Standards Development

Scope

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-matched implants.

This document also applies to instrumentation for use in association with non-active surgical implants manufactured by AM.

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 factors which are either unique to additively manufactured implants or which require additional consideration for additively manufactured implants. These factors might not be currently included within existing implant specific standards.

This document is not applicable to implants which contain or incorporate tissues or cells, or their derivates, of animal or human origin.

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 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.