EN ISO 11138-2-2017 医疗保健产品消毒. 生物指标. 第2部分 环氧乙烷灭菌过程生物指标Sterilization of health care products

BSENISO11138-2:2017

BSIStandardsPublication

Sterilizationofhealth

careproducts—Biological

indicators

Part2:Biologicalindicatorsforethyleneoxidesterilizationprocesses(ISO

11138-2:2017)

bsi.

BSENISO11138-2:2017

BRITISHSTANDARD

Nationalforeword

ThisBritishStandardistheUKimplementationofENISO

11138-2:2017.ItsupersedesBSENISO11138-2:2009whichiswithdrawn.

TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/198,SterilizationandAssociatedEquipmentand

Processes.

Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.

Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.

@TheBritishStandardsInstitution2017.

PublishedbyBSIStandardsLimited2017

ISBN9780580898327

ICS11.080.01

CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.

ThisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon30April2017.

Amendments/corrigendaissuedsincepublication

DateTextaffected

EUROPEANSTANDARD

NORMEEUROPÉENNE

EUROPÄISCHENORM

ENISO11138-2

March2017

ICS11.080.20

SupersedesENISO11138-2:2009

EnglishVersion

Sterilizationofhealthcareproducts-Biologicalindicators

-Part2:Biologicalindicatorsforethyleneoxide

sterilizationprocesses(IS011138-2:2017)

Stérilisationdesproduitsdesanté-Indicateurs

biologiques-Partie2:Indicateursbiologiquespourla

stérilisationàI'oxyded'éthylène(ISO11138-2:2017)

SterilisationvonProduktenfurdie

Gesundheitsfürsorge-BiologischeIndikatoren-Teil2:BiologischeIndikatorenfürSterilisationsverfahrenmit

Ethylenoxid(ISO11138-2:2017)

ThisEuropeanStandardwasapprovedbyCENon19January2017.

CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferences

concerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementCentreortoanyCENmember.

ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCEN-CENELECManagementCentrehasthesamestatusastheofficialversions.

CENmembersarethenationalstandardsbodiesofAustria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,FormerYugoslavRepublicofMacedonia,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,

Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,TurkeyandUnitedKingdom.

EUROPEANCOMMITTEEFORSTANDARDIZATION

COMITÉEUROPÉENDENORMALISATION

EUROPÄISCHESKOMITEEFÜRNORMUNG

CEN-CENELECManagementCentre:AvenueMarnix17,B-1000Brussels

@2017

CENAllrightsofexploitationinanyformandbyanymeansreserved

worldwideforCENnationalMembers.

Ref.No.ENISO11138-2:2017E

3

BSENISO11138-2:2017

ENISO11138-2:2017(E)

Europeanforeword

Thisdocument(ENIS011138-2:2017)hasbeenpreparedbyTechnicalCommitteeISO/TC198“SterilizationofhealthcareproductsincollaborationwithTechnicalCommitteeCEN/TC102“Sterilizersandassociatedequipmentforprocessingofmedicaldevices”,thesecretariatofwhichisheldbyDIN.

ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbySeptember2017andconflictingnationalstandardsshallbewithdrawnatthelatestbySeptember2017.

Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.CEN[and/orCENELEC]shallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.

ThisdocumentsupersedesENIS011138-2:2009.

Thestandardisafulltechnicalrevisionofthepreviousversion.ThefollowingamendmentshavebeenmadeincomparisonwithENISO11138-2:2009:

一requirementsonpopulationandresistance(clause9)revised,rmationtominimumD-valueat30℃deleted;

一AnnexA,inparticularA.2.4step6revised;

—informativeAnnexBonrationalefortheinclusionofasecondD-valueanddeletionoftherequirementforaminimumD-valueat30℃added;

一informativeAnnexZArespectiverelationshipbetweenthisEuropeanStandardandtheessentialrequirementsofDirective93/42/EEC[O]L169]aimedtobecoveredwasdeleted.

ENISO11138consistsofthefollowingparts,underthegeneraltitleSterilizationofhealthcare

products—Biologicalindicators:

一Part1:Generalrequirements

一Part2:Biologicalindicatorsforethyleneoxidesterilizationprocesses

一Part3:Biologicalindicatorsformoistheatsterilizationprocesses

一Part4:Biologicalindicatorsfordryheatsterilizationprocesses

一Part5:Biologicalindicatorsforlow-temperaturesteamandformaldehydesterilizationprocesses

AccordingtotheCEN-CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,FormerYugoslavRepublicofMacedonia,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,

Netherlands,Norway,Poland,Portugal,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,TurkeyandtheUnitedKingdom.

4

BSENISO11138-2:2017ENISO11138-2:2017(E)

Endorsementnotice

ThetextofISO11138-2:2017hasbeenapprovedbyCENasENISO11138-2:2017withoutany

modification.

BSENISO11138-2:2017ISO11138-2:2017(E)

Contents

Page

Foreword iv

Introduction V

1Scope

1

2Normativereferences

1

3Termsanddefinitions

1

4Generalrequirements

1

5Testorganism

1

6Suspension

2

7Carrierandprimarypackaging

2

8Inoculatedcarriersandbiologicalindicators

2

9Populationandresistance

2

AnnexA(normative)Methodfordeterminationofresistancetoethyleneoxidesterilization……4

AnnexB(informative)RationalefortheinclusionofasecondminimumDvalue

specificationasaresultofchangestothetestgasusedtoevaluateresistanceand

deletionoftherequirementforaminimumDvalueat30℃

5

Bibliography

6

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BSENISO11138-2:2017

ISO11138-2:2017(E)

Foreword

ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(IS0memberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.

TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.InparticularthedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentsshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(see/directives).

Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.DetailsofanypatentrightsidentifiedduringthedevelopmentofthedocumentwillbeintheIntroductionand/orontheISOlistofpatentdeclarationsreceived(see/patents).

Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.

Foranexplanationonthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISO'sadherencetotheWorldTradeOrganization(WTO)principlesintheTechnicalBarrierstoTrade(TBT)seethefollowingURL:/iso/foreword.html.

ThisdocumentwaspreparedbyTechnicalCommitteeISO/TC198,Sterilizationofhealthcareproducts.

Thisthirdeditioncancelsandreplacesthesecondedition(IS011138-2:2006),whichhasbeentechnicallyrevised.

AlistofallpartsofISO11138canbefoundontheISOwebsite.

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BSENISO11138-2:2017ISO11138-2:2017(E)

Introduction

ISO11138-1specifiesproduction,labelling,testmethodsandperformancerequirementsforthemanufactureofbiologicalindicatorsincludinginoculatedcarriersandsuspensionsintendedforuseinvalidationandmonitoringofsterilizationprocesses.Thisdocumentgivesspecificrequirementsforthosebiologicalindicatorsintendedforuseinethyleneoxidesterilizationprocesses.

TheISO11138seriesrepresentsthecurrent"state-ofthe-art"accordingtotheexpertsrepresentingmanufacturers,usersandregulatoryauthoritiesinvolvedindevelopingthestandard.Theintentisnottopromotetheuseofbiologicalindicatorswheresuchuseisnotadvised,butrathertoprovidecommonrequirementsfortheproductionofthosebiologicalindicatorsthatareknowntobeinusetoday.

Standardsexistprovidingrequirementsforthevalidationandcontrolofethyleneoxidesterilization(seeISO11135andISO14937).

NOTEItispossiblethatsomecountriesorregionshavepublishedotherstandardscoveringrequirementsforsterilizationorbiologicalindicators.

Adviceonselection,useandinterpretationofresultswhenusingbiologicalindicatorscanbefoundinISO14161.

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BSENISO11138-2:2017

INTERNATIONALSTANDARD

BSEN

ISO

ISO11138-2:2017

11138-2:2017(E)

Sterilizationofhealthcareproducts—Biological

indicators

Part2:

Biologicalindicatorsforethyleneoxidesterilization

processes

1Scope

Thisdocumentspecifiesrequirementsfortestorganisms,suspensions,inoculatedcarriers,biologicalindicatorsandtestmethodsintendedforuseinassessingtheperformanceofsterilizersandsterilizationprocessesemployingethyleneoxidegasasthesterilizingagent,eitheraspureethyleneoxidegasormixturesofthisgaswithdiluentgases,atsterilizingtemperatureswithintherangeof29℃to65℃.

NOTE1Requirementsforvalidationandcontrolofethyleneoxidesterilizationprocessesareprovidedby

ISO11135andISO14937.

NOTE2Nationalorregionalregulationscanproviderequirementsforworkplacesafety.

2Normativereferences

Thefollowingdocumentsarereferredtointhetextinsuchawaythatsomeoralloftheircontentconstitutesrequirementsofthisdocument.Fordatedreferences,onlytheeditioncitedapplies.For

undatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.

ISO11138-1:2017,Sterilizationofhealthcareproducts—Biologicalindicators—Part1:Generalrequirements

ISO18472,Sterilizationofhealthcareproducts—Biologicalandchemicalindicators—Testequipment

3Termsanddefinitions

Forthepurposesofthisdocument,thetermsanddefinitionsgiveninISO11138-1apply.

ISOandIECmaintainterminologicaldatabasesforuseinstandardizationatthefollowingaddresses:

—IECElectropedia:availableat/

一ISOOnlinebrowsingplatform:availableat

/obp/

4Generalrequirements

TherequirementsofISO11138-1apply.

5Testorganism

5.1ThetestorganismsshallbesporesofBacillusatrophaeus,Bacillussubtilisorotherstrainsof

microorganismsofdemonstratedequivalentperformanceasrequiredbythisdocument.

NOTE1SomestrainsofBacillussubtilishavebeenreclassifiedasBacillusatrophaeus.

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NOTE2BacillusatrophaeusATCC9372,NCTC10073,NCIMB8058,DSM2277,NRRLB-4418andCIP77.18havebeenfoundtobesuitable¹).

5.2IfatestorganismotherthanBacillusatrophaeusisused,thesuitabilityoftheresistanceofthattestorganismshallbedetermined.

6Suspension

TherequirementsofISO11138-1apply.

7Carrierandprimarypackaging

7.1ThesuitabilityofthecarrierandprimarypackagingmaterialsforbiologicalindicatorsforuseinethyleneoxidesterilizationprocessesshallbedemonstratedinaccordancewiththerequirementsofISO11138-1:2017,5.2andAnnexB.

7.2Theexposureconditionstodeterminecomplianceshallbe

a)minimumexposuretemperature:greaterthanorequalto55℃,

b)sterilizingagent:ethyleneoxidegasataconcentrationnotlessthan800mg/linairatgreaterthanorequalto70%RH

c)maximumexposuretemperature:asstatedbythebiologicalindicatormanufacturer,and

d)exposuretime:greaterthanorequalto6h.

NOTETheseconditionshavebeenselectedtorepresentarealisticchallengetothecarrierwhileremainingwithinthepracticallimitsofanethyleneoxidesterilizationprocess.

8Inoculatedcarriersandbiologicalindicators

TherequirementsofISO11138-1apply.

9Populationandresistance

9.1ThemanufacturershallstatetheresistancecharacteristicsinaccordancewithISO11138-1:2017,6.4.

9.2Theviablecountshallbestatedwithincrementslessthanorequalto0,1×10nperunit(e.g.permlofsuspension,perinoculatedcarrierorperbiologicalindicator).

9.3Forinoculatedcarriersandbiologicalindicators,theviablecountshallbegreaterthanorequalto1,0×106.

9.4TheresistanceshallbeexpressedastheDvalueinminutes,at54℃.TheDvalueofeachbatch/lotofbiologicalindicatorsorinoculatedcarriersshallbestatedinminutes,toonedecimalplaceat54℃.

9.5Suspensions,inoculatedcarriersorbiologicalindicatorscontainingBacillusatrophaeussporesshallhaveaDvalueofnotlessthan2,5minat54℃whentestedaccordingtotheconditionsinAnnexAusingtestgasmixtures(seeAnnexB).OthermicroorganismsshallhaveDvaluessupportingthe

application.

1)Theseareexamplesofsuitableproductsavailablecommercially.ThisinformationisgivenfortheconvenienceofusersofthisdocumentanddoesnotconstituteanendorsementbyISOoftheseproducts.

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BSENISO11138-2:2017ISO11138-2:2017(E)

9.6Suspensions,inoculatedcarriersorbiologicalindicatorscontainingBacillusatrophaeussporesshallhaveaDvalueofnotlessthan2,0minat54℃whentestedaccordingtotheconditionsinAnnexAusingatestgasconsistingof100%E0(seeAnnexB).OthermicroorganismsshallhaveDvaluessupportingtheapplication.

9.7TheresistancecharacteristicsspecifiedinthisdocumentandanyotherpartsofISO11138shallbedefinedusingthespecificcriticalvariablesassociatedwiththereferencedsterilizationprocess.

9.8DvaluesaredeterminedaccordingtomethodsgiveninISO11138-1:2017,AnnexCandAnnexD.

9.9DeterminationofDvalueandsurvival-killresponsecharacteristicsrequiretheuseofaresistometerapplyingthereferenceresistometerprocessparameters(seeAnnexA).

9.10Thesurvival-killwindowcanbecalculatedusingtheformulaeinISO11138-1:2017,AnnexE.

NOTEThisinformationcanbeofvaluetotheuserwhencomparingdifferentbatchesfromthesamemanufacturer.

EXAMPLEUsingtheformulaeinISO11138-1:2017,AnnexEwiththeminimumpopulationandminimumDvaluerequirementsspecifiedinthisdocument,thesurvival-killresponsecharacteristicsare:

一at54℃,2,5Dvalue;survivaltimegreaterthanorequalto10minandkilltimelessthanorequalto25min;

一at54℃,2,0Dvalue;survivaltimegreaterthanorequalto8minandkilltimelessthanorequalto20min.

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ISO11138-2:2017(E)

AnnexA

(normative)

Methodfordeterminationofresistancetoethyleneoxide

sterilization

A.1Principle

Thismethodrequirestheuseofatestapparatusreferredtoasaresistometerinthisdocument.ThespecificationsoftheresistometerprocessparametersforethyleneoxidesterilizationprocessesareprovidedinISO18472.

SpecificrequirementsrelatedtothetestmethodareprovidedinA.2.

A.2Procedure

A.2.1Loadthesamplesontosuitablesampleholders.

A.2.2Preheattheresistometerchambertothetestconditionof54℃.

A.2.3Placetheloadedsampleholdersinthechamber,closethechamberandinitiatethetestcycle.

A.2.4Carryoutthefollowingsequenceofoperations:

一Step1:Evacuatethechambertoavacuumsetpointof10kPa±0,5kPa.

一Step2:Admitsufficientwatervapourtoraisetherelativehumidityinthechamberto60%±10%.Maintaintheseconditionsforaperiodof30min±1min.Thesamplesshouldbeallowedtowarmtoabovethedewpointpriortoinjectionofwatervapourtoavoidthepotentialforcondensation.

一Step3:Admitethyleneoxidegastothechambertoobtainaconcentrationof600mg/l±30mg/l

within60s.Forthe0minexposuretime,noethyleneoxidegasshallbeadmitted.

一Step4:Maintaintheseconditionsfortherequiredexposuretime±5s.

一Step5:Attheendoftheexposuretime,evacuatethechamberto10kPaorlesswithin60sandthenadmitfilteredair,oraninertgas(suchasnitrogen)toambientpressure.

一Step6:Repeatstep5fouradditionaltimesormoreifnecessarytoreduceoperatorexposuretoanysterilantremaininginthechamber.

一Step7:Attheendoftheabovetestcycle,removethesamplesfromthechamberandtransferthesamplestothegrowthmediumandincubate(seeISO11138-1:2017,Clause7).

A.2.5Thetransferperiodshallbedocumentedandthesametimeperiodshallbeusedforalltests.

A.3Determinationofresistance

ResistancecharacteristicsshallbedeterminedaccordingtomethodsgiveninIS011138-1:2017,AnnexesC,DandE.

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AnnexB

(informative)

RationalefortheinclusionofasecondminimumDvalue

specificationasaresultofchangestothetestgasusedtoevaluate

resistanceanddeletionoftherequirementforaminimumDvalue

at30℃

B.1InclusionofasecondminimumDvalue

ThisdocumentrequiresDvaluetestingofethyleneoxide(EO)biologicalindicators(BIs)inanISO18472compliantresistometerusingethyleneoxidegasatanominalconcentrationof600mg/l.Historically,thiswasoftenaccomplishedbyBImanufacturersusingtestgasmixtures.Asof31December2014,the

U.S.EPACleanAirActprohibitedthesaleanduseofHCFC-based(hydrochlorofluorocarbon)productsintheUnitedStates,requiringU.S.-basedBImanufacturerstochangetheDvaluetestgasfromHCFC/EO

to100%E0.

RoundrobinDvaluetestingat54℃completedbythreeU.S.-basedbiologicalindicatormanufacturersonfourdifferentbiologicalindicatorproductsdemonstratedthatDvaluesobtainedusing100%EOwereconsistentlylowerthanDvaluesobtainedintheHCFC/EOmixture,eventhoughthenominalEOconcentrationforbothsetsoftestswas600mg/l.ThereporteddifferencesbetweenDvalueswereashighas40%.ThisstudyhasnowbeenpublishedinPharmaceuticalTechnology(2014)[4].

ISO11138-2:2006hasbeenamendedbychangingthe54℃Dvaluerequirementtoaddanoptionofa2,0minDvaluespecificationfortestsperformedin100%E0,basedondatareportedinthepeerreviewedpublication.ProvidinganoptionforBImanufacturerstomaintaincompliancewiththestandardwithoutchangingtheactualBIresistancewaspreferredoverdrivingmanufacturerstoincreaseBIresistancetomeetthestandard.ThisscenariowouldcreatemoreriskofpositiveBlsforenduserswhosesterilizationprocesseswerevalidatedagainstthelowerresistanceBIs.

B.2DeletionoftherequirementforaDvalueat30℃

Duetomissingdatatosupporttherequirementfora12,5minuteminimumDvalueat30℃,andtheabsenceofevidencefortheactualuseofthistestmethod,ithasbeendeletedfromthisdocument.

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ISO11138-2:2017(E)

Bibliography

[1]ISO11135,Sterilizationofhealth-careproducts—Ethyleneoxide—Requirementsforthe

development,validationandroutinecontrolofasterilizationprocessformedicaldevices

[2]ISO14161,Sterilizationofhealthcareproducts—Biologicalindicators—Guidanceforthe

selection,useandinterpretationofresults

[3]ISO14937,Sterilizationofhealthcareproducts—Generalrequirementsforcharacterizationofasterilizingagentandthedevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices

[4]KRUSHEFSKIG.“Effectsof100%EthyleneOxideTestGasontheResistanceofEthyleneOxide

BiologicalIndicators,"PharmaceuticalTechnology38(12)2014

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