ASTM_F_2458_-_05_2015.pdf

Designation:F245805(Reapproved 2015)Standard Test Method forWound Closure Strength of Tissue Adhesives and Sealants1This standard is issued under the fixed designation F2458;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 covers a means for comparison ofwound closure strength of tissue adhesives used to help securethe apposition of soft tissue.With the appropriate choice ofsubstrate,it may also be used for purposes of quality control inthe manufacture of medical devices used as tissue adhesives.1.2 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.3 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 AdhesivesE4 Practices for Force Verification of Testing Machines2.2 Other Document:American Association of Tissue Banking,Standards forTissue Banking33.Terminology3.1 Many terms in this test method are defined in Terminol-ogy D907.3.2 Definitions:3.2.1 tissue adhesiveany material used as a medical de-vice to help secure the apposition of two wound edges oropposed soft tissues.3.2.2 tissue sealanta surface coating with adequate adhe-sive strength to prevent leakage of body fluids.3.2.3 cohesive strengthinternal strength of the adhesive.3.2.4 adhesive strengththe strength of the tissue adhesive/substrate interface.3.2.5 cohesive failurefailure of the internal adhesive bond.3.2.6 adhesive failurefailure of the adhesive/substratebond.3.2.7 substrate failurefailure of the tissue substrate.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 of thematerial to resist imposed mechanical forces.Therefore,themechanical properties of the materials,and in particular theadhesive properties,are important parameters in evaluatingtheir fitness for use.In addition,the mechanical properties of agiven adhesive composition can provide a useful means ofdetermining product consistency for quality control or as ameans for determining the effects of various surface treatmentson the substrate prior to use of the device.4.2 The complexity and variety of individual applicationsfor tissue adhesive devices,even within a single indicated use(surgical procedure,which itself may vary depending onphysical site and clinical intention)is such that the results of asingle tensile strength test is not suitable for determiningallowable design stresses without thorough analysis and under-standing of the application,adhesive behaviors,and clinicalindications.4.3 This test method may be used for comparing adhesivesor bonding processes for susceptibility to fatigue,mode offailure,and environmental changes,but such comparisons mustbe made with great caution since different adhesives mayrespond differently to varying conditions.4.4 A correlation of the test method results with actualadhesive performance in live human tissue has not beenestablished.1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved May 1,2015.Published July 2015.Originally approvedin 2005.Last previous edition approved in 2010 as F2458-05(2010).DOI:10.1520/F2458-05R15.2For 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 of 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 5.Apparatus5.1 Testing MachineA testing machine of the constant-rate-of-crosshead-movement type and comprising essentiallythe following:5.1.1 Fixed MemberA fixed or essentially stationarymember carrying one grip.5.1.2 Movable MemberA movable member carrying asecond grip.5.1.3 GripsGrips for holding the test specimen betweenthe fixed member and the movable member of the testingmachine can be either the fixed or sel