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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 establishes a method for detecting and evaluating internal imperfections of cast metallic surgical implants and related weldments.</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;">The procedures established in this document apply to film-based methods.</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;">The recommendations on the acceptance limits for internal imperfections in cast metallic surgical implants are given in <span class="citeapp"><span style="color: black; mso-color-alt: windowtext;">Annex A</span></span>.</span></p>
<p><span lang="EN-GB" style="font-size: 11.0pt; mso-bidi-font-size: 12.0pt; font-family: 'Cambria',serif; mso-fareast-font-family: 'MS Mincho'; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-GB; mso-fareast-language: JA; mso-bidi-language: AR-SA;">NOTE<span style="mso-tab-count: 1;"> </span>In this document, when not otherwise specified, the term “manufacturer” refers to the “implant manufacturer”, and the term “product” refers to the “metallic cast implant for surgery” or to the “component of metallic cast implant for surgery”.</span></p>
Reģistrācijas numurs (WIID)
79957
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 establishes a method for detecting and evaluating internal imperfections of cast metallic surgical implants and related weldments.</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;">The procedures established in this document apply to film-based methods.</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;">The recommendations on the acceptance limits for internal imperfections in cast metallic surgical implants are given in <span class="citeapp"><span style="color: black; mso-color-alt: windowtext;">Annex A</span></span>.</span></p>
<p><span lang="EN-GB" style="font-size: 11.0pt; mso-bidi-font-size: 12.0pt; font-family: 'Cambria',serif; mso-fareast-font-family: 'MS Mincho'; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-GB; mso-fareast-language: JA; mso-bidi-language: AR-SA;">NOTE<span style="mso-tab-count: 1;"> </span>In this document, when not otherwise specified, the term “manufacturer” refers to the “implant manufacturer”, and the term “product” refers to the “metallic cast implant for surgery” or to the “component of metallic cast implant for surgery”.</span></p>
