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.ysisofgeneticdisorderswiththeperspectiveusedSa1.ivaisincreasing1.yusedasanon-invasivea1.ternativespecimentob1.oodfortheexaminationofhumanDNA.Sa1.ivanatura1.1.ycontainsmicroorganismsandextraneoussubstances(e.g.fooddebris),whichmakethereforeneededformoreandandamongfo