ASTM_F_3014_-_14.pdf

Designation:F301414Standard Test Method forPenetration Testing of Needles Used in Surgical Sutures1This standard is issued under the fixed designation F3014;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.INTRODUCTIONThe purpose of this test method is to provide a common method for fixturing and measuring thepenetration force of a surgical needle.Most surgical needles are coated to facilitate passage throughtissue.This coating needs to be both lubricious and durable.The lubricity of the coating acts to lowerthe penetration force,while the durability of the coating maintains the needles ability to pass throughtissue multiple times with minimum increase in penetration force.It has been observed that,when acoating is found to be more lubricious,that coating is often less durable.Likewise,when a coating isfound to be more durable,that coating is often less lubricious.Comparative measurements of lubricityand durability can provide an expectation of how the coated needle may perform during actual use.This standard does not presently address the testing medium.Test medium will be addressed in thenext phase of this test method development.However,this test method does require certain mediumcharacteristics to be identified.1.Scope1.1 This test method describes the procedure for penetrationtesting sharp and blunt needles used for the placement ofsurgical sutures.It only describes the test procedures(Phase 1)and does not define a test medium at this time.Test media willbe address in the next phase(Phase 2)of this test methodsevolution.1.2 This test method applies to straight and curved surgicalneedles.1.3 This test method does not intend to address the value ofthe test with respect to actual conditions of use.1.4 In this test method,it is assumed the needles used forthis test have passed all applicable quality standards and haveno physical malformation that would inappropriately influencethe test results.1.5 This test method quantifies the force required for aneedle to pass through a medium and its ability to do somultiple times.1.6 UnitsThe values stated in either SI units or inch-pound units are to be regarded separately as standard.Thevalues stated in each system may not be exact equivalents;therefore,each system shall be used independently of the other.Combining values from the two systems may result in noncon-formance with the standard.1.7 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:2E122 Practice for Calculating Sample Size to Estimate,WithSpecified Precision,the Average for a Characteristic of aLot or ProcessF1840 Terminology for Surgical Suture Needles3.Terminology3.1 DefinitionsTerms used in this test method are inaccordance with Terminology F1840.3.2 Definitions of Terms Specific to This Standard:3.2.1 compound curved surgical needle,nneedle havingmore than one radius of curvature associated with the shape ofthe needle.3.2.2 needle test gripping location,narea in front of theattachment zone or tangent portion of the needle where theneedle will be clamped/secured in the test fixture.1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.33 on Medical/Surgical Instruments.Current edition approved March 1,2014.Published April 2014.DOI:10.1520/F3014-14.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2.2.1 Discussion3.2.2 can be exempt for exceptionallysmall needles.4.Summary of Test Method4.1 Securely clamp the needle into the clamping fixture in auniform area in front of the attachment zone or tangent portionof the needle,distal to the needle point.This is referred to asthe needle test gripping location,such that the needle move-ment is restricted.4.1.1 The needle shall be held so that the needle passesthrough the medium perpendicular to the test medium.4.2 The clamping fixture is rotated forward to commencepassing the needle through the media according to Table 1 orTable 2,as applicable.4.3 As the needle penetrates and passes through the mediumat 90,data about the force needed to penetrate the medium iscontinuously collected.5.Significance and Use5.1 This test method provides a means of assessing thepen