1、BSIStardsPublicationMolecularinvitrodiagnosticexaminations—SpecificationsfpreexaminationprocessesfvenouswholebloodPart3:IsolatedcirculatingcellfreeDNAfromplasmaPDCENTS168353:2015TECHNICALSPECIFICATIONSPCIFICATIONTECHNIQU
2、ETECHNISCHESPEZIFIKATIONCENTS168353October2015ICS11.100.30EnglishVersionMolecularinvitrodiagnosticexaminationsSpecificationsfpreexaminationprocessesfvenouswholebloodPart3:IsolatedcirculatingcellfreeDNAfromplasmaTestsdedi
3、agnosticmolculaireinvitroSpcificationsrelativesauxprocessuspranalytiquespourlesangtotalveineuxPartie3:ADNlibrecirculantextraitduplasmaMolekularanalytischeinvitrodiagnostischeVerfahrenSpezifikationenfrpranalytischeProzess
4、efrvenseVollblutprobenTeil3:AusPlasmaisoliertezirkulierendezellfreieDNSThisTechnicalSpecification(CENTS)wasapprovedbyCENon31August2015fprovisionalapplication.TheperiodofvalidityofthisCENTSislimitedinitiallytothreeyears.A
5、ftertwoyearsthemembersofCENwillberequestedtosubmittheircommentsparticularlyonthequestionwhethertheCENTScanbeconvertedintoaEuropeanStard.CENmembersarerequiredtoannouncetheexistenceofthisCENTSinthesamewayasfanENtomaketheCE
6、NTSavailablepromptlyatnationallevelinanappropriatefm.Itispermissibletokeepconflictingnationalstardsinfce(inparalleltotheCENTS)untilthefinaldecisionaboutthepossibleconversionoftheCENTSintoanENisreached.CENmembersarethenat
7、ionalstardsbodiesofAustriaBelgiumBulgariaCroatiaCyprusCzechRepublicDenmarkEstoniaFinlFmerYugoslavRepublicofMacedoniaFranceGermanyGreeceHungaryIcelIrelItalyLatviaLithuaniaLuxembourgMaltaherlsNwayPolPtugalRomaniaSlovakiaSl
8、oveniaSpainSwedenSwitzerlTurkeyUnitedKingdom.EUROPEANCOMMITTEEFSTARDIZATIONCOMITEUROPENDENMALISATIONEUROPISCHESKOMITEEFRNMUNGCENCENELECManagementCentre:AvenueMarnix17B1000Brussels?2015CENAllrightsofexploitationinanyfmbya