ASTM F1829-2016 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear《剪切解剖关节锁紧机构静态评价的标准试验方法》.pdf

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1、Designation: F1829 98 (Reapproved 2009)F1829 16Standard Test Method forStatic Evaluation of Anatomic Glenoid Locking Mechanismin 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

2、 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 the static shear disassembly force of modular

3、anatomic glenoidcomponents used in shoulder prostheses. It is intended to be used as a design validation and for comparison with other anatomictotal shoulder arthroplasty prostheses.1.2 Although the methodology described does not replicate all physiological force conditions, it is a means of in vitr

4、ocomparison of modular anatomic glenoid component designs and the strength of the retention mechanism between the articularinsert and glenoid backing under the stated test conditions.1.3 This test method covers modular glenoid components comprised of a separate articular insert and backing. The inse

5、rt andbacking can be fabricated from any combination of the following materials: metal alloys, polymeric materials, composite materials.1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.5 This standard does not purport to

6、address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatorylimitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E4 Practices

7、 for Force Verification of Testing MachinesF1378 Specification for Shoulder ProsthesesF2028 Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation3. Terminology3.1 Definitions:3.1.1 anatomic total shoulder arthroplasty system, nshoulder implant system that has a concave glenoid c

8、omponent and aconvex humeral component design.3.1.2 glenoid component, nthe prosthetic portion that replaces the glenoid fossa of the scapula and articulates with the naturalhumeral head or a prosthetic replacement.3.2 Definitions:Definitions of Terms Specific to This Standard:3.2.1 articular insert

9、insert, nthe polymericconcave prosthetic portion of a multiple piece multi-piece glenoid componentthat articulates with the humeral head. This articular insert is most often polymeric.3.2.2 “d”“d”, noffset distance from the edge of the glenoid backing locking mechanism to the centerline of the point

10、 ofload application on the articular insert as shown in Fig. 1 and Fig. 2.3.2.3 glenoid backingbacking, nthe metallic or composite material prosthetic portion of a multiple piece glenoid componentthat attaches to the scapula.1 This test method is under the jurisdiction of ASTM Committee F04 on Medic

11、al and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved Feb. 1, 2009March 1, 2016. Published March 2009April 2016. Originally approved in 1997. Last previous edition approved in 20032009 asF1829 98 (2009).(2003). DOI: 10.1

12、520/F1829-98R09.10.1520/F1829-16.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.This document is not an ASTM

13、 standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all

14、 cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.1.4 glenoid componentthe prosthetic portion that replaces the glenoid foss

15、a of the scapula and articulates with the naturalhumeral head or a prosthetic replacement.4. Significance and Use4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the performanceof metal-backed glenoid prosthesesmetal or composite-backed an

16、atomic glenoid prostheses locking mechanisms to resist staticshear loading.4.2 The glenoid component is used in shoulder replacements and should conform to the criteria specified in Specification F1378.4.3 The loading of metal-backed metal or composite-backed anatomic glenoid prostheses in vivo will

17、, in general, differ fromthe loading defined in this test method. The results obtained here cannot be used to directly predict in vivo performance. However,this test method is designed to allow for comparisons between different metal backed or composite-backed anatomic glenoidlocking mechanism desig

18、ns, when tested under similar circumstances.FIG. 1 Schematic of Static Glenoid Locking Strength Inferior-to-Superior DirectionFIG. 2 Schematic of Static Glenoid Locking Strength Anterior-to-Posterior DirectionF1829 1624.4 This test method may not be appropriate for all types of implant applications.

19、 The user is cautioned to consider theappropriateness of the method in view of the materials being tested and their potential application.4.5 In order for the test data on metal-backed metal or composite-backed anatomic glenoid components to be comparable,reproducible, and capable of being correlate

20、d among laboratories, it is essential that uniform procedures be established.5. Apparatus5.1 The test fixture shall be constructed so that the line of load application is parallel to the intended axis of the implant (thatis, inferior to superior or anterior to posterior).6. Equipment6.1 The tests wi

21、ll be performed on either mechanical or hydraulic load frames with adequate load capacity and that meet thecriteria of Practices E4.7. Sampling7.1 A minimum of five samples with the load oriented in the inferior-to-superior direction shall be tested per device.7.2 A minimum of five samples with the

22、load oriented in the anterior-to-posterior direction shall be tested per device.8. Sample and Test Specimen8.1 All articular insert test components shall be representative of final manufactured implant quality products.8.2 Glenoid backing test components may either be in the form of the final implan

23、t or may be a simplified model with the exactlocking mechanism to be used on the final implant. The materials and surface shall be representative of implant quality products.All manufacturing processes (including heat treatment) should be followed.8.3 All components should be sterilized according to

24、 the manufacturers recommendations, if that process could affect theresults.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 load isapplied in an inferior-to-super

25、ior 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 physiologicalenvironment if the conditions (that is, temperature, humidity, and fluid) of the test environment are recorded.9.3 Apply a vertical load to the a

26、ssembly offset at a specified distance from the locking mechanism.9.4 Load should be applied to the articular insert with a blunt edge loading applicator.9.5 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 the

27、 following occurs:9.6.1 The articular insert disengages from the glenoid backing,9.6.2 The disengagement force has reached a maximum and continues to decrease, or9.6.3 Gross deformation of the insert occurs without dislocation of the insert.9.7 Record the load versus displacement and the failure mod

28、e. The glenoid backing should be visually inspected for damageafter each test run.9.8 Repeat the procedure with a new insert and with the load applied 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, thic

29、kness, and materials) relevant to the particular implants tested. If the glenoid component isnot symmetric then details of the non-symmetry and its relation to the test configuration should be specified,10.1.2 The distance, “d”, between the top of the locking mechanism and the centerline of the poin

30、t of load application (see Fig.1 and Fig. 2),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, and10.1.7 The number of glenoid backing test components used.used, and10.1.8 Load displacement curves for each te

31、st.F1829 16311. Precision and Bias11.1 The precision and bias of this test method needs to be established. Test results that can be used to establish precision andbias are solicited.12. Keywords12.1 arthroplasty; disassembly; glenoid; modular; orthopaedic medical devices; shoulder arthroplastyAPPEND

32、IX(Nonmandatory Information)X1. RATIONALEX1.1 A minimum of five test specimens is recommended for this test method. The investigator should determine if additionalspecimens are required. Statistical methods that take into account variability in the components being tested may be used to achievethe d

33、esired level of significance.X1.2 This test method is intended to allow the investigator to compare different glenoid locking mechanism designs as subjectedto shear loading. This test method is not intended to test for all modes of failure or loading to which the component may besubjected. The inves

34、tigator should determine if additional test conditions are necessary. It is believed that fatigue, particularly ina rocking motion, is more likely to cause disassembly of the glenoid locking mechanism clinically and will provide further insightinto the glenoid components behavior.X1.3 The size of th

35、e glenoid component shall be determined by the investigator. In general, the worst case size should be chosenbased on evaluation or experience. There may also be a reason why an investigator wishes to test a size that is not worst case. Thistest method may also be used for this purpose.X1.4 Worst ca

36、se loading of the glenoid component may vary, depending on the material, design, and clinical indications. Theinvestigator shall evaluate the possible clinical and design-related failure modes and attempt to determine a worst case condition.X1.5 It is recognized that for some materials the environme

37、nt may have an effect on the response to loading. The test environmentused and the rationale for that choice shall be described in the test report.X1.6 The loading of metal-backed metal or composite-backed anatomic glenoid prostheses in vivo will, in general, differ from theloading defined in this t

38、est method. The results obtained here cannot be used to directly predict in vivo performance. The resultsobtained from this test method do not imply that the prosthesis will be clinically successful.ASTM International takes no position respecting the validity of any patent rights asserted in connect

39、ion 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, are entirely their own responsibility.This standard is subject to revision at any time by the responsibl

40、e 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 standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consi

41、deration 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 Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Ba

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