Designation:D7102−17StandardGuideforDeterminationofEndotoxinonSterileMedicalGloves1ThisstandardisissuedunderthefixeddesignationD7102;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.INTRODUCTIONThisguideisestablishedanddesignedtodeterminethequalitativeorquantitativepresenceofbacterialendotoxinonsterilemedicalgloves.BacterialendotoxinsarefoundintheoutermembraneofGramnegativebacteriaandmaycontaminateglovesduringthemanufacturingprocess.Conse-quencesofendotoxinintroducedintoapatientduringinvasiveproceduresaredosedependentandmayincludeinflammation,fever,nausea,pain,clotformation,hypoglycemiaandreducedprofusionoftheheart,kidney,andliveraswellasendotoxicshock.Endotoxinsarenotinactivatedbyroutinemethodsutilizedintheroutinesterilizationofmedicalglovesincludingirradiation(gammaorE-beam),ethyleneoxide,orsteam.1.Scope1.1Thisguidecoversaselectionofmethodologiesforthedeterminationofbacterialendotoxinongloveswhensuchadeterminationisappropriate.1.2Asbacteriamaycontinuetogrowonnon-sterilegloves,reportableendotoxinlevelsareonlyappropriateforgloveslabeledassterile.Becausemostenvironmentscontainendotoxin,onceaboxofglovesisopenedandtheglovesaremanipulated,endotoxinlevelswillincreasemakingitinappro-priatetoreportendotoxinlevelsonboxedgloves(ex.exami-nationgloves).Thisistrueeveniftheboxhadundergonesterilizationpriortodistribution.1.3Thisguidemayalsobeappropriateforinternalqualitycontroloralertpurposesatdifferentstagesofmanufacturingorduringprocesschangeevaluations.1.4Thisguideisnotapplicabletothedeterminationofpyrogensotherthanbacterialendotoxins.1.5Thesamplepreparationmethoddescribedmustbeusedregardlessofthetestmethodselected.Thismethoddoesnotdescribelaboratorytestmethodvalidation,analystqualification,orreagentconfirmation.Product-specificvalida-tionisaddressed.1.6Thesafeandprope...
