This book represents the first European effort to provide a collection
of test descriptions used in evaluation of the compatibility of
biomaterials in contact with tissues and blood. The urge to compile this
book arose from the fact that it is the properties of the material which
ultimatively seem to determine the functional outcome of a medical
device, almost regardless of how ingenious the construction of the very
device is. The longer the exposure is, the more important these basic
properties become. Unfortunately only a small part of the interactive
phenomena is fully elucidated and understood. This challenge reflects
itself in an effort to cover numerous aspects of testing, beginning with
fundamental analysis of the material, continuing with the mechanical
properties, the resistance to degradation and the analysis of surface
and chemical properties including adsorption patterns of proteins ending
with test on cell cultures, ex vivo and in vivo. A number of the tests
which are generally accepted as being important are already described as
official requirements (primarily Pharmacopeas). These official
requirements are not included in order to limit the size of the book. It
is the aim of this book to present the tests like a recipe in a uniform
way to ease the reader in finding his/her way through the material and
to present it as a kind of "cook-book" in an order to provide an easy
access to copy the procedures. This has unfortunately not been possible
in all circumstances.