Designation:D5151−19StandardTestMethodforDetectionofHolesinMedicalGloves1ThisstandardisissuedunderthefixeddesignationD5151;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethodcoversthedetectionofholesinmedicalgloves.1.2Thistestmethodislimitedtothedetectionofholesthatallowwaterleakageundertheconditionsofthetest.1.3Thesmallestholesizethatwillallowwaterleakageinamedicalglovehasnotbeendeterminedandisbeyondthescopeofthistestmethod.1.4Thesafeandproperuseofmedicalglovesisbeyondthescopeofthistestmethod.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafety,health,andenvironmentalpracticesanddeter-minetheapplicabilityofregulatorylimitationspriortouse.1.7Thisinternationalstandardwasdevelopedinaccor-dancewithinternationallyrecognizedprinciplesonstandard-izationestablishedintheDecisiononPrinciplesfortheDevelopmentofInternationalStandards,GuidesandRecom-mendationsissuedbytheWorldTradeOrganizationTechnicalBarrierstoTrade(TBT)Committee.2.Terminology2.1DefinitionsofTermsSpecifictoThisStandard:2.1.1medicalgloves,n—medicalgloves,asusedinthistestmethod,refertobothsurgicalandexaminationgloves.3.SignificanceandUse3.1Thistestmethodisdesignedtodetectholesthatleakwaterandtherebycompromisetheusefulnessoftheglove.3.2Thistestmethodissuitableanddesignedasareferencemethodtoevaluatesamplesofmedicalgloves.4.Apparatus4.1Mandrel—Aclearplastictube,nominally660.5cmoutsidediameter,5cminsidediameteror50mmschedule80poly(vinylchloride)(PVC)pipe,3861cmlong.Themandrelshallhaveaclamporrubberbandforsecuringtheglovetothemandrel.4.2GraduatedCylinderorBeaker—Asaminimum,the...
