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.
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