【astm標準】d 6978 - 05 (2013)

1、Designation:D6978?05(Reapproved2013)StardPracticefAssessmentofResistanceofMedicalGlovestoPermeationbyChemotherapyDrugs1ThisstardisissuedunderthefixeddesignationD6978thenumberimmediatelyfollowingthedesignationindicatesthe

2、yearofiginaladoptioninthecaseofrevisiontheyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperepsilon()indicatesaneditialchangesincethelastrevisionreapproval.1.Scope1.1Thispracticecoversaprotoco

3、lftheassessmentofresistanceofmedicalglovematerialstopermeationbypotentiallyhazardouscancerchemotherapydrugsunderconditionsofcontinuouscontact.Anassessmentismadebasedonthepermeation(breakthrough)ofninechemotherapydrugsthr

4、oughtheglovematerialoveracertainperiodoftime.1.2Itisemphasizedthattheconditionsusedinthisassessmentareintendedtoapproximatethewstcaseconditionfclinicaluses.Thedatashouldberestrictedtouseonarelativebasiswhencomparingglove

5、materials.1.3Thisstarddoesnotpurpttoaddressallofthesafetyconcernsifanyassociatedwithitsuse.Itistheresponsibilityoftheuserofthisstardtoestablishappropriatesafetyhealthpracticesdeterminetheapplicabilityofregulatylimitation

6、spritouse.2.ReferencedDocuments2.1ASTMStards:2D471TestMethodfRubberProperty—EffectofLiquidsD3577SpecificationfRubberSurgicalGlovesD3578SpecificationfRubberExaminationGlovesD3767PracticefRubber—MeasurementofDimensionsD525

7、0SpecificationfPoly(vinylchlide)GlovesfMedicalApplicationD6319SpecificationfNitrileExaminationGlovesfMedicalApplicationD6977SpecificationfPolychlopreneExaminationGlovesfMedicalApplicationF739TestMethodfPermeationofLiquid

8、sGasesthroughProtectiveClothingMaterialsunderConditionsofContinuousContact3.Terminology3.1Definitions:3.1.1SeeTestMethodF739Section3onTerminologyfafulllistoftermsdefinitions.3.1.2breakthroughdetectiontimen—thetimeinminut

9、esmeasuredfromthestartofthetesttothesamplingtimethatimmediatelyprecedesthesamplingtimeatwhichthepermeationratereaches0.01gcm2min.SeeTestMethodF739section12.4.2fcalculationofpermeationratewithreplenishment.3.1.3validateds

10、tatisticalrationalen—requiresthatanobjectivecausereasonbestatedastowhytheinitialtestwasincrect.4.SignificanceUse4.1Theobjectiveofthispracticeistoprovideaunifmprocedurefassessingtheresistanceofmedicalglovematerialstoperme

11、ationbychemotherapydrugstoestablishaconsistentreptingofthetestdata.5.TestProtocol5.1SummaryofTestMethod:5.1.1TheglovesinquestionshallbetestedinaccdancewiththemethodsetoutinTestMethodF739ProcedureA.5.1.2Theresistanceofame

12、dicalglovematerialtopermeationbychemotherapydrugsshallbedeterminedbymeasuringthebreakthroughdetectiontimeofthedrugsthroughtheglovematerial.Thetestmethodinvolvesusingthetestmaterialserveasamembrane(partition)betweenthetwo

13、halvesofatestcell.Onehalfofthecellshallcontainthedonsolutionofthetestdrugtheotherhalfshallcontaintheappropriatecollectionmediumthatisdistilledwaterotherliquidwhichdoesnotinfluencethepermeationofthedrugbeingtested.Atestdr

14、ugpermeatesthroughthesamplematerialwhenthetestdrugisabletopassthroughthetestmaterial.Asthetestdrugcontinuouslypassesthroughthesamplematerialitsconcentrationincreasesovertime.Thecollectionmediumshallbesampledatrecdedtimei

15、ntervalsanalyzedquantitativelytodeterminetheconcentrationofthepermeateddrug.Theconcentrationofthedruginthecollectionmediumshallbeusedtocalculatethebreakthroughdetectiontimepermeationrate(see3.1.3)inaccdancewithTestMethod

16、F739.1ThispracticeisunderthejurisdictionofASTMCommitteeD11onRubberisthedirectresponsibilityofSubcommitteeD11.40onConsumerRubberProducts.CurrenteditionapprovedJan.12013.PublishedApril2013.iginallyapprovedin2005.Lastprevio

17、useditionapprovedin2005asD6978–05.DOI:10.1520D697805R13.2FreferencedASTMstardsvisittheASTMwebsitewww.astm.gcontactASTMCustomerServiceat.FAnnualBookofASTMStardsvolumeinfmationrefertothestard’sDocumentSummarypageontheASTMw

18、ebsite.Copyright?ASTMInternational100BarrHarbDrivePOBoxC700WestConshohockenPA194282959.UnitedStates1thedrugstested(see6.16.2)theinfmationoftheglovesusedftesting.Thereptshallincludeatleastthefollowing:7.1.1Theglovemanufac

19、turer’sreferenceftheglovematerialsubmittedftestthatistypeofglove(fexampleexaminationsurgeon’sgloves)glovematerial(fexamplenaturalrubberlatexnitrilesofth)glovephysicalspecifications(fexampletensilestrengthelongation)pinho

20、leAQLlotbatchnumber7.1.2Thelocationofthearea(thatispalmcuff)wherethe5by5cmglovematerialspecimenwasobtainedftesting7.1.3Thethicknessofthetestsamplemeasuredmanuallywithinnearest20mgraduation7.1.4Thenameofthenineclinicaldru

21、gstestednameofmanufacturerslotnumberexpirationdatetheconcentration(mgmL)atwhichthedrugistestedthechemicalnameofthesolventused7.1.5Thesolventusedasacollectionmedium(fexampledistilledwaterotherliquids)7.1.6Thebreakthroughd

22、etectiontime(see3.1.2)7.1.7Ifnopermeationwasdetectedthepermeationratedidnotreach0.01gcm2minreptthefactthatnopermeationwasdetectedthatthepermeationratedidnotreachtheprescribedpermeationrateof0.01gcm2minduringthe4htestperi

23、od7.1.8Whetherpermeationtakesplacenotthedurationofthetestperiodshallberepted(fexample4h)7.1.9Anyobservedphysicalchangesofthetestsamplesshallbedocumented.Suchphysicalchangesincludebutarenotlimitedtosignsofflakingswellingd

24、isintegrationembrittlementdiscolationinaccdancewithTestMethodD471.8.Keywds8.1breakthroughdetectiontimechemotherapypatientexaminationglovepermeationratesurgeon’sgloveBIBLIOGRAPHY(1)AmericanSocietyofHealthSystemsPharmacist

25、s(ASHP)“TechnicalAssistanceBulletinonHlingofCytotoxicHazardousDrugs”1990.(2)BSEN3743“ProtectiveGlovesAgainstChemicalsMicroganismsPart3DeterminationofResistancetoPermeationbyChemicals”1999.(3)ConnT.H.“PermeabilityofNitril

26、eRubberLatexPolyurethaneNeopreneGlovesto18AntineoplasticDrugs”AmericanJournalofHealthSystemPharmacyVol561999pp.24502453.(4)HHSPublicationsFDA964257“GuidancefMedicalGloves:AWkshopManual”September1996.(5)KleinM.LambovN.Sam

27、evN.etal.“PermeationofCytotoxicFmulationsThroughSwatchesfromedMedicalGloves”AmericanJournalofHealthSystemPharmacyVol602003pp.10061011.(6)KlingerT.BoenigerM.“InuseTestingInterpretationofChemicalResistantGlovePerfmance”App

28、liedOccupationalEnvironmentalHygieneVol17(5)2002pp.368378.(7)OccupationalSafetyHealthAdministration(OSHA)PUB811GuidelinesfCytotoxic(Antineoplastic)Drugs1990.(8)OncologyNursingSociety(ONS)“SafeHlingofCytotoxicDrugs”Indepe

29、ndentStudyModule1997.(9)PhysiciansDeskReference(PDR)currentedition.(10)29CFR1910.1030BloodbnePathogensAppendixA.(11)SingletonL.ConnT.H.“AnEvaluationofthePermeabilityofChemotherapyGlovestoThreeCancerChemotherapyDrugs”O(jiān)nco

30、logyNursingFumVol261999pp.14911496.ASTMInternationaltakesnopositionrespectingthevalidityofanypatentrightsassertedinconnectionwithanyitemmentionedinthisstard.Usersofthisstardareexpresslyadvisedthatdeterminationofthevalidi

31、tyofanysuchpatentrightstheriskofinfringementofsuchrightsareentirelytheirownresponsibility.Thisstardissubjecttorevisionatanytimebytheresponsibletechnicalcommitteemustbereviewedeveryfiveyearsifnotrevisedeitherreapprovedwit

32、hdrawn.YourcommentsareinvitedeitherfrevisionofthisstardfadditionalstardsshouldbeaddressedtoASTMInternationalHeadquarters.Yourcommentswillreceivecarefulconsiderationatameetingoftheresponsibletechnicalcommitteewhichyoumaya

33、ttend.IfyoufeelthatyourcommentshavenotreceivedafairhearingyoushouldmakeyourviewsknowntotheASTMCommitteeonStardsattheaddressshownbelow.ThisstardiscopyrightedbyASTMInternational100BarrHarbDrivePOBoxC700WestConshohockenPA19

34、4282959UnitedStates.Individualreprints(singlemultiplecopies)ofthisstardmaybeobtainedbycontactingASTMattheaboveaddressat6108329585(phone)6108329555(fax)(email)throughtheASTMwebsite(www.astm.g).Permissionrightstophotocopyt