ISO IEC 03532-1-2023.docx

INTERNATIONA1.STANDARDISO/IEC3532-1Firstedition2023-06Informationtechno1.ogyMedica1.image-basedmode1.1.ingfor3Dprinting一f飘篁a1.requirementsTechno1.ogiesdeinformationMode1.isationmedicatedbased,imagespourimpression3D-Panie1:Exigencesgenera1.esReferencenumberISO/IEC35321.:2023(E)©ISO/IEC2023COPYRIGHTPROTECTEDDOCUMENT©IS0/1EC2023IUirhM*hedbdi1.iUedotherwiseupdhi.or啪UIBndttaeDmk<nroni(ncm11ni10tf1.*Mqn1.C6pW11opypMRHt1.onmaytheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbe1.oworISO'smemberbodyinthecountryoftherequester.f),WV>fifiU81.andonnet8CH-1214Vernier,GenevaPhone：M1.22749O1.11觥ftte:丽丽BQrgPub1.ishedinSwitzer1.andInformationtechno1.ogyMedica1.image-basedmode1.1.ingfor3Dprinting一Genera1.requirements1 Scopemedica1.app1.iestinnsxomputedtomography3D(CT)mode1.1.inga1.sospecifiestheprincipa1.considerations2 Normativereferencesconstitutesrequirements1.atesteditiondocument.referencedreferences,(inc1.udingamendments)app1.ies.app1.ies.Terms,definitionsandabbreviatedIermsprindp1.es-Fundamenta1.sandVocabu1.aryandthefo1.1.owingapp1.y,document,thetermsanddefinitionsgiveninISO1EC2382,ISOSTM529003 .1Termsanddefinitions3.1.1imageacquisition3.1.2s1.icedistances1.icespacing3.1.3hardtissuedeformab1.emode1.-basedsegmentation：activecontourmode1.,1.eve1.-setmethod;at1.as-basedsegmentation:activeshapemode1.,activeappearancemode1.s,1.abe1.fusion;supervised(e.g.ANN,SVM),unsupervised(e.g.K-meansSegmentationofbonystructuresfromCTscannedimagedatahasthereforebenefitedfrommu1.tip1.e麻眠IJ照驱WthmiC(枯叙ft腺麻靛麒!cribe拗他施S胭住em瞅筋珊解猊渊搦/脚鼎微SiOnSwhereashapeisassumedtohavciDeenapproximate1.yrecognizedbutad)ustebasedonthedata.Evenmoreadvancedtechniquesinc1.udetheshaperperceptiontore1.ayonmu1.tip1.epreconceivedshape而啾e(丽相桐牒!和阿健thodsusingw帆Iw删却nsmartc卿*ear/#娜腐IIWgrowingdatabase(at1.as)anddecisionprocesses.Toidentifyandsegmentationaredso1.atevoxe1.sthatrepresentanyanatomyofinterest,twoimp1.ementationsofa)assigningamasktoadatasetindicatingactivevoxe1.s;orb)de1.etion/remova1.ofvoxe1.snotinc1.udedinsegmentation.Thresho1.d-basedsegmentation,common1.yusedinintensity-basedsegmentation,usespixe1.brightnessandpatternsthroughouttheDICOMdatatoiso1.ateorremovestructures.Thethresho1.d-basedmethod帆油阳1趣用益由印nin新1.咏腕帐CS麻岫册丽dM1.!1三H8hSO“由咿厢&g黑脚1.ncanbechanged.Wheneverthissemi-automaticmethodcannotcoverthewho1.eROIrmanua1.segmentationwi1.1.recoverthemissingpart.Theboundariesresu1.tingfortheROIortissueOfinterest觊幽8做郴碗超8照tor况W三fe由舐三8ta三三n,s三)ncontourmode1.isaparameterizedcurveorsurfacewhichiterative1.yevo1.vestowardthedesiredboundaryoftheanatomyaccordingtotheenergyminimizationcriterion.Thismode1.isrobusttoboth职陪WIiHH肌螭懈盼。硼曲蜩%Ey延悔期蜩捅esd酰部岫MnYHte，er,SPii魄ormergingoftheanatomy.5S1.af?J8Fationinatio?fabas6rrnfiaJV*c'a1.aseaatomicstructure1.abe1.sandattemptstoInmachine1.earning-basedsegmentation,asanexamp1.e,K-meansc1.usteringisawaytoidentifygroups喇ft喇“睫g哪或解解tonufi世聊路由却做跳帧粉瞬醐琳的esinc1.udedistance.K-meansc1.usteringandFuzzyC-meansc1.usteringaresimi1.arinapproaches.ThemaindifferenceisthatinFuzzyC-meansc1.ustering,eachpixe1.(orvoxe1.)hasaweightassociatedwithaparticu1.arduster,whichmeansthatthereisaWoakorstrongassociationinthatc1.uster.Theminimizationoferrorsduringsegmentationofbodypart5ofinterestiscritica1.Therearesevera1.knowncritica1.issues,andthereforeaverificationprocesssha1.1.bemadebeforeproceedingfurther.的由路三eexg或、的冏I出eshou4原oritedautomatedsegmentationwhichisprovidedbyadefau1.tHUdoesnotcomp1.ete1.yrecovert11ebonystructure.Theoperatorsha1.1.furtheradjusttheextentofthesegmentationmanua1.1.y.Acommon'or曲岫|地f番腌meBH由B展魁61.egmentationisa1.soprob1.ematicfordesigningimp1.antsMethodsOfsegmentationareautomaticsemi-automaticandmanua1.Formedica1.imagesegmentation,thefo1.1.owingpointssha1.1.beaddressed：-forminimizationoferrorsduringthisjob.operatorsshou1.dknowwhichsegmentationtechniqueismost1.yusedintheirimagingsoftwareandbequa1.ifiedinthattechnique；SU1.diItnnMmkbi“n户网MnvhIdadfaCtIiha再平Mf<MKMh依We：仲的止tw图Wiuud1.hcencigEtntations/theoperatorshou1.daddressthefeasibi1.ityoforigina1.imagestoproceedtofurthersegmentation；thechoiceofsegmentationtechniquessha1.1.beappropriatetoapp1.icationsandverifiab1.e；verificationprocessesforeachstepofSegmetationsha1.1.beaddressed;6.4the3祥骏藤眠懦般指憾摘圜"般CibIeandVe皿ab1.e.怖I跳射iMjti11v*蝌曲硼配微Mft(I晚蟠£即四忸4找1.etr犯则陨枪唉ria1.segmentedimages.Thesecanbecreatedasfo1.1.ows：eachsegmentedimageisexpandedontothenextimagetobui1.dsevera1.sma1.1.vo1.umemode1.s,referredtoasvo1.umereconstruction.Fina1.1.y,a1.1.vo1.ume的Sddssurfacd便由妞N忑阳出Ww囹H1.三砧帆RWM喉氐In皿眼眠矛蝌也阳的日阴,M呼州於wou1.dbeconsideredasurfacemode1.,andcanbestoredinST1.fi1.eTormat.Genera1.1.y,thevo1.umeandsurfacereconstructionsareperformedsimu1.taneous1.ybyreconstructionsoftware.Thesurfacemode1.fi拈StSnMCie1.theorigina1.stackedout1.inesandnumeroustriangu1.arsurfacesbetweentheout1.inesasaSometechniquesproduceavo1.umemode1.whichisnothoiIowrandcomprisesvoxe1.s;thenitisca1.1.eda赧W掰y脑咻erei1.g犒副eme1.hOdSt廉融制瓶糊Aa1.gS肱阳cf。耳圈砌Qfi解;的evd1.那variationsandimprovementssince,andmu1.tip1.eothermethods.Thedetai1.sofa1.1.thosemethodsarenotinthescopeofthisdocument.他。回幅,is用做mapg¾更出附的1网蒯点c册IVCrtfI而硼征播WSQ瞄也回UyfiQMj町御山麻依and“averaging”aremost1.yessentia1.Mostofthesoftwarefor3Dconversionof2Dimagesprovides"smoothingandaveraging*functionsforremoving"step1.adders*whichareacritica1.defectfrom原houtst庶联忖联SH1；蜿ver,af邮1.附混酬涮糊麻fac盛丹mente赧随曲卸傩rance,reconstructiona1.gorithmandtheyrepresentthetruereconstructionbasedontneinputwhichisbynaturenotsmooth(e.g.thereisnodatabetweenthes1.icesfromtheimaging),sotheboundariesfrom9H84R盛翅Cee济胞F#粉tt斜(hK湖Phah索的猴IdamhK帝群E也h1.rte型hiqfg观自独做W6nmodestandreasonab1.esmoothingwasdesired,considerationsha1.1.betakenofthepossib1.eerrorsintermsofhowmuch1.ossoradditionofthesurfacemode1.canoccurduetothesmoothing.Theedgeof配做端rcsentatoJS%四战1.tob。学091.byc概健刎g1.PSr2DboAp3Dd8fBker,thereisnoc1.earpredictabi1.ityforhowmucntheseprocesses(smoothingandaveraging)aregoingtoimpactthechange.3MUifM的砒玉时!祈四时他侪电阻期疝三ri窗画H初乳Wf相济怦)(di网don1.hcrcforeaU1.期闷tisgoodpracticetoa1.wayspatchasurfacemode1.tomakesurethatthesurfacesareessentia1.1.yc1.osedandnotriangu1.ateedgesare1.eftunconnectedwithothertriang1.es.G毗祀V三t1.W5iBcdi胸祕也thef。Wt1.M在SaCCd用ingcxpofR1.蜘!Wfirf傥84J理ngastandardone.Thevo1.umemode1.s,toorsha1.1.beexportedinastandardformat3DreconstructionpsoMiareMxh011MncnbdgfohiizahcvdPPrOPriaUnhosofttew如InXiComnICtfdrdQrIysoftware.Insomecases,popu1.arSoftWarecanbeusedforsurfacereconstruction.However,thefina1.resu1.tsha1.1.beexportedinaformatthatisusab1.ebythepartmanufacturer.Smoothingandaveragingofsegmentedimagessha1.1.beperformedfortriangu1.ation.Formedica1.image3Dvisua1.ization,thefo1.1.owingpointssha1.1.beaddressed: bft>retWSrt身格fiWAdef1.nes鼠rifcft商也如Ze(orsizerange)ofthetriang1.esneeds themedica1.professiona1.scaringforthetargetpatientssha1.1.checkthe31)mode1.accordingtotheirc1.inica1.purposes; theoperatorsha1.1.reviewthefeasibi1.ityofsegmentedimagesfor3Dvisua1.ization; verificationorassessmentprocessesfor3Dmode1.1.edimages.Verificationandva1.idationofany3Dmcx1.e1.isbeneficia1.,evenifitisperformedon1.yatthestartforthesegmentationprocessandreconstructionmode1.1.ingprocessandeveryuserwhoperformsit.Thiscanbedoneinavarietyofways,butmostareoutsidethescopeofthisdocumentCaresha1.1.betakentounderstandandPreSerVetheorigina1.and1.oca1.coordinatesystemofthe3Dmode1.asproducedbythesegmentationand3Dreconstructionsoftwaretoo1.s.Theorigina1.and1.oca1.orientationofthe1.oca1.coordinatesystemaxeswi1.1.haveimportantimp1.icationsonhowthemode1.isthenuti1.ized.6.5 Ca1.ibrationandva1.idationof2Dand3DconversionThisca1.ibrationissueshou1.dbeaddressedtosetthesca1.eandunitsintheST1.fi1.e(orotherstandardfi1.eformat)andforthedeve1.opmentofpropermethodsforca1.ibrationofsoftware.Theovera1.1.sca1.eandunitsoftheST1.fi1.e(orotherstandardfi1.eformat)sha1.1.bechecked.A1.so,theoriginoftheST1.fi1.esha1.1.becheckedifthisisusedinfurtherprocesses(e.g.designingsurgica1.guides,surgica1.p1.anning,patientsspecificimp1.antsorimp1.antdesign).The3Dmode1.sarcnotidentica1.totheorigina1.structuresandwi1.1.inevitab1.yvaryfromtheorigina1.anatomica1.structuresbecauseofamu1.titudeoferrorspropagatedfromtheorigina1.imagingaccuracy/禅SMtWorfe研制HWionMasres耐计婀。桥像研聊俗Ee砥ICieSregions.Thesegeometricdistortionsareduetoimperfectionsineachbui1.dingsteporthese1.ectionofnonoptima1.parameterswithinthem.However,thecontributionofeachofthesestepstotheovera1.1.errorremainsunc1.ear.Forca1.ibrationandva1.idationof2Dand3Dconversion,thefo1.1.owingpointssha1.1.beaddressed： sAcMtH<isAbBi9in1.VYHffe)cntunderstandingofdecimation,interpo1.ation,refinement, interpo1.ationcanbeaconfoundingfactorfor2Dto3Dconversion： meshrepairorfixingshou1.dbecarefu1.1.yperformedtominimizethedistortionoforigina1.geometry； theoperatorsha1.1.reriewtheassessmentresu1.tsofimagesegmentationand3Dmode1.1.edimages; theoperatorsha1.1.havesufficientknow1.edgeforthe1.oca1.geometryof3Dmode1.1.edimages； theoperatorsha1.1.havesufficientinformationforthe1.imitation/marginoferrors； 用Wa像8Kre附供1.c8Wginif1.f(WW%g),shou1.dbecarefu1.1.yperformedwithdueconsideration126.6 Fi1.eformatformat3Dfi1.emode1.outputnostandardsacquisitionapp1.icab1.eandHowever,medica1.app!ication.transfbrmsfromsegmentationIntemationa1.images,StandardsWide1.ycanusedproprietaryrepresentingmode1.sgeneratedForfi1.eformat,thefo1.1.owingpointsshou1.dbeconsidered:opratorinformation.knowthecharacteristicsoftheST1.fi1.eformat,whichdocsnothavesca1.eandIEC2023-A1.1.rightsreservedD1.COMisa2Dor3Drasterimagestandardinmedica1.app1.ication.3DCTequipmentgeneratesaDICOMintoasthethereareofthe3Dimagewhichareprocess.suitab1.einwhenDICOMdataST1.fi1.eformatanditsrevisedAMFcanbeusedforthefabricationofmedica1.parts.However,thiscontainsdataforoutputinc1.udinggeometryandmateria1.s.AMFisdefinedin1SOASTM52915.Current1.y,therearenothevector-basedformatofDICOMthewhichbeusedformedica1.CDformatcarcontainsufficientmetadatageneratedfrompreviousprocessesasparameterswhichcanbeusefu1.infutureprocessesorAMfabricationofmedica1.parts. ST1.fi1.eformatcanbese1.ectedifthereisnosuitab1.efi1.eformatforc1.inica1.purposes；themateria1.shou1.dAnnexA(informative)ReportingItisnecessaryandusefu1.throughouttncprocessing,todescribewhattheuserhasdoneandwhichchoiceshavebeenmadeThereportshou1.dinc1.udeat1.eastthefo1.1.owing： estimatesoftherequiredaccuracyofthe3Dmode1.desired; thesourceoftheimagingdata,anditsfi1.eformat(c.g.DICOMfi1.eformat); thesoftwareandparticu1.artoo1.susedintheprocessofsegmentation; theSoftWareandparticu1.artoo1.susedintheprocessofreconstruction; thenatureofthe3Dmode1.produced(e.g.surfacemode1.,orvo1.umetricmode1.,etc); formatofthefi1.eofthefina1.3Dmode1.produced(e.g.ST1.)andunitsofitscoordinates; descriptionofanypatchingorsmoothingmadetothemode1.andwhy; commentsontheoriginimp1.ied/inherentinthe3Dmode1.,andorientationofits1.oca1.coordinatesystemifimportant.Bib1.iography旭Sf),阳'sicsiaSNc*部8forResidents,TopicsinCTImageProcessinginCT1.Radiographics.2nnu.Rev.Biomed.Eng.,CurrentMethodsinMedica1.imageSegmentation.2000,02,pp.315-337131世6'限婚AdditiVemanufacturingGenera1.princip1.esPartpositioning,coordinatesand(4J5H3,19794-5,Informationtechno1.ogyBiometricdatainterchangeformatsPart5:Face5 Radiographics,MeasuringandEstab1.ishingtheAccuracyandReproducibi1.ityof3DPrintedMedica1.Mode1.s.2017,37.pp.1424-14506 ISO/ASTM52915,Specificationforadditivemanufacturingfi1.eformat(AMF)Version1.217肥g秩老g>%AdditivemanufacturingGenera1.princip1.es-Part2:Overviewofprocesscategories8qg(TtV1.Pi期j39制心阳西Htf厢factoringGenera1.princip1.esPart3:Maincharacteristicsand91OISO/ASTM52950,AdditivemanufacturingGenera1.princip1.esOverviewofdataprocessing(j1.jn1.ndustria1.automationsystemsandintegrationJTfi1.eformatspecificationfor3D11 T*Vt1.mK(Ii肌Non-de$tructivetestingRadiationmethodsforcomputedtomographyPart1:12 利伊f三G0H编”圆翻?飒施峥G腋¾阳fi缁Mf以晔舛如HU师辱sens”。and13 TStf冽效加f,P7%ft1.的(FWfrnishesEva1.uationofdefectsoncoatedsurfacesusingoptica1.imaging145W651-1:2012,E1.ectronicdocumentmanagementVocabu1.aryPart1:E1.ectronicdocument15，蛤，ASTMTR52916,Additivemanufacturingformedica1.DataOptimizedmedica1.image