S. Dawids – författare

Proceedings of a Workshop sponsored by the Commission of the European Communities as advised by the Committee on Medical and Public Health Research and the Committee on Bioengineering Evaluation of Technology Transfer and Standardization

This book contains the first collection of selected tests for the evaluation of blood compatible materials. The tests are given as recipes, including a list of equipment and materials used in each particular test, which means that persons not very well versed in the field are able to perform the tests. In most tests reference results are given to provide further guidance. Researchers from many countries have contributed. The text includes the following: guidelines for Selecting Animals, Testing for Mechanical Properties, Biodegradation, Surface Analysis, Detection of Protein Adsorption, Activation of Haemostasis and other Activation Systems, Detection of Thrombosis, Fibrinolysis and Emboli formation and Detection of Toxicity. A separate chapter on rules for good manufacturing Practice and Good Laboratory Practice is included. This book is of great value for range of disciplines, from the experimental research laboratory to the official approval laboratory.

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.