ISO/TC 150/JWG 1
| Project No. | ISO 5092:2025 |
|---|---|
| Title | <p class="MsoBodyText"><span lang="EN-GB">This document identifies factors that affect the safety and performance of surgical implants due to the fact that these implants are manufactured additively.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document applies to non-active implants manufactured additively, including custom-made implants and patient-matched implants.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document also applies to instrumentation for use in association with non-active surgical implants manufactured by additive manufacturing (AM).</span></p> <p class="MsoBodyText"><span lang="EN-GB">While this document is not intended to apply to active implants, certain clauses or subclauses of this document can potentially still be used in the context of active implants.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document identifies factors which are either unique to additively manufactured implants or which require additional consideration for additively manufactured implants. These factors have not always been included within existing implant specific standards.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document is not applicable to implants which contain or incorporate tissues or cells, or their derivates, of animal or human origin.</span></p> |
| Registration number (WIID) | 80762 |
| Scope | <p class="MsoBodyText"><span lang="EN-GB">This document identifies factors that affect the safety and performance of surgical implants due to the fact that these implants are manufactured additively.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document applies to non-active implants manufactured additively, including custom-made implants and patient-matched implants.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document also applies to instrumentation for use in association with non-active surgical implants manufactured by additive manufacturing (AM).</span></p> <p class="MsoBodyText"><span lang="EN-GB">While this document is not intended to apply to active implants, certain clauses or subclauses of this document can potentially still be used in the context of active implants.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document identifies factors which are either unique to additively manufactured implants or which require additional consideration for additively manufactured implants. These factors have not always been included within existing implant specific standards.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document is not applicable to implants which contain or incorporate tissues or cells, or their derivates, of animal or human origin.</span></p> |
| Status | Standarts spēkā |
| ICS group | 11.040.40 25.030 |