【国外标准】 Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices

5.1 This test method is intended to assess the locking strength of the acetabular liner in a modular acetabular shell when subjected to three different force application conditions.5.2 This test method may not be appropriate for all implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials and design being tested and their potential application.5.3 While these test methods may be used to measure the force required to disengage modular acetabular devices, comparison of such data for various device designs must take into consideration the size of the implant and the type of locking mechanism evaluated. The location of the locking mechanism relative to the load application may be dependent upon the size and design of the acetabular device. In addition, the locking mechanism itself may vary with size, particularly if the design is circumferential in nature (for example, a larger diameter implant would have a greater area of acetabular shell and liner interface than a small diameter implant).5.4 Material failure is possible before locking mechanism failure during either push-out or offset pull-out/lever-out conditions. This is due to the possibility that the shear strength of the material may be exceeded before the locking mechanism is fully tested.1.1 This test method covers a standard methodology by which to measure the attachment strength between the modular acetabular shell and liner. Although the methodology described does not replicate physiological loading conditions, it has been described as a means of comparing the integrity of various locking mechanisms.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.3 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.1.4 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.