYEQUIPMENTwithextraoralX RAYIMAGE RECEPTO
33、R(forexample,dentalpanoramicX RAYEQUIPMENT orcephalometricX RAY). Thisstandardappliestodentalfilmanddigitalimageacquisitionandprocessing. 1.2Object Thisstandarddefines a) theessentialparameterswhichdescribetheperformanceoftheabovementioneddental X RAYEQUIPMENT withregardtoimagingpropertiesand PATIEN
34、Tdose; b) methodsoftestingandwhethermeasuredquantitiesrelatedtothoseparameterscomply withthespecifiedtolerances. Thesemethodsrelymainlyonnoninvasivemeasurements,usingappropriatetestequipment, performedduringoraftertheinstallationiscompleted.Signedstatementscoveringstepsinthe installationproceduremay
35、beusedaspartoftheacceptancetesting. Theaimistoverifycomplianceoftheinstallationwithspecificationsaffectingtheimagequality and PATIENTdose,andtodetectmalfunctionsthatarenotinagreementwiththose specifications. Thisstandarddoesnotinitselfspecifytolerancesfortheparametersunderinvestigation. Neitherisiti
36、ntendedtoconsider c) aspectsofmechanicalandelectricalsafety; d) aspectsofmechanical,electricalandsoftwareperformance,unlesstheyareessentialto theperformanceofthetestsdirectlyaffectingimagequalityand PATIENTdose.8 6122334IEC:2000(E) 2 Normativereferences Thefollowingnormativedocumentscontainprovision
37、swhich,throughreferenceinthistext, constituteprovisionsofthispartofIEC61223.Fordatedreferences,subsequentamendments to,orrevisionsof,anyofthesepublicationsdonotapply.However,partiestoagreements basedonthispartofIEC61223areencouragedtoinvestigatethepossibilityofapplyingthe mostrecenteditionsofthenorm
38、ativedocumentsindicatedbelow.Forundatedreferences,the latesteditionofthenormativedocumentreferredtoapplies.MembersofIECandISOmaintain registersofcurrentlyvalidInternationalStandards. IEC60336:1993, XraytubeassembliesformedicaldiagnosisCharacteristicsoffocalspots IEC604171:1998, Graphicalsymbolsforus
39、eonequipmentPart1:Overviewandapplication IEC604172:1998, GraphicalsymbolsforuseonequipmentPart2:Symboloriginals IEC60522:1999, DeterminationofthepermanentfiltrationofXraytubeassemblies IEC606011:1988, MedicalelectricalequipmentPart1:Generalrequirementsforsafety IEC60601228:1993, Medicalelectricalequ
40、ipmentPart228:Particularrequirementsforthe safetyofXraysourceassembliesandXraytubeassembliesformedicaldiagnosis IEC60788:1984, MedicalradiologyTerminology IEC60878:1988, Graphicalsymbolsforelectricalequipmentinmedicalpractice IEC612231:1993,EvaluationandroutinetestinginmedicalimagingdepartmentsPart1
41、 Generalaspects IEC61267:1994,MedicaldiagnosticXrayequipmentRadiationconditionsforuseinthe determinationofcharacteristics ISO2092:1981, LightmetalsandtheiralloysCodeofdesignationbasedonchemicalsymbols 3Terminology 3.1 Degreeofrequirements Inthisstandard,certaintermswhicharenotprintedin SMALLCAPITAL
42、Shaveparticular meanings,asfollows: “shall“ indicatesarequirementthatismandatoryforcompliance; “should“ indicatesastrongrecommendationthatisnotmandatoryforcompliance; “may“ indicatesapermittedmannerofcomplyingwitharequirementorofavoidingthe needtocomply; “specific“ isusedtoindicatedefinitiveinformat
43、ionstatedinthisstandardorreferencedin otherstandards,usuallyconcerningparticularoperatingconditions,test arrangementsorvaluesconnectedwithcompliance; “specified“ isusedtoindicatedefinitiveinformationstatedbythe MANUFACTURERin ACCOMPANYINGDOCUMENTSorinotherdocumentationrelatingtothe EQUIPMENT underconsideration,usuallyconcerningitsintendedpurposes,orthepara metersorconditionsassociate
