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Significance and Use
This test method can be used to describe the effects of materials, manufacturing, and design variables on the performance of metal-backed glenoid prostheses locking mechanisms to resist static shear loading.
The glenoid component is used in shoulder replacements and should conform to the criteria specified in Specification F 1378
The loading of metal-backed 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 backed glenoid locking mechanism designs, when tested under similar circumstances.
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.
In order for the test data on metal-backed 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 glenoid components used in shoulder prostheses. It is intended to be used as a design validation and for comparison with other prostheses.
1.2 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.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E4 Practices for Force Verification of Testing Machines
F1378 Specification for Shoulder Prostheses
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42321900(Shoulder joint implants)