<p><span lang="EN-GB">This document specifies a test method for determining short-term deformation of a press-fit acetabular component for total hip joint replacement under specific laboratory conditions. This document 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.</span></p>
<p><span lang="EN-GB">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 (e.g. those identified in <!-- [if supportFields]><span style='color:#0563C1'><span
style='mso-element:field-begin'></span><span
style='mso-spacerun:yes'> </span>REF Section_sec_8 \r \h <span
style='mso-element:field-separator'></span></span><![endif]-->Clause 8<!-- [if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E000000530065006300740069006F006E005F007300650063005F0038000000</w:data>
</xml><![endif]--><!-- [if supportFields]><span style='color:#0563C1'><span
style='mso-element:field-end'></span></span><![endif]-->), and, if necessary, a comparison of results to a reference implant tested under the same conditions. Depending on this evaluation, either additional testing or clinical data, or both, which is outside the scope of this document, can be necessary.</span></p>
<p><span lang="EN-GB">The loading of the acetabular components in vivo differs, in general, from the loading defined in this test method. The results obtained here cannot be used to directly predict in vivo performance.</span></p>
<p><span lang="EN-GB">This document does not cover methods that examine the test specimens.</span></p>
Registration number (WIID)
85682
Scope
<p><span lang="EN-GB">This document specifies a test method for determining short-term deformation of a press-fit acetabular component for total hip joint replacement under specific laboratory conditions. This document 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.</span></p>
<p><span lang="EN-GB">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 (e.g. those identified in <!-- [if supportFields]><span style='color:#0563C1'><span
style='mso-element:field-begin'></span><span
style='mso-spacerun:yes'> </span>REF Section_sec_8 \r \h <span
style='mso-element:field-separator'></span></span><![endif]-->Clause 8<!-- [if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E000000530065006300740069006F006E005F007300650063005F0038000000</w:data>
</xml><![endif]--><!-- [if supportFields]><span style='color:#0563C1'><span
style='mso-element:field-end'></span></span><![endif]-->), and, if necessary, a comparison of results to a reference implant tested under the same conditions. Depending on this evaluation, either additional testing or clinical data, or both, which is outside the scope of this document, can be necessary.</span></p>
<p><span lang="EN-GB">The loading of the acetabular components in vivo differs, in general, from the loading defined in this test method. The results obtained here cannot be used to directly predict in vivo performance.</span></p>
<p><span lang="EN-GB">This document does not cover methods that examine the test specimens.</span></p>
