This document identifies factors that affect the safety and performance of surgical implants due to the fact that 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 additive manufacturing (AM).

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.

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.

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

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