1、BRITISH STANDARD BS EN 13312-4:2001 Biotechnology Performance criteria for piping and instrumentation Part 4: Tubes and pipes The European Standard EN 13312-4:2001 has the status of a British Standard ICS 07.080; 07.100.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 1
2、3312-4:2001 This British Standard, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 April 2001 BSI 04-2001 ISBN 0 580 37459 9 National foreword This British Standard
3、is the official English language version of EN 13312-4:2001. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-r
4、eferences The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic C
5、atalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the
6、 text; present to the responsible 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 comprises a front cover, an ins
7、ide front cover, the EN title page, pages 2 to 9 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 NORMEEUROPENNE EUROPISCHENORM EN133124 February2001 ICS07.080;0
8、7.100.01 Englishversion BiotechnologyPerformancecriteriaforpipingand instrumentationPart4:Tubesandpipes BiotechnologieCritresdeperformancepourtuyauteries etinstrumentationPartie4:Tubesettuyauterie BiotechnikLeistungskriterienfrLeitungssystemeund InstrumentierungTeil4:RohreundRohrleitungen ThisEurope
9、anStandardwasapprovedbyCENon13January2001. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtained
10、onapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENme
11、mbersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG
12、ManagementCentre:ruedeStassart,36B1050Brussels 2001CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN133124:2001EPage2 EN133124:2001 Contents Page Foreword.3 Introduction 4 1 Scope.4 2 Normativereferences .4 3 Termsanddefinitions.4 4 Hazards4 5 Perfor
13、manceclasses 5 6 Classificationandverificationofperformance.5 7 Markingandpackaging 6 8 Documentation6 AnnexA(informative)Guidanceontestmethodsfordetermining leaktightness,cleanabilityandsterilizabilityoftubesandpipes.7 AnnexB(informative)Guidanceofdesignfortubesandpipes8 Bibliography .9Page3 EN1331
14、24:2001 Foreword ThisEuropeanStandardhasbeenpreparedbyTechnicalCommitteeCEN/TC233 “Biotechnology“,thesecretariatofwhichisheldbyAFNOR. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherby publicationofanidenticaltextorbyendorsement,atthelatestbyAugust2001,and conflictingnationalstand
15、ardsshallbewithdrawnatthelatestbyAugust2001. ThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbythe EuropeanCommissionandtheEuropeanFreeTradeAssociation. ThisstandardisoneofaseriesofEuropeanStandardsconcernedwithperformancecriteria forpipingandinstrumentation.Thesestandardsare: EN133121, Bi
16、otechnologyPerformancecriteriaforpipingandinstrumentationPart1: Generalperformancecriteria. EN133122, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart2: Couplings. EN133123, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart3: Samplingandinoculationdevices. EN133124, Biot
17、echnologyPerformancecriteriaforpipingandinstrumentationPart4: Tubesandpipes. EN133125, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart5: Valves. EN133126, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart6: Equipmentprobes. Thisstandardincludesabibliography. Accordingto
18、theCEN/CENELECInternalRegulations,thenationalstandardsorganizations ofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnited K
19、ingdom.Page4 EN133124:2001 Introduction UseofthisEuropeanStandardwillaidtheequipmentmanufacturerintheclassificationof tubesandpipeswithregardtosafeperformanceinbiotechnologicalprocesses.The classificationiseasilyunderstandableandreadilyutilizablebytheuserandtheregulatory authorities. 1 Scope ThisEur
20、opeanStandardspecifiesperformancecriteriafortubesandpipesusedin biotechnologicalprocesseswithrespecttothepotentialhazardstotheworkerandthe environmentfrommicroorganismsinuse. ThisEuropeanStandardapplieswheretheintendeduseofthetubesandpipesincludes hazardousorpotentiallyhazardousmicroorganismsusedinb
21、iotechnologicalprocessesor whereexposureoftheworkerortheenvironmenttosuchmicroorganismsisrestrictedfor reasonsofsafety.ThisEuropeanStandardisalsoapplicabletoflexiblepipesandtubes. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedorundatedreference,provisionsfromother publications.Theseno
22、rmativereferencesarecitedattheappropriateplacesinthetextand thepublicationsarelistedhereafter.Fordatedreferences,subsequentamendmentstoor revisionsofanyofthesepublicationsapplytothisEuropeanStandardonlywhen incorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe publicationre
23、ferredtoapplies(includingamendments). EN133121:2001, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart 1:Generalperformancecriteria. 3 Termsanddefinitions Forthepurposesofthisstandard,thetermsanddefinitionsgiveninEN133121:2001 apply. 4 Hazards Thefollowinghazardsshallbetakenintoaccount
24、. a)Releaseofmicroorganismscausedbyincorrectlyweldedjointsandseams. NOTE1Discontinuitiesintheinternalsurfacelikeexcessivepenetrationor undercutcanharboursoilandcanpreventdrainage.Poorweldingtechniquessuch asmisalignment,lackofadequateremovalofoxygentopreventoxidationduring welding,uneventemperaturea
25、ndunevenspeedcanalsoresultinavarietyof surfaceimperfectionsandpoorweldpenetrationandpossibleleakages. b)Releaseofmicroorganismscausedbymismatchingoftubesandpipesresultingin inappropriatecleaningandthereforeinappropriatesterilization.Page5 EN133124:2001 NOTE2Mismatchingleadstoincorrectlyweldedjoints.
26、Thisisverylikelytooccur becausethereisamultiplicityofinternalandexternalsizesandcombinationshereof withinexistingstandards(see1,2,3,4,5,6,7,8,9,10and11). Furthermore,manyofthesesizesareveryclosetoeachotherandcannotbe differentiatedinexistinginstallationmerelybymeasuringtheirexternaldiameters. NOTE3D
27、istortionfromtheoriginaldimensionsoftubesandpipesduringtransport cancausemismatching. c)Poorinstallationdesignresultingindeadspotsandsoiltraps,inadequatemechanical support,poordrainageandcoldspots.Poorinstallationdesigncaninitselfreducethe performanceclassesforcleanabilityandsterilizabilitybelowthat
28、whichisrequired. d)Inadequatematerialsused,evensometypesofstainlesssteel,leadingtoavarietyof corrosionmechanisms,abrasionandchemicalattackbyprocessandcleaningmaterials. Useofthesematerialscanreducetheperformanceclassesforcleanability,leaktightness andsterilizabilitybelowthatwhichisrequired. e)Releas
29、eofmicroorganismscausedbyoverpressurizingofespeciallyflexibletubes and/orhightemperatureand/oraggressivemedia. f)Releaseofmicroorganismscausedbybreakageresultingfromfatigueandoverflexing. 5 Performanceclasses Thetubesandpipesshallbeclassifiedforleaktightness,cleanabilityandsterilizabilityin accordan
30、cewith5.1to5.4ofEN133121:2001. Theselectionoftheappropriateclassforperformanceoftubesandpipesshallbemadein accordancewith5.5ofEN133121:2001. NOTE1Leaktightnessoftubesandpipescanbeobtainedbyaqualityassurance approachtomanufactureandinstallation.Inparticular,jointsshouldbewelded whereverpossibleandwel
31、dingpracticeshouldbedocumented.Orbitalwelding shouldbeusedwherepossible. NOTE2Inspectionofweldsbyboroscopyandradiographycanbecarriedoutona specificpercentageofwelds.Intheeventoffailuresonneighbouringseamwelds,all weldsinthesameweldingrun(man,day)shouldbeexamined.Failureofseamwelds canbeavoidedbyqual
32、ityassuranceofthesupplier,usingaqualitysystemin accordancewithENISO9001:1994(see12)orequivalent. 6 Classificationandverificationofperformance Tubesandpipesshallconformtothegeneralrequirementsgiveninclause6ofEN13312 1:2001.Tubesandpipesthatareanintegralpartofaunitofequipmentshallmeetthe performancere
33、quirementsforthatunitofequipment. Guidanceontestmethodsfordeterminingleaktightnessoftubesandpipesisgivenin annexA. GuidanceondesignfortubesandpipesisgiveninannexB.Page6 EN133124:2001 7 Markingandpackaging Tubesandpipesshallconformtotherequirementsgivenin clause7ofEN133121:2001. 8 Documentation Tubes
34、andpipesshallconformtotherequirementsgivenin clause8ofEN133121:2001.Page7 EN133124:2001 AnnexA(informative) Guidanceontestmethodsfordeterminingleaktightness,cleanabilityand sterilizabilityoftubesandpipes AlistoftestmethodsforleaktightnessisgivenintableA.1ofEN12298:1998(see13). Fromthatlistsuitablete
35、stmethodstothetestingoftubesandpipesaregivenintableA.1. TableA.1Suitablealternativeleaktightnesstestmethodsfortubesandpipes Number Testmethod 1 Pressurelossgas/air 2 Pressurelossliquid 3 Heliumprobe 4S F 6 ,e.g.Freon a probe 5 Thermalconductivity 6 Ultrasonics 8 Tracerliquiddyes 12 Traceraerosol(NaC
36、l) 14 Qualitativebioaerosolmonitoring 15 Quantitativebioaerosolmonitoring 17 Surfaceconductivity 19 Bacteriatightness NOTERestrictiveuseofSF 6shouldbeconsideredduetoenvironment protection a Freonisanexampleofasuitableproductavailablecommercially.This informationisgivenfortheconvenienceoftheuserofthi
37、sStandardand doesnotconstituteanendorsementofCENoftheseproducts.Page8 EN133124:2001 AnnexB(informative) Guidanceofdesignfortubesandpipes B.1 Materials Stainlesssteelwithanappropriatecorrosionresistanceshouldbeused.Itshouldbein accordancewithEN100881:1995(see7)orsimilar.Optimalcleanabilityandimproved
38、 corrosionresistancearegivenbyelectromechanicalpolishingmaterial.Incaseofhigher requirementsoncorrosionresistance,e.g.onchloridecontainingmedia,stainlesssteel 1.4539(see6)shouldbeused. B.2 Welding Orbitalweldingshouldbeusedwhereverpossible.OrbitalThungstenInertGas(TIG) weldingwithargonUgasprotection
39、shouldbeused.Allweldingoperatorsshouldproduce sampleweldswhichmeetrequirements. Weldedjointsarepreferredtocouplingsunlessademountablefacilityisrequired.The numberofweldsshouldbeminimisedbycarefuldesignandbyuseofpipebendingrather thanuseofprefabricatedcomponentssuchaselbows.Valves,couplings,teesandot
40、her componentsshouldasfaraspossiblehaveextendedweldonstubsinordertopermituseof closedheadorbitalwelders.Weldqualityshouldbecontrolledbydocumentationof parametersused,timeanddayofweld,identityofoperatorandpurgesectionandlocation ofweld.Internalaccessibleseamweldscanbesubjectedtoboroscopicinspectionan
41、d radiologicalinspectionbyanindependentinspector. Toavoidfailureofseamweldsorpoorweldquality,thespecificationandapprovalof weldingproceduresformetallicmaterialsshouldbeinaccordancewithEN2883:1992(see 14).Informationonpossiblefailureofseamweldsandpoorweldqualityisgivenin ENISO65201:1998(see15). B.3 D
42、imensions Tubesandpipeswithtightlycontrolleddimensionsshouldbeusedtoavoidmismatchingin respecttointernaldiameter,externaldiameterorovality,forexamplemetrictubingwith ovalitytolerancesinaccordancewithISO1127(see1),orequivalentswithfinertolerances forinternaldiameter,externaldiameterorovality(see4).Qu
43、alityassuranceofthis specificationfortheasdeliveredmaterialshouldbedocumentedunderENISO9001:1994 (see12)oranequivalentqualitymanagementsystem. B.4 Surfaceroughness Seamweldedandcolddrawntubeispreferredtoseamweldedbeadrolledtubebecauseof thesuperiorsurfacefinish.Incaseorrequirementsofbetterroughnessandcorrosion resistanceanelectrochemicalpolishingofstainlesssteelpipesshouldbepreferredwhere applicable.Page9 EN133124:2001 Bibliography 1 ISO1127:1992, StainlesssteeltubesDimensions,tolerancesandconventional massesperunitlength . 2 ISO2037:1992, Stainlesssteeltubesforthefoodindustry. 3 BS4825,
