ISO 7206-12-2016 pdf free.Implants for surgery – Partial and total hip joint prostheses – Part 12: Deformation test method for acetabular shells.
This part of Iso 7206 specifies a test method for determining short-term deformation of a press-fit acetahular 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.
This part of ISO 7206 does not cover methods of examining the test specimen.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 2768-2, General tolerances — Part 2: Geometrical tolerances for features without individual tolerance indications
150 7206-1, Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions
ISO 7206-2, Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
ISO 21534. Non-active surgical implants —Joint replacement implants — Particular requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7206-1, ISO 7206-2 and ISO 21534 and the following, apply.
3.1 metal backing deformation
amount of geometrical deviation (inner diameter and circularity of metal backing in a defined measurement plane) from design specifications under loading conditions
3.2 spherical socket deformation
articulating surface deformation
amount of geometrical deviation (diameter and circularity in a defined measurement plane) from design specifications under loading conditions
3.3 frontal face reference plane
plane, perpendicular to the component polar axis, nominally at the frontal face level (see Eigurei. a).ISO 7206-12 pdf free download.