ASTM F1829-1998(2003) Standard Test Method for Static Evaluation of the Glenoid Locking Mechanism in Shear《静态评价剪切中关节窝锁紧结构的标准试验方法》.pdf

1、Designation: F 1829 98 (Reapproved 2003)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 (e) 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 compon

3、entsused 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 thefol

4、lowing materials: metal alloys, polymeric materials, com-posite materials.1.3 The values stated in SI units are regarded as thestandard.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 es

5、tablish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:E 4 Practices for Force Verification of Testing Machines2F 1378 Specification for Shoulder Prosthesis33. Terminology3.1 Definitions:3.1.1

6、 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 and

7、Fig. 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 prostheti

8、c 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 mechanismsto resist static shear loading.4.2 The glenoid component is used in shoulder replace

9、-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 can not be used to directlypredict in vivo performance. However, this

10、 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 metho

11、d 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 fi

12、xture 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

13、 criteria of Practices E 4.7. Sampling7.1 A minimum of five samples with the load oriented in theinferior to superior direction shall be tested per device.1This practice is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of S

14、ubcommitteeF04.22 on Arthroplasty.Current edition approved Sept. 10, 2003. Published October 2003. Originallyapproved in 1997. Last previous edition approved in 1998 as F 1829 - 98.2Annual Book of ASTM Standards, Vol 03.01.3Annual Book of ASTM Standards, Vol 13.01.1Copyright ASTM International, 100

15、Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.7.2 A minimum 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

16、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 manuf

17、acturing processes (including heat treat-ment) should be followed.8.3 All components should be sterilized according to manu-facturer recommended specifications for clinical use, if thisprocess could affect the results.8.4 A new articular insert should be used for each test.FIG. 1 Schematic of Static

18、 Glenoid Locking Strength Inferior to Superior DirectionFIG. 2 Schematic of Static Glenoid Locking Strength Anterior to Posterior DirectionF 1829 98 (2003)29. Procedure9.1 Following proper assembly of an insert into a backing,the assembly is attached to the test machine such that the loadis applied

19、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 simulated physiologicalenvironment if the conditions of the test environment arerecorded (that is, temperature, humidity, fluid).9.3 Apply a vertica

20、l 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.9.5 A constant displacement rate should be used and re-corded (for example, 25.4 mm/min).9.6 Testing of samples shall be terminated w

21、hen one of thefollowing occurs:9.6.1 The articular insert disengages from the glenoid back-ing,9.6.2 The disengagement force has reached a maximum andcontinues to decrease, and9.6.3 Gross deformation of the insert occurs without dislo-cation of the insert.9.7 Record load versus displacement and the

22、failure mode.The glenoid backing should be visually inspected for damageafter each test run.9.8 Repeat 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 relevant to

23、 the particular implants tested(that is, size, thickness, materials). If the glenoid component isnot symmetric then details of the non-symmetry and its relationto the test configuration should be specified,10.1.2 The distance, “d”, between the top of the lockingmechanism and the centerline of the po

24、int of load application(see Fig. 1),10.1.3 The displacement rate,10.1.4 The maximum load to failure,10.1.5 The failure mode,10.1.6 The indentor loading applicator configuration.10.1.7 Number of glenoid backing test components used.11. Precision and Bias11.1 The precision and bias of this test method

25、 needs to beestablished. Test results that can be used to establish precisionand bias are 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

26、 recommendedfor this test method. The investigator should determine ifadditional specimens 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 investi

27、gatorto compare different glenoid locking mechanism designs assubjected to shear loading. 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

28、 that fatigue,particularly in a rocking motion, is more likely to causedisassembly of the 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 ca

29、se sizeshould be chosen based on evaluation or experience. Theremay also be a reason why 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 material, design, and clinical

30、 indications.The investigator shall evaluate the possible clinical and design-related failure modes and attempt to determine a worst casecondition.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

31、for that choice shall bedescribed in the test report.X1.6 The loading of metal backed 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 testme

32、thod do not imply that the prosthesis will be clinicallysuccessful.F 1829 98 (2003)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

33、 validity of any such patent rights, and the riskof infringement of such rights, 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

34、 comments are invited either for revision of this standard or for additional standardsand 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

35、have not received a fair hearing you shouldmake your views known to the ASTM Committee 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 (2003)4