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Biological Evaluation Of Medical Devices Part 10 Tests For Irritation And Delayed Type Hypersensitivity
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Book Synopsis Biocompatibility and Performance of Medical Devices by : Jean-Pierre Boutrand
Download or read book Biocompatibility and Performance of Medical Devices written by Jean-Pierre Boutrand and published by Woodhead Publishing. This book was released on 2019-11-21 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Safety Evaluation of Pharmaceuticals and Medical Devices by : Shayne C. Gad
Download or read book Safety Evaluation of Pharmaceuticals and Medical Devices written by Shayne C. Gad and published by Springer Science & Business Media. This book was released on 2010-10-26 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.
Book Synopsis Bio-Implant Interface by : J.E. Ellingsen
Download or read book Bio-Implant Interface written by J.E. Ellingsen and published by CRC Press. This book was released on 2003-04-29 with total page 467 pages. Available in PDF, EPUB and Kindle. Book excerpt: Achieving good clinical outcomes with implanted biomaterials depends upon achieving optimal function, both mechanical and biological, which in turn depends upon integrating advances realized in biological science, material science, and tissue engineering. As these advances push back the frontiers of biomaterial medicine , the control and patterning
Book Synopsis Testing Tribocorrosion of Passivating Materials Supporting Research and Industrial Innovation by : Jean-Pierre Celis
Download or read book Testing Tribocorrosion of Passivating Materials Supporting Research and Industrial Innovation written by Jean-Pierre Celis and published by Routledge. This book was released on 2017-07-05 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: This first edition of Testing Tribocorrosion of Passivating Materials Supporting Research and Industrial Innovation: A Handbook treats in a clear, concise, and practical manner an important material degradation and protection matter. It is designed as a handbook and provides a well structured approach of the basics needed to investigate the tribocorrosion behavior of passivating materials, and to conduct in a correct way a laboratory investigation on it. It provides answers on practical and theoretical approaches of tribocorrosion phenomena to engineers and medical persons involved with material assemblies subjected to aggressive environmental and mechanical conditions. For academic researchers it is a pertinent tool assisting them in how they can perform a tribocorrosion investigation and obtain results that are correctly interpreted and can be exchanged. Different parts of the book are illustrated with practical examples. This handbook is truly an indispensable guide for every professional who comes into contact with the complex material degradation and protection processes that take place under combined corrosion and wear conditions. Fields of interest include: transportation (aeronautics, maritime, rail, automotive), medical implants (orthopaedics, dentistry), biochemistry, food production, energy production, and machining. The coordination of this handbook writing was done by Professor Jean-Pierre Celis (Katholieke Universiteit Leuven, Belgium) and Professor Pierre Ponthiaux (Ecole Centrale Paris, France) assisted by twelve European experts who contributed jointly to the nine chapters of this handbook. Main topics dealt with are tribocorrosion phenomena in medical and industrial sectors, depassivation and repassivation phenomena, impact on synergism in tribocorrosion, specific testing techniques, coupling tribology-to-corrosion, design of a testing protocol, and normalisation.
Book Synopsis Practical Guide to Chemical Safety Testing by : Derek J. Knight
Download or read book Practical Guide to Chemical Safety Testing written by Derek J. Knight and published by iSmithers Rapra Publishing. This book was released on 2003 with total page 482 pages. Available in PDF, EPUB and Kindle. Book excerpt: Annotation This book describes the different tests that must be performed on new chemicals and other materials to demonstrate to the regulatory authorities that they are safe for use. Tests vary from physico-chemical, measuring properties such as melting point and density, through genetic toxicity studies, to mammalian toxicology and studies to investigate effects on the environment. This book describes clearly the process of obtaining approval for use in a variety of global regions and across different applications. It also explains why different tests are performed and the implications of the results.
Book Synopsis Plastics in Medical Devices by : Vinny R. Sastri
Download or read book Plastics in Medical Devices written by Vinny R. Sastri and published by Elsevier. This book was released on 2010-03-05 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.
Book Synopsis Titanium in Medicine by : D.M. Brunette
Download or read book Titanium in Medicine written by D.M. Brunette and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 1019 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing scientific and technical in-depth information in a clear format with a homogeneous structure, this text is suited for educational and self-teaching purposes as well as a reference on titanium for biomedical applications. It covers the whole area relevant to the use of titanium for implants, devices and instruments in medicine: material and surface science, physics, chemistry, biology, medicine, quality and regulatory aspects.
Book Synopsis Biological Performance of Materials by : Jonathan Black
Download or read book Biological Performance of Materials written by Jonathan Black and published by CRC Press. This book was released on 2005-12-20 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioengineers need a thorough grounding in biocompatibility - the biological performance of materials. Until now, there were no publications suitable for a neophyte in the field; prior publications were either not comprehensive or focused on rather narrow interests. Drawing on the author's 35 years of experience as a teacher, researcher, and consultant in biomaterials science and engineering (BSE), Biological Performance of Materials: Fundamentals of Biocompatibility, Fourth Edition focuses primarily on principles of biological performance at a relatively fundamental level, analyzing interactions between living organisms and nonliving materials used in medical devices - the subject that sets BSE apart as a distinct field of investigation. Following an introductory section, the book is divided into three sections: the material response to biological systems, host response to biomaterials, and test methods for determining biological response in vitro as well as in animal models and clinical settings. Supplemental "Interparts" summarize the physical properties of commonly used metallic, polymeric, and ceramic biomaterials. They also provide a guide to understanding the clinical performance of implanted biomaterials.
Book Synopsis Biosynthetic Polymers for Medical Applications by : Laura Poole-Warren
Download or read book Biosynthetic Polymers for Medical Applications written by Laura Poole-Warren and published by Elsevier. This book was released on 2015-11-23 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biosynthetic Polymers for Medical Applications provides the latest information on biopolymers, the polymers that have been produced from living organisms and are biodegradable in nature. These advanced materials are becoming increasingly important for medical applications due to their favorable properties, such as degradability and biocompatibility. This important book provides readers with a thorough review of the fundamentals of biosynthetic polymers and their applications. Part One covers the fundamentals of biosynthetic polymers for medical applications, while Part Two explores biosynthetic polymer coatings and surface modification. Subsequent sections discuss biosynthetic polymers for tissue engineering applications and how to conduct polymers for medical applications. - Comprehensively covers all major medical applications of biosynthetic polymers - Provides an overview of non-degradable and biodegradable biosynthetic polymers and their medical uses - Presents a specific focus on coatings and surface modifications, biosynthetic hydrogels, particulate systems for gene and drug delivery, and conjugated conducting polymers
Book Synopsis Biomaterials in the Design and Reliability of Medical Devices by : Michael N. Helmus
Download or read book Biomaterials in the Design and Reliability of Medical Devices written by Michael N. Helmus and published by Springer Science & Business Media. This book was released on 2003-01-31 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book highlights the responsibility of medical device designers and engineers to eliminate sites of failure and to test devices to demonstrate their ultimate safety and efficacy. It also evaluates biomaterials and their properties as related to the design and reliability of medical devices. The principles that are described are readily applicable to the biomaterial scaffolds used for generating tissue-engineered constructs.
Book Synopsis Biomedical Composites by : Luigi Ambrosio
Download or read book Biomedical Composites written by Luigi Ambrosio and published by Woodhead Publishing. This book was released on 2017-07-20 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical Composites, Second Edition, provides revised, expanded, and updated content suitable for those active in the biomaterials and bioengineering field. Three new chapters cover modeling of biocomposites, 3D printing of customized scaffolds, and constructs and regulatory issues. Chapters from the first edition have been revised in order to provide up-to-date, comprehensive coverage of developments in the field. Part One discusses the fundamentals of biocomposites, with Part Two detailing a wide range of applications of biocomposites. Chapters in Part Three discuss the biocompatibility, mechanical behavior, and failure of biocomposites, while the final section looks at the future for biocomposites. Professor Luigi Ambrosio is the Director of the Institute for Composite and Biomedical Materials, Italy. He is a renowned scientist with expertise in biomedical composites and has published over 150 papers in international scientific journals and books, 16 patents, and over 250 presentations at international and national conferences. - Led by an expert editor with many years of experience in academia and widely recognized as an international expert on biomedical composites - Features an overview of biocomposites for a wide range of biomedical applications - Provides revised, expanded, and updated coverage, including three new chapters
Book Synopsis Biomedical Materials by : Roger Narayan
Download or read book Biomedical Materials written by Roger Narayan and published by Springer Science & Business Media. This book was released on 2009-06-20 with total page 573 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical Materials provides a comprehensive discussion of contemporary biomaterials research and development. Highlighting important topics associated with Engineering, Medicine and Surgery, this volume reaches a wide scope of professionals, researchers and graduate students involved with biomaterials. A pedagogical writing style and structure provides readers with an understanding of the fundamental concepts necessary to pursue research and industrial work on biomaterials, including characteristics of biomaterials, biological processes, biocompatibility, and applications of biomaterials in implants and medical instruments. Written by leading researchers in the field, this text book takes readers to the forefront of biomedical materials development, providing them with a taste of how the field is changing, while also serving as a useful reference to physicians and engineers.
Book Synopsis Polymeric Biomaterials by : Severian Dumitriu
Download or read book Polymeric Biomaterials written by Severian Dumitriu and published by CRC Press. This book was released on 2013-01-17 with total page 920 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomaterials have had a major impact on the practice of contemporary medicine and patient care. Growing into a major interdisciplinary effort involving chemists, biologists, engineers, and physicians, biomaterials development has enabled the creation of high-quality devices, implants, and drug carriers with greater biocompatibility and biofunctiona
Download or read book Federal Register written by and published by . This book was released on 2013-08 with total page 518 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis In Situ Tissue Regeneration by : Sang Jin Lee
Download or read book In Situ Tissue Regeneration written by Sang Jin Lee and published by Academic Press. This book was released on 2016-07-17 with total page 460 pages. Available in PDF, EPUB and Kindle. Book excerpt: In Situ Tissue Regeneration: Host Cell Recruitment and Biomaterial Design explores the body's ability to mobilize endogenous stem cells to the site of injury and details the latest strategies developed for inducing and supporting the body's own regenerating capacity. From the perspective of regenerative medicine and tissue engineering, this book describes the mechanism of host cell recruitment, cell sourcing, cellular and molecular roles in cell differentiation, navigational cues and niche signals, and a tissue-specific smart biomaterial system that can be applied to a wide range of therapies. The work is divided into four sections to provide a thorough overview and helpful hints for future discoveries: endogenous cell sources; biochemical and physical cues; smart biomaterial development; and applications. - Explores the body's ability to mobilize endogenous stem cells to the site of injury - Details the latest strategies developed for inducing and supporting the body's own regenerating capacity - Presents smart biomaterials in cell-based tissue engineering applications—from the cell level to applications—in the first unified volume - Features chapter authors and editors who are authorities in this emerging field - Prioritizes a discussion of the future direction of smart biomaterials for in situ tissue regeneration, which will affect an emerging and lucrative industry
Book Synopsis Advances in Aluminum Oxide Research and Application: 2013 Edition by :
Download or read book Advances in Aluminum Oxide Research and Application: 2013 Edition written by and published by ScholarlyEditions. This book was released on 2013-06-21 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in Aluminum Oxide Research and Application: 2013 Edition is a ScholarlyBrief™ that delivers timely, authoritative, comprehensive, and specialized information about ZZZAdditional Research in a concise format. The editors have built Advances in Aluminum Oxide Research and Application: 2013 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about ZZZAdditional Research in this book to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Advances in Aluminum Oxide Research and Application: 2013 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.
Book Synopsis Implantable Sensor Systems for Medical Applications by : Andreas Inmann
Download or read book Implantable Sensor Systems for Medical Applications written by Andreas Inmann and published by Elsevier. This book was released on 2013-01-02 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: Implantable sensor systems offer great potential for enhanced medical care and improved quality of life, consequently leading to major investment in this exciting field. Implantable sensor systems for medical applications provides a wide-ranging overview of the core technologies, key challenges and main issues related to the development and use of these devices in a diverse range of medical applications.Part one reviews the fundamentals of implantable systems, including materials and material-tissue interfaces, packaging and coatings, microassembly, electrode array design and fabrication, and the use of biofuel cells as sustainable power sources. Part two goes on to consider the challenges associated with implantable systems. Biocompatibility, sterilization considerations and the development of active implantable medical devices in a regulated environment are discussed, along with issues regarding data protection and patient privacy in medical sensor networks. Applications of implantable systems are then discussed in part three, beginning with Microelectromechanical systems (MEMS) for in-vivo applications before further exploration of tripolar interfaces for neural recording, sensors for motor neuroprostheses, implantable wireless body area networks and retina implants.With its distinguished editors and international team of expert contributors, Implantable sensor systems for medical applications is a comprehensive guide for all those involved in the design, development and application of these life-changing technologies. - Provides a wide-ranging overview of the core technologies, key challenges and main issues related to the development and use of implantable sensor systems in a range of medical applications - Reviews the fundamentals of implantable systems, including materials and material-tissue interfaces, packaging and coatings, and microassembly - Considers the challenges associated with implantable systems, including biocompatibility and sterilization
