EN 12462-1998 生物技术 泵性能标准

CENEuropeanCommitteeforStandardizationComiteÂEuropeÂendeNormalisationEuropaÈischesKomiteefuÈrNormungCentralSecretariat:ruedeStassart36,B-1050Brussels©1998CENAllrightsofexploitationinanyformandbyanymeansreservedworldwideforCENnationalMembers.Ref.No.EN12462:1998EEUROPEANSTANDARDEN12462NORMEEUROPEÂENNEEUROPAÈISCHENORMJuly1998ICS07.080;23.080Descriptors:biotechnology,worksafety,accidentprevention,environmentalprotection,hazards,contamination,micro-organisms,transgenicmicro-organisms,laboratoryequipment,pumps,specifications,operatingrequirements,leaktightness,cleaning,sterilization,classificationsEnglishversionBiotechnologyÐPerformancecriteriaforpumpsBiotechnologieÐCriteÁresdeperformancepourlespompesBiotechnikÐLeistungskriterienfuÈrPumpenThisEuropeanStandardwasapprovedbyCENon1July1998.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCentralSecretariathasthesamestatusastheofficialversions.CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom.Page2EN12462:1998©BSI1998ForewordThisEuropeanStandardhasbeenpreparedbyTechnicalCommitteeCEN/TC233,Biotechnology,theSecretariatofwhichisheldbyAFNOR.ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbyJanuary1999,andconflictingnationalstandardsshallbewithdrawnatthelatestbyJanuary1999.ThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropeanFreeTradeAssociation.AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnitedKingdom.ContentsPageForeword2Introduction31Scope32Normativereferences33Definitions34Hazards45Performanceclasses46Typesofpumps57Classificationandverificationofperformance68Markingandpackaging69Documentation6AnnexA(informative)Bibliography7Page3EN12462:1998©BSI1998IntroductionThemechanicalsafetyofpumps,whicharewidelyusedinbiotechnologicalprocesses,iscoveredbyEN292-1andEN292-2.However,itisimportanttoconsidertheperformanceofpumpsusedintheseprocesseswithregardtothepotentialhazardposedbythemicro-organisminuse.Forsomemicro-organisms,additionaltechnologyisneededtopreventtheirreleasetotheenvironment.Considerationshouldbegiventoworkers,theenvironmentandthepublicingeneral.Useofthisstandardcanfacilitatethespecificationwithregardtobiosafetyperformanceofpumpsbythemanufacturerinaformwhichcanbeeasilyunderstoodandreadilyutilizedbytheenduser.1ScopeThisEuropeanStandardspecifiesperformancecriteriaforpumpsusedinbiotechnologicalprocesses,inwhichthereleaseofmicro-organismsshouldbelimitedorpreventedforreasonsofsafety.Thisstandardappliesiftheintendeduseofthepumpincludeshazardousorpotentiallyhazardousmicro-organisms.Thisstandardappliestopumpswithnoauxiliaryequipment,borderedbytheconnectionsontheunitofequipment.Italsoappliestopumpsystemsequippedwithallauxiliaryequipmentnecessaryforoperationofpumpsandtoaccomplishcleaningandsterilization.NOTEAdditionalcriteriaforindividualcomponentsofequipmentsuchaspipesandcouplingsaregiveninPerformancecriteriaforpipingandinstrumentationÐPart1:Generalperformancecriteria(seeannexA[9])andPerformancecriteriaforpipingandinstrumentationÐPart2:Couplings(seeannexA[7]).ThesetwoEuropeanStandardsarebeingprepared.2NormativereferencesThisEuropeanStandardincorporatesbydatedorundatedreference,provisionsfromotherpublications.Thesenormativereferencesarecitedattheappropriateplacesinthetextandthepublicationsarelistedhereafter.Fordatedreferences,subsequentamendmentstoorrevisionsofanyofthesepublicationsapplytothisEuropeanStandardonlywhenincorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthepublicationreferredtoapplies.EN285,SterilizationÐSteamsterilizersÐLargesterilizers.EN292-1,SafetyofmachineryÐBasicconcepts,generalprinciplesfordesignÐPart1:Basicterminology,methodology.EN292-2,Technicalprinciplesandspecifications.EN1672-2,FoodprocessingmachineryÐBasicconceptsÐPart2:Hygienerequirements.EN12296,BiotechnologyÐEquipmentÐGuidanceontestingproceduresforcleanability.EN12297,BiotechnologyÐEquipmentÐGuidanceontestingproceduresforsterilizability.EN12298,BiotechnologyÐEquipmentÐGuidanceontestingproceduresforleaktightness.ISO4287,GeometricalProductSpecifications(GPS)ÐSurfacetexture:ProfilemethodÐTerms,definitionsandsurfacete