ISO/TC 150/JWG 1
| Project No. | ISO/FDIS 5092 |
|---|---|
| Title | <p class="MsoNormal"><span lang="EN-GB">This document identifies factors that affect the safety and performance of surgical implants due to the fact these implants are manufactured additively.</span></p> <p class="MsoNormal"><span lang="EN-GB" style="mso-fareast-language: JA;">This document applies to non-active implants</span><span lang="EN-GB"> manufactured additively, including </span><span lang="EN-GB" style="mso-fareast-language: JA;">custom-made implants, and patient-matched implants.</span></p> <p class="MsoNormal"><span lang="EN-GB" style="mso-fareast-language: JA;">This document also applies to instrumentation for use in association with non-active surgical implants manufactured by AM.</span></p> <p class="MsoNormal"><span lang="EN-GB" style="mso-fareast-language: JA;">While this document is not intended to apply to active implants, parts of the document can potentially still be used in the context of active implants.</span></p> <p class="MsoNormal"><span lang="EN-GB">This document <span style="mso-spacerun: yes;"> </span>identifies factors, which are either unique to additively manufactured implants or which require additional consideration for additively manufactured implants that might not be currently included within existing implant specific standards, which might have to be revised and updated. </span></p> <p class="MsoNormal"><span lang="EN-GB">This document does not apply to tissue-engineered implants manufactured by AM.</span></p> <p class="MsoNormal"><span lang="EN-GB" style="font-size: 10.0pt; mso-bidi-font-size: 11.0pt;">NOTE 1<span style="mso-tab-count: 1;"> </span>This document provides references to existing or currently developed relevant documents in ISO/TC 150, ISO/TC 261, ASTM F04 and ASTM F42.</span></p> <p class="MsoNormal"><span lang="EN-GB" style="font-size: 10.0pt; mso-bidi-font-size: 11.0pt;">NOTE 2<span style="mso-tab-count: 1;"> </span>Application of a quality management system, such as that described in ISO 13485, could be appropriate to help ensure that the implant achieves its intended performance.</span></p> |
| Registration number (WIID) | 80762 |
| Scope | <p class="MsoNormal"><span lang="EN-GB">This document identifies factors that affect the safety and performance of surgical implants due to the fact these implants are manufactured additively.</span></p> <p class="MsoNormal"><span lang="EN-GB" style="mso-fareast-language: JA;">This document applies to non-active implants</span><span lang="EN-GB"> manufactured additively, including </span><span lang="EN-GB" style="mso-fareast-language: JA;">custom-made implants, and patient-matched implants.</span></p> <p class="MsoNormal"><span lang="EN-GB" style="mso-fareast-language: JA;">This document also applies to instrumentation for use in association with non-active surgical implants manufactured by AM.</span></p> <p class="MsoNormal"><span lang="EN-GB" style="mso-fareast-language: JA;">While this document is not intended to apply to active implants, parts of the document can potentially still be used in the context of active implants.</span></p> <p class="MsoNormal"><span lang="EN-GB">This document <span style="mso-spacerun: yes;"> </span>identifies factors, which are either unique to additively manufactured implants or which require additional consideration for additively manufactured implants that might not be currently included within existing implant specific standards, which might have to be revised and updated. </span></p> <p class="MsoNormal"><span lang="EN-GB">This document does not apply to tissue-engineered implants manufactured by AM.</span></p> <p class="MsoNormal"><span lang="EN-GB" style="font-size: 10.0pt; mso-bidi-font-size: 11.0pt;">NOTE 1<span style="mso-tab-count: 1;"> </span>This document provides references to existing or currently developed relevant documents in ISO/TC 150, ISO/TC 261, ASTM F04 and ASTM F42.</span></p> <p class="MsoNormal"><span lang="EN-GB" style="font-size: 10.0pt; mso-bidi-font-size: 11.0pt;">NOTE 2<span style="mso-tab-count: 1;"> </span>Application of a quality management system, such as that described in ISO 13485, could be appropriate to help ensure that the implant achieves its intended performance.</span></p> |
| Status | Izstrādē |
| ICS group | 11.040.40 25.030 |