This handbook addresses the needs of those who are involved in inventing, developing, and testing implants and are concerned about the interactions between biomaterial and body tissue. The authors explore the physical, chemical, mechanical and regulatory considerations of synthetic materials used in surgical and implant procedures, and how these factors impact the latest developments and new approaches. This updated edition provides the biomaterials professional with necessary information on a range of issues, including bulk characterization, surface evaluations, toxicological evaluations, in vitro methods for safety evaluation, methods for evaluating materials in special applications, surgical considerations, systems implantology, soft and hard tissue history, regulatory aspects, and clinical trials.
Metals Alloys and Ceramics. Polymers. Composites. Dental Materials. Textiles. Absorbable Materials and Pertinent Devices. Biomaterial Surface Analysis. Ceramics and Glasses. Corrosion and Biodegradation. Friction and Wear. Reference Materials. Property Modification. Surface Topography. Particulate Material. Sterilization Effects. Perspectives. Testing. Hypersensitivity Induction. Tumor Induction. In-Use Testing of Biomaterials in Biomedical Devices. Mammalian Cell Culture Models. Hemocompatability: Effects on Cellular Elements. Hemocompatability: Effects on Humoral Elements. Genotoxicity. Tissue Engineering Concepts. Immunoisolation Devices. Drug Delivery Systems. Biosensors. Protection Of Research Animals. Animal Selection. Surgical Procedure. Implant Infections. General Compatibility. Hemocompatability. Osteocompatability. Odontocompatability. Tissue Preparation. Evaluation By Light Microscopy. Evaluation by Scanning Electron Microscopy. Evaluation by Histiochemical and Quantitative Microscopy. Evaluation Through Molecular and Cellular Biology Approaches. The Cage Implant Testing System. Evaluation of Explanted Cardiovascular Prostheses. Processing. Special Aspects of the Permucosal Interface. Intra Vitam Staining Techniques. Quantitative Morphology of the Implant-Bone Interface. Microradiography. Legal Aspects. Pre-clinical Testing Guidelines. Clinical Trial Guidelines. Protection of Human Subjects. Patient Selection. Multiphasic Device Testing. Design of Clinical Trials. Malpractice Risk in Clinical Trials. Information for the Public. Toxicological Evaluations. In Vitro Assessment of Safety. Active Implants. Implantology. Soft Tissue Histology. Hard Tissue Histology. Regulations. Clinical trials.