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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
@IS02017-Allrightsreservediii
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.
iv@IS02017-Allrightsreserved
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.
@IS02017-AllrightsreservedV
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.
@IS02017-Allrightsreserved1
BSENISO11138-2:2017
ISO11138-2:2017(E)
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.
2@IS02017-Allrightsreserved
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.
@IS02017-Allrightsreserved3
BSENISO11138-2:2017
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.
4@IS02017-Allrightsreserved
BSENISO11138-2:2017ISO11138-2:2017(E)
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.
@IS02017-Allrightsreserved5
BSENISO11138-2:2017
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
6@IS02017-Allrightsreserved
BSENISO11138-2:2017
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