The “PI-58 Hip joint prosthesis fatigue test” standard developed by PI Medical Implants is mainly based on the following standards developed by the International Standards Organization (ISO):
The ISO 7206-4 standard describes a test method for determining the endurance properties of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joints under specified laboratory conditions. It also defines the test conditions to take into account the important parameters affecting the components and describes how the specimen is set up for testing. It also specifies the test parameters and requirements for the endurance limit of stemmed femoral components tested in accordance with this standard. The value of the endurance limit test forces and the corresponding number of load cycles are specified.
This test method was developed for prostheses with one plane of symmetry, preformed anteversion or antetorsion, or double curvature of the stem.
This standard does not cover methods for examining the test sample after testing, these must be agreed upon between the testing laboratory and the party sending the sample for testing.
During testing, the bottom of the specimen is embedded in a solid medium and a cyclic load is applied to the head of the specimen to produce axial compression, bi-plane bending and torsion until the specimen fails or the prescribed number of cycles are reached. The specimen is then examined for defects caused by the loading regime.
ISO 7206-6 describes the test methods for durability characteristics and fatigue performance of the neck region of stemmed femoral components of total hip joint prostheses and of stemmed femoral components used alone in partial hip joint replacement under specified laboratory conditions. This standard does not cover the investigation of the performance of the head or neck-head junction. It is applicable to modular and non-modular designs made of metallic or non-metallic materials. In addition, this standard specifies test conditions to take into account the important parameters affecting the hip femoral components and describes how the specimen is prepared for testing.
During testing, the sample is embedded in a solid medium. For modular bodies, the projecting part of the test sample is immersed in a liquid test medium. A cyclic load is applied to the head of the sample until one of the conditions specified in the standard occurs.
The ISO 7206-8 standard describes the durability performance of pedunculated femoral components of total hip joint replacements and pedunculated femoral components used alone in partial hip joint replacements, determined under specified laboratory conditions using a method involving torsion application. However, this standard does not apply to prostheses for specific clinical situations and to prostheses where the centerline of the stem is curved in three dimensions and does not lie in any plane containing the neck axis. The femoral component is tested in a ready-to-use condition.
When testing strength performance, the femoral component shall not fracture under the conditions specified in the standard. Furthermore, tests shall not be terminated prior to completion of the loading regime for reasons other than loosening of the specimen in the embedding environment.
Among the numerous testing, measurement, analysis and evaluation studies that our organization has carried out for businesses in various sectors, it also provides testing services defined in the “PI-58 Hip joint prosthesis fatigue test” standard with its trained and expert staff and advanced technological equipment.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
