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<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document specifies the characteristics of, and corresponding test methods for bio-stable ceramic-bone-substitute material based on an alumina-reinforced zirconia matrix composite for use as bone spacers, bone replacements and components in orthopaedic joint prostheses.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document is intended for composite materials which are based on a zirconia matrix, i.e. zirconia as the dominating phase in the composite with a mass fraction of >60 %, similar to the material described in<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;"> ISO 13356</span></span></span>, but extended by means of a certain amount of alumina and other defined ingredients.</span></p>
<p class="Note" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE<span style="mso-tab-count: 1;"> </span>The required properties in this document differ from those in <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">6474</span></span></span>‑<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">1</span></span></span> with respect to strength and fracture toughness. Furthermore, there are requirements specifically applicable for zirconia-containing materials (see <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">13356</span></span></span>).</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">In the material composition as defined in this document, additional additives are listed. Typical additives for alumina or zirconia ceramics are Mg, Y, Ce and others. Such additives can be useful in order to improve the mechanical properties and/or the chemical stability of the alumina-zirconia composite material.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document does not cover biocompatibility (see <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">10993</span></span></span>‑<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">1</span></span></span>). It is the responsibility of the manufacturer to evaluate the biocompatibility of the specific ceramic composite material which is produced within the framework of this document.</span></p>
Reģistrācijas numurs (WIID)
86077
Darbības sfēra
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document specifies the characteristics of, and corresponding test methods for bio-stable ceramic-bone-substitute material based on an alumina-reinforced zirconia matrix composite for use as bone spacers, bone replacements and components in orthopaedic joint prostheses.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document is intended for composite materials which are based on a zirconia matrix, i.e. zirconia as the dominating phase in the composite with a mass fraction of >60 %, similar to the material described in<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;"> ISO 13356</span></span></span>, but extended by means of a certain amount of alumina and other defined ingredients.</span></p>
<p class="Note" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE<span style="mso-tab-count: 1;"> </span>The required properties in this document differ from those in <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">6474</span></span></span>‑<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">1</span></span></span> with respect to strength and fracture toughness. Furthermore, there are requirements specifically applicable for zirconia-containing materials (see <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">13356</span></span></span>).</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">In the material composition as defined in this document, additional additives are listed. Typical additives for alumina or zirconia ceramics are Mg, Y, Ce and others. Such additives can be useful in order to improve the mechanical properties and/or the chemical stability of the alumina-zirconia composite material.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document does not cover biocompatibility (see <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">10993</span></span></span>‑<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">1</span></span></span>). It is the responsibility of the manufacturer to evaluate the biocompatibility of the specific ceramic composite material which is produced within the framework of this document.</span></p>