ISO 7206-10 – Implants for surgery — Partial and total hip-joint prostheses Part 10: Determination of resistance to static load of modular femoral heads
Some designs of stemmed femoral components of total hip-joint prostheses comprise a stem/neck component and a component that forms the articulating surface, which is commonly in the form of a partial sphere incorporating a female conical taper connection for attachment to the neck of the stem. It is important, therefore, that the head and neck are of sufficient strength to withstand the static axial loads likely to be exerted on the prosthesis during use. This method addresses the static strength and attachment of the head. It should be noted that the test conditions described in this part of ISO 7206 do not exactly reproduce all the factors in the clinical situation.
This part of ISO 7206 applies to femoral heads of partial or total hip-joint replacements of modular construction (i.e. a head/neck conical taper connection) and describes methods of determining the load required, under specified laboratory conditions, to cause failure of the head (disassembly or fracture). It applies to components made of metallic and non-metallic materials.
A static compressive or tensile load is applied to the head/neck assembly of the hip-joint prosthesis and increased until either the head or the neck, or the connection between them, fails, or until the chosen maximum force has been applied without the occurrence of failure.