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Biocompatibility Protocols For Medical Devices And Materials
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Book Synopsis Biocompatibility Protocols for Medical Devices and Materials by : Prakash Srinivasan Timiri Shanmugam
Download or read book Biocompatibility Protocols for Medical Devices and Materials written by Prakash Srinivasan Timiri Shanmugam and published by Elsevier. This book was released on 2023-04-07 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocompatibility Protocols for Medical Devices and Materials provides comprehensive coverage of the basic science and toxicological testing protocols necessary for the risk assessment and safety analysis of medical devices and materials which are based on the ISO guidelines for body contact and duration of contact. The book begins with device/component selection for toxicological experiments and provides an introduction to topics such as sensitization, irritation tests, material-mediated pyrogenicity, and bacterial-mediated pyrogenicity. Toxicology-related chapters explain the protocols for cytotoxicity, acute systemic toxicity, repeated-exposure systemic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity testing. Biocompatibility Protocols for Medical Devices and Materials is a practical guide that provides step-by-step toxicological protocols ranging from materials selection to data interpretation for toxicologists, biomedical researchers, healthcare professionals, product developers, and others working in risk assessment and safety analysis of medical devices. Explains the biocompatibility test protocols for medical devices Provides an overview about chemical characterization Describes toxicokinetic, carcinogenicity, and reproductive toxicity studies Discusses the basic points needed to leverage the data from another device
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 Biomaterials, Medical Devices, and Combination Products by : Shayne Cox Gad
Download or read book Biomaterials, Medical Devices, and Combination Products written by Shayne Cox Gad and published by CRC Press. This book was released on 2015-12-01 with total page 606 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical
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 Biopolymers for Biomedical and Biotechnological Applications by : Bernd H. A. Rehm
Download or read book Biopolymers for Biomedical and Biotechnological Applications written by Bernd H. A. Rehm and published by John Wiley & Sons. This book was released on 2020-12-01 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides insight into biopolymers, their physicochemical properties, and their biomedical and biotechnological applications This comprehensive book is a one-stop reference for the production, modifications, and assessment of biopolymers. It highlights the technical and methodological advancements in introducing biopolymers, their study, and promoted applications. "Biopolymers for Biomedical and Biotechnological Applications" begins with a general overview of biopolymers, properties, and biocompatibility. It then provides in-depth information in three dedicated sections: Biopolymers through Bioengineering and Biotechnology Venues; Polymeric Biomaterials with Wide Applications; and Biopolymers for Specific Applications. Chapters cover: advances in biocompatibility; advanced microbial polysaccharides; microbial cell factories for biomanufacturing of polysaccharides; exploitation of exopolysaccharides from lactic acid bacteria; and the new biopolymer for biomedical application called nanocellulose. Advances in mucin biopolymer research are presented, along with those in the synthesis of fibrous proteins and their applications. The book looks at microbial polyhydroxyalkanoates (PHAs), as well as natural and synthetic biopolymers in drug delivery and tissue engineering. It finishes with a chapter on the current state and applications of, and future trends in, biopolymers in regenerative medicine. * Offers a complete and thorough treatment of biopolymers from synthesis strategies and physiochemical properties to applications in industrial and medical biotechnology * Discusses the most attracted biopolymers with wide and specific applications * Takes a systematic approach to the field which allows readers to grasp and implement strategies for biomedical and biotechnological applications "Biopolymers for Biomedical and Biotechnological Applications" appeals to biotechnologists, bioengineers, and polymer chemists, as well as to those working in the biotechnological industry and institutes.
Book Synopsis Biocompatiblity by : Julian H. Braybrook
Download or read book Biocompatiblity written by Julian H. Braybrook and published by John Wiley & Sons. This book was released on 1997-08-04 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents both an overview and forward assessment of medical device materials and test methods. Highlighting the complex problem of host responses and related issues which may restrict the accuracy and reliability of existing test methodology, the book provides an unbiased appraisal of the requirements for biocompatibility and the approaches that have been developed to evaluate it.
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 520 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 consult
Book Synopsis Medical Devices by : World Health Organization
Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
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 1999-07-21 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt: A balanced approach to understanding the response of living tissues and systems to manufactured biomaterials and the effect of life processes on the properties and behaviour of successful and unsuccessful biomaterials. This third edition contains a glossary of specialized terms; discussion of the emerging area of tissue engineering; more sources; and more tables to additional generic biomaterials properties.
Book Synopsis Biocompatibility of Dental Materials by : Gottfried Schmalz
Download or read book Biocompatibility of Dental Materials written by Gottfried Schmalz and published by Springer Science & Business Media. This book was released on 2008-10-10 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive and scientifically based overview of the biocompatibility of dental materials. Up-to-date concepts of biocompatibility assessment are presented, as well as information on almost all material groups used in daily dentistry practice. Furthermore, special topics of clinical relevance (e.g,, environmental and occupational hazards and the diagnosis of adverse effects) are covered. The book will: improve the reader’s ability to critically analyze information provided by manufacturers supply a better understanding of the biocompatibility of single material groups, which will help the reader choose the most appropriate materials for any given patient and thus prevent adverse effects from developing provide insights on how to conduct objective, matter-of-fact discussions with patients about the materials to be used in dental procedures advise readers, through the use of well-documented concepts, on how to treat patients who claim adverse effects from dental materials feature clinical photographs that will serve as a reference when analyzing clinical symptoms, such as oral mucosa reactions.
Book Synopsis Biocompatibility Workshop Notebook by :
Download or read book Biocompatibility Workshop Notebook written by and published by . This book was released on 1991 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine
Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The Medical Device R&D Handbook by : Theodore R. Kucklick
Download or read book The Medical Device R&D Handbook written by Theodore R. Kucklick and published by CRC Press. This book was released on 2005-11-21 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Ha
Book Synopsis Biomaterials and Medical Devices by : Ferdyansyah Mahyudin
Download or read book Biomaterials and Medical Devices written by Ferdyansyah Mahyudin and published by Springer. This book was released on 2016-02-26 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Device Design written by and published by Academic Press. This book was released on 2012-12-17 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products
Book Synopsis Biological Performance of Materials by : Jonathan Black
Download or read book Biological Performance of Materials written by Jonathan Black and published by Marcel Dekker. This book was released on 1992 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Radiologic Guide to Orthopedic Devices by : Tim B. Hunter
Download or read book Radiologic Guide to Orthopedic Devices written by Tim B. Hunter and published by Cambridge University Press. This book was released on 2017-05-11 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive reference on radiologic appearance, uses and complications of orthopedic devices, for radiologists, orthopedists, physicians, and students.
