ISO/AWI 5092

Abstract

This document identifies factors that affect the safety and performance of surgical implants due to the fact these implants are manufactured additively. This document applies to non-active implants manufactured additively, including custom-made implants and patient-specific implants. 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. This document identifies gaps with respect to additive manufacturing in existing implant specific standards, which might have to be revised and updated. This document does not apply to tissue-engineered implants manufactured by AM. NOTE 1 This document provides references to existing or currently developed relevant documents in ISO/TC 150, ISO/TC 261, ASTM F04 and ASTM F42. NOTE 2 This document does not require that manufacturers have a quality management system in place. However, the 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.