BS-EN-ISO-23640-2013-Evaluation-of-stability-of-in

BSIStandardsPublicationInvitrodiagnosticmedicaldevices—EvaluationofstabilityofinvitrodiagnosticreagentsBSENISO23640:2013NationalforewordThisBritishStandardistheUKimplementationofENISO23640:2013.ItsupersedesBSENISO23640:2011whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/212,IVDs.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.©TheBritishStandardsInstitution2013PublishedbyBSIStandardsLimited2013ISBN9780580822568ICS11.100.10CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.ThisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon31March2013.AmendmentsissuedsincepublicationAmd.No.DateTextaffectedBRITISHSTANDARDBSENISO23640:2013EUROPEANSTANDARDNORMEEUROPÉENNEEUROPÄISCHENORMENISO23640February2013ICS11.100.10SupersedesENISO23640:2011EnglishVersionInvitrodiagnosticmedicaldevices-Evaluationofstabilityofinvitrodiagnosticreagents(ISO23640:2011)Dispositifsmédicauxdediagnosticinvitro-Évaluationdelastabilitédesréactifsdediagnosticinvitro(ISO23640:2011)In-vitro-Diagnostika-HaltbarkeitsprüfungvonReagenzienfürin-vitro-diagnostischeUntersuchungen(ISO23640:2011)ThisEuropeanStandardwasapprovedbyCENon8January2013.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementCentreortoanyCENmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCEN-CENELECManagementCentrehasthesamestatusastheofficialversions.CENmembersarethenationalstandardsbodiesofAustria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,FormerYugoslavRepublicofMacedonia,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Slovakia,Slovenia,Spain,Sweden,Switzerland,TurkeyandUnitedKingdom.EUROPEANCOMMITTEEFORSTANDARDIZATIONCOMITÉEUROPÉENDENORMALISATIONEUROPÄISCHESKOMITEEFÜRNORMUNGManagementCentre:AvenueMarnix17,B-1000Brussels©2013CENAllrightsofexploitationinanyformandbyanymeansreservedworldwideforCENnationalMembers.Ref.No.ENISO23640:2013:EBSENISO23640:2013ENISO23640:2013(E)2ContentsPageForeword.......................................................................................................................................................3AnnexZA(informative)RelationshipbetweenthisEuropeanStandardandtheEssentialRequirementsofEUDirective98/79/EC..........................................................................................4BSENISO23640:2013ENISO23640:2013(E)3ForewordThetextofISO23640:2011hasbeenpreparedbyTechnicalCommitteeISO/TC212“Clinicallaboratorytestingandinvitrodiagnostictestsystems”oftheInternationalOrganizationforStandardization(ISO)andhasbeentakenoverasENISO23640:2013byTechnicalCommitteeCEN/TC140“Invitrodiagnosticmedicaldevices”thesecretariatofwhichisheldbyDIN.ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbyAugust2013,andconflictingnationalstandardsshallbewithdrawnatthelatestbyAugust2013.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.CEN[and/orCENELEC]shallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.ThisdocumentsupersedesENISO23640:2011.ThisdocumenthasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropeanFreeTradeAssociation,andsupportsessentialrequirementsofEUDirective.ForrelationshipwithEUDirective,seeinformativeAnnexZA,whichisanintegralpartofthisdocument.AccordingtotheCEN-CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,FormerYugoslavRepublicofMacedonia,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Slovakia,Slovenia,Spain,Sweden,Switzerland,TurkeyandtheUnitedKingdom.EndorsementnoticeThetextofISO23640:2011hasbeenapprovedbyCENasENISO23640:2013withoutanymodification.BSENISO23640:2013ENISO23640:2013(E)4AnnexZA(informative)RelationshipbetweenthisEuropeanStandardandtheEssentialRequirementsofEUDirective98/79/ECThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropeanFreeTradeAssociationtoprovideonemeansofconformingtoEssentialRequirementsoftheNewApproachDirective98/79/EConinvitrodiagnosticmedicaldevices.OncethisstandardiscitedintheOfficialJournaloftheEuropeanUnionunderthatDirectiveandhasbeenimplementedasanationalstandardin