【国外标准】 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear

4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the performance of metal or composite-backed anatomic glenoid prostheses’ locking mechanisms to resist static shear 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 or composite-backed anatomic glenoid prostheses in vivo will, in general, differ from the 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 or composite-backed anatomic glenoid locking mechanism designs, when tested under the same testing conditions.4.4 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested and their potential application.4.5 In order for the test data on metal or composite-backed anatomic glenoid components to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established.1.1 This test method covers a method for determining the static shear disassembly force of modular anatomic glenoid components used in anatomic total shoulder arthroplasty prostheses.1.2 Although the methodology described does not replicate all physiological force conditions, it is a means of in vitro comparison of modular anatomic glenoid component designs and the strength of the retention mechanism between the articular insert 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 insert and backing 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 address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.