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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.
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.
Hemocompatibility of Biomaterials for Clinical Applications: Blood-Biomaterials Interactions summarizes the state-of-the-art on this important subject. The first part of the book reviews the latest research on blood composition and response, mechanisms of coagulation, test standards and methods. Next, the book assesses techniques for modifying biomaterial surfaces and developing coatings to improve hemocompatibility. In the final sections, users will find discussions on ways to improve the hemocompatibility of particular classes of biomaterials and a review of methods for improving medical devices. - Provides comprehensive information on the fundamentals of hemocompatibility and new technologies - Combines research in the biomaterials field in a digestible format for clinical applications - Provides a complete overview biomaterials in current use and test methods
Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. - Presents diverse insights from experts in government, industry and academia - Delivers a comprehensive overview of testing and interpreting medical device performance - Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market
Encyclopedic presentation of the clinical applications of biomaterials from markets and advanced concepts to pharmaceutical applications and blood compatibility.
The present book relates to the scientific records of a workshop held in Patras, Greece, in June 1989, under the auspices and with financial support of the European Economic Communities (Concerted Action EUROBIOMAT - Hemocompatibility - of the Medical Research Programme, Project: 11.1.212). This concerted action promotes the collaboration on science and technology on the particular field of hemocompatible biomaterials: exchange of experts, scholarships and scientific workshops within the EC-member countries and COST countries such as Sweden, Finland, Turkey, Switzerland. The first part of this monography refers to the oral presentations of the par ticipants. The second part gives the book its unique character: the scientific discussion on updated aspects of protein adsorption of synthetic polymers in contact with blood. This second part is subdivided into nine chapters where specific topics were discussed freely, open-minded and even controversially. This book intends to elucidate recurrent questions concerning the initial event when blood contacts artificial surfaces. Young investigators will consider this book to be appropriate to get familiar with the scientific background and the most relevant techniques and methods.
Biomedical Product and Materials Evaluation: Standards and Ethics provides a much-needed overview of the procedures, issues, standards and ethical issues in the early development of biomedical products. The book covers a range of key biomedical products, from 3D printed organs and blood derived products, to stem calls and decellularized tissue products. Each chapter reviews a single product type, associated materials, biomedical applications, proven development strategies, and potential challenges. The core focus of the book is on the standardization and ethical aspects of biomedical product development, with these elements addressed and discussed in chapters dedicated to product evaluation. This is a useful reference for academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production, as well as those working in the fields of biomedical engineering, biotechnology and toxicology. - Covers a variety of biomedical products, including specific biomaterials, organs-on-chips, wound care products, combinational products, and more - Delves into strategies and considerations for product evaluation, including cytotoxicity assays, microbial and blood compatibility studies - Discusses standardization and ethical hurdles in biomedical product development and how to overcome them
The second edition of this bestselling title provides the most up-to-date comprehensive review of all aspects of biomaterials science by providing a balanced, insightful approach to learning biomaterials. This reference integrates a historical perspective of materials engineering principles with biological interactions of biomaterials. Also provided within are regulatory and ethical issues in addition to future directions of the field, and a state-of-the-art update of medical and biotechnological applications. All aspects of biomaterials science are thoroughly addressed, from tissue engineering to cochlear prostheses and drug delivery systems. Over 80 contributors from academia, government and industry detail the principles of cell biology, immunology, and pathology. Focus within pertains to the clinical uses of biomaterials as components in implants, devices, and artificial organs. This reference also touches upon their uses in biotechnology as well as the characterization of the physical, chemical, biochemical and surface properties of these materials. - Provides comprehensive coverage of principles and applications of all classes of biomaterials - Integrates concepts of biomaterials science and biological interactions with clinical science and societal issues including law, regulation, and ethics - Discusses successes and failures of biomaterials applications in clinical medicine and the future directions of the field - Cover the broad spectrum of biomaterial compositions including polymers, metals, ceramics, glasses, carbons, natural materials, and composites - Endorsed by the Society for Biomaterials
This book provides tabular and text data relating to normal and diseased tissue materials and materials used in medical devices. Comprehensive and practical for students, researchers, engineers, and practicing physicians who use implants, this book considers the materials aspects of both implantable materials and natural tissues and fluids. Examples of materials and topics covered include titanium, elastomers, degradable biomaterials, composites, scaffold materials for tissue engineering, dental implants, sterilization effects on material properties, metallic alloys, and much more. Each chapter author considers the intrinsic and interactive properties of biomaterials, as well as their appropriate applications and historical contexts. Now in an updated second edition, this book also contains two new chapters on the cornea and on vocal folds, as well as updated insights, data, and citations for several chapters.
Novel injectable materials for non-invasive surgical procedures are becoming increasingly popular. An advantage of these materials include easy deliverability into the body, however the suitability of their mechanical properties must also be carefully considered. Injectable biomaterials covers the materials, properties and biomedical applications of injectable materials, as well as novel developments in the technology.Part one focuses on materials and properties, with chapters covering the design of injectable biomaterials as well as their rheological properties and the mechanical properties of injectable polymers and composites. Part two covers the clinical applications of injectable biomaterials, including chapters on drug delivery, tissue engineering and orthopaedic applications as well as injectable materials for gene delivery systems. In part three, existing and developing technologies are discussed. Chapters in this part cover such topics as environmentally responsive biomaterials, injectable nanotechnology, injectable biodegradable materials and biocompatibility. There are also chapters focusing on troubleshooting and potential future applications of injectable biomaterials.With its distinguished editor and international team of contributors, Injectable biomaterials is a standard reference for materials scientists and researchers working in the biomaterials industry, as well as those with an academic interest in the subject. It will also be beneficial to clinicians. - Comprehensively examines the materials, properties and biomedical applications of injectable materials, as well as novel developments in the technology - Reviews the design of injectable biomaterials as well as their rheological properties and the mechanical properties of injectable polymers and composites - Explores clinical applications of injectable biomaterials, including drug delivery, tissue engineering, orthopaedic applications and injectable materials for gene delivery systems