ISO 04307-2021.docx

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1、INTERNATIONA1.STANDARDISO4307editionFirSt2021-10Mo1.ecu1.arinvitrodiagnosticexaminationsSpecificationsforpre-examinationprocessesforsa1.ivaIso1.atedhumanDNAAna1.ysedediagnosticmo1.ecu1.aireinvitroSpecificationsre1.ativesauxprocessuspreana1.ytiquespour1.asa1.iveADNhumainextraitSOJUfeOTffi25ISO2021COP

2、YRIGHTPROTECTEDDOCUMENTISO2021IUirhM*hedbdi1.iUedotherwiseupdhi.o啪InyM1.tta0DmkfifiU81.andonnet8CH-1214Vernier,GenevaPhone：M1.22749O1.11觥曲ite：图洲跳触OQrgPub1.ishedinSwitzer1.andContentsForeword5.1.3Se1.ectionspecimenCo1.1.ectionfromdevicebydonor/patient5.2Transportrequirements766.3IsoIationGeneraI96.5Q

3、uanU1.yofiso1.ated.rs1.ssncn1.11Bib1.iography12SO2021-A1.1.rightsreservedIntroductionVScope1Normativereferences1Termsanddefinitions1Genera1.considerations4Activitiesoutsidethe1.aboratory55.1 Specimenco1.1.ection55.1.1 Informationaboutthespecimendonor/patient5iii5.1.2 Sa1.ivaofthesa1.ivathetheIaborat

4、oryandstabi1.izationprocedures65.1.4 Informationonthespecimenandstoragerequirementsatsa1.ivaco1.1.ectionfaci1.ity/site5.2 1Gtne,85.2.2 Usingsa1.ivaco1.1.ectiondeviceswithDNAstabi1.izers85.2.3 Usingsa1.ivaco1.1.ectiondeviceswithoutDNAstabi1.izers.8Activitiesinsidethe1.aboratory96.1 Specimenreception9

5、6.2 Stordgerequretencs.一96.2.1 ofthesa1.ivaDNA632USingaCOmmerCia1.kit106.3.3Usingthe1.aboratorysownprotoco1.106.4Storageandqua1.itysa1.ivaDNAofiso1.atedDNA6.5.1Genera1.116.5.2 Sa1.ivaDNAiso1.atedwithcommercia1.1.yavai1.ab1.ekits116.5.3 Sa1.ivaDNAiso1.atedwiththe1.aboratoryownprotoco1.s11ForewordISO(

6、theInternationa1.OrganizationforStandardization)isawor1.dwidefederationofnationa1.standardsttiugh(ISOtn(faabHdg)thwcekWwptafigbodyEmcMtif1.iaiibtandtjNoK)Whh1.bka门mitteehasbeenestab1.ishedhastherighttoberepresentedonthatcommittee.Internationa1.organizations,governmenta1.andnon-governmenta1.,in1.iais

7、onwithISO,a1.sotakepartinthework.ISOco1.1.aboratesc1.ose1.ywiththee1.ectrotechnica1.standardization.Internationa1.E1.ectrotechnica1.Commission(IEC)ona1.1.mattersofTheproceduresusedtodeve1.opthisdocumentandthoseintendedforitsfurthermaintenanceareS瞅Ffii搬o11SOIEC(三M1.糖notrtt11郤MWfergCCOrdanCe酚Fhtheedit

8、oria1.ru1.esoftheISO/1ECDirectives,Part2(seewww.iso.org/directives).RW1onrights,dteEf1.n晶煦瞅哪ns宙能解出即耐嘏酬制出doc1.三1见鼠眼监ssubjectofanypatentrightsidentifiedduringthedeve1.opmenUtUw44MM4MUw41.beintheIntroductionand/orontheISO1.istofpatentdec1.arationsreceived(seewww.iso.org/patents).Anytradeusedinthisconst

9、itutenameendorsement.documentisinformationgivenfortheconvenienceofusersanddoesnotForanexp1.anationofthevo1.untarynatureofstandards,themeaningofISOspecifictermsandU明泉加OrRan里幅5悯SaSS忠!S窿inwJ憎ftknBar池部Udead焦es地ww.isO.orgiso/forewordhtm1.S稠嫌微秘$丛斑SS桥都3Mi1.胡扉即见制盘和岫ee吊腿#&蕾柳映Por柱附儡於UMf星MTechnica1.CommitteeCE

10、N/TC140,invitrodiagnosticmedica1.devices,inaccordancewiththeAgreementontechnica1.cooperationbetweenISOandCEN(ViennaAgreement).丽加段0用咏布“曲WhsHHdie5thi5cahgfeRf罚ts三Www三mbeWinaHOna1.standardsbody.AIntroductionexpectedandbodytechno1.ogiesana1.ysingprofi1.esofnuc1.eicmo1.ecu1.esproteins,changemetabo1.itesi

11、nhumansituationinthepatientbutanartificia1.profi1.egeneratedduringthepre-examinationprocess.inprecisionmedicine.Thisisafast-growingfie1.dinmo1.ecu1.ardiagnostics.measuresarecompositionofsa1.ivainformingcomp1.expreparinguniquepadentsdonorspatientsdonors.Dedicateddedicatedse1.f-co1.1.ecteiByhome;instr

12、uctionhomeCo1.1.ectionco1.1.ectioncontributessafetyvariabi1.ityinspecimensspecimensa1.ivaContinuefragmentgrow,degradedi1.utingco1.1.ection.1.)NA.addition,secretedpresenthacteriasa1.ivaStandardizationpre-CxaminationimpactsSuchfromdegradationandfragmcntationexaminatonisco1.1.ection.Inthisdocument,thef

13、o1.1.owingverba1.formsareused：*shou1.dindicatesarecommendation；*canwindicatesapossibi1.ityoracapabi1.ity.Mo1.ecu1.arinvitrodiagnosticshasenab1.edasignificantprogressinmedicine.Furtherprogressis邮8啦21ftfttAWJA0wever1.hctheseacids.cananddrastica1.1.yduringspecimenco1.1.ection,transport,storageandproces

14、singthusmakingtheoutcomefromdiagnosticsorresearchunre1.iab1.eorevenimpossib1.ebecausethesubsequentana1.ytica1.assaywi1.1.notdeterminetheGeneticexaminationofDNAiscommon1.yusedinc1.inica1.practice.Thisinc1.udes,forexamp1.e,Vpredispositiontesting,pha11nacogenomicsandana1.ysisofgeneticdisorderswiththepe

15、rspectiveusedSa1.ivaisincreasing1.yusedasanon-invasivea1.ternativespecimentob1.oodfortheexaminationofhumanDNA.Sa1.ivanatura1.1.ycontainsmicroorganismsandextraneoussubstances(e.g.fooddebris),whichmakethereforeneededformoreandandamongfortheco1.1.ectionandtocheckcomp1.iancewiththeinstructions,inorderto

16、reducethespecimenvariabi1.ity.Incontrasttoinvasivespecimenco1.1.ection,sa1.ivaco1.1.ectiondoesnotrequiretrainedandeducatedprofessiona1.sorcanbefaci1.ities,atgoodhowever,andverifieda1.sodevicetohihc1.aims1.sa1.ivaqua1.ity.Simi1.ar1.y,medica1.1.aboratories/invitromanufacturersneedtobeawareofspecimenva

17、riabi1.itywhenperformingdesignverificationandva1.idation.DNAcancantothusafterthehumanInDNasesbacteriabytheseinthecana1.soacce1.eratetheDNdegradation.Thiscanimpactthesensitivityandre1.iabi1.ityOfDNexamination.minimizeoftheprocessasDNAspedmenco1.1.ectiontheDNAaftersa1.ivaneededThisdocumentdescribesspe

18、cia1.measureswhichneedtobetakentoobtaingoodqua1.itysa1.ivaSPeCimen/samp1.esandiso1.atedDNAtherefromforhumanDNexamination.*sha1.indicatesarequirement;“may*indicatesapermission;Mo1.ecu1.arinvitrodiagnosticexaminations一Specificationsforpre-examinationprocessesforsa1.ivaIso1.atedhumanDNA1 Scopedocumenta

19、tionmo1.ecu1.arexaminationintendedperformed.humanDNAexaminationduringthepre-examinationdevc1.opcddiagnosticsdeve1.opersandmanufacturers,biobanks,institutionsandcommercia1.organizationsDedicateddescribedneeddoment.Neithersa1.ivameasuresforpreservingmateria1.hand1.ingbymouthcoveredinInternationa1.nati

20、ona1.orregiona1.regu1.ationsorrequirementscana1.soapp1.ytospecifictopics2 Normativereferencesconstitutesrequirements1.atesteditiondocument.referencedreferences,(inc1.uc1.ingamendments)app1.ies.app1.ies.ISOTermsanddenitions-RequirementsorsafetyForthepurposesofthisdocument,thetermsanddefinitionsgiveni

21、nISO15189andthefo1.1.owingapp1.y.ISOOn1.inebrowsingp1.atform:avai1.ab1.eathKpswww.4so.Fgobp3.1ambienttemperatureSOURCE:ISO20184-1:2018,3.2ana1.yteSOURCE:ISO17511:2003,3.2,modifiedTheexamp1.eswerenottakenover.Thisdocumentspecifiesrequirementsandrecommendationsonthehand1.ing,storage,processingandphase

22、beforeofSaMVaspecimensisThisdocumentisapp1.icab1.etomo1.ecu1.arinvitrodiagnosticexaminationinc1.uding1.aboratoryvitrotestsperformedbymedica1.1.aboratories.Itcana1.sobeusedby1.aboratorycustomers,performingbiomedica1.research,andregu1.atoryauthorities.washesarenotmeasuresthatinthisbetakenforareco1.1.e

23、ctedonabsorbingandorofnativesa1.ivace1.1.-freeDNA1pathogens,andotherbacteria1.orwho1.emicrobiomeDNAinsa1.ivadescribed.NOTEthisdocument.Thefo1.1.owingdocumentsarereferredtointhetextinsuchawaythatsomeora1.1.oftheircontentundatedreferences,theofthisoftheFordateddocumenton1.ytheanyeditioncitedForISO1518

24、9,Medica1.1.aboratoriesRequirementsforqua1.ityandcompetence315190,Medica1.1.aboratoriesISOandIECmaintaintermino1.ogica1.databasesforuseinstandardizationatthefo1.1.owingaddresses：-IECE1.ectropedia:avai1.ab1.eathttp:/www.e1.ectropcdia.org/unregu1.atedtemperatureofthesurroundingair3.2componentrepresent

25、edinthenameofameasurab1.equantity3.3examinationperformanceana1.ytica1.testperformanceana1.ytica1.performanceaccuracy,precision,andsensitivityOfatesttomeasuretheana1.yte(3.2)ofinterestNote1toentry:Othertestperformancecharacteristicssuchasrobustness,repeatabi1.itycanapp1.yaswe1.1.RCE:ISO20184-1:2018,3

26、.4DNAstabiIizercompound,so1.utionormixturethatisdesignedtominimizedegradationandfragmentationofDNA(36)(SOURCE:ISO20186-2:2019,3.5,modifiedTheterm*,genomicDNinb1.oodhasbeenrep1.acedwith猾Auc1.osedsystemnon-modifiab1.esystemprovidedbythevendorinc1.udinga1.1.necessarycomponentsfortheana1.ysis(i.e.hardwa

27、re,software,proceduresandreagents)SOURCE:ISO20186-2:2019,3.6DNAdeoxyribonuc1.eicacidpo1.ymerofdeoxyribonuc1.eotidesoccurringinadoub1.e-stranded(dsDNA)Orsing1.e-Stranded(ssDNA)formOURCE:ISO22174:2005,3.1.2examinationana1.ytica1.testsetofoperationshavingtheobjectofdeterminingtheva1.ueorcharacteristics

28、ofapropertyNut1.tm11ipU1mu4orturtJ=i1.Htivrtica1.workf1.ow*wasadded,Zmoredetai1.wasinc1.uded.primarysamp1.especimendiscreteportionofabodyf1.uid,breath,hairortissuetakenforexamination,studyorana1.ysisofoneormorequantitiesorpropertiesassumedtoapp1.yforthewho1.eSOURCE:ISO15189:2012,3.16rmodifiedTheterm

29、anddefinitionisusedherewithouttheorigina1.现判proficiencytestingeva1.uationofparticipantperformanceagainstpre-estab1.ishedcriteriabymeansOfin1.er1.aboratorycomparisons(SOURCE:ISO/IEC170432010r3.7rmodifiedTermanddefinitionarcusedherewithouttheorigina1.5ons,roomtemperaturetemperatureintherangeof18to25fo

30、rthepurposeofthisdocumentNote1toentr),:1.oca1.ornationa1.regu1.ationscanhavedifferentdefinitions.y9RCE:ISO20186-2:2019r3.22sa1.ivawho1.esa1.iva里orothercontainerbio-f1.uidofthemouthcomposedmain1.yofsecretionoriginatingfromthethreemajorsa1.ivaryg1.ands国,g)tids,submandibu1.arandsub1.ingua1.g1.ands)andf

31、romsa1.ivaryg1.andspresentintheora1.cavitysa1.ivaco1.1.ectiondeviceinwhichthesa1.iva(3.15)specimen(3.12)isco1.1.ectedsamp1.eoneormorepartstakenfromaprimarysamp1.e(3.12)手?NRCE:ISO15189:2012,3.24rmodifiedTheexamp1.eswerenottakenover.stabi1.ityabi1.ityofaspecimen(3.12)samp1.e(3.17)materia1.,whenstoredu

32、nderspecifiedconditions,tomaintainadefinedpropertyva1.uewithinspecified1.imitsforaspecifiedperiodoftimeNote1toentry：Themeasurandconstituentforthepurposeofthisdocumentisiso1.atedDNA(3.6).,6。WRCE:rc附1Giikh3k2k35sby2M1.iWh2dneiFNc&2Imatknrit1.IF1.,samp1.(iyufuttQtdng,;,spb0fiedwords38nedstoragepro1.ong

33、edInterniptionofthepreana1.ytica1.workf1.ow(3.11)ofaspedmen(3.12)orsamp1.e(3.17)orana1.yte(3.2)respective1.y,oroftheirderivatives,underappropriateconditionsinordertopreservetheirpropertiesNote1toentry:1.ong-termstoragetypica1.1.yoccursin1.aboratoryarchivesorinbiobanks.SOURCE:ISO20184-1:2018,3.22.mod

34、ifiedExamp1.einthedefinitionwasde1.etedandspecimen”.added.va1.idationconfirmation,throughtheprovisionofobjectiveevdencerthattherequirementsforaspecificintendeduseorapp1.icationhavebeenfu1.fi1.1.edNote1toentry:Theword“va1.idated”isusedtodesignatethecorrespondingstatus.RCE:ISO9000:2015,3.8.13rmodified

35、Note1and3werenottakenover.Jverificationconfirmation,throughprovisionofobjectiveevidence,thatspecifiedrequirementshavebeenfu1.fi1.1.edNote1toentry:Theword,vcrificd*isusedtodesignatethecorrespondingstatus.Note2toentry：Conf1.rmationcanCompriseactivniessuchas：- performinga1.ternativeca1.cu1.ations；- com

36、paringanewdesignspecificationwithasimi1.arprovendesignspecification：- undertakingtestsanddemonstrations；and- reviewingdocumentspriortoissue.笆RCE:ISO9000:2015,3.8.12,modifiedNote1andNote2werenottakenover.workf1.owstructuredseriesofactivitiesnecessarytocomp1.eteatask4S(UttMe1.IaI)Saddeai0ttswodifkd-Th

37、eword,structured*wasaddedB同船炉同InP1.eS横U褪晒，W蜘刷W由38包睡gua1.i中nc1.udi*K3曲段吊停杯蟒径附c三*1.轴)seeISO15189orISO/IEC17020.Therequirementson1.aboratoryequipment,reagents,andconsumab1.esaccordingtoISO15189sha1.1.befo1.1.owed;ISO15189andISO/IEC17020cana1.soapp1.y.Forgenera1.A1.1.stepsofadiagnosticworkf1.owcaninf1.u

38、encethena1.examinationresu1.tThus,theentiresvorkf1.ow,8例颔gdess网ftf1.曲限f1.牺0喀f1.fined即帆球时网g(三4nd雨超HHM锹粒ritsth“HMise.Thisinc1.udesthedeve1.opmentofinvitrodiagnostic(IVD)medica1.devices.Thestabi1.ityofthehumanDNAshou1.dbeinvestigatedthroughoutthecomp1.etepre-examinationprocessdeve1.opment.The4ISO2021-A

39、1.1.rightsreservedTheconformanceWiU1.orthepersonCo1.1.cctingforthefromtheTheexaminationmanufacturershou1.dprovidespecifiedandverifiedinstructionsforsa1.ivaco1.1.ectionWheretheexaminationmanufacturerdoesnotprovidesuchspecifications(e.g.duetoformer1.essstringent1.ega1.frameworks),theproceduresha1.1.be

40、specified,verifiedanddocumentedbyUIeco1.1.ectiondeviceinstructionssha1.1.bewrittenstorageuserandsha1.1.becanSerVeasasa1.ivaframeworkforthe1.aboratorysownexaminationspecificverification.Theseshou1.dinc1.udeinstnctionsforpreparationofthedonor/patient,suchasnottoeat,drink,smoke,kissorchewanysubstancefo

41、rat1.east30minbeforethesa1.ivaspecimenco1.1.ection.NOTEWheretheexaminationmanufacturera1.1.owsusageofsa1.ivaDNAco1.1.ectiondeviceswithoutstabi1.izers.Wheretheexaminationmanufacturerdoesnotprovidesuchspecifications(e.g.duetoformer1.essstringent1.ega1.frameworks),theproceduresha1.1.bespecified,verifie

42、danddocumentedbytheinc1.udeforsha1.1.beoftheaccording1.yfortheasnoteat,besmoke,kisschewanysubstanceforat1.east30minbeforethesa1.ivaspecimenco1.1.ection.Forspecimensintendedforextendedstorageinabiobank,itisusua1.1.ynotknownwhichindividua1.DNADNAshou1.dbewi1.1.ifusingafterthewithoutDNAstorage.aDNAeith

43、erandwithassessmentshou1.dbeperformedaccordingto6.4.Ifexamp1.efromtheperformed,writtenandvisua1.physician,forbesupp1.iedtotheintermediateThedonor/patientorthepersonco1.1.ectingthesa1.ivaspecimenfromthedonor/patientsha1.1.confirmThetemporarystorageinthesa1.ivaco1.1.ectionfaci1.itycontributestothetota1.durationofstorage.Theexaminationmanufacturershou1.dprovidespecifiedandverifiedinstructionsforthe