ASTM_F_2258_-_05_2015.pdf

Designation:F225805(Reapproved 2015)Standard Test Method forStrength Properties of Tissue Adhesives in Tension1This standard is issued under the fixed designation F2258;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 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.3.2.2 tissue sealanta surface coating with adequate adhe-sive strength to prevent leakage of body fluids.4.Significance and Use4.1 The utility,range,and efficacy of adhesives in clinicalmedicine are well documented in the literature.Whether beingused as an adhesive,hemostatic,sealant,or carrier for drugs orgrowth factors,or both,the scope of adhesive use in clinicalmedicine continues to expand.There are several factors whichare vital to the success and efficacy of a medical tissue adhesiveincluding,(1)adequate tissue bonding strength,(2)tissuecompatibility,(3)acceptable biodegradable properties whenthe adhesive is used internally,(4)availability,(5)ease ofapplication,and(6)cost.4.2 Medical adhesives are currently used for a variety ofapplications and tissue types.Applications range from fixationof external tissues to internal application for use with eithersimilar or dissimilar opposing surfaces.While the biological orchemical makeup,or both,of the adhesive may define itscharacteristics,additional mechanical factors including adhe-sive volume or method of application,or both,may alsocontribute significantly toward the performance of the adhe-sive.In an effort to fairly and adequately quantify adhesivebonding strength for medical adhesives,it is important todevelop a consistent,reproducible testing standard for evalua-tive and comparative purposes.Due to the fact that theadhesives will be used on or in living tissues,a readilyavailable biological testing surface is preferred.4.3 The data generated from a standardized testing methodon biologic tissue may vary from that found in vivo,however,testing results should offer valuable information on the poten-tial bonding capacity and for the preparation of subsequent invivo experiments.4.4 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 tensile test arenot suitable for determining allowable design stresses withoutthorough analysis and understanding of the application andadhesive behaviors.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 F2258 05(2010).DOI:10.1520/F2258-05R15.2For 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 4.5 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:5.1.