Designation:D6976−13(Reapproved2018)StandardSpecificationforRubberContraceptives—VaginalDiaphragms1ThisstandardisissuedunderthefixeddesignationD6976;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversrequirementsforcontraceptivevaginaldiaphragms,hereaftercalleddiaphragms.1.2Vaginalbarrierdevicesknownascervicalcaps,vaginalspongesandfemalecondomsarenotincludedinthisspecifi-cation.1.3Thisinternationalstandardwasdevelopedinaccor-dancewithinternationallyrecognizedprinciplesonstandard-izationestablishedintheDecisiononPrinciplesfortheDevelopmentofInternationalStandards,GuidesandRecom-mendationsissuedbytheWorldTradeOrganizationTechnicalBarrierstoTrade(TBT)Committee.2.ReferencedDocuments2.1ASTMStandards:2D412TestMethodsforVulcanizedRubberandThermoplas-ticElastomers—TensionD573TestMethodforRubber—DeteriorationinanAirOvenD3767PracticeforRubber—MeasurementofDimensions2.2ISOStandards:3ISO2859SamplingProceduresandTablesforInspectionbyAttributesISO10993BiologicalEvaluationofMedicalDevices2.3FederalRegulations:U.S.CodeofFederalRegulations,Title21,FoodandDrugAdministration,Section177.2600,RubberArticlesIn-tendedforRepeatedUse43.Classification3.1Thefollowingtypesofdiaphragmsarecoveredbythisspecification:3.1.1Type1—Coilspringdiaphragm.3.1.2Type2—Flatspringdiaphragm(alsocalledwatchspringorMensingadiaphragm).3.1.3Type3—Archingorbow-benddiaphragm.4.MaterialsandManufacture4.1Diaphragmsshallbemadeofanelasticpolymerwitharimreinforcedwithmetalorothersuitablematerial.Thediaphragmdressingmaterial,compoundingmaterials,andrimreinforcingmaterialshallnothaveadeleteriouseffectontherubberorbeharmfultotheuserundernormalconditionsofuse.Manufacturersshouldevaluatethecytotoxicity,sensitization,irritation,andacutesystemictoxicitypotentialofthediaphragmperISO1...
