Biocompatibility And Performance Of Medical Devices
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Biocompatibility And Performance Of Medical Devices
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Author : Jean-Pierre Boutrand
language : en
Publisher: Woodhead Publishing
Release Date : 2019-11-21
Biocompatibility And Performance Of Medical Devices written by Jean-Pierre Boutrand and has been published by Woodhead Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-21 with Technology & Engineering categories.
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
Biocompatibility And Performance Of Medical Devices
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Author : Jean-Pierre Boutrand
language : en
Publisher: Elsevier
Release Date : 2012-10-26
Biocompatibility And Performance Of Medical Devices written by Jean-Pierre Boutrand and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-10-26 with Medical categories.
Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe and biocompatible, and that they will perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices.Part one introduces the key concepts and challenges faced in relation to biocompatibility in medical devices, with consideration of biological safety evaluation planning and biomechanical and biochemical compatibility in innovative biomaterials. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices. Topics covered include material and chemical characterisation, allowable limits for toxic leachables, in vivo and in vitro testing and blood compatibility assessment. Testing and interpreting medical device performance is the focus of part three, with chapters describing preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing of soft and hard tissue implants. Part four provides information on the regulation of medical devices in the European Union, Japan and China, and the book concludes with part five, a review of histopathology principles for biocompatibility and performance studies.With its distinguished editor and international team of expert contributors, Biocompatibility and performance of medical devices is a vital tool for all those involved in the research, design, production and application of medical devices, including research directors, production companies and medical regulatory agencies, as well as industry professionals and academics. - Examines the key concepts and challenges faced in relation to biocompatibility in medical devices - Discusses evaluation and characterisation issues, including material and chemical characterization, allowable limits for toxic leachables, in vivo and in vitro testing, and blood compatibility assessment - Delivers a comprehensive overview of testing and interpreting medical device performance
Biological Performance Of Materials
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Author : Jonathan Black
language : en
Publisher: Marcel Dekker
Release Date : 1992
Biological Performance Of Materials written by Jonathan Black and has been published by Marcel Dekker this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with Medical categories.
Handbook Of Biomaterials Biocompatibility
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Author : Masoud Mozafari
language : en
Publisher: Woodhead Publishing
Release Date : 2020-06-16
Handbook Of Biomaterials Biocompatibility written by Masoud Mozafari and has been published by Woodhead Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-06-16 with Technology & Engineering categories.
Handbook of Biomaterials Biocompatibility is a systematic reference on host response to different biomaterials, taking into account their physical, mechanical and chemical properties. The book reviews recent progress in the design and study of biomaterials biocompatibility, along with current understanding on how to control immune system response. Sections provide the fundamental theories and challenges of biomaterials biocompatibility, the role of different biomaterials physicochemical surface properties on cell responses, cell responses to different physicochemical properties of polymers, ceramics, metals, carbons and nanomaterials, and biomaterials in different tissues, such as the cardiac, nervous system, cartilage and bone. This resource will be suitable for those working in the fields of materials science, regenerative engineering, medicine, medical devices and nanotechnology.
Medical Textile Materials
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Author : Yimin Qin
language : en
Publisher: Woodhead Publishing
Release Date : 2015-11-21
Medical Textile Materials written by Yimin Qin and has been published by Woodhead Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-11-21 with Medical categories.
Medical Textile Materials provides the latest information on technical textiles and how they have found a wide range of medical applications, from wound dressings and sutures, to implants and tissue scaffolds. This book offers a systematic review of the manufacture, properties, and applications of these technical textiles. After a brief introduction to the human body, the book gives an overview of medical textile products and the processes used to manufacture them. Subsequent chapters cover superabsorbent textiles, functional wound dressings, bandages, sutures, implants, and other important medical textile technologies. Biocompatibility testing and regulatory control are then addressed, and the book finishes with a review of research and development strategy for medical textile products. - Provides systematic and comprehensive coverage of the manufacture, properties, and applications of medical textile materials - Covers recent developments in medical textiles, including antimicrobial dressings, drug-releasing materials, and superabsorbent textiles - Written by a highly knowledgeable author with extensive experience in industry and academia
Biomaterials And Medical Devices
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Author : Ferdyansyah Mahyudin
language : en
Publisher: Springer
Release Date : 2016-02-26
Biomaterials And Medical Devices written by Ferdyansyah Mahyudin and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-02-26 with Technology & Engineering categories.
This book presents an introduction to biomaterials with the focus on the current development and future direction of biomaterials and medical devices research and development in Indonesia. It is the first biomaterials book written by selected academic and clinical experts experts on biomaterials and medical devices from various institutions and industries in Indonesia. It serves as a reference source for researchers starting new projects, for companies developing and marketing products and for governments setting new policies. Chapter one covers the fundamentals of biomaterials, types of biomaterials, their structures and properties and the relationship between them. Chapter two discusses unconventional processing of biomaterials including nano-hybrid organic-inorganic biomaterials. Chapter three addresses biocompatibility issues including in vitro cytotoxicity, genotoxicity, in vitro cell models, biocompatibility data and its related failure. Chapter four describes degradable biomaterial for medical implants, which include biodegradable polymers, biodegradable metals, degradation assessment techniques and future directions. Chapter five focuses on animal models for biomaterial research, ethics, care and use, implantation study and monitoring and studies on medical implants in animals in Indonesia. Chapter six covers biomimetic bioceramics, natural-based biocomposites and the latest research on natural-based biomaterials in Indonesia. Chapter seven describes recent advances in natural biomaterial from human and animal tissue, its processing and applications. Chapter eight discusses orthopedic applications of biomaterials focusing on most common problems in Indonesia, and surgical intervention and implants. Chapter nine describes biomaterials in dentistry and their development in Indonesia.
Medical Devices
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2010
Medical Devices written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Medical categories.
Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
Polymeric Biomaterials Structure And Function
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Author : Severian Dumitriu
language : en
Publisher: CRC Press
Release Date : 2013
Polymeric Biomaterials Structure And Function written by Severian Dumitriu and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with Medical categories.
The third edition of a bestseller, this comprehensive reference presents the latest polymer developments and most up-to-date applications of polymeric biomaterials in medicine. Expanded into two volumes, the first volume covers the structure and properties of synthetic and natural polymers as well as bioresorbable hybrid membranes, drug delivery systems, cell bioassay systems, and electrospinning for regenerative medicine. This substantially larger resource includes state-of-the-art research and successful breakthroughs in applications that have occurred in the last ten years.
Public Health Effectiveness Of The Fda 510 K Clearance Process
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2010-10-04
Public Health Effectiveness Of The Fda 510 K Clearance Process written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-10-04 with Medical categories.
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.