Biomaterials And Medical Devices
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Biomaterials And Medical Devices
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Author : Ferdyansyah Mahyudin
language : en
Publisher: Springer
Release Date : 2016-02-26
Biomaterials And Medical Devices written by Ferdyansyah Mahyudin and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-02-26 with Technology & Engineering categories.
This book presents an introduction to biomaterials with the focus on the current development and future direction of biomaterials and medical devices research and development in Indonesia. It is the first biomaterials book written by selected academic and clinical experts experts on biomaterials and medical devices from various institutions and industries in Indonesia. It serves as a reference source for researchers starting new projects, for companies developing and marketing products and for governments setting new policies. Chapter one covers the fundamentals of biomaterials, types of biomaterials, their structures and properties and the relationship between them. Chapter two discusses unconventional processing of biomaterials including nano-hybrid organic-inorganic biomaterials. Chapter three addresses biocompatibility issues including in vitro cytotoxicity, genotoxicity, in vitro cell models, biocompatibility data and its related failure. Chapter four describes degradable biomaterial for medical implants, which include biodegradable polymers, biodegradable metals, degradation assessment techniques and future directions. Chapter five focuses on animal models for biomaterial research, ethics, care and use, implantation study and monitoring and studies on medical implants in animals in Indonesia. Chapter six covers biomimetic bioceramics, natural-based biocomposites and the latest research on natural-based biomaterials in Indonesia. Chapter seven describes recent advances in natural biomaterial from human and animal tissue, its processing and applications. Chapter eight discusses orthopedic applications of biomaterials focusing on most common problems in Indonesia, and surgical intervention and implants. Chapter nine describes biomaterials in dentistry and their development in Indonesia.
Regulatory Affairs For Biomaterials And Medical Devices
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Author : Stephen F. Amato
language : en
Publisher: Elsevier
Release Date : 2014-10-27
Regulatory Affairs For Biomaterials And Medical Devices written by Stephen F. Amato and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-10-27 with Technology & Engineering categories.
All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. - Addresses global regulations and regulatory issues surrounding biomaterials and medical devices - Especially useful for smaller companies who may not employ a full time vigilance professional - Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing
Biomaterials Medical Devices And Tissue Engineering An Integrated Approach
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Author : Frederick Silver
language : en
Publisher: Springer Science & Business Media
Release Date : 1993-11-30
Biomaterials Medical Devices And Tissue Engineering An Integrated Approach written by Frederick Silver and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993-11-30 with Technology & Engineering categories.
are then selected and must meet the general 'biocompatibility' require ments. Prototypes are built and tested to include biocompatibility evalua tions based on ASTM standard procedures. The device is validated for sterility and freedom from pyrogens before it can be tested on animals or humans. Medical devices are classified as class I, II or III depending on their invasiveness. Class I devices can be marketed by submitting notification to the FDA. Class II and III devices require either that they show equivalence to a device marketed prior to 1976 or that they receive pre-marketing approval. The time from device conception to FDA approval can range from months (class I device) to in excess of ten years (class III device). Therefore, much planning is necessary to pick the best regulatory approach. 2. Wound Dressings and Skin Replacement 2.1 Introduction Wounds to the skin are encountered every day. Minor skin wounds cause some pain, but these wounds will heal by themselves in time. Even though many minor wounds heal effectively without scarring in the absence of treatment, they heal more rapidly if they are kept clean and moist. Devices such as Band-Aids are used to assist in wound healing. For deeper wounds, a variety of wound dressings have been developed including cell cultured artificial skin. These materials are intended to promote healing of skin damaged or removed as a result of skin grafting, ulceration, burns, cancer excision or mechanical trauma.
Biomaterials Medical Devices And Combination Products
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Author : Shayne Cox Gad
language : en
Publisher: CRC Press
Release Date : 2015-12-01
Biomaterials Medical Devices And Combination Products written by Shayne Cox Gad and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-12-01 with Medical categories.
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
Metallic Biomaterials Processing And Medical Device Manufacturing
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Author : Cuie Wen
language : en
Publisher: Woodhead Publishing
Release Date : 2020-08-20
Metallic Biomaterials Processing And Medical Device Manufacturing written by Cuie Wen and has been published by Woodhead Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-08-20 with Technology & Engineering categories.
Metallic Biomaterials Processing and Medical Device Manufacturing details the principles and practices of the technologies used in biomaterials processing and medical device manufacturing. The book reviews the main categories of metallic biomaterials and the essential considerations in design and manufacturing of medical devices. It bridges the gap between the designing of biomaterials and manufacturing of medical devices including requirements and standards. Main themes of the book include, manufacturing, coatings and surface modifications of medical devices, metallic biomaterials and their mechanical behaviour, degradation, testing and characterization, and quality controls, standards and FDA regulations of medical devices. The leading experts in the filed discuss the requirements, challenges, recent progresses and future research directions in the processing of materials and manufacturing of medical devices. Metallic Biomaterials Processing and Medical Device Manufacturing is ideal for those working in the disciplines of materials science, manufacturing, biomedical engineering, and mechanical engineering.
Szycher S Dictionary Of Biomaterials And Medical Devices
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Author : Michael Szycher
language : en
Publisher: Routledge
Release Date : 2019-08-08
Szycher S Dictionary Of Biomaterials And Medical Devices written by Michael Szycher and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-08 with Medical categories.
This dictionary contains thousands of definitions from various related disciplines and minimizes the need for several dictionaries. The book defines everything from AAMI (Association for the Advancement of Medical Instrumentation) to zymogen (proenzyme). The editor, an internationally recognized expert in the area of biomaterials, has combined knowledge from the fields of medicine, pharmacology, physiology, polymer chemistry, biochemistry, metallurgy, and organic chemistry.
Biocompatibility And Performance Of Medical Devices
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Author : Jean-Pierre Boutrand
language : en
Publisher: Woodhead Publishing
Release Date : 2019-11-21
Biocompatibility And Performance Of Medical Devices written by Jean-Pierre Boutrand and has been published by Woodhead Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-21 with Technology & Engineering categories.
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
Joining And Assembly Of Medical Materials And Devices
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Author : Y N Zhou
language : en
Publisher: Elsevier
Release Date : 2013-05-31
Joining And Assembly Of Medical Materials And Devices written by Y N Zhou and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-31 with Medical categories.
As medical devices become more intricate, with an increasing number of components made from a wide range of materials, it is important that they meet stringent requirements to ensure that they are safe to be implanted and will not be rejected by the human body. Joining and assembly of medical materials and devices provides a comprehensive overview of joining techniques for a range of medical materials and applications.Part one provides an introduction to medical devices and joining methods with further specific chapters on microwelding methods in medical components and the effects of sterilization on medical materials and welded devices. Part two focuses on medical metals and includes chapters on the joining of shape memory alloys, platinum (Pt) alloys and stainless steel wires for implantable medical devices and evaluating the corrosion performance of metal medical device welds. Part three moves on to highlight the joining and assembly of medical plastics and discusses techniques including ultrasonic welding, transmission laser welding and radio frequency (RF)/dielectric welding. Finally, part four discusses the joining and assembly of biomaterial and tissue implants including metal-ceramic joining techniques for orthopaedic applications and tissue adhesives and sealants for surgical applications.Joining and assembly of medical materials and devices is a technical guide for engineers and researchers within the medical industry, professionals requiring an understanding of joining and assembly techniques in a medical setting, and academics interested in this field. - Introduces joining methods in medical applications including microwelding and considers the effects of sterilization on the resulting joints and devices - Considers the joining, assembly and corrosion performance of medical metals including shape memory alloys, platinum alloys and stainless steel wires - Considers the joining and assembly of medical plastics including multiple welding methods, bonding strategies and adhesives
Biomaterials Associated Infection
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Author : Fintan Moriarty
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-09-29
Biomaterials Associated Infection written by Fintan Moriarty and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-09-29 with Technology & Engineering categories.
Biomaterials associated infection (BAI) is one of the most common complications associated with implantation of any biomaterial regardless of form or function. These infections usually involve bacterial colonization and biofilm formation on the biomaterial itself, rendering the infection impervious to antimicrobials and host defenses. In addition, it is becoming increasingly clear that infection of the surrounding tissues also plays an important role in BAI, and that the infection may be influenced by the composition and design of the implanted biomaterial. In this book, worldwide leaders in the field address this critical problem in the translation of biomaterials research into clinical practice. The book begins with an emphasis on the latest research in the pathogenesis of BAI from microbiological, immunological, and materials science perspectives. The current state of the art in antimicrobial activation of biomaterials through surface modification and the incorporation of antimicrobial agents is then discussed. In the concluding chapters, successful translation of a selection of antimicrobial technologies from preclinical research into clinical use is described alongside a discussion of the utility of these devices and perspectives for future development. This book is essential reading for researchers and clinicians who are interested in understanding the fundamentals of BAI, the latest in antimicrobial materials research, and the state of the art in clinically available antimicrobial containing medical devices.