ISO/DIS 7206-12

Implants for surgery — Partial and total hip joint prostheses — Part 12: Deformation test method for press-fit acetabular components

Scope

This part of ISO 7206 specifies a test method for determining short-term deformation of a press-fit acetabular component for total hip joint replacement under specific laboratory conditions. It also defines the conditions of testing so that the important parameters that affect the components are taken into account and it describes how the specimen is set up for testing.
The described method is intended to be used to measure the amount of deformation under load and plastic deformation after unloading of various designs and materials used for acetabular components in total hip joint replacement. These measurements are then used in an evaluation of risks associated with acetabular cup deformation for the acetabular component under evaluation to determine if its performance can be adversely affected. In the evaluation of risks associated with acetabular component deformation, it can be useful to take into consideration various design, material, and surgical implantation factors (for example, those identified in Clause 8), and, if necessary, a comparison of results to a reference implant tested under the same conditions. Depending on this evaluation, additional testing and/or clinical data, which is outside the scope of this document, can be necessary.
The loading of the acetabular components 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. This part of ISO 7206 does not cover methods of examining the test specimens.