Biomedical Product And Materials Evaluation

Author : P.V. Mohanan
Publisher : Woodhead Publishing
Page : 808 pages
File Size : 51,8 Mb
Release : 2022-01-22
Category : Technology & Engineering
ISBN : 9780128241738

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Biomedical Product and Materials Evaluation by P.V. Mohanan Pdf

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
Page : 944 pages
File Size : 43,7 Mb
Release : 1998-12-18
Category : Medical
ISBN : 1560324791

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Handbook Of Biomaterials Evaluation by Andreas F von Recum Pdf

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 : Julian H. Braybrook
Publisher : John Wiley & Sons
Page : 256 pages
File Size : 48,7 Mb
Release : 1997-08-04
Category : Medical
ISBN : UOM:39015041353999

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Biocompatiblity by Julian H. Braybrook Pdf

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 : Roger Narayan
Publisher : Springer Science & Business Media
Page : 573 pages
File Size : 48,6 Mb
Release : 2009-06-20
Category : Technology & Engineering
ISBN : 9780387848723

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Biomedical Materials by Roger Narayan Pdf

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 : Buddy D. Ratner
Publisher : Elsevier
Page : 500 pages
File Size : 46,6 Mb
Release : 1996
Category : Medical
ISBN : 0125824610

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Biomaterials Science by Buddy D. Ratner Pdf

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 : Parvez I. Haris,Dennis Chapman
Publisher : IOS Press
Page : 216 pages
File Size : 40,9 Mb
Release : 1998
Category : Medical
ISBN : 905199365X

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New Biomedical Materials by Parvez I. Haris,Dennis Chapman Pdf

In recent years there have been tremendous advances in the fields of chemistry, physics and biology which have a direct impact on advances in biomaterials science. Many areas of healthcare depend upon the development of novel biomaterials. This book contains contribution from scientists who have made numerous innovative and exciting advances in the field of biomedical materials. The latest advances in the field are covered including studies of cell interactions with biomaterials. The assessment of the potential applications for the development of new biomaterials, tissue engineering and future medical devices are discussed. It will also provide an opportunity to discuss the latest developments in the field and the vision for the future. The book clearly illustrates how basic and applied research are being combined to produce novel biomaterials.

Author : International Organization for Standardization
Publisher : Unknown
Page : 28 pages
File Size : 43,8 Mb
Release : 2006
Category : Electronic
ISBN : UOM:39015068750713

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Biological Evaluation of Medical Devices by International Organization for Standardization Pdf

Author : Babak Arjmand,Moloud Payab,Parisa Goodarzi
Publisher : Springer Nature
Page : 164 pages
File Size : 55,7 Mb
Release : 2020-02-05
Category : Medical
ISBN : 9783030356262

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Biomedical Product Development: Bench to Bedside by Babak Arjmand,Moloud Payab,Parisa Goodarzi Pdf

This textbook covers all the steps in manufacturing a biomedical product from bench to bedside. It specifically focuses on quality assurance and management and explains the different good practice principles in the various phases of product development as well as how to fulfill them: Good laboratory practice, good manufacturing practice and good clinical practice. It provides readers with the know-how to design biomedical experiments to ensure quality and integrity, to plan and conduct standard preclinical studies and to assure the quality of the final manufactured biomedical products. Importantly, it also addresses ethical concerns and considerations. The book discusses the guidelines and ethical considerations for preclinical and clinical studies, to allow readers to identify safety concerns regarding biomedical products and to improve pre-clinical studies for the development of better products. This textbook is a valuable guide for biomedical students (B.Sc., M.S., and Ph.D. students) in the field of molecular medicine, medical biotechnology, stem cell research and related areas, as well as for professionals such as quality control staff, tissue bankers, policy-makers and health professionals.

Author : Roger Narayan
Publisher : Woodhead Publishing
Page : 0 pages
File Size : 46,5 Mb
Release : 2016-11-14
Category : Medical
ISBN : 0081006039

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Monitoring and Evaluation of Biomaterials and their Performance In Vivo by Roger Narayan Pdf

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 : Karen M. Becker,John J. Whyte
Publisher : Springer Science & Business Media
Page : 360 pages
File Size : 44,6 Mb
Release : 2007-11-05
Category : Technology & Engineering
ISBN : 9781597450041

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Clinical Evaluation of Medical Devices by Karen M. Becker,John J. Whyte Pdf

The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.

Author : Amit Bandyopadhyay,Susmita Bose
Publisher : Newnes
Page : 450 pages
File Size : 49,7 Mb
Release : 2013-03-12
Category : Technology & Engineering
ISBN : 9780124158634

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Characterization of Biomaterials by Amit Bandyopadhyay,Susmita Bose Pdf

One of the key challenges current biomaterials researchers face is identifying which of the dizzying number of highly specialized characterization tools can be gainfully applied to different materials and biomedical devices. Since this diverse marketplace of tools and techniques can be used for numerous applications, choosing the proper characterization tool is highly important, saving both time and resources. Characterization of Biomaterials is a detailed and multidisciplinary discussion of the physical, chemical, mechanical, surface, in vitro and in vivo characterization tools and techniques of increasing importance to fundamental biomaterials research. Characterization of Biomaterials will serve as a comprehensive resource for biomaterials researchers requiring detailed information on physical, chemical, mechanical, surface, and in vitro or in vivo characterization. The book is designed for materials scientists, bioengineers, biologists, clinicians and biomedical device researchers seeking input on planning on how to test their novel materials, structures or biomedical devices to a specific application. Chapters are developed considering the need for industrial researchers as well as academics. Biomaterials researchers come from a wide variety of disciplines: this book will help them to analyze their materials and devices taking advantage of the multiple experiences on offer. Coverage encompasses a cross-section of the physical sciences, biological sciences, engineering and applied sciences characterization community, providing gainful and cross-cutting insight into this highly multi-disciplinary field. Detailed coverage of important test protocols presents specific examples and standards for applied characterization

Author : Arvind Kumar Bhatt,Ravi Kant Bhatia,Tek Chand Bhalla
Publisher : Academic Press
Page : 520 pages
File Size : 54,8 Mb
Release : 2023-02-03
Category : Science
ISBN : 9780128161104

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Basic Biotechniques for Bioprocess and Bioentrepreneurship by Arvind Kumar Bhatt,Ravi Kant Bhatia,Tek Chand Bhalla Pdf

Basic Biotechniques for Bioprocess and Bioentrepreneurship deals with the entire field of industrial biotechnology, starting from the basic laboratory techniques to scale-up, process development, demonstration, and finally its commercialization. The book compiles currently scattered materials on this topic and updates this information based on practical experience and requirements. The book will be an ideal source for new entrepreneurs who wish to start their own commercial units. Offers guidance for readers/researchers/start-ups/entrepreneurs on how to develop new microbiological and biotechnical processes Focuses on basic knowledge and possible solutions to the practical difficulties at all levels in one place through understanding of basic techniques in lab, during bioprocess development, commercialization, technology transfer, marketing, and others which is presently not available in the field Provides multifaceted coverage, with industry insights from experienced practitioners and leaders in the field Gives possible best solutions to the practical difficulties at all levels, i.e. lab, scaleup, and commercial stage Addresses ethical and other regulatory issues

Author : Zhentao Yu
Publisher : Elsevier
Page : 246 pages
File Size : 54,7 Mb
Release : 2022-01-21
Category : Medical
ISBN : 9780128241653

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Titanium Alloys for Biomedical Development and Applications by Zhentao Yu Pdf

Titanium Alloys for Biomedical Development and Applications: Design, Microstructure, Properties and Application systematically introduces basic theories and progress in the research of biomedical ß-Ti alloys achieved by researchers from different fields. It focuses on a high-strength and low elastic modulus biomedical ß-Ti alloy (TLM), etc. designed by the authors. The alloy design methods, microstructural characteristics, mechanical properties, surface treatment methods and biocompatibility of the TLM alloy are discussed in detail, along with a concise description of the medical devices made from this alloy and the application examples. This book will appeal to researchers as well as students from different disciplines, including materials science, biology, medicine and engineering fields. Fills the knowledge gap in the current research and application of newly developed biomedical ß-Ti alloys Discusses the selection principles used for proper biomedical Ti alloys for medical and dental devices Includes details on the technological data basis for the application of biomedical ß-Ti alloys with a focus on the TLM ß-Ti alloy

Author : Jonathan Black
Publisher : CRC Press
Page : 520 pages
File Size : 40,6 Mb
Release : 2005-12-20
Category : Medical
ISBN : 9781420057843

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Biological Performance of Materials by Jonathan Black Pdf

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

Author : Jean-Pierre Boutrand
Publisher : Elsevier
Page : 544 pages
File Size : 42,5 Mb
Release : 2012-10-26
Category : Medical
ISBN : 9780857096456

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Biocompatibility and Performance of Medical Devices by Jean-Pierre Boutrand Pdf

Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe and biocompatible, and that they will perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices. Part one introduces the key concepts and challenges faced in relation to biocompatibility in medical devices, with consideration of biological safety evaluation planning and biomechanical and biochemical compatibility in innovative biomaterials. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices. Topics covered include material and chemical characterisation, allowable limits for toxic leachables, in vivo and in vitro testing and blood compatibility assessment. Testing and interpreting medical device performance is the focus of part three, with chapters describing preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing of soft and hard tissue implants. Part four provides information on the regulation of medical devices in the European Union, Japan and China, and the book concludes with part five, a review of histopathology principles for biocompatibility and performance studies. With its distinguished editor and international team of expert contributors, Biocompatibility and performance of medical devices is a vital tool for all those involved in the research, design, production and application of medical devices, including research directors, production companies and medical regulatory agencies, as well as industry professionals and academics. Examines the key concepts and challenges faced in relation to biocompatibility in medical devices Discusses evaluation and characterisation issues, including material and chemical characterization, allowable limits for toxic leachables, in vivo and in vitro testing, and blood compatibility assessment Delivers a comprehensive overview of testing and interpreting medical device performance