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Author : Nancy J. Stark
Publisher : Unknown
Page : 300 pages
File Size : 54,9 Mb
Release : 1996-03-01
Category : Electronic
ISBN : 1889160008
Author : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
Page : 586 pages
File Size : 47,7 Mb
Release : 2019-11-21
Category : Medical
ISBN : 9780081026441
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
Author : Julian H. Braybrook
Publisher : John Wiley & Sons
Page : 256 pages
File Size : 49,9 Mb
Release : 1997-08-04
Category : Medical
ISBN : UOM:39015041353999
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.
Author : Gottfried Schmalz,Dorthe Arenholt Bindslev
Publisher : Springer Science & Business Media
Page : 392 pages
File Size : 40,6 Mb
Release : 2008-10-10
Category : Medical
ISBN : 9783540777823
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.
Author : Yimin Qin
Publisher : Woodhead Publishing
Page : 264 pages
File Size : 54,7 Mb
Release : 2015-11-21
Category : Technology & Engineering
ISBN : 9780081006245
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
Author : Shayne C. Gad
Publisher : Springer Nature
Page : 490 pages
File Size : 53,7 Mb
Release : 2020-02-24
Category : Medical
ISBN : 9783030352417
While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.
Author : World Health Organization
Publisher : World Health Organization
Page : 147 pages
File Size : 48,8 Mb
Release : 2010
Category : Medical
ISBN : 9789241564045
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
Author : Shayne Cox Gad,Samantha Gad-McDonald
Publisher : CRC Press
Page : 606 pages
File Size : 51,8 Mb
Release : 2015-12-01
Category : Medical
ISBN : 9781482248388
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
Author : Mitsuo Niinomi
Publisher : Elsevier
Page : 432 pages
File Size : 54,6 Mb
Release : 2010-03-31
Category : Technology & Engineering
ISBN : 9781845699246
Despite recent advances in medical devices using other materials, metallic implants are still one of the most commercially significant sectors of the industry. Given the widespread use of metals in medical devices, it is vital that the fundamentals and behaviour of this material are understood. Metals in biomedical devices reviews the latest techniques in metal processing methods and the behaviour of this important material. Initial chapters review the current status and selection of metals for biomedical devices. Chapters in part two discuss the mechanical behaviour, degradation and testing of metals with specific chapters on corrosion, wear testing and biocompatibility of biomaterials. Part three covers the processing of metals for biomedical applications with chapters on such topics as forging metals and alloys, surface treatment, coatings and sterilisation. Chapters in the final section discuss clinical applications of metals such as cardiovascular, orthopaedic and new generation biomaterials. With its distinguished editor and team of expert contributors, Metals for biomedical devices is a standard reference for materials scientists, researchers and engineers working in the medical devices industry and academia. Reviews the latest techniques in metal processing methods including surface treatment and sterilisation Examines metal selection for biomedical devices considering biocompatibility of various metals Assesses mechanical behaviour and testing of metals featuring corrosion, fatigue and wear
Author : Costas Sikalidis
Publisher : BoD – Books on Demand
Page : 566 pages
File Size : 43,5 Mb
Release : 2011-09-06
Category : Science
ISBN : 9789533073507
The current book consists of twenty-four chapters divided into three sections. Section I includes fourteen chapters in electric and magnetic ceramics which deal with modern specific research on dielectrics and their applications, on nanodielectrics, on piezoceramics, on glass ceramics with para-, anti- or ferro-electric active phases, of varistors ceramics and magnetic ceramics. Section II includes seven chapters in bioceramics which include review information and research results/data on biocompatibility, on medical applications of alumina, zirconia, silicon nitride, ZrO2, bioglass, apatite-wollastonite glass ceramic and b-tri-calcium phosphate. Section III includes three chapters in applications of ceramics in environmental improvement and protection, in water cleaning, in metal bearing wastes stabilization and in utilization of wastes from ceramic industry in concrete and concrete products.
Author : Jonathan Black
Publisher : Marcel Dekker
Page : 408 pages
File Size : 50,8 Mb
Release : 1992
Category : Medical
ISBN : UOM:39015029233353
Author : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publisher : Academic Press
Page : 218 pages
File Size : 41,9 Mb
Release : 2020-01-25
Category : Technology & Engineering
ISBN : 9780128209615
Trends in Development of Medical Devices covers the basics of medical devices and their development, regulations and toxicological effects, risk assessment and mitigation. It also discusses the maintenance of a medical device portfolio during product lifecycle. This book provides up-to-date information and knowledge on how to understand the position and benefits of new introduced medical devices for improving healthcare. Researchers and industry professionals from the fields of medical devices, surgery, medical toxicology, pharmacy and medical devices manufacture will find this book useful. The book's editors and contributors form a global, interdisciplinary base of knowledge which they bring to this book. Provides a roadmap to medical devices development and the integration of manufacturing steps to improve workflows Helps engineers in medical devices industries to anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, government regulations Presents new strategies that readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce imperfections in production and develop products that enable completely new treatment possibilities
Author : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publisher : Academic Press
Page : 331 pages
File Size : 45,7 Mb
Release : 2020-06-10
Category : Medical
ISBN : 9780128209202
Toxicological Aspects of Medical Device Implants provides comprehensive information on the use of medical implant and devices and the balance between the application of the devices in relation to any potential adverse effects. In order to ensure the safety and effectiveness of medical devices, many international policies, regulations, and standards have been established, and the book also discusses medical devices within this regulatory framework. The book covers a broad range of disease topics and disease-specific implants and an interdisciplinary team of experts brings a wealth of information on implants used in various disease models and associated risk factors. Toxicological Aspects of Medical Device Implants is a comprehensive resource for toxicologists, biomedical engineers, immunologists, medical staff, regulators, and manufacturers working in the field who need to be aware of the potential toxicity and device management of such a wide variety of implants and devices and their health risks. Discusses the adverse toxicological effects of medical devices Covers a broad range of disease topics and disease specific implants Offers contributions from experts from across several disciplines
Author : Roger Narayan
Publisher : Springer Science & Business Media
Page : 573 pages
File Size : 47,7 Mb
Release : 2009-06-20
Category : Technology & Engineering
ISBN : 9780387848723
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.
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 141 pages
File Size : 40,6 Mb
Release : 2010-10-04
Category : Medical
ISBN : 9780309162906
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.