BS EN 867-5-2001 Non-biological systems for use in sterilizers - Specification for indicator systems and process challenge devices for use in performance testing for small steriliz.pdf

1、BRITISH STANDARD BS EN 867-5:2001 Non-biological systems for use in sterilizers Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S The European Standard EN 867-5:2001 has the status of a British Standard IC

2、S 11.080.10; 19.100 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 867-5:2001 This British Standard, having been prepared under the direction of the Sector Policy and Strategy Committee for Materials and Chemicals, was published under the authority of the Standards Polic

3、y and Strategy Committee on 18 October 2001 BSI 18 October 2001 ISBN 0 580 38542 6 National foreword This British Standard is the official English language version of EN 867-5:2001. The UK participation in its preparation was entrusted by Technical Committee LBI/35, Sterilizers, autoclaves and disin

4、fectors, to Subcommittee LBI/35/3, Sterilization indicators, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred t

5、o 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 Catalogue. A British Standard does not purport to include all the necessary provisions of a contra

6、ct. 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 text; present to the responsible European committee any enquiries on the interpretation, or prop

7、osals 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 inside front cover, the EN title page, pages 2 to 24, an inside back cover and a back cover. The BSI

8、 copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN8675 August2001 ICS11.080.10 Englishversion NonbiologicalsystemsforuseinsterilizersPart5: Specificationfo

9、rindicatorsystemsandprocesschallenge devicesforuseinperformancetestingforsmallsterilizersType BandTypeS Systmesnonbiologiquesdestinstreutilissdansdes strilisateursPartie5:Spcificationsdessystmes indicateursetdispositifsdpreuvedeprocddestins treutilisspourlesessaisdeperformancesrelatifsaux petitsstri

10、lisateursdeTypeBetdeTypeS NichtbiologischeSystemefrdenGebrauchin SterilisatorenTeil5:FestlegungenvonIndikatorsystemen undPrfkrpernfrdieLeistungsprfungvonKlein SterilisatorenvomTypBundvomTypS ThisEuropeanStandardwasapprovedbyCENon25July2001. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulat

11、ionswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(

12、English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greec

13、e, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2001CEN Allrightsofexploitationinanyformandbyanymeansre

14、served worldwideforCENnationalMembers. Ref.No.EN8675:2001EEN8675:2001(E) 2 Contents page Foreword3 Introduction . 4 1Scope . 4 2Normativereferences . 5 3Termsanddefinitions . 5 4Requirements6 5Testmethods . 12 6Marking,labellingandpackaging16 AnnexA (normative) Smallsteamexposureapparatusandsteamfor

15、testpurposes17 AnnexB (normative) Testcyclesforevaluationofindicatorperformanceintheporousloadprocess challengedevices19 AnnexC (normative) Testcyclesforevaluationofindicatorsystemsforuseinhollowloadprocess challengedevices22 AnnexD (normative) Testcyclesforevaluationofindicatorsystemsforuseinhollow

16、loadprocess challengedevices23 Bibliography24EN8675:2001(E) 3 Foreword ThisEuropeanStandardhasbeenpreparedbyTechnicalCommitteeCEN/TC 102“Sterilizersformedical purposes“,thesecretariatofwhichisheldbyDIN. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltext

17、or byendorsement,atthelatestbyFebruary2002,andconflictingnationalstandardsshallbewithdrawnatthelatest byFebruary2002. ThisEuropeanStandardhasbeenconsideredbyCEN/TC 102asoneofaseriesofEuropeanStandardsconcerned withnonbiologicalindicatorsusedinthetesting,monitoringandroutineoperationofsterilizers.The

18、sestandardsare: EN8671 NonbiologicalsystemsforuseinsterilizersPart1:Generalrequirements EN8672 NonbiologicalsystemsforuseinsterilizersPart2:Processindicators(ClassA) EN8673 NonbiologicalsystemsforuseinsterilizersPart3:SpecificationforClassBindicatorsforusein theBowieandDicktest EN8674 Nonbiologicals

19、ystemsforuseinsterilizersPart4:Specificationforindicatorsasanalternative totheBowieandDicktestforthedetectionofsteampenetration prEN8675 NonbiologicalsystemsforuseinsterilizersPart5:Specificationforindicatorsystemsand processchallengedevicesforuseinperformancetestingforsmallsterilizersTypeBandTypeS

20、InadditionCEN/TC 102WorkingGroup7haspreparedaseriesofEuropeanStandardsdescribingbiological indicatorsforuseinsterilizers.TheseEuropeanStandardsare: EN8661 BiologicalsystemsfortestingsterilizersandsterilizationprocessesPart1:Generalrequire ments EN8662 Biologicalsystemsfortestingsterilizersandsterili

21、zationprocessesPart2:Particularsystems foruseinethyleneoxidesterilizers EN8663 BiologicalsystemsfortestingsterilizersandsterilizationprocessesPart3:Particularsystems foruseinmoistheatsterilizers EN8664 BiologicalsystemsfortestingsterilizersandsterilizationprocessesPart4:Particularsystems foruseinirr

22、adiationsterilizers EN8665 BiologicalsystemsfortestingsterilizersandsterilizationprocessesPart5:Particularsystems foruseinlowtemperaturesteamandformaldehydesterilizers EN8666 BiologicalsystemsfortestingsterilizersandsterilizationprocessesPart6:Particularsystems foruseindryheatsterilizers EN8667 Biol

23、ogicalsystemsfortestingsterilizersandsterilizationprocesses Part 7:Particular requirementsforselfcontainedbiologicalindicatorsystemsforuseinmoistheatsterilizers EN8668 BiologicalsystemsfortestingsterilizersandsterilizationprocessesPart8:Particularrequire mentsforselfcontainedbiologicalindicatorsyste

24、msforuseinethyleneoxidesterilizers TheannexesA,B,CandDarenormative. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark,Finland, France,Germany,Greece,Iceland,Ireland,Italy

25、,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden, SwitzerlandandtheUnitedKingdom.EN8675:2001(E) 4 Introduction TheindicatorsandprocesschallengedevicesdescribedinthisEuropeanStandardareintendedspecificallyforusein carryingouttestsonsmallsteamsterilizers,TypeBorTypeS. prEN13060Parts2and4specifyreq

26、uirementsandtestsforsmallsteamsterilizersTypeBwhichareintendedto processsolidproducts,hollowproducts,andporousproductsanyofwhichmaybewrappedinoneormorelayersof sterilizationgradepackagingmaterials(seeEN868)andforsmallsteamsterilizersTypeSwhichmayalsobe specifiedbythemanufacturerofthesmallsteamsteril

27、izerasintendedtoprocesshollowproductsand/orporous products. Smallsterilizersunabletoaccommodateasterilizationmodule(600mmx300mmx300mm)cannotbetestedusing thetestsdescribedinEN285:1996forlargesterilizersforwrappedgoodsandporousloadseitherbecausethe chambersizeisunabletoaccommodatethestandardtestpacks

28、orbecausetheefficacyofthetestsisimpairedwhen thetestpackoccupiesalargeproportionofthechambervolume. TheindicatorsystemsdescribedinthisEuropeanStandardareintendedtobeused,inconjunctionwiththe appropriateprocesschallengedevice,todemonstratetherapidandcompletepenetrationofsteamintotheprocess challenged

29、evice.Theconstructionoftheprocesschallengedeviceandtheperformanceoftheindicatoraredesigned toensurethatpenetrationofsteamintheloadwithinthesterilizerwillprovideadequateassurancethatsteam penetrationwilloccurinroutineloads. 1Scope ThisEuropeanStandardspecifiestheperformancerequirementsandtestmethodsf

30、ornonbiologicalindicator systems,includingtheprocesschallengedeviceswithinwhichtheyareintendedtofunction,tobeusedfortestingthe steampenetrationperformanceofsmallsteamsterilizers,TypeBorTypeSwhereappropriate.Thetestsystems specifiedareintendedforuseonlyinsmallsteamsterilizersTypeBconformingtoprEN1306

31、02andhavingausable chamberspacegreaterthan10landforsmallsteamsterilizersTypeSconformingtoprEN130604alsohavinga usablechamberspacegreaterthan5l. Nonbiologicalindicatorsystemsandtheassociateprocesschallengedevicesarespecifiedforvarioustypesofload. Thepossibleloadsareconsideredintwoclasses:Porousloads,

32、whichcanbewrappedorunwrapped,orhollow instrumentloads,whichalsocanbewrappedorunwrapped. TherelevantsectionofthisEuropeanStandardonporousloadsspecifiestherequirementsfor: astandardprocesschallengedevicetobeusedinthesmallloadtestforporousloadsinsmallsteamsterilizers; anindicatorsystemforuseintheporous

33、loadprocesschallengedevice.AnindicatorforthispurposeisaClass BindicatorasdescribedinEN8671. anindicatoremployinganalternativeprocesschallengedeviceequivalenttotheporousloadprocesschallenge device. TherelevantsectionofthisEuropeanStandardonhollowinstrumentsspecifiestherequirementsfor: hollowloadproce

34、sschallengedevicestobeusedtosimulatehollowinstrumentloadsasdefinedinprEN13060 4; anindicatorsystem,foruseinoneofthehollowloadprocesschallengedevice,forassessingsteampenetration inawrappedloadofhollowinstruments.AnindicatorforthispurposeisaClassBindicatorasdescribedin EN8671. Theprocesschallengedevic

35、esdescribedinthisstandardareintendedforuseonlyinsterilizersofsufficientsizeto accommodatetheprocesschallengedevicewithnopartoftheprocesschallengedevicecloserthan20mmfromthe vesselwall;inthecaseoftheporousloadprocesschallengedevicethetotalinternalvolumeofthevesselisnotless than10l.EN8675:2001(E) 5 2N

36、ormativereferences ThisEuropeanStandardincorporates,bydatedorundatedreference,provisionsfromotherpublications.These normativereferencesarecitedattheappropriateplacesinthetext,andthepublicationsarelistedhereafter.Fordated referencessubsequentamendmentsto,orrevisionsof,anyofthesepublicationsapplytothi

37、sEuropeanStandardonly whenincorporatedintoitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthepublication referredtoapplies(includingamendments). EN285:1996 SterilizationSteamsterilizersLargesterilizers. EN8663 BiologicalsystemsfortestingsterilizersandsterilizationprocessesPart3:Particu

38、larsystemsforuseinmoist heatsterilizers. EN8671 NonbiologicalsystemsforuseinsterilizersPart1:Generalrequirements. EN8673:1997 NonbiologicalindicatorsystemsforuseinsterilizersPart3:SpecificationforClassBindicatorsforuseinthe BowieandDicktest. EN8674 NonbiologicalsystemsforuseinsterilizersPart4:Specif

39、icationforindicatorsasanalternativetotheBowieand Dicktestforthedetectionofsteampenetration. prEN130602 SmallsteamsterilizersPart2:ParticularrequirementsandtestmethodsfortypeBsterilizers,intendedforthe sterilizationofwrappedsolid,hollowandporousproducts. prEN130604 SmallsteamsterilizersPart4:Particul

40、arrequirementsandtestmethodsfortypeSsterilizers,intendedforthe sterilizationofproductsspecifiedbythemanufacturerofthesterilizer. EN20187 Paper,boardandpulpsStandardatmosphereforconditioningandtestingandprocedureformonitoringthe atmosphereandconditioningofsamples(ISO187:1990). EN20534 Paperandboard D

41、eterminationofthicknessandapparentbulkdensityorapparentsheetdensity (ISO534:1988). ENISO3696:1995 WaterforanalyticallaboratoryuseSpecificationandtestmethods(ISO3696:1987). ENISO5457:1999 TechnicalproductdocumentationSizesandlayoutofdrawingsheets(ISO5457:1999). ISO100121 Qualityassurancerequirementsf

42、ormeasuringequipmentPart1:Metrologicalconfirmationsystemformeasuring equipment. 3Termsanddefinitions ForthepurposesofthisEuropeanStandard,thedefinitionsgiveninEN8671andthefollowingdefinitionsapply: 3.1 hollowload deviceshavingaminimumdiameterof2mmorgreaterandnopointinternallyatadistancegreaterthan15

43、00times theminimuminternaldiameterfromdirectopenconnectionwiththesurroundingenvironmentEN8675:2001(E) 6 3.2 processchallengedevice objectwhichsimulatestheworstcaseofconditionsforattainmentofthespecifiedsterilizationconditionswithinthe itemstobesterilized NOTEThedeviceissoconstructedthatabiologicalornonbiologicalindicatorsystemcanbeplacedwithinthedevicein thepositionwhichitismostdifficultforthesterilizingagenttoreach.Thedesignoftheprocesschallengedevicedepends on thenatureofthegoodstobesterilizedandthesterilization