1、Designation: F 1829 98 (Reapproved 2009)Standard Test Method forStatic Evaluation of Glenoid Locking Mechanism in Shear1This standard is issued under the fixed designation F 1829; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the
2、 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 compone
3、ntsused 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 thefoll
4、owing 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 us
5、e. 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 MachinesF 1378 Specification
6、 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
7、 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
8、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
9、loading.4.2 The glenoid component is used in shoulder replace-ments and should conform to the criteria specified in Specifi-cation F 1378.4.3 The loading of metal-backed glenoid prostheses in vivowill, in general, differ from the loading defined in this testmethod. The results obtained here cannot b
10、e 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 u
11、ser 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
12、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 orhydrau
13、lic load frames with adequate load capacity and thatmeet the criteria of Practices E4.7. 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 directi
14、on shall be tested per device.1This test method is under the jurisdiction of ASTM 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.
15、 Last previous edition approved in 2003 as F 1829 98(2003).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.1C
16、opyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.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
17、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 (including heat treat-ment) should be followed.8.3 All components
18、should be sterilized according to themanufacturers recommendations, if that process could affectthe results.8.4 A new articular insert should be used for each test.9. Procedure9.1 Following proper assembly of an insert into a backing,the assembly is attached to the test machine such that the loadis
19、applied in an inferior-to-superior direction (see Fig. 1).9.2 This test is to be performed in air at room temperature.It is permissible to perform this test in a simulated physiologi-cal environment if the conditions (that is, temperature, humid-ity, and fluid) of the test environment are recorded.9
20、.3 Apply a vertical load to the assembly offset at aspecified distance from the locking mechanism.9.4 Load should be applied to the articular insert with ablunt edge loading applicator.FIG. 1 Schematic of Static Glenoid Locking Strength Inferior-to-Superior DirectionFIG. 2 Schematic of Static Glenoi
21、d Locking Strength Anterior-to-Posterior DirectionF 1829 98 (2009)29.5 A constant displacement rate (for example, 25.4 mm/min) should be used and recorded.9.6 Testing of samples shall be terminated when one of thefollowing occurs:9.6.1 The articular insert disengages from the glenoid back-ing,9.6.2
22、The disengagement force has reached a maximum andcontinues to decrease, or9.6.3 Gross deformation of the insert occurs without dislo-cation of the insert.9.7 Record the load versus displacement and the failuremode. The glenoid backing should be visually inspected fordamage after each test run.9.8 Re
23、peat the procedure with a new insert and with the loadapplied in an anterior-to-posterior direction (see Fig. 2).10. Report10.1 The test report shall include the following:10.1.1 All details (that is, size, thickness, and materials)relevant to the particular implants tested. If the glenoidcomponent
24、is not symmetric then details of the non-symmetryand its relation to the test configuration should be specified,10.1.2 The distance, “d”, between the top of the lockingmechanism and the centerline of the point of load application(see Fig. 1),10.1.3 The displacement rate,10.1.4 The maximum load to fa
25、ilure,10.1.5 The failure mode,10.1.6 The indentor loading applicator configuration, and10.1.7 The number of glenoid backing test componentsused.11. Precision and Bias11.1 The precision and bias of this test method needs to beestablished. Test results that can be used to establish precisionand bias a
26、re solicited.12. Keywords12.1 arthroplasty; disassembly; glenoid; modular; ortho-paedic medical devices; shoulder arthroplastyAPPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 A minimum of five test specimens is recommendedfor this test method. The investigator should determine ifadditional specim
27、ens are required. Statistical methods that takeinto account variability in the components being tested may beused to achieve the desired level of significance.X1.2 This test method is intended to allow the investigatorto compare different glenoid locking mechanism designs assubjected to shear loadin
28、g. This test method is not intended totest for all modes of failure or loading to which the componentmay be subjected. The investigator should determine if addi-tional test conditions are necessary. It is believed that fatigue,particularly in a rocking motion, is more likely to causedisassembly of t
29、he glenoid locking mechanism clinically andwill provide further insight into the glenoid componentsbehavior.X1.3 The size of the glenoid component shall be deter-mined by the investigator. In general, the worst case sizeshould be chosen based on evaluation or experience. Theremay also be a reason wh
30、y an investigator wishes to test a sizethat is not worst case. This test method may also be used forthis purpose.X1.4 Worst case loading of the glenoid component mayvary, depending on the material, design, and clinical indica-tions. The investigator shall evaluate the possible clinical anddesign-rel
31、ated failure modes and attempt to determine a worstcase condition.X1.5 It is recognized that for some materials the environ-ment may have an effect on the response to loading. The testenvironment used and the rationale for that choice shall bedescribed in the test report.X1.6 The loading of metal-ba
32、cked glenoid prostheses invivo will, in general, differ from the loading defined in this testmethod. The results obtained here cannot be used to directlypredict in vivo performance. The results obtained from this testmethod do not imply that the prosthesis will be clinicallysuccessful.F 1829 98 (200
33、9)3ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights,
34、are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional stan
35、dardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Comm
36、ittee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F 1829 98 (2009)4
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