Designation:D7102−10StandardGuideforDeterminationofEndotoxinonSterileMedicalGloves1ThisstandardisissuedunderthefixeddesignationD7102;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.Becausemostenvironmentscontainendo-toxin,onceaboxofglovesisopenedandtheglovesaremanipulated,endotoxinlevelswillincreasemakingitinappro-priatetoreportendotoxinlevelsonboxedgloves(ex.exami-nationgloves).Thisistrueeveniftheboxhadundergonesterilizationpriortodistribution.1.3Thisguidemayalsobeappropriateforinternalqualitycontroloralertpurposesatdifferentstagesofmanufacturingorduringprocesschangeevaluations.1.4Thisguideisnotapplicabletothedeterminationofpyrogensotherthanbacterialendotoxins.1.5Thesamplepreparationmethoddescribedmustbeusedregardlessofthetestmethodselected.Thismethoddoesnotdescribelaboratorytestmethodvalidation,analystqualifica-tion,orreagentconfirmation.Product-specificvalidationisaddressed.1.6Thesafeandprop...
