ASTM International - ASTM F1820-97(2003)
Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device
|Publication Date:||10 April 2003|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
significance And Use:
This test method is intended to help assess the axial locking strength of the acetabular liner in a modular shell when subjected to a tensile loading condition. Additional means of evaluating the... View More
This test method is intended to help assess the axial locking strength of the acetabular liner in a modular shell when subjected to a tensile loading condition. Additional means of evaluating the locking mechanisms of modular acetabular devices may be appropriate depending upon the design of the device (that is, lever-out, torsional strength, fatigue, and so forth).
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.
While this test method 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, larger diameter implants would have a greater area of acetabular shell/acetabular liner interface than a small diameter implant).View Less
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 means of comparing integrity of various locking mechanisms.
1.2 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.