Designation:F1441−03(Reapproved2014)StandardSpecificationforSoft-TissueExpanderDevices1ThisstandardisissuedunderthefixeddesignationF1441;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoverstherequirementsforsingleusesalineinflatable,smoothandtexturedtissueexpansiondevicestobeusedintraoperativelyorimplantedfortypicallylessthan6monthsandthenremoved.1.2Limitations:1.2.1Thisspecificationappliesonlytosoft-tissueexpanderdevicesfabricatedwithelastomershells.Itdoesnotnecessarilycoveranycustomfabricatedsofttissueexpanderdevicemanufacturedtoanyotherspecification.1.2.2Thisspecificationapplies,inpart,tocombination“expander/mammary”devicesasclassifiedinSection4.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard,valuesinparenthesesareforinformationonly.1.4Thefollowingstatementpertainsonlytothetestmeth-odsandrequirementsportion,Section9,ofthisspecification.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2D412TestMethodsforVulcanizedRubberandThermoplas-ticElastomers—TensionD624TestMethodforTearStrengthofConventionalVul-canizedRubberandThermoplasticElastomersD1349PracticeforRubber—StandardConditionsforTest-ingF703SpecificationforImplantableBreastProsthesesF748PracticeforSelectingGenericBiologicalTestMethodsforMaterialsandDevicesF1251TerminologyRelatingtoPolymericBiomaterialsinMedicalandSurgicalDevices(Withdrawn2012)3F2038GuideforSiliconeElastomers,Gels,andFoamsUsedinMedicalApplicationsPartI—FormulationsandUn-curedMaterialsF2042GuideforSiliconeElastomers,Gels,andFoamsUsedinMedicalApplicationsPartII—CrosslinkingandFa...
