ASTM_F_2256_-_05_2015.pdf

Designation:F225605(Reapproved 2015)Standard Test Method forStrength Properties of Tissue Adhesives in T-Peel byTension Loading1This standard is issued under the fixed designation F2256;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 is intended to provide a means forcomparison of the adhesive strengths of tissue adhesivesintended for use as surgical adhesives or sealants,or both,onsoft tissue.With the appropriate choice of substrate,it may alsobe used for purposes of quality control in the manufacture oftissue adhesive based medical devices.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 American Association of Tissue Banks Standards:3Standards for Tissue Banking3.Terminology3.1 DefinitionsMany terms in this test method are definedin Terminology D907.3.2 Definitions:3.2.1 flexibleas used in this test method,indicates that theadherends shall have such dimensions and physical propertiesas to permit bending them through any angle up to 90 withoutbreaking or cracking.3.2.2 tissue adhesivefor the purposes of this test method,tissue adhesive is defined as a compound or system intendedfor use in closing wounds(surgical or traumatic)or for sealingagainst leakage of body fluids.3.2.3 tissue sealanta surface coating with adequate adhe-sive strength to prevent leakage of body fluids.3.2.4 T-peel strengththe average load per unit width ofbond line required to produce progressive separation of twobonded flexible adherends,under conditions designated in thismethod.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)is such that the results of a T-Peel test arenot suitable for determining allowable design stresses withoutthorough analysis and understanding of the application andadhesive behaviors.4.3 This test method may be used for comparing adhesivesor bonding processes for susceptibility to fatigue and environ-mental changes,but such comparisons must be made with greatcaution since different adhesives may respond differently tovarying conditions.5.Apparatus5.1 Testing Machine,of the constant-rate-of-crosshead-movement type and comprising essentially the following: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 2003.Last previous edition approved in 2010 as F2256 05(2010).DOI:10.1520/F2256-05R15.2For 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 the American Association of Tissue Banks(AATB),1350Beverly Rd.,Suite 220-A,McLean,VA 22101.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 5.1.1 Fixed Member,a fixed or essentially stationary mem-ber carrying one grip.5.1.2 Movable Member,a movable member carrying asecond grip.5.1.3 Grips,for holding the test specimen between the fixedmember and the movable member of the testing machine canbe either the fixed or self-aligning type.5.1.3.1 Fixed Grips are rigidly attached to the