ASTM_F_1829_-_98_2009.pdf

Designation:F182998(Reapproved 2009)Standard Test Method forStatic Evaluation of Glenoid Locking Mechanism in Shear1This standard is issued under the fixed designation F1829;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 method for determining thestatic shear disassembly force of modular glenoid componentsused in shoulder prostheses.It is intended to be used as adesign validation and for comparison with other prostheses.1.2 This test method covers modular glenoid componentscomprised of a separate articular insert and backing.The insertand backing can be fabricated from any combination of thefollowing materials:metal alloys,polymeric materials,com-posite materials.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:2E4 Practices for Force Verification of Testing MachinesF1378 Specification for Shoulder Prostheses3.Terminology3.1 Definitions:3.1.1 articular insertthe polymeric prosthetic portion of amultiple piece glenoid component that articulates with thehumeral head.3.1.2“d”offset distance from the edge of the glenoidbacking locking mechanism to the centerline of the point ofload application on the articular insert as shown in Fig.1 andFig.2.3.1.3 glenoid backingthe metallic or composite materialprosthetic portion of a multiple piece glenoid component thatattaches to the scapula.3.1.4 glenoid componentthe prosthetic portion that re-places the glenoid fossa of the scapula and articulates with thenatural humeral head or a prosthetic replacement.4.Significance and Use4.1 This test method can be used to describe the effects ofmaterials,manufacturing,and design variables on the perfor-mance of metal-backed glenoid prostheses locking mecha-nisms to resist static shear loading.4.2 The glenoid component is used in shoulder replace-ments and should conform to the criteria specified in Specifi-cation F1378.4.3 The loading of metal-backed glenoid prostheses in vivowill,in general,differ from the loading defined in this testmethod.The results obtained here cannot be used to directlypredict in vivo performance.However,this test method isdesigned to allow for comparisons between different metalbacked glenoid locking mechanism designs,when tested undersimilar circumstances.4.4 This test method may not be appropriate for all types ofimplant applications.The user is cautioned to consider theappropriateness of the method in view of the materials beingtested and their potential application.4.5 In order for the test data on metal-backed glenoidcomponents to be comparable,reproducible,and capable ofbeing correlated among laboratories,it is essential that uniformprocedures be established.5.Apparatus5.1 The test fixture shall be constructed so that the line ofload application is parallel to the intended axis of the implant(that is,inferior to superior or anterior to posterior).6.Equipment6.1 The tests will be performed on either mechanical orhydraulic load frames with adequate load capacity and thatmeet the criteria of Practices E4.1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved Feb.1,2009.Published March 2009.Originallyapproved in 1997.Last previous edition approved in 2003 as F1829 98(2003).DOI:10.1520/F1829-98R09.2For 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 7.Sampling7.1 Aminimum of five samples with the load oriented in theinferior-to-superior direction shall be tested per device.7.2 Aminimum of five samples with the load oriented in theanterior-to-posterior direction shall be tested per device.8.Sample and Test Specimen8.1 All articular insert test components shall be representa-tive of final manufactured implant quality products.8.2 Glenoid backing test components may either be in theform of the final implant or may be a simplified model with theexact locking mechanism to be used on the final implant.Thematerials and surface shall be representative of implant qualityproducts.All manufacturing processes(includin