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首页 ASTM F2100 – 04

ASTM F2100 – 04.pdf

ASTM F2100 – 04

用户rzefzhoy5u
2013-12-26 0人阅读 举报 0 0 0 暂无简介

简介:本文档为《ASTM F2100 – 04pdf》,可适用于工程科技领域

Designation:F–StandardSpecificationforPerformanceofMaterialsUsedinMedicalFaceMasksThisstandardisissuedunderthefixeddesignationFthenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevisionAnumberinparenthesesindicatestheyearoflastreapprovalAsuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapprovalScopeThisspecificationcoverstestingandrequirementsformaterialsusedintheconstructionofmedicalfacemasksthatareusedinprovidinghealthcareservicessuchassurgeryandpatientcareThisspecificationprovidesfortheclassificationofmedicalfacemaskmaterialperformanceMedicalfacemaskmaterialperformanceisbasedontestingforbacterialfiltrationefficiency,differentialpressure,submicronparticulatefiltrationefficiency,resistancetopenetrationbysyntheticblood,andflammabilityThisspecificationdoesnotaddressallaspectsofmedicalfacemaskdesignandperformanceThisspecificationdoesnotspecificallyevaluatetheeffectivenessofmedicalfacemaskdesignsasrelatedtothebarrierandbreathabilitypropertiesThisspecificationdoesnotalsoapplytorespiratoryprotection,whichmaybenecessaryforsomehealthcareservicesThevaluesstatedinSIunitsorinotherunitsshallberegardedseparatelyasstandardThevaluesstatedineachsystemmustbeusedindependentlyoftheother,withoutcombiningvaluesinanywayThefollowingprecautionarycaveatpertainsonlytothetestmethodsportion,Section,ofthisspecification:Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuseItistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouseReferencedDocumentsASTMStandards:FTerminologyRelatingtoProtectiveClothingFTestMethodforResistanceofMedicalFaceMaskstoPenetrationbySyntheticBlood(HorizontalProjectionofFixedVolumeataKnownVelocity)FTestMethodforEvaluatingtheBacterialFiltrationEfficiency(BFE)ofMedicalFaceMaskMaterials,UsingaBiologicalAerosolofStaphylococcusaureusFTestMethodforDeterminingtheInitialEfficiencyofMaterialsUsedinMedicalFaceMaskstoPenetrationbyParticulatesUsingLatexSpheresANSIASQCStandard:ANSIASQCZSamplingProceduresandTablesforInspectionbyAttributesISOStandard:ISOSamplingPlansforInspectionbyAttributesMilitaryStandard:MILMCMilitarySpecification,Mask,Surgical,DisposableFederalStandards:CFRPartStandardfortheFlammabilityofClothingTextilesCFRPartOccupationalExposuretoBloodbornePathogens:FinalRuleCFRPartApprovalofRespiratoryProtectiveDevicesTerminologyDefinitions:bacterialfiltrationeffıciency(BFE),ntheeffectivenessofmedicalfacemaskmaterialinpreventingthepassageofaerosolizedbacteriaexpressedinthepercentageofaknownquantitythatdoesnotpassthemedicalfacemaskmaterialatagivenaerosolflowratebodyfluid,nanyliquidproduced,secreted,orexcretedbythehumanbodyDiscussionInthisspecification,bodyfluidsincludeliquidspotentiallyinfectedwithbloodbornepathogens,including,butnotlimitedto,blood,semen,vaginalsecretions,cerebrospinalfluid,synovialfluidandperitonealfluid,amnioticfluid,salivaindentalprocedures,andanybodyfluidthatisvisiblycontaminatedwithblood,andallbodyfluidsinThisspecificationisunderthejurisdictionofASTMCommitteeFonProtectiveClothingandisthedirectresponsibilityofSubcommitteeFonBiologicalCurrenteditionapprovedMarch,PublishedAprilOriginallyapprovedinLastpreviouseditionapprovedinasF–aForreferencedASTMstandards,visittheASTMwebsite,wwwastmorg,orcontactASTMCustomerServiceatserviceastmorgForAnnualBookofASTMStandardsvolumeinformation,refertothestandard’sDocumentSummarypageontheASTMwebsiteAvailablefromAmericanSocietyforQuality(ASQ),NPlankintonAve,Milwaukee,WIAvailablefromAmericanNationalStandardsInstitute(ANSI),WrdSt,thFloor,NewYork,NYAvailablefromStandardizationDocumentsOrderDesk,DODSSP,Bldg,SectionD,RobbinsAve,Philadelphia,PAAvailablefromUSGovernmentPrintingOfficeSuperintendentofDocuments,NCapitolSt,NW,MailStop:SDE,Washington,DCCopyright©ASTMInternational,BarrHarborDrive,POBoxC,WestConshohocken,PA,UnitedStatessituationswhereitisdifficultorimpossibletodifferentiatebetweenbodyfluids(seeCFRPart)bodyfluidsimulant,naliquidwhichisusedtoactasamodelforhumanbodyfluidsdifferentialpressure,nthemeasuredpressuredropacrossamedicalfacemaskmaterialDiscussionInthisspecification,differentialpressureisexpressedasapressureperunitareaflammability,nthosecharacteristicsofamaterialthatpertaintoitsrelativeeaseofignitionandrelativeabilitytosustaincombustionmedicalfacemask,nanitemofprotectiveclothingdesignedtoprotectportionsofthewearer’sface,includingatleastthemucousmembraneareasofthewearer’snoseandmouth,fromcontactwithbloodandotherbodyfluidsduringmedicalproceduresDiscussionExamplesofmedicalfacemasksincludesurgicalmasks,proceduremasks,isolationmasks,lasermasks,dentalmasks,andpatientcaremaskspenetration,ninaprotectiveclothingmaterialoritem,theflowofachemicalonanonmolecularlevelthroughclosures,porousmaterials,seamsandpinholesorotherimperfectionsinprotectiveclothingDiscussionInthisspecification,bloodorbodyfluidsreplacethetermchemicalandthespecificpenetrationliquidissyntheticblood,abodyfluidsimulantprotectiveclothing,naproductwhichisspecificallydesignedandconstructedfortheintendedpurposeofisolatingpartsofthebodyfromapotentialhazardDiscussionTheprimarypurposeofprotectiveclothingistoactasabarrierforthewearertoahazardHowever,theproductmayalsoofferprotectionasabarrierwhichpreventsthebodyfrombeingasourceofcontaminationsubmicronparticulatefiltrationeffıciency,ntheefficiencyofthefiltermaterialincapturingaerosolizedparticlessmallerthanonemicronexpressedasthepercentageofaknownnumberofparticlesthatdoesnotpassthemedicalfacemaskmaterialatagivenflowratesyntheticblood,namixtureofareddyesurfactant,thickeningagent,anddistilledwaterhavingasurfacetensionandviscosityrepresentativeofbloodandsomeotherbodyfluids,andthecolorofbloodDiscussionThesyntheticbloodinthistestmethoddoesnotsimulateallofthecharacteristicsofbloodorbodyfluids,forexample,polarity(wettingcharacteristics),coagulation,contentofcellmatterFordefinitionsofotherprotectiveclothingrelatedtermsusedinthistestmethod,refertoTerminologyFSignificanceandUseThisspecificationcoverstheminimumperformancerequirementsformaterialsusedintheconstructionofmedicalfacemasksThisspecificationprovidesclassificationofperformanceforarangeofmedicalfacemaskmaterialsMedicalfacemaskperformanceclassesarebasedonthebarrierperformancepropertiesofthemedicalfacemaskmaterials(fluidresistance,bacterialfiltrationefficiency,andsubmicronfiltrationefficiency)Thelistofspecifiedpropertiesrepresentsindustrypracticesforcharacterizingmaterialperformance,butdoesnotincludeallaspectsofperformancethatmaybenecessarytoprotecthealthcareworkersTherefore,thisspecificationdoesnotcovermedicalfacemasksforallpossibleusesituationsForexample,theCenterforDiseaseControlandPrevention(CDC)specificallyrequiresNIOSHrespiratorsthatareatleastefficientfortuberculosisexposurecontrolNOTEThisspecificationdoesnotprovidespecificcriteriafordemonstratingmedicalfacemaskprotectionofthepatientNOTEThelevelofprotectionprovidedbymedicalfacemasksdependsonseveralfactorsnotconsideredinthisspecificationExamplesincludefacialfit,materialdegradationfromwearerchallenges(perspiration,talking,sneezingandthelengthoftimethemedicalfacemaskisworn)UsersofthisspecificationarecautionedthatimprovedresistanceofmedicalfacemaskstopenetrationbysyntheticbloodcancauseareductioninmedicalfacemaskbreathabilityIngeneral,increasingsyntheticbloodpenetrationresistance(andbacterialfiltrationefficiencyandsubmicronparticulatefiltrationefficiency)resultsinincreasingpressuredroporreductionofbreathabilityformedicalfacemasksofthesamedesignThisspecificationoritsrequirementsdoesnotevaluatemedicalfacemasksforregulatoryapprovalasrespiratorsItspecificallyonlyevaluatesthematerialsusedintheconstructionofthemedicalfacemaskandnotthesealofthemedicalfacemaskagainstthewearer’sfaceorotherdesignfeaturesthatdetermineitseffectivenessofpreventingparticleorliquidexposuretothewearerIfrespiratoryprotectionforthewearerisneeded,aNIOSHcertifiedrespirator,meetingtherequirementsofCFRPart,shouldbeusedTheselectionoftheappropriatemedicalfacemaskmustbegovernedbythepotentialexposurehazardsbasedonthespecificareasofperformanceassociatedwithclassofmedicalfacemasksGeneralusemasksprovideminimalfluidresistanceandaresuitableforsituationssuchasinisolationsettingsandforcertaintypesofpatientcareWhereproceduresinvolvethegenerationofsubmicronparticles,suchasinlaserorelectrocauterysurgery,submicronfilteringmasksareappropriateWhereproceduresinvolvetheprobabilityorlikelyexposuretobloodorbodyfluids,selectfluidresistantmedicalfacesmasksClassificationMedicalfacemaskmaterialscoveredunderthisspecificationshallbedesignatedasoneormoreofthefollowingperformanceclassesasbasedonthebarrierperformancepropertiesofthematerialsusedinmedicalfacemasks:LowBarrier,ModerateBarrier,andHighBarrierLowbarriermedicalfacemaskmaterialsareevaluatedforresistancetopenetrationbysyntheticbloodattheminimumvelocityspecifiedinTestMethodF,bacterialfiltrationefficiencyanddifferentialpressureModeratebarriermedicalfacemaskmaterialsareevaluatedfortheirabilitytocapturesubmicronparticlesandareevaluatedforresistancetopenetrationbysyntheticbloodatthemiddlevelocityspecifiedinTestMethodF,bacterialfiltrationefficiency,anddifferentialpressureF–HighbarriermedicalfacemaskmaterialsareevaluatedforresistancetopenetrationbysyntheticbloodatthemaximumvelocityspecifiedinTestMethodF,submicronparticulatefiltration,bacterialfiltrationefficiency,anddifferentialpressureRequirementsThepropertiesofthemedicalfacemaskmaterialshallconformtothespecificationsrequirementsinTable,astestedinaccordancewithSectionNOTEMedicalfacemaskmaterialscomprisespecimenstakenfrommanufacturedmedicalfacemasks,withalllayersarrangedinproperorderMaterialsusedintheconstructionofmedicalfacemasksshallmeettherequirementsforClass,normalflammabilityspecifiedinCFRPartSamplingTestingshallbeperformedonmaterialstakenfrommanufacturedmedicalfacemasksAnacceptablequalitylimitofshallbeusedforallrequiredtestingtoestablishconformanceofmedicalfacemaskstoaspecificperformanceclassExamplesofacceptablesamplingplansarefoundinANSIASQCZandISONumberofTestsAsufficientnumberofmedicalfacemasksshallbeevaluatedforeachtesttoachievetheestablishedacceptablequalitylimitorconfidencelevelTestMethodsBacterialFiltrationEffıciencyDeterminethebacterialfiltrationefficiencyasdirectedinTestMethodFDifferentialPressureDeterminebreathingresistanceordifferentialpressureasspecifiedinparagraphofMILMCNOTEThistestmethodprovidesameasurementofpressureperunitareaofmaterialspecimentestedSubMicronParticulateFiltrationDetermineparticulatefiltrationefficiencyasdirectedinTestMethodFResistancetoPenetrationbySyntheticBloodDeterminesyntheticbloodpenetrationresistanceasspecifiedinTestMethodFFlammabilityDetermineflammabilityasspecifiedinCFRPartReportWhenrequestedbythepurchaser,areportshallbeprovidedwiththefollowinginformation:ManufacturernameManufactureraddressandphonenumberProductorstylenameTheperformanceclassasclassifiedbythisspecificationTheresultsofeachtestusedforclassifyingthemedicalfacemaskmaterialtothisspecificationAnoptionalstatementindicatingcomplianceofthemedicalfacemaskmaterialswiththisspecification,includingthenumber,yearorissue,andrevisionletterKeywordsbacterialfiltrationefficiencydifferentialpressurefluidresistancegeneralusemedicalfacemasksparticlefiltrationefficiencysubmicronfiltrationASTMInternationaltakesnopositionrespectingthevalidityofanypatentrightsassertedinconnectionwithanyitemmentionedinthisstandardUsersofthisstandardareexpresslyadvisedthatdeterminationofthevalidityofanysuchpatentrights,andtheriskofinfringementofsuchrights,areentirelytheirownresponsibilityThisstandardissubjecttorevisionatanytimebytheresponsibletechnicalcommitteeandmustbereviewedeveryfiveyearsandifnotrevised,eitherreapprovedorwithdrawnYourcommentsareinvitedeitherforrevisionofthisstandardorforadditionalstandardsandshouldbeaddressedtoASTMInternationalHeadquartersYourcommentswillreceivecarefulconsiderationatameetingoftheresponsibletechnicalcommittee,whichyoumayattendIfyoufeelthatyourcommentshavenotreceivedafairhearingyoushouldmakeyourviewsknowntotheASTMCommitteeonStandards,attheaddressshownbelowThisstandardiscopyrightedbyASTMInternational,BarrHarborDrive,POBoxC,WestConshohocken,PA,UnitedStatesIndividualreprints(singleormultiplecopies)ofthisstandardmaybeobtainedbycontactingASTMattheaboveaddressorat(phone),(fax),orserviceastmorg(email)orthroughtheASTMwebsite(wwwastmorg)TABLEMedicalFaceMaskMaterialRequirementsbyPerformanceClassCharacteristicLowBarrierModerateBarrierHighBarrierBacterialfiltrationefficiency,$$$Differentialpressure,mmHOcm<<<Submicronparticulatefiltrationefficiencyatmicron,Notrequired$$Resistancetopenetrationbysyntheticblood,minimumpressureinmmHgforpassresultFlamespreadClassClassClassF–主营业务范围:ASTMASTMASTMASTM、NASNASNASNAS、NASMNASMNASMNASM、MILMILMILMIL、ISOISOISOISO、ENENENEN、DINDINDINDIN、JISJISJISJIS等技术标准翻译技术资料翻译NADCAPNADCAPNADCAPNADCAP认证标准资料翻译国外技术标准中文版优惠低价代购等。业务QQQQQQQQ:专业专注于技术翻译诚信实惠物超所值的服务可靠的质量保证

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