This document established the currently recognized approaches and special considerations neededwhen evaluating the in vitro and in vivo performance of absorbable metals and implants fabricated, inwhole or in part, from them. This document describes how the evaluation of these metals can differfrom those utilized for permanent non-absorbable implantable implants (or subcomponents), in thatabsorbable metal implants (or subcomponents) are – by design – intended to be absorbed in theirentirety by the host.
This document provides guidance regarding the materials considerations, in vitro degradation/fatigue characterization, and biological evaluation of medical implants made of absorbable metals. Theprovided content is intended to deliver added clarity to the evaluation of these materials and implantsto increase awareness of critical factors and reduce potential for generation of erroneous or misleadingtest results.
