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Author : Nancy J. Stark
Publisher :
ISBN 13 : 9781889160009
Total Pages : 300 pages
Book Rating : 4.1/5 (6 download)
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 : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
ISBN 13 : 0081026447
Total Pages : 586 pages
Book Rating : 4.0/5 (81 download)
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 : Shayne Cox Gad
Publisher : CRC Press
ISBN 13 : 1482248387
Total Pages : 606 pages
Book Rating : 4.4/5 (822 download)
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 : Julian H. Braybrook
Publisher : John Wiley & Sons
ISBN 13 :
Total Pages : 256 pages
Book Rating : 4.3/5 (91 download)
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 : Yimin Qin
Publisher : Woodhead Publishing
ISBN 13 : 0081006241
Total Pages : 264 pages
Book Rating : 4.0/5 (81 download)
Download or read book Medical Textile Materials written by Yimin Qin and published by Woodhead Publishing. This book was released on 2015-11-21 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Gottfried Schmalz
Publisher : Springer Science & Business Media
ISBN 13 : 3540777822
Total Pages : 392 pages
Book Rating : 4.5/5 (47 download)
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.
Author : Shalinee Naidoo
Publisher : Arcler Press
ISBN 13 : 9781774076293
Total Pages : pages
Book Rating : 4.0/5 (762 download)
Download or read book Biocompatibility Testing of Medical Devices written by Shalinee Naidoo and published by Arcler Press. This book was released on 2020-11 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocompatibility, is by definition, a measurement of how compatible a device is with a biological system. The purpose of performing biocompatibility testing is to determine the safety of a device for human use, taking into consideration the intended use and specific legal requirements at the time of registration. This is essential to determine whether a device has the potential to cause adverse effects as many devices may be subject to degradation when implanted into tissues or subjected to the surrounding degradation effects of body. Manufacturers must be able to show safety of all device components and the finished device through acceptable toxicological data and related literature. If a manufacturer cannot show this information, then their device will need to undergo testing. This volume aims to provide a simple understanding around the concepts of biocompatible medical devices. Much information is provided to help manufacturers when choosing appropriate tests and to ensure that biomaterials and finished devices are safe and will perform as intended when used in a clinical setting. Key concepts of the ISO 10993 series of standards is provided as well as some of the major challenges faced by medical device manufacturers when considering biocompatibility testing. A simple understanding around the evaluation and characterization of biocompatible materials as well as the regulation of such devices are provided. In addition, a simplified overview of how to set up a basic biocompatibility testing laboratory is also included.
Author : Marie B. Teixeira
Publisher : CRC Press
ISBN 13 : 1466503548
Total Pages : 208 pages
Book Rating : 4.4/5 (665 download)
Download or read book Design Controls for the Medical Device Industry, Second Edition written by Marie B. Teixeira and published by CRC Press. This book was released on 2013-11-12 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company’s design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today’s third-party auditor/investigator expectations and saves you valuable time and money. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe.
Author : David F. Williams
Publisher : CRC PressI Llc
ISBN 13 : 9780849366277
Total Pages : pages
Book Rating : 4.3/5 (662 download)
Download or read book Techniques in Biocompatibility Testing written by David F. Williams and published by CRC PressI Llc. This book was released on 1986-07-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 248 pages
Book Rating : 4.3/5 (91 download)
Download or read book Techniques of Biocompatibility Testing written by and published by . This book was released on 1986 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Shayne C. Gad
Publisher : Springer Nature
ISBN 13 : 3030352412
Total Pages : 490 pages
Book Rating : 4.0/5 (33 download)
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 : David F. Williams
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (632 download)
Download or read book Techniques of Biocompatibility Testing written by David F. Williams and published by . This book was released on 1986 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Jonathan Black
Publisher : Marcel Dekker
ISBN 13 :
Total Pages : 408 pages
Book Rating : 4.3/5 (91 download)
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 : Prakash Srinivasan Timiri Shanmugam
Publisher : Academic Press
ISBN 13 : 0128209615
Total Pages : 218 pages
Book Rating : 4.1/5 (282 download)
Download or read book Trends in Development of Medical Devices written by Prakash Srinivasan Timiri Shanmugam and published by Academic Press. This book was released on 2020-01-25 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9241564040
Total Pages : 147 pages
Book Rating : 4.2/5 (415 download)
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
Author :
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (632 download)
Download or read book Techniques of Biocompatibility Testing written by and published by . This book was released on 1986 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Marie Teixeira
Publisher : CRC Press
ISBN 13 : 9780203909386
Total Pages : 258 pages
Book Rating : 4.9/5 (93 download)
Download or read book Design Controls for the Medical Device Industry written by Marie Teixeira and published by CRC Press. This book was released on 2002-09-20 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilize
