1、BRITISH STANDARD BS EN 13312-6:2001 Biotechnology Performance criteria for piping and instrumentation Part 6: Equipment probes The European Standard EN 13312-6:2001 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
2、13312-6:2001 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 37461 0 National foreword This British Standard
3、 is the official English language version of EN 13312-6:2001. 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-
4、references 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
5、Catalogue. 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 th
6、e 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 in
7、side 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 NORMEEUROPENNE EUROPISCHENORM EN133126 F
8、ebruary2001 ICS07.080;07.100.01 Englishversion BiotechnologyPerformancecriteriaforpipingand instrumentationPart6:Equipmentprobes BiotechnologieCritresdeperformancepourtuyauteries etinstrumentationPartie6:Sondesdinstrumentation BiotechnikLeistungskriterienfrLeitungssystemeund InstrumentierungTeil6:Ge
9、rtesonden ThisEuropeanStandardwasapprovedbyCENon13January2001. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational st
10、andardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe offi
11、cial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISC
12、HESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2001CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN133126:2001EPage2 EN133126:2001 Contents Page Foreword. 3 Introduction 4 1 Scope. 4 2 Normativereferences . 4 3 Termsanddefinition
13、s. 4 4 Hazards 5 5 Performanceclasses 5 6 Classificationandverificationofperformance. 5 7 Markingandpackaging 6 8 Documentation6 AnnexA(informative)Guidanceontestmethodsfordetermining leaktightnessofequipmentprobes 7 Bibliography .8Page3 EN133126:2001 Foreword ThisdraftEuropeanStandardhasbeenprepare
14、dbytheTechnicalCommitteeCEN/TC233 “Biotechnology“,thesecretariatofwhichisheldbyAFNOR. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherby publicationofanidenticaltextorbyendorsement,atthelatestbyAugust2001,and conflictingnationalstandardsshallbewithdrawnatthelatestbyAugust2001. Thi
15、sEuropeanStandardhasbeenpreparedunderamandategiventoCENbythe EuropeanCommissionandtheEuropeanFreeTradeAssociation. ThisstandardisoneofaseriesofEuropeanStandardsconcernedwithperformancecriteria forpipingandinstrumentation.Thesestandardsare: EN133121, BiotechnologyPerformancecriteriaforpipingandinstru
16、mentationPart1: Generalperformancecriteria. EN133122, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart2: Couplings. EN133123, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart3: Samplingandinoculationdevices. EN133124, BiotechnologyPerformancecriteriaforpipingandinstrume
17、ntationPart4: Tubesandpipes. EN133125, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart5: Valves. EN133126, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart6: Equipmentprobes. Thisstandardincludesabibliography. AccordingtotheCEN/CENELECInternalRegulations,thenationalsta
18、ndardsorganizations ofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnited Kingdom.Page4 EN133126:2001 Introduction Equipmen
19、tprobesaredevicesusedtomeasureprocessparameterssuchaspH, concentrationofoxygen,biomassandothersubstratesandproducts,temperature, pressure,foamlevelandconductivity.Theyareinsertedintoapieceofequipmentthrough thebarrierthatenclosestheclosedsystem.Thereforeprobescanbeindirectcontactwith themicroorganis
20、msbeingusedintheprocess. Usuallyameasuringsystemorameasuringchainconsistsofaequipmentprobecontaining asensor,asignaltransmitterandasignalindicator.Themeasuringsystemcanbestand aloneorcoupledtoamonitoringandcontrolsystem. Theperformancecriteriacleanabilityandsterilizabilitywillbeinfluencedbythedesign
21、ofthe probe,whereasthecriterionleaktightnesswillbemainlyinfluencedbythewaytheprobeis housedintheequipment. UseofthisEuropeanStandardwillaidtheequipmentmanufacturerintheclassificationof equipmentprobeswithregardtosafeperformanceinbiotechnologicalprocesses.The classificationiseasilyunderstandableandre
22、adilyutilizablebytheuserandtheregulatory authorities. 1 Scope ThisEuropeanStandardspecifiesperformancecriteriaforequipmentprobesusedin biotechnologicalprocesseswithrespecttothepotentialhazardstotheworkerandthe environmentfrommicroorganismsinuse. ThisEuropeanStandardapplieswheretheintendeduseoftheequ
23、ipmentprobesincludes hazardousorpotentiallyhazardousmicroorganismsusedinbiotechnologicalprocessesor whereexposureoftheworkerortheenvironmenttosuchmicroorganismsisrestrictedfor reasonsofsafety. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedorundatedreference,provisionsfromother publica
24、tions.Thesenormativereferencesarecitedattheappropriateplacesinthetextand thepublicationsarelistedhereafter.Fordatedreferences,subsequentamendmentstoor revisionsofanyofthesepublicationsapplytothisEuropeanStandardonlywhen incorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe
25、publicationreferredtoapplies(includingamendments). EN133121:2001, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart 1:Generalperformancecriteria. 3 Termsanddefinitions Forthepurposesofthisstandard,thetermsanddefinitionsgiveninEN133121:2001 apply.Page5 EN133126:2001 4 Hazards Thefollowi
26、nghazardsshallbetakenintoaccount. a)Releaseofmicroorganismscausedbynoncompatibilityofequipmentprobesand ports. b)Releaseofmicroorganismscausedbydeteriorationofthegasket. c)Releaseofmicroorganismscausedbyimproperreplacementofgaskets. d)Releaseofmicroorganismscausedbylooseningoftheequipmentprobe. e)Re
27、leaseofmicroorganismscausedbybreakageoftheequipmentprobe. f)Releaseofmicroorganismscausedbytransportofmicroorganismsthroughthebarrier oftheclosedsystemifthepositionofaslidingequipmentprobeisadjusted. Hazardsmentionedundera),b),c)andd)arediscussedinmoredetailinEN133122(see 1)andEN133123(see2). Althou
28、ghthisstandarddoesnotapplytotheconsequencesofmalfunctioningofthe measuringsystemofwhichtheequipmentprobeispart,thefollowingshallbetakeninto account: releaseofmicroorganismscanoccurcausedbymalfunctioningofthemeasuring system,leadingtonoorincorrectactionsbasedonmisinformation; releaseofmicroorganismsw
29、henopeningordismantlingtheequipmentcausedby inadequateinactivationprocedureresultingfrommalfunctioningofpressureand/or temperatureindicators. 5 Performanceclasses Theequimentprobeshallbeclassifiedforleaktightness,cleanabilityandsterilizabilityin accordancewith5.1to5.4ofEN133121:2001. Theselectionoft
30、heappropriateclassforperformanceofanequipmentprobeshallbemade inaccordancewith5.5ofEN133121:2001. 6 Classificationandverificationofperformance 6.1 General Theequipmentprobesshallconformtothegeneralrequirementsgivenin6.1ofEN13312 1:2001.Page6 EN133126:2001 6.2 Leaktightness Theequipmentprobesshallcon
31、formtotherequirementsgivenin6.2ofEN133121:2001. GuidanceontestmethodsfordeterminingleaktightnessofequipmentisgiveninannexA. NOTEGenerallyequipmentprobesaredesignedtobeleaktighttoaspecified maximumpressureandmaybeverifiedbypressuretestingwhennecessary. Pressuretestingaloneisnotproofofleaktightnessfor
32、microbiologicaluse. 6.3 Cleanability Theequipmentprobesshallconformtotherequirementsgivenin6.3ofEN133121:2001. 6.4 Sterilizability Theequipmentprobesshallconformtotherequirementsgivenin6.4ofEN133121:2001. 7 Markingandpackaging Theequipmentprobesshallconformtotherequirementsgivenin clause7ofEN13312 1
33、:2001. 8 Documentation Theequipmentprobesshallconformtotherequirementsgivenin clause8ofEN13312 1:2001.Page7 EN133126:2001 AnnexA(informative) Guidanceontestmethodsfordeterminingleaktightnessofequipmentprobes AlistoftestmethodsforleaktightnessisgivenintableA.1ofEN12298:1998(see3). Fromthatlistsuitabl
34、etestmethodstothetestingofequipmentprobesaregivenintable A.1. TableA.1Suitablealternativeleaktightnesstestmethodsforequipmentprobes Number Testmethod 1 Pressurelossgas/air 2 Pressurelossliquid 5 Thermalconductivity 11 Electronicparticlecounting 12 Traceraerosol(NaCl) 14 Qualitativebioaerosolmonitori
35、ng 15 QuantitativebioaerosolmonitoringPage8 EN133126:2001 Bibliography 1 EN133122, BiotechnologyPerformancecriteriaforpipingandinstrumentation Part2:Couplings. 2 EN133123, BiotechnologyPerformancecriteriaforpipingandinstrumentation Part3:Samplingandinoculationdevices. 3 EN12298:1998, BiotechnologyEq
36、uipmentGuidanceontestingproceduresfor leaktightness.blankBS EN 13312-6:2001 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British Standards. It presents the UK view on standards in Europe and at the internati
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