BS PD ISO/TS 20721:2020

This document established the currently recognized approaches and special considerations needed when evaluating the in vitro and in vivo performance of absorbable metals and implants fabricated, in whole or in part, from them. This document describes how the evaluation of these metals can differ from those utilized for permanent non-absorbable implantable implants (or subcomponents), in that absorbable metal implants (or subcomponents) are – by design – intended to be absorbed in their entirety 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. The provided content is intended to deliver added clarity to the evaluation of these materials and implants to increase awareness of critical factors and reduce potential for generation of erroneous or misleading test results.

All current amendments available at time of purchase are included with the purchase of this document.