ASTM_F_2392_-_04_2015.pdf

Designation:F239204(Reapproved 2015)Standard Test Method forBurst Strength of Surgical Sealants1This standard is issued under the fixed designation F2392;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This test method provides a means for comparison of theburst or rupture strength of sealants on soft tissue.This testmethod can be used as a clinically relevant model for qualityassurance,development,and comparative testing of differentadhesives or adherends.1.2 This test method measures only burst strength or“co-hesive strength”of an adhesive/adherend system,and not theadhesive strength.1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.4 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D907 Terminology of Adhesives2.2 American Association for Tissue Banks(AATB)Stan-dard:Standards for Tissue Banking33.Terminology3.1 DefinitionsMany terms in this test method are definedin Terminology D907.3.2 Definitions:3.2.1 adhesive failurefailure of the sealant/substrate inter-face during burst testing.3.2.2 burst strengththe average pressure required to causefailure of the sealant,either by cohesive or adhesive mecha-nisms.3.2.3 cohesive failurefailure of the sealant during bursttesting.3.2.4 cohesive strengththe internal strength of the sealant,sometimes referred to as the adhesive bulk strength.3.2.5 substrate failurefailure of the substrate during bursttesting.3.2.6 tissue sealanta surface coating to prevent leakage ofbody fluids.4.Significance and Use4.1 Materials and devices that function at least in part byadhering to living tissues are finding increasing use in surgicalprocedures,either as adjuncts to sutures and staples or as frankreplacements for those devices in a wide variety of medicalprocedures.While the nature and magnitude of the forcesinvolved varies greatly with indication and with patient specificcircumstances,all uses involve,to some extent,the ability ofthe material to resist imposed mechanical forces.Therefore,themechanical properties of the materials,and in particular theadhesive and cohesive properties,are important parameters inevaluating their fitness for use.In addition,the mechanicalproperties of a given sealant composition can provide a usefulmeans of determining product consistency for quality control,or as a means for determining the effects of various surfacetreatments on the substrate prior to use of the device.4.2 The complexity and variety of individual applicationsfor sealant,even within a single indicated use(surgicalprocedure),is such that the results of a burst test are notsuitable for determining allowable design stresses withoutthorough analysis and understanding of the application andsealant behaviors.4.3 This test method may be used for comparing sealants forsusceptibility to environmental changes,but such comparisonsmust be made with great caution since different sealants mayrespond differently to varying conditions.4.4 As the true sealant strength is strongly dependent on thestrength of the sealant/substrate interface,the selection of aproper test substrate is critical.Care must be taken whenextrapolating in vitro test results to in vivo expectations.In1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devicesand is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved May 1,2015.Published July 2015.Originally approvedin 2004.Last previous edition approved in 2010 as F2392 04(2010).DOI:10.1520/F2392-04R15.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from American Association for Tissue Banks(AATB),1320 OldChain Bridge Rd.,Suite 450,McLean,VA 22101.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 vitro sealant optimization may not translate to expected in vivoperformance due to differences in substrate surface,strength,and elasticity.5.Apparatus5.1 Testing MachineAtesting machine for determining thesealant strength and system failure mechanism and comprisingessentially the following:5.1.1 Test FixtureA stationary fixture containing the testsubstrate and applied sealant.Fluid flows into the fixture at afixed rate,allowing for the pressurizat