ISO/TC 150/SC 4/WG 1 - Mechanical testing

This document specifies a test method for determining the endurance properties, under specified laboratory conditions, of tibial trays used in knee-joint prostheses to support and secure the plastic articulating surface. It applies to tibial trays which cover both the medial and lateral plateaux of the tibia. The test method does not apply to tibial components manufactured solely from plastic materials. This document does not cover methods of examining and reporting the final condition of the test specimen; these can be the subject of agreement between the test laboratory and the parties submitting the specimen for test. NOTE Correlation of test results with in vivo performance has not been established.

This document specifies methods of determining the compressive (fracture) or the tension (disassembly) loads required, under specific laboratory conditions, to cause failure of a modular head system. This document applies to components made of metallic and non-metallic materials, such as femoral heads of partial or total hip-joint replacements of modular construction (i.e. a head/neck conical taper connection). This document excludes methods of examining and reporting the test specimens.

ISO 7206-12:2016 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. Furthermore, this part of ISO 7206 specifies the test parameters of press-fit acetabular components tested in accordance with this part of ISO 7206. The described method is intended to be used to evaluate the comparison of various designs and materials used for acetabular components in total hip joint replacement when tested under similar conditions. 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. ISO 7206-12:2016 does not cover methods of examining the test specimen.

ISO 7206-13:2016 describes a method of determining the torque required, under specified laboratory conditions, to loosen the fixation of the head of hip joint prostheses in which the head is not intended to rotate relative to the neck. It applies to the femoral component of total or partial hip joint replacements in which the head and neck/stem (in the following referred to as cone) are secured together by a locking conical taper or any other means and in which the head and cone are separate components, and which are made of metallic or non-metallic materials. It does not cover methods of examining the test specimens; these should be agreed between the test laboratory and the party submitting the specimen for test.

This standard defines a test method and laboratory conditions so that the important parameters that affect the components are taken into account and describes how the specimen is set up for testing. The test method has been developed for prostheses that have a plane of symmetry and may not be suitable for other designs. The standard does not cover methods of examining and reporting of the test specimen. The informative Annex A includes a guidance on composition of high-alumina cement embedding medium.