BS EN 13641-2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents《消除和降低与体外诊断试剂有关的感染的危险性》.pdf

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1、BRITISH STANDARD BS EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents The European Standard EN 13641:2002 has the status of a British Standard ICS 11.100 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 13641:2002 This Brit

2、ish Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 27 May 2002 BSI 27 May 2002 ISBN 0 580 39780 7 National foreword This British Standard is the

3、 official English language version of EN 13641:2002. The UK participation in its preparation was entrusted to Technical Committee CH/69, In vitro diagnostic systems, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cr

4、oss-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or o

5、f British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users of this publication are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to

6、 understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document co

7、mprises a front cover, an inside front cover, the EN title page, pages 2 to 8, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPEN

8、NE EUROPISCHENORM EN13641 May2002 ICS11.100 Englishversion Eliminationorreductionofriskofinfectionrelatedtoinvitro diagnosticreagents Eliminationourductiondurisquedinfectionrelatifaux ractifsdediagnosticinvitro EliminierungoderHerabsetzungdesvonReagenzienfrin vitrodiagnostischeUntersuchungenausgehen

9、den Infektionsrisikos ThisEuropeanStandardwasapprovedbyCENon5January2002. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uch

10、national standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatu

11、sasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMA

12、LISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2002CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN13641:2002EEN13641:2002(E) 2 Foreword ThisdocumentEN13641:2002hasbeenpreparedbyTechnicalCommitteeCEN/TC140“Invitr

13、odiagnostic medicaldevices“,thesecretariatofwhichisheldbyDIN . ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextor byendorsement,atthelatestbyNovember2002,andconflictingnationalstandardsshallbewithdrawnatthelatest byNovember2002. Thisdocumenthasbeenpre

14、paredunderamandategiventoCENbytheEuropeanCommissionandtheEuropean FreeTradeAssociation,andsupportsessentialrequirementsofEUDirective(s). ForrelationshipwithEUDirective(s),seeinformativeannexZA,whichisanintegralpartofthisdocument. ThisstandardincludesaBibliography. AccordingtotheCEN/CENELECInternalRe

15、gulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark,Finland, France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain, Sweden,SwitzerlandandtheUnitedKingdom.EN13641:2002

16、(E) 3 Introduction Althoughmedicallaboratorystaffroutinelyhandlespecimensthatarepotentiallyinfectiousandappropriate protectivemeasuresandsafetyprocedureshavetobefollowed,accordingtotheprovisionsofthe Directive98/79/EConinvitrodiagnosticmedicaldevices(IVDMDs)(seeBibliography,1)theadditionalriskof acc

17、identalinfectioncausedbyIVDMDscontaininginfectiousorpotentiallyinfectiousmaterialistobereducedtoa minimum.ThisrequirementoftheEUDirectiveisanessentialrequirementrelatingtothedesignandmanufacture ofIVDMDs.Manufacturersareobligedtoensurebyappropriatedesignfeaturesandmanufacturingprocedures thattherisk

18、ofinfectionpresentedbytheproductitselfisminimal.TheEUDirectivedoesnotspecificallyaddress thefollowingaspectswhicharecoveredbyspecificinternational,Europeanand/ornationallegislation: generalaspectsofworkersprotectionandthemeasuresthathavetobeimplementedwheninfectiousor potentiallyinfectiousmaterialsa

19、rehandledinlaboratoriesormanufacturingsites, transportationofinfectiousgoods, disposalroutesandprocesses.EN13641:2002(E) 4 1 Scope ThisEuropeanStandardspecifiesrequirementsrelatedtodesignandmanufactureinordertoeffectivelycontrol theriskofinfectioncausedbyinvitrodiagnosticreagentsincludingreagentprod

20、ucts,calibrators,controlmaterials andkits,hereinaftercalledIVDreagents.Thestandardisapplicabletoinvitrodiagnosticreagentscontaining materialofhumanorigin.Thestandardisalsoapplicabletoinvitrodiagnosticreagentscontainingmaterials obtainedbybiotechnologyprocessesormaterialsofanimalorigin,inparticularin

21、viewofrelevantzoonoses,when theresultsofariskanalysisrevealthatthereisariskofhumaninfection. Thestandarddoesnotapplytothefollowing: instrumentsandspecimenreceptacles; NOTE 1 Thepreventionofinfectionduetohandlingofbiologicalmaterialsthroughoutsuchequipmentis addressedinotherrelevantInternationaland/o

22、rEuropeanStandards. generalaspectsofworkersprotection; transportationofinfectiousgoods; disposalmeasures. NOTE2Someofthemostrelevantdocumentsrelatingtoaspectsnotcoveredbythisstandardarelistedin Bibliographyforinformation. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedorundatedreferenc

23、e,provisionsfromotherpublications.These normativereferencesarecitedattheappropriateplacesinthetext,andthepublicationsarelistedhereafter.For datedreferences,subsequentamendmentstoorrevisionsofanyofthesepublicationsapplytothisEuropean Standardonlywhenincorporatedinitbyamendmentorrevision.Forundatedref

24、erencesthelatesteditionofthe publicationreferredtoapplies(includingamendments). EN375, Informationsuppliedbythemanufacturerwithinvitrodiagnosticreagentsforprofessionaluse. EN376, Informationsuppliedbythemanufacturerwithinvitrodiagnosticreagentsforselftesting. 3 Termsanddefinitions Forthepurposesofth

25、isEuropeanStandard,thefollowingtermsanddefinitionsapply. 3.1 potentiallyinfectiousbiologicalmaterial materialwhichmightcontaininfectiousviabletransmissibleagentsalbeitwithalowprobability NOTEPotentiallyinfectiousbiologicalmaterialincludesallhumanandallanimalsourcedmaterials,includingthespecimens for

26、 routinediagnosticexaminationandbiologicalmaterialsofunknownorigin. 3.2 infectiousbiologicalmaterial materialwhichisknownorhighlylikelytocontainviablemicroorganismsorothertransmissibleagentswhichare knownorsuspectedtocausediseaseinhumans NOTEOthertransmissibleagentsaree.g.prions.EN13641:2002(E) 5 3.

27、3 invitrodiagnosticreagent IVDreagent invitrodiagnosticmedicaldevicewhichisareagent,reagentproduct,calibrator,controlmaterialorkit NOTE1Forthedefinitionofaninvitrodiagnosticmedicaldevicesee1. NOTE2InsomecasesaparticularIVDreagent,asdefinedforuseinhumanmedicine,mayservealsoinveterinarymedicine. EN375

28、:2001 4 Requirementsrelatedtodesignandmanufacture 4.1 General InordertoeliminateorreducetoaminimumtheriskofinfectionrelatedtoIVDreagentsthefollowingaspectsshall beconsidered: rationaleforusinginfectiousorpotentiallyinfectiousbiologicalmaterial; sourcingandtestingrequirements(stipulatedinmaterialspec

29、ifications); inactivationorotherappropriatemeasurestoreducetheriskofinfection; warningstobegivenintheinformationsuppliedbythemanufacturer. 4.2 Useofinfectiousbiologicalmaterialsorpotentiallyinfectiousbiologicalmaterials TheuseofinfectiousbiologicalmaterialsinIVDreagentsshallbeavoidedasfaraspossible.

30、IfIVDreagents containsuchmaterialasaningredientorcomponent,itsuseshallbebasedonasoundscientificortechnical rationale.Infectiousmaterialmaybeusedonlyifitisindispensableforthediagnosticpurposeoftheproduct (e.g.positivecontrols,materialsneededtoutiliserelevantantigensorantibodiesinthefinalkitconfigurat

31、ion.) Theuseofpotentiallyinfectiousbiologicalmaterialsshallbecriticallyquestionedinanycase(weighingrisks againstbenefit). Ifeithertypeofmaterialisused,additionalmeasuresasspecifiedin4.3,4.4andclause5shallbeconsideredto reducetheriskofinfectiontoaminimum.Thejustificationforuseofsuchmaterialsshallbedo

32、cumented. 4.3 Rawmaterialspecifications 4.3.1 General Forallinfectiousandpotentiallyinfectiousbiologicalmaterialsusedinthemanufactureofreagents,appropriate specificationsshallbedefined(includingsourcingandtestingrequirements)inordertocontroladequatelytherisk ofinfection. 4.3.2 Sourcingrequirements A

33、ppropriateproceduresforsourcinginfectiousorpotentiallyinfectiousbiologicalmaterialsshallbeestablishedand documentedbytheIVDreagentsmanufacturer. Informationshallbeavailableon supplieroftherawmaterial;EN13641:2002(E) 6 typeofmaterial(e.g.blood,plasma,serum,tissue,urine,cells); natureofthesource(e.g.h

34、uman,animal,microbial); origin(e.g.geographicalsite,humandonorsgroup); purificationproceduresandchemicaltreatments,ifperformed. 4.3.3 Testingrequirements Testingofmarkersforthemostrelevantinfections,suchasHIV1andHIV2antibodies,HCVantibodiesand HB s Agshallbeperformed. Asarule,testsbasedonCEMarkedIVD

35、reagentsshallbeused,whereavailable.Othertechniquesmaybeused onlyiftheirrelevantperformancecharacteristicsareatleastequivalentanddocumented. Inthecaseofhumanblood,includingplasmaandserum,eachindividualdonationshallbetested.Ifinjustified casestestingisperformedonpooledmaterial,anappropriatelysensitive

36、testingtechnologyshallbeused(e.g. PCRorotheramplificationtechniques). Traceabilityoftestresultsshallbeensured.Acertificateofanalysisforthesourcematerialmaybeconsidered. Onlymaterialsfoundtobenonreactiveintheabovementionedtestsshallbeused,exceptwhenreactivematerial isindispensableforthediagnosticpurp

37、ose.Anyexceptionshallbejustifiedanddocumented. 4.4 Manufacturingprocess Ifinfectiousbiologicalmaterialsareused,inactivationorotherappropriatemeasurestoreducetoaminimumthe riskofinfectionshallbeperformedunlesstheperformanceoftheIVDreagentisadverselyaffected.Adequate evidenceoneffectivenessandlimitati

38、onsofsuchmeasuresshallbeavailable(e.g.useofliteratureevidence, “stateoftheart“procedures,validationdata). Duringtheproductionprocessappropriateorganisationalandhygienicmeasuresshallbetakentoprevent secondarycontamination(inparticularcrosscontamination).InfectiousmaterialsandIVDreagentscontaining inf

39、ectiousmaterialsshallbestoredandfilledinappropriatecontainersthateffectivelyavoiddisseminationof infectiousagents. 5 Informationsuppliedbythemanufacturer InadditiontotherequirementsspecifiedinEN375andEN376appropriatestatementsabouttherelevantinfection markerstestedandtheoutcomeobtainedshallbeinclude

40、dintheinstructionsforuse. Anywarninggivenshallbeappropriatetotheparticularriskofinfection(potentialorknown)presentedbythe reagent.Differentwordingshallbeconsideredfordifferentlevelsofrisk. Forexample,incasealltheperformedtestsshownoreactivityfortherelevantinfectionmarkersoraneffective treatmenthasbe

41、enperformed,averygeneralwarningabouttheresidualriskmaybesufficient.Bycontrast,an explicitandveryclearwarningshallbemadeifinfectiousmaterialispresentforjustifiedreasonsandadditional measuresshallbesuggestedtotheusertoreducetheriskofinfection.EN13641:2002(E) 7 AnnexZA (informative) ClausesofthisEurope

42、anStandardaddressingessentialrequirementsorotherprovisionsof EUDirectives ThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandthe EuropeanFreeTradeAssociation,andsupportsessentialrequirementsoftheEUDirective98/79/EC. WARNING OtherrequirementsandotherEUDirectivesmaybea

43、pplicabletotheproduct(s)fallingwithinthe scopeofthisstandard. Thefollowingclausesofthisstandard,asdetailedinTableZA.1,arelikelytosupportrequirementsoftheEU Directive98/79/EC. Compliancewiththeseclausesofthisstandardprovidesonemeansofconformingtothespecificessential requirementsoftheDirectiveconcerne

44、dandassociatedEFTAregulations. TableZA.1CorrespondencebetweenthisEuropeanStandardandDirective98/79/EC Clauses/subclausesof thisEuropeanStandard Correspondingessentialrequirementsof Directive98/79/EC Qualifyingremarks/Notes 4.1 A.1,A.2,B.2.1 4.2 B.2.1,B.2.2 4.3.1 B.2.2 4.3.2 B.2.2,B.2.5 4.3.3 B.2.1,B.2.2 4.4 B.2.1,B.2.2 5 B.8.4(j),B.8.7(q),B.8.