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.
Auflage
Sprache
Verlagsort
Zielgruppe
Für höhere Schule und Studium
Für Beruf und Forschung
Research
Illustrationen
Maße
Höhe: 241 mm
Breite: 160 mm
Dicke: 42 mm
Gewicht
ISBN-13
978-0-7923-2107-1 (9780792321071)
DOI
10.1007/978-94-011-1640-4
Schweitzer Klassifikation
I General Introduction.- Haemocompatibility: What does it mean?.- Guidelines for selecting the proper animal species for a particular test.- II Test Methods for the Detection of Mechanical Properties.- Test for short time stress and strain.- Test for tensile stress.- Test for tear strength.- Test for dynamic stress and strain.- Test for material fatigue.- Test for creep, relaxation and set.- Test for material compliance.- Test for porosity of vascular grafts.- III Test Methods for the Detection of Biodegradation.- Boiling test for in vitro degradation of biomaterials.- Enzymatic in vitro degradation of polymers.- Tissue implantation test.- IV Test Methods for Surface Analysis.- Electron spectroscopy for chemical analysis (ESCA).- Secondary ion mass spectroscopy (SIMS).- Fourier transform attenuated total reflection infrared spectroscopy (ATR/FT-IR).- Fourier transform attenuated total reflection infrared spectroscopy (ATR/FT-IR): Application to proteins adsorption studies.- Calcium-thiocyanate method for the quantification of sites on polymer surfaces.- Contact angles and surface free energies of solids.- Scanning electron microscopy (SEM).- V Test Methods for the Detection of Protein Adsorption on Polymers.- Test for plasma protein adsorption to biomaterials using an enzyme-immunoassay.- The detection of adsorbed plasma proteins from membrane materials using SDS-polyacrylamide gel electrophoresis of desorbed proteins.- Reflectrometry as a tool for dynamically measuring protein adsorption.- Measurement of protein adsorption to solid surfaces in relation to blood compatibility using radioiodine labelling methods.- VI Test Methods for the Activation of Haemostasis and other Activation Systems.- Modified resonance thrombography.- Quantitative platelet aggregation in vitro.- Platelet deposition on biomaterials measured with a capillary perfusion model.- Enzyme immunoassay determination of specific proteins in plasma.- Human adult endothelial cell culture conditions for optimal colonization of biomaterials used in vascular surgery.- Determination of protein C in plasma.- A centrifugation technique for the preparation of suspensions of non activated washed human platelets.- Measurement of circulating fibrinopeptide A in plasma.- Assessment of the fibrinolytic system.- VII Test Methods for the Detection of Thrombosis, Fibrinolysis and Emboli Formation.- Dynamic ex vivo thrombogenicity test in modified Dudley test.- Ex vivo acute arteriovenous shunt.- Chronic artificial external arteriovenous shunt.- Intravascular implantation test.- VIII Test Methods for the Detection of Toxicity.- In vitro toxicity test for biomaterials.- In vitro toxicity tests using biological methods.- In vitro cytocompatibility tests.- IX GLP-GMP Rules for Testing of Polymers.- Rules for good laboratory practice (GLP). General considerations.- Rules for good manufacturing practice (GMP). General considerations.- Authors Index.
