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. | File Size : | 1
file
, 2.3 MB |
| ISBN(s) : | 9780580920837 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 24 |
| Product Code(s) : | 30332158, 30332158, 30332158 |
| Published : | 09/16/2020 |