<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 provides additional requirements and guidance for the evaluation of medical devices manufactured utilizing human tissues or derivatives which are non-viable or rendered non-viable. This document is applicable to materials of human origin (homo sapiens) such as:</span></p>
<p id="P90" class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>heart valves, bones, ligaments, amniotic membranes, cornea;</span></p>
<p id="P91" class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>derivatives of human tissues, such as collagen obtained from human tissue such as skin or tendons;</span></p>
<p id="P92" class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>materials produced in vivo such as enzymes and coagulation factors.</span></p>
<p id="P93" 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 apply to materials of animal origin.</span></p>
<p id="P94" 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, in conjunction with <span class="stdpublisher">ISO</span> <span class="stddocNumber">14971</span>, a procedure to identify the hazards and hazardous situations associated with medical devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. </span></p>
<p id="P95" class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document outlines the decision process for determining the acceptability of residual risks, taking into account the risk profile and expected benefit as compared to available alternatives, in line with <span class="stdpublisher">ISO</span> <span class="stddocNumber">14971</span>. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing human materials such as:</span></p>
<p id="P96" class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">a)<span style="mso-tab-count: 1;"> </span>contamination by bacteria, moulds, yeasts or parasites;</span></p>
<p id="P97" class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">b)<span style="mso-tab-count: 1;"> </span>contamination by viruses;</span></p>
<p id="P98" class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">c)<span style="mso-tab-count: 1;"> </span>contamination by agents causing transmissible spongiform encephalopathies (TSEs) and other transmissible agents;</span></p>
<p id="P99" class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">d)<span style="mso-tab-count: 1;"> </span>material responsible for undesired pyrogenic, immunological or toxicological reactions.</span></p>
<p id="P100" class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE 1<span style="mso-tab-count: 1;"> </span>It is not a requirement of this document to have a full quality management system during manufacture. However, attention is drawn to international standards for quality management systems (see <span class="stdpublisher">ISO</span> <span class="stddocNumber">13485</span>) that control all stages of production or reprocessing of medical devices.</span></p>
<p id="P101" class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE 2<span style="mso-tab-count: 1;"> </span>For guidance on the application of this document, see <span class="citeapp">Annex A</span>.</span></p>
<p id="P102" 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 address requirements for consent to donation of human materials. </span></p>
<p id="P103" class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing human materials which are non-viable or have been rendered non-viable.</span></p>
Registration number (WIID)
86868
Scope
<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 provides additional requirements and guidance for the evaluation of medical devices manufactured utilizing human tissues or derivatives which are non-viable or rendered non-viable. This document is applicable to materials of human origin (homo sapiens) such as:</span></p>
<p id="P90" class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>heart valves, bones, ligaments, amniotic membranes, cornea;</span></p>
<p id="P91" class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>derivatives of human tissues, such as collagen obtained from human tissue such as skin or tendons;</span></p>
<p id="P92" class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>materials produced in vivo such as enzymes and coagulation factors.</span></p>
<p id="P93" 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 apply to materials of animal origin.</span></p>
<p id="P94" 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, in conjunction with <span class="stdpublisher">ISO</span> <span class="stddocNumber">14971</span>, a procedure to identify the hazards and hazardous situations associated with medical devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. </span></p>
<p id="P95" class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document outlines the decision process for determining the acceptability of residual risks, taking into account the risk profile and expected benefit as compared to available alternatives, in line with <span class="stdpublisher">ISO</span> <span class="stddocNumber">14971</span>. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing human materials such as:</span></p>
<p id="P96" class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">a)<span style="mso-tab-count: 1;"> </span>contamination by bacteria, moulds, yeasts or parasites;</span></p>
<p id="P97" class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">b)<span style="mso-tab-count: 1;"> </span>contamination by viruses;</span></p>
<p id="P98" class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">c)<span style="mso-tab-count: 1;"> </span>contamination by agents causing transmissible spongiform encephalopathies (TSEs) and other transmissible agents;</span></p>
<p id="P99" class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">d)<span style="mso-tab-count: 1;"> </span>material responsible for undesired pyrogenic, immunological or toxicological reactions.</span></p>
<p id="P100" class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE 1<span style="mso-tab-count: 1;"> </span>It is not a requirement of this document to have a full quality management system during manufacture. However, attention is drawn to international standards for quality management systems (see <span class="stdpublisher">ISO</span> <span class="stddocNumber">13485</span>) that control all stages of production or reprocessing of medical devices.</span></p>
<p id="P101" class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE 2<span style="mso-tab-count: 1;"> </span>For guidance on the application of this document, see <span class="citeapp">Annex A</span>.</span></p>
<p id="P102" 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 address requirements for consent to donation of human materials. </span></p>
<p id="P103" class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing human materials which are non-viable or have been rendered non-viable.</span></p>
