Designation:F2258−05(Reapproved2015)StandardTestMethodforStrengthPropertiesofTissueAdhesivesinTension1ThisstandardisissuedunderthefixeddesignationF2258;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethodisintendedtoprovideameansforcomparisonoftheadhesivestrengthsoftissueadhesivesintendedforuseassurgicaladhesivesorsealants,orboth,onsofttissue.Withtheappropriatechoiceofsubstrate,itmayalsobeusedforpurposesofqualitycontrolinthemanufactureoftissueadhesivebasedmedicaldevices.1.2ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2D907TerminologyofAdhesivesE4PracticesforForceVerificationofTestingMachines2.2AmericanAssociationofTissueBanksStandards:3StandardsforTissueBanking3.Terminology3.1Definitions—ManytermsinthistestmethodaredefinedinTerminologyD907.3.2Definitions:3.2.1tissueadhesive—forthepurposesofthistestmethod,tissueadhesiveisdefinedasacompoundorsystemintendedforuseinclosingwounds(surgicalortraumatic)orforsealingagainstleakageofbodyfluids.3.2.2tissuesealant—asurfacecoatingwithadequateadhe-sivestrengthtopreventleakageofbodyfluids.4.SignificanceandUse4.1Theutility,range,andefficacyofadhesivesinclinicalmedicinearewelldocumentedintheliterature.Whetherbeingusedasanadhesive,hemostatic,sealant,orcarrierfordrugsorgrowthfactors,orboth,thescopeofadhesiveuseinclinicalmedicinecontinuestoexpand.Thereareseveralfactorswhicharevitaltothesuccessandefficacyofamedicaltissueadhesiveincluding,(1)adequatetissuebondingstrength,(2)tis...
