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

ISBN-13: 9780792320029 / Angielski / Twarda / 1992 / 248 str.

W. Lemm; W. Lemm

Opis

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.

Spis treści

Foreword. The Concerted Action EUROBIOMAT -- Hemocompatibility --. Introduction. Part I: Physical, Chemical and Physico-Chemical Methods for Surface and Bulk Characterization. Surface Characterization of EUROBIOMAT Reference Polymers. Surface Analysis of Polymer Biomaterials by Electron Spectroscopy for Chemical Analysis (ESCA). Surface Infrared Analysis of Standard Biomaterials. Contact Angles of Polymer Reference Materials. Zeta-Potentials and Surface Tensions. The Surface Energy Spectra of Polumers. Supercriticial Fluid Extraction/Chromatography (SFE/C) of Additives from Standard Biomaterials for Use in Biocompatibility Testing. Determination of Surface Energetic properties by Contact Angle Measurements. Advancing and Receding Water Contact Angle Measurements with Drops, Bubbles and Plates. Screening Test for Residual Ethylene Oxide on Reference Materials. The Average Molecular Weight of the Reference Materials. Part II: Biological, Biochemical, Immunological, Hematological and Toxicological Methods to Evaluate the Biocompatibility of the Reference Materials. Activation of the Human Complement System by 'Standard' Polymers. Photometric Enzyme Immunoassay for the Quantitative Determination of C3a-des Arg in Human Plasma Incubated with polymeric Biomaterials. Complement Activation, Cytotoxicity and leaching of Substances. Enzyme-Linked Immunosorbent Assays for Biocompatibility Testing. Measurement of Platelet Adhesion, Released beta-Thromboglobulin and Generated Fibrinopeptide A Using Whole Non-anti-coagulated Blood at Flow Conditions. Perfusion Technique for in vitro Evaluation of Platelet Interaction with Biomaterials in Catheter Form. In vitro Hemocompatibility Scredding Test by using the Resonance-Thrombography. The Hemocompatibility of Reference materials in vitro; Comparative Investigation of Platelet Adhesion/Activation and Platelet Aggregability. Cell Culture Cytotxocity Assays as Part of the Biocoompatibility Testing of Standard Biomaterals. Quantitative Evaluation of Cytotoxicity in vitro of Extracts from Standard Biomaterials. In vitro Toxicity of the Reference Materials. The Ciliata-Test. Keratinocyte Cell Cultures for Testing of a Polether-Urethane as a Diffusion Limiting and Potentially Haemocaompatible External Membrane for Enzyme Electrode Biocompatibility Evaluation of Reference Materials.