Biocompatibility And Performance Of Medical Devices

Author : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
ISBN 13 : 0081026447
Total Pages : 586 pages
Book Rating : 4.41/5 ( download)

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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 586 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

Author : Nancy J. Stark
Publisher :
ISBN 13 : 9781889160009
Total Pages : 300 pages
Book Rating : 4.08/5 ( download)

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Download or read book Biocompatibility Testing and Management written by Nancy J. Stark and published by . This book was released on 1996-03-01 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Jonathan Black
Publisher : CRC Press
ISBN 13 : 9781420051971
Total Pages : 484 pages
Book Rating : 4.70/5 ( download)

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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.

Author : Julian H. Braybrook
Publisher : John Wiley & Sons
ISBN 13 :
Total Pages : 256 pages
Book Rating : 4.99/5 ( download)

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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.

Author : Jonathan Black
Publisher : CRC Press
ISBN 13 : 9780849339592
Total Pages : 526 pages
Book Rating : 4.96/5 ( download)

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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.

Author : Jonathan Black
Publisher : Marcel Dekker
ISBN 13 :
Total Pages : 408 pages
Book Rating : 4.53/5 ( download)

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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:

Author : Shayne Cox Gad
Publisher : CRC Press
ISBN 13 : 1482248387
Total Pages : 606 pages
Book Rating : 4.88/5 ( download)

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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

Author : Shayne C. Gad
Publisher : Springer Nature
ISBN 13 : 3030352412
Total Pages : 490 pages
Book Rating : 4.17/5 ( download)

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Download or read book Integrated Safety and Risk Assessment for Medical Devices and Combination Products written by Shayne C. Gad and published by Springer Nature. This book was released on 2020-02-24 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Masoud Mozafari
Publisher : Woodhead Publishing
ISBN 13 : 9780081029671
Total Pages : 0 pages
Book Rating : 4.75/5 ( download)

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Download or read book Handbook of Biomaterials Biocompatibility written by Masoud Mozafari and published by Woodhead Publishing. This book was released on 2020-06-16 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309162904
Total Pages : 141 pages
Book Rating : 4.06/5 ( download)

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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.