Biomedical Product and Materials Evaluation PDF Download

Author: P.V. Mohanan
Publisher: Woodhead Publishing
ISBN: 012824173X
Category : Technology & Engineering
Languages : en
Pages : 808

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Book Description
Biomedical Product and Materials Evaluation: Standards and Ethics provides a much-needed overview of the procedures, issues, standards and ethical issues in the early development of biomedical products. The book covers a range of key biomedical products, from 3D printed organs and blood derived products, to stem calls and decellularized tissue products. Each chapter reviews a single product type, associated materials, biomedical applications, proven development strategies, and potential challenges. The core focus of the book is on the standardization and ethical aspects of biomedical product development, with these elements addressed and discussed in chapters dedicated to product evaluation. This is a useful reference for academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production, as well as those working in the fields of biomedical engineering, biotechnology and toxicology. Covers a variety of biomedical products, including specific biomaterials, organs-on-chips, wound care products, combinational products, and more Delves into strategies and considerations for product evaluation, including cytotoxicity assays, microbial and blood compatibility studies Discusses standardization and ethical hurdles in biomedical product development and how to overcome them

Author: Andreas F von Recum
Publisher: CRC Press
ISBN: 9781560324799
Category : Medical
Languages : en
Pages : 944

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Book Description
This handbook addresses the needs of those who are involved in inventing, developing, and testing implants and are concerned about the interactions between biomaterial and body tissue. The authors explore the physical, chemical, mechanical and regulatory considerations of synthetic materials used in surgical and implant procedures, and how these factors impact the latest developments and new approaches. This updated edition provides the biomaterials professional with necessary information on a range of issues, including bulk characterization, surface evaluations, toxicological evaluations, in vitro methods for safety evaluation, methods for evaluating materials in special applications, surgical considerations, systems implantology, soft and hard tissue history, regulatory aspects, and clinical trials.

Author: Jean-Pierre Boutrand
Publisher: Woodhead Publishing
ISBN: 0081026447
Category : Medical
Languages : en
Pages : 586

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Book Description
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: 1482248387
Category : Medical
Languages : en
Pages : 606

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Book Description
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: Roger Narayan
Publisher: Woodhead Publishing
ISBN: 9780081006030
Category : Medical
Languages : en
Pages : 0

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Book Description
Monitoring and Evaluation of Biomaterials and Their Performance In Vivo provides essential information for scientists and researchers who need to assess and evaluate performance, monitor biological responses, gauge efficacy, and observe changes over time. Crucially, it also enables the optimization of design for future biomaterials and implants. This book presents readers with comprehensive coverage of the topic of in vivo monitoring of medical implants and biomaterials.

Author: Buddy D. Ratner
Publisher: Elsevier
ISBN: 9780125824613
Category : Medical
Languages : en
Pages : 500

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Book Description
Providing a balanced, insightful approach to both the learning of the science and technology of biomaterials, this text serves as a key reference for practitioners who are involved in the applications of materials in medicine. --

Author: Nancy L. Moureau
Publisher: Springer
ISBN: 3030031497
Category : Medical
Languages : en
Pages : 303

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Book Description
This Open access book offers updated and revised information on vessel health and preservation (VHP), a model concept first published in poster form in 2008 and in JVA in 2012, which has received a great deal of attention, especially in the US, UK and Australia. The book presents a model and a new way of thinking applied to vascular access and administration of intravenous treatment, and shows how establishing and maintaining a route of access to the bloodstream is essential for patients in acute care today. Until now, little thought has been given to an intentional process to guide selection, insertion and management of vascular access devices (VADs) and by default actions are based on crisis management when a quickly selected VAD fails. The book details how VHP establishes a framework or pathway model for each step of the patient experience, intentionally guiding, improving and eliminating risk when possible. The evidence points to the fact that reducing fragmentation, establishing a pathway, and teaching the process to all stakeholders reduces complications with intravenous therapy, improves efficiency and diminishes cost. As such this book appeals to bedside nurses, physicians and other health professionals.

Author: Jie Chen
Publisher: CRC Press
ISBN: 1351021966
Category : Mathematics
Languages : en
Pages : 220

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Book Description
Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. The book is designed not only for biopharmaceutical professionals, such as statisticians, safety specialists, pharmacovigilance experts, and pharmacoepidemiologists, who can use the book as self-learning materials or in short courses or training programs, but also for graduate students in statistics and biomedical data science for a one-semester course. Each chapter provides supplements and problems as more readings and exercises.

Author: William Murphy
Publisher: Springer
ISBN: 1493933051
Category : Technology & Engineering
Languages : en
Pages : 676

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Book Description
This book provides tabular and text data relating to normal and diseased tissue materials and materials used in medical devices. Comprehensive and practical for students, researchers, engineers, and practicing physicians who use implants, this book considers the materials aspects of both implantable materials and natural tissues and fluids. Examples of materials and topics covered include titanium, elastomers, degradable biomaterials, composites, scaffold materials for tissue engineering, dental implants, sterilization effects on material properties, metallic alloys, and much more. Each chapter author considers the intrinsic and interactive properties of biomaterials, as well as their appropriate applications and historical contexts. Now in an updated second edition, this book also contains two new chapters on the cornea and on vocal folds, as well as updated insights, data, and citations for several chapters.

Author: Mohamed N. Rahaman
Publisher: John Wiley & Sons
ISBN: 1119551080
Category : Science
Languages : en
Pages : 724

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Book Description
MATERIALS FOR BIOMEDICAL ENGINEERING A comprehensive yet accessible introductory textbook designed for one-semester courses in biomaterials Biomaterials are used throughout the biomedical industry in a range of applications, from cardiovascular devices and medical and dental implants to regenerative medicine, tissue engineering, drug delivery, and cancer treatment. Materials for Biomedical Engineering: Fundamentals and Applications provides an up-to-date introduction to biomaterials, their interaction with cells and tissues, and their use in both conventional and emerging areas of biomedicine. Requiring no previous background in the subject, this student-friendly textbook covers the basic concepts and principles of materials science, the classes of materials used as biomaterials, the degradation of biomaterials in the biological environment, biocompatibility phenomena, and the major applications of biomaterials in medicine and dentistry. Throughout the text, easy-to-digest chapters address key topics such as the atomic structure, bonding, and properties of biomaterials, natural and synthetic polymers, immune responses to biomaterials, implant-associated infections, biomaterials in hard and soft tissue repair, tissue engineering and drug delivery, and more. Offers accessible chapters with clear explanatory text, tables and figures, and high-quality illustrations Describes how the fundamentals of biomaterials are applied in a variety of biomedical applications Features a thorough overview of the history, properties, and applications of biomaterials Includes numerous homework, review, and examination problems, full references, and further reading suggestions Materials for Biomedical Engineering: Fundamentals and Applications is an excellent textbook for advanced undergraduate and graduate students in biomedical materials science courses, and a valuable resource for medical and dental students as well as students with science and engineering backgrounds with interest in biomaterials.