EN ISO 21043-3 2025.docx

1、ENISO21043-3June2025EuropeanstandardNormeeuropeenneEuropaischenormICS07.140EnglishVersionForensicsciences-Part3:AnalysisISO21043-3:2025Forensik-Teil3:Analyse(ISO21043-3:2025)Criminalistique-Partie3:Analyse(ISO21043-3:2025)ThisEuropeanStandardwasapprovedbyCENon26August2024.CENmembersareboundtocomplyw

2、iththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementCentreortoanyCENmember.ThisEurope

3、anStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCEN-CENELECManagementCentrehasthesamestatusastheofficialversions.CENmembersarethenationalstandardsbodiesofAustria,Belgium,Bulg

4、aria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,RepublicofNorthMacedonia,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,TiirkiyeandUnitedKingdom.富EUROPEANCOMM

5、ITTEEFORSTANDARDIZATIONCOMITEEUROPEENDENORMALISATIONEuropaischeskomiteefurnormungCEN-CENELECManagementCentre:RuedelaScience23,B-1040BrusselsRef.No.ENISO21043-3:2025E2025CENAllrightsofexploitationinanyformandbyanymeansreservedworldwideforCENnationalMembers.ContentsPageEuropeanforeword3Europeanforewor

6、dThisdocument(ENISO21043-3:2025)hasbeenpreparedbyTechnicalCommitteeISO/TC272ForensicsciencesincollaborationwithTechnicalCommitteeCEN/TC419nForensicScienceProcessesthesecretariatofwhichisheldbyNEN.ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyend

7、orsement,atthelatestbyDecember2025,andconflictingnationalstandardsshallbewithdrawnatthelatestbyDecember2025.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.CENshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.Anyfeedbackandquestionsonthi

8、sdocumentshouldbedirectedtotheusersnationalstandardsbody/nationalcommittee.AcompletelistingofthesebodiescanbefoundontheCENwebsite.AccordingtotheCEN-CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Bulgaria,Croa

9、tia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,RepublicofNorthMacedonia,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,TiirkiyeandtheUnitedKingdom.EndorsementnoticeTh

10、etextofISO21043-3:2025hasbeenapprovedbyCENasENISO21043-3:2025withoutanymodification.ISOInternationalStandardISO21043-3Firstedition2025-06ForensicsciencesPart3:AnalysisCriminalistiquePartie3:AnalyseReferencenumberISO21043-3:2025(en)COPYRIGHTPROTECTEDDOCUMENTISO2025Allrightsreserved.Unlessotherwisespe

11、cified,orrequiredinthecontextofitsimplementation,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO,sm

12、emberbodyinthecountryoftherequester.ISOcopyrightofficeCP401Ch.deBlandonnet8CH-1214Vernier,GenevaPhone:+4122749Ol11Email:copyrightiso.orgWebsite:www.iso.orgPublishedinSwitzerlandContentsPageForewordivIntroductionv1 Scope12 Normativereferences13 Termsanddefinitions14 Generalrequirements14.1 General14.

13、2 Validationandverificationofmethods24.3 Equipmentandconsumables34.4 Calibrationandperformancechecks34.5 Metrologicaltraceability34.6 Referencesamples,controlsamples,collectionsanddatabases44.7 Measurementuncertaintyandsignificantfigures44.8 Performancemonitoring45 Personnel.56 Facilities57 Environm

14、entalconditions58 Acceptanceandrejectionofrequestsanditems68.1 Acceptanceandrejectionofthecustomersrequest68.2 Recordingofacceptedorrejecteditems69 Analyticalstrategy69.1 Generalrequirements69.2 Assessmentpriortoanalysis79.3 Selectionofmethods79.4 Itemselection,samplingandpreparation710 Purposeofthe

15、analysis810.1 Classificationoridentification810.2 Quantification810.3 Questionofsource810.4 Reconstruction811 Reliabilityofobservations9AnnexA(informative)Examples10Bibliography12ForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodie

16、s).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmentabinliaisonwithISO,alsotakepar

17、tinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.Inparticular,thedifferentapprovalcriterianeededfort

18、hedifferenttypesofISOdocumentshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(seewww.iso.org/directives).ISOdrawsattentiontothepossibilitythattheimplementationofthisdocumentmayinvolvetheuseof（八）patent(三).ISOtakesnopositionconcerningtheevidence,validit

19、yorapplicabilityofanyclaimedpatentrightsinrespectthereof.Asofthedateofpublicationofthisdocument,ISOhadnotreceivednoticeof（八）patent(三)whichmayberequiredtoimplementthisdocument.However,implementersarecautionedthatthismaynotrepresentthelatestinformation,whichmaybeobtainedfromthepatentdatabaseavailablea

20、twww.iso.org/patents.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.Foranexplanationofthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconform

21、ityassessment,aswellasinformationaboutISOsadherencetotheWorldTradeOrganization(WTo)principlesintheTechnicalBarrierstoTrade(TBT),seeWWW.isoQrgisoforeword.htmLThisdocumentwaspreparedbyTechnicalCommitteeISO/TC272,Forensicsciences,incollaborationwiththeEuropeanCommitteeforStandardization(CEN)TechnicalCo

22、mmitteeCEN/TC419,Forensicscienceprocesses,inaccordancewiththeAgreementontechnicalcooperationbetweenISOandCEN(ViennaAgreement).AlistofallpartsintheISO21043seriescanbefoundontheISOwebsite.Anyfeedbackorquestionsonthisdocumentshouldbedirectedtotheusersnationalstandardsbody.Acompletelistingofthesebodiesc

23、anbefoundatWWW.iso.org/membnrs.htmLIntroductionThisdocumentispartofaseriesthatincludesthedifferentcomponentsoftheforensicprocessfromscenetocourtroom.OtherpartsoftheISO21043seriesare:ISO21043-1;ISO21043-2;ISO21043-4;ISO21043-5.TheexamplesgiveninAnneXAareprovidedforinformationonly.Forensicsciences一Par

24、t3:Analysis1 ScopeThisdocumentspecifiesrequirementsandprovidesrecommendationstosafeguardtheprocessfortheanalysisofitemsofpotentialforensicvalue.Itincludesrequirementsandrecommendationsfortheselectionandapplicationofsuitablemethod(三)fortheanalysistomeettheneedsofthecustomerandfulfiltherequest.Therequ

25、irementsaredesignedtoensuretheuseofsuitablemethods,propercontrols,qualifiedpersonnelandappropriateanalyticalstrategiesthroughouttheforensicanalysisofitems.Thisdocumentisapplicabletoactivitiesconductedbyaforensicserviceproviderthatoccuratthesceneandwithinafacility.Thisdocumentisapplicabletoalldiscipl

26、inesofforensicscience;however,itisnotapplicabletotherecoveryofdigitaldatawhichiscoveredbyISO/IEC27037.Therequirementsandrecommendationsfacilitatethecomprehensive,accurateandreliableanalysisofitems.2 NormativereferencesThefollowingdocumentsarereferredtointhetextinsuchawaythatsomeoralloftheircontentco

27、nstitutesrequirementsofthisdocument.Fordatedreferences,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.ISO21043-1,ForensicsciencesParti:VocabularyISO21043-2,ForensicsciencesPart2:Recognition,recording,collecting,transportandstora

28、geofitems3 TermsanddefinitionsForthepurposesofthisdocument,thetermsanddefinitionsgiveninISO21043-1apply.ISOandIECmaintainterminologydatabasesforuseinstandardizationatthefollowingaddresses:一ISOOnlinebrowsingplatform:availableathttps:WWW.iso.org/obp一IECElectropedia:availableathttps:WWW.electropedia.or

29、g/4 Generalrequirements4.1 GeneralTheprocedures,includingmethods,fortheanalysisofitemsshallbedocumented,suitablefortheirintendeduseand,whenapplicable,includeinformationregarding:a) measuresthatmitigatetheriskofloss,degradation,contaminationoralterationofitems;b) theselectionofmethodssuitabletoaddres

30、sthecustomersrequest;c) methodlimitations;ISO2025-Allrightsreservedd) maintenance,operationandcalibrationofequipment(hardwareandsoftware),includingrelevantperformanceparametersthatcansubstantiallyimpacttheobservationsandtheirinterpretation;e) selectionorsamplingofitems;f) useofreferencesamplesandcon

31、trolsamples;g) metrologicaltraceability;h) itempreparation;i) environmentalconditionsthatcansubstantiallyimpacttheobservationsandtheirinterpretation;j) activitiestodemonstratereliabilityoftheobservations;k) assessmentofmeasurementuncertainty;l) useofanyexternalserviceproviders.Theexaminershallrecord

32、therelevantobservations,data,informationandmethodsusedduringanalysis.Informationincludesreferencetouniquelyidentifiedequipmentandconsumablesthatcansubstantiallyimpactthereliabilityoftheobservations.Deviationsfromaprocedureshallberecordedandtherecordretained.RefertoISO21043-2forfurtherrequirementsand

33、recommendationsforitemhandlingandcontrol,includingcollectingpackaging,labelling,transport,storageandchainofcustody.4.2 Validationandverificationofmethods4.2.1 Methods,includingsoftware,calculationsandmeasurements,shallbevalidatedpriortoimplementation.Priortoimplementation,methodspreviouslyvalidatede

34、lsewhereshallbeverifiedatthefacilitywheretheyaretobeused,priortoimplementation.Off-the-shelfanalysissoftwareusedwithinitsintendedpurposeandscopemaybeconsideredsufficientlyvalidatedbutshallbeverified.Knownsourceitems,comparabletothoseencounteredincasework,shallbeusedformethodvalidationandverification

35、Whenchangesaremadetoavalidatedmethod,theinfluenceofsuchchangesshallbedeterminedandwheretheyarefoundtoaffecttheoriginalvalidation,anewmethodvalidationshallbeperformedpriortoimplementatio111l.4.2.2 Methodvalidationshouldincludethefollowingperformancecharacteristics,ifapplicable:a) precision;b) accura

36、cy;c) limitofdetectiond) limitofquantitation;e) specificityorselectivity;f) calibration;g) robustness;h) carry-overorcontamination.4.2.3 Recordsofmethodvalidationandverificationshallberetained,e.g.intheformofavalidationplanandavalidationreport.Theseshallinclude:a) procedureused;b) specificationofthe

37、requirements;c) determinationoftheperformancecharacteristicsofthemethod;d) observationsobtained;e) statementonthevalidityofthemethod,detailingitssuitabilityfortheintendeduse,relevantlimitationsofthemethodandcaveatsaboutitsuse;f) identifieroftheperson(三)whoperformedthevalidationorverification.NOTESee

38、ISOIEC17025:2017,7.2forguidance.4.3 EquipmentandconsumablesAllequipmentthatcansubstantiallyimpacttheobservationsshallbeuniquelyidentified.Recordsoftheversionofthesoftwareandfirmwareshallberetained,ifapplicable.Equipmentshallbemaintainedandoperatedaspermanufacturersinstructionortheforensicserviceprov

39、idersdocumentedprocedure.Consumablesthatcansubstantiallyimpacttheobservationsshallbecheckedagainstpre-establishedacceptancecriteriaforproperorintendedfunctionbeforeuse.Ifconsumablesformpartofabatchsupply,thenabatchcheckwhereappropriatemaybeused.Thechecksshallberecordedandtherecordretained.NOTEThefre

40、quencyofthecheckscandependonthetypeofconsumableandthefrequencyofuse.RefertoISO21043-2forfurtherrequirementsandrecommendationsforequipmentandconsumables.4.4 CalibrationandperformancechecksEquipmentandsoftwarethatcansubstantiallyimpacttheobservationsshallbecheckedagainstpre-establishedacceptancecriter

41、iaforproperorintendedfunctionpriortouse.Suchequipmentandsoftwareshallbeperiodicallycheckedtosupporttheircontinueduse.Recordsofcalibrationorperformancechecksshallberetained.Theserecordsshallinclude:a) theuniqueidentityoftheequipment;b) theversionofthesoftwareandfirmwareused,ifapplicable;c) theidentit

42、yofanyreferencesamplesorcontrolsamplesused;d) thedateofcalibrationorperformancechecks,andtheidentityofthepersonnelperformingthem;e) theresultsofthecalibrationorperformancechecks,andthecorrespondingevaluation;f) actionstakenwhencalibrationorperformancechecksareoutsidetheexpectedoutcome.4.5 Metrologic

43、altraceabilityWhenitisnecessarytoguaranteethereliabilityofobservations,metrologicaltraceabilityofmeasurementsshallbeestablishedthroughappropriatecalibrationofmeasuringequipmentoruseofcertifiedreferencematerials.NOTESeeISO/IEC17025:2017,6.5forguidance.4.6 Referencesamples,controlsamples,collectionsan

44、ddatabasesTheforensicserviceprovidershall,ifapplicable,utilizereferencesamples,controlsamples,collectionsordatabasesintheanalysisofitems.Referencesamplesandcontrolsamplesshallbe:a) uniquelyidentified;b) traceabletocertifiedreferencematerialsorobtainedfromknownsources.Theoriginofsamplesortherelevantk

45、nowncharacteristicsofsamplesincollectionsanddatabasesshallbedocumented.Referencesamples,controlsamplesandcollectionsshallbestoredinamannerthatmitigatestheriskofloss,degradation,contaminationoralteration.Referencesamplesorcontrolsamplesshallnotbeusedbeyondtheirexpirydate,unlessithasbeencheckedthatthe

46、yremainfitforpurposebeyondthisdate.Theresultsofthecheckshallberetained.Databasesshallbestoredinamannerthatmitigatestheriskoflossandunauthorizedalterationofdata.4.7 MeasurementuncertaintyandsignificantfiguresTheforensicserviceprovidershallhaveadocumentedproceduretoestimatethemeasurementuncertaintyofr

47、eportedmeasurementobservations.Estimationofmeasurementuncertaintyshallbeincludedinthevalidationofquantitativemethods.Whenestimatingmeasurementuncertainty,allcomponentsofsamplingandanalysisthatcansubstantiallyimpactmeasurementuncertaintyshallbetakenintoaccount.Themajorsourcesofuncertaintyrelatingtoam

48、ethodshallbedocumentedalongwiththeoveralluncertaintyandanexplanationofhowtheoveralluncertaintywasderived.Theforensicserviceprovidershallhaveadocumentedprocedureaddressingtheuseofsignificantfiguresandtheroundingofnumericalvalues.4.8 Performancemonitoring4.8.1 Theforensicserviceprovidershallhaveadocumentedprocedurethataddressesthemonitoringofitsperformance,whichmayinclude:a) proficiencytesting;b) interlaboratorycomparison;c) intralaboratorycompa