The Reference Materials of the European Communities : Results of Hemocompatibility Tests

The demand for hemocompatibility is one of the fundamental requirements for a safe and sufficient application of artificial surfaces in contact with blood. Thrombus formation and infarctions of the capillary vascular system after blood-biomaterial interaction, as well as the activation of the complement system and the phenomenon of biodegradation, remain problematic areas. However, medical devices where large areas of artificial surfaces contact the blood of patients are applied in enormous quantities. In spite of the significance of this branch of modern medicine and some spectacular successes in therapy, organ support and organ replacement, clearly specified criteria and instructions for the design of devices and artificial blood-contacting surfaces do not yet exist. Standardized and generally-accepted test procedures for the precise quantification and validation of events at the blood-biomaterial interface are urgently needed: their absence limits safe medical therapy and the development of more efficient hemocompatible materials. This volume addresses the need for hemocompatibility standards by presenting the results of tests performed on the surfaces of the Reference Materials of the European Communities. Promoted by the EUROBIOMAT Research program of the European Communities in cooperation with the International Standards organization, this is a major contribution to the development of internationally accepted hemocompatibility test standards. Front Matter....Pages i-xxi Front Matter....Pages 1-1 Surface Characterization of EUROBIOMAT Reference Polymers....Pages 3-16 Testing of Standard Biomaterials....Pages 17-26 Surface Infrared Analysis of Standard Biomaterials....Pages 27-35 Contact Angles on Polymer Reference Materials....Pages 37-47 Zeta-Potentials and Surface Tensions....Pages 49-63 The Surface Energy Spectra of Polymers....Pages 65-73 Supercritical Fluid Extraction / Chromatography (SFE/C) of Additives from Standard Biomaterials for Use in Biocompatibility Testing....Pages 75-84 Determination of Surface Energetic Properties by Contact Angle Measurements....Pages 85-94 Advancing and Receding Water Contact Angle Measurements with Drops, Bubbles and Plates....Pages 95-106 Screening Test for Residual Ethylene Oxide on Reference Materials....Pages 107-112 The Average Molecular Weight of the Reference Materials....Pages 113-117 Front Matter....Pages 119-119 Activation of the Human Complement System by “Standard” Polymers (Eurobiomat)....Pages 121-126 Photometric Enzyme Immunoassay for the Quantitative Determination of C3a-desArg in Human-Plasma Incubated with Polymeric Biomaterials....Pages 127-138 Complement Activation, Cytotoxicity and Leaching of Substances....Pages 139-146 Enzyme-Linked Immunosorbent Assays for Biocompatibility Testing....Pages 147-155 Measurement of platelet adhesion, released β-thromboglobulin and generated fibrinopeptide A using whole non-anticoagulated blood at flow conditions....Pages 157-164 Perfusion Technique for in Vitro Evaluation of Platelet Interaction with Biomaterials in Catheter Form....Pages 165-171 In-Vitro Hemocompatibility Screening Test by Using the Resonance-Thrombography....Pages 173-182 The Hemocompatibility of Reference Materials in Vitro — Comparative Investigation of Platelet Adhesion/Activation and Platelet Aggregability....Pages 183-192 Cell Culture Cytotoxicity Assays as Part of the Biocompatibility Testing of Standard Biomaterials....Pages 193-200 Front Matter....Pages 119-119 Quantitative Evaluation of Cytotoxicity in vitro of Extracts from Standard Biomaterials....Pages 201-209 In-Vitro Toxicity of the Reference Materials. The Ciliata-Test....Pages 211-216 Keratinocyte Cell Cultures for testing Polymers for Percutaneous Devices....Pages 217-225 Blood Testing of a Polyether-Urethane as a Diffusion Limiting and Potentially Haemocompatible External Membrane for Enzyme Electrode Biosensors....Pages 227-235 Biocompatibility Evaluation of Reference Materials....Pages 237-248