BIOMATERIALS AND MEDICAL DEVICES

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Biomaterials And Medical Devices

Author : Ferdiansyah Mahyudin
ISBN : 9783319148458
Genre : Technology & Engineering
File Size : 45.76 MB
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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.
Category: Technology & Engineering

Electrofluidodynamic Technologies Efdts For Biomaterials And Medical Devices

Author : Vincenzo Guarino
ISBN : 9780081017463
Genre : Technology & Engineering
File Size : 43.32 MB
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Electrofluidodynamic Technologies (EFDTs) for Biomaterials and Medical Devices: Principles and Advances focuses on the fundamentals of EFDTs - namely electrospinning, electrospraying and electrodynamic atomization - to develop active platforms made of synthetic or natural polymers for use in tissue engineering, restoration and therapeutic treatments. The first part of this book deals with main technological aspects of EFDTs, such as basic technologies and the role of process parameters. The second part addresses applications of EFDTs in biomedical fields, with chapters on their application in tissue engineering, molecular delivery and implantable devices. This book is a valuable resource for materials scientists, biomedical engineers and clinicians alike. Presents a complete picture of Electrofluidodynamic technologies and their use in biomedicine Provides a comprehensive, professional reference on the subject, covering materials processing, fabrication and the use of novel devices for tissue engineering and therapeutics Focuses on technological advances, with an emphasis on studies and clinical trials
Category: Technology & Engineering

Regulatory Affairs For Biomaterials And Medical Devices

Author : Stephen F. Amato
ISBN : 9780857099204
Genre : Medical
File Size : 65.77 MB
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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
Category: Medical

Sterilisation Of Biomaterials And Medical Devices

Author : Sophie Lerouge
ISBN : 9780857096265
Genre : Technology & Engineering
File Size : 59.57 MB
Format : PDF
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The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes. Following an introduction to the key concepts and challenges involved in sterilisation, the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for ‘self-sterilisation’ and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices. With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area. Reviews established and commonly used technologies alongside new and emerging processes Introduces and reviews the key concepts and challenges involved in sterilisation Discusses future trends in the sterilisation of biomaterials and medical devices
Category: Technology & Engineering

Biomaterials And Medical Device Associated Infections

Author : L Barnes
ISBN : 9780857097224
Genre : Technology & Engineering
File Size : 41.28 MB
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Despite advances in materials and sterilisation, patients who receive biomaterials of medical device implants are still at risk of developing an infection around the implantation site. This book reviews the fundamentals of biomaterials and medical device related infections and methods and materials for the treatment and prevention of infection. The first part of the book provides readers with an introduction to the topic including analyses of biofilms, diagnosis and treatment of infection, pathology and topography. The second part of the book discusses a range of established and novel technologies and materials which have been designed to prevent infection. Provides analysis of biofilms and their relevance to implant associated infections. Assesses technologies for controlling biofilms. Considers advantages and disadvantages of in vivo infection studies.
Category: Technology & Engineering

Design Engineering Of Biomaterials For Medical Devices

Author : David Hill
ISBN : 0471967084
Genre : Medical
File Size : 24.41 MB
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Written by an exceptionally experienced author in the area of medical equipment product design, this text presents a comprehensive overview of such sound principles and state-of-the-art techniques covering a whole host of material types, biocompatability, the design process and future trends within this exciting field. An all-in-one reference text, concise and easy-to-read. Wide audience appeal, from industry professionals to students of design.
Category: Medical

Biomaterials Medical Devices And Combination Products

Author : Shayne Cox Gad
ISBN : 9781482248388
Genre : Medical
File Size : 77.39 MB
Format : PDF
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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 safety of the materials used in producing medical devices as well as the devices themselves. Starting with material characterization and selection, considerations of concerns arising from packaging and contact with production machinery, and extensive coverage of combination products, the book also provides the latest approaches to isolating, quantitating, identifying and assessing the risk arising from chemical entities released from market-ready devices. Also incorporated are new case examples and citations with the means of access to Internet-based regulatory and scientific sites, reflecting the universal adoption of this technology into our world. The book takes into consideration the fact that device markets are global, the continual advancement of technology, and the increasing global harmonization of safety regulations. Each aspect of device safety evaluation is reviewed in terms of the International Organization for Standardization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health, Labour, and Welfare (MHLW) perspectives.
Category: Medical

Biomaterials Medical Devices And Tissue Engineering An Integrated Approach

Author : Frederick Silver
ISBN : 9789401107358
Genre : Technology & Engineering
File Size : 78.97 MB
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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.
Category: Technology & Engineering

Biocompatibility And Performance Of Medical Devices

Author : Jean-Pierre Boutrand
ISBN : 9780857096456
Genre : Medical
File Size : 67.94 MB
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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
Category: Medical

New Functional Biomaterials For Medicine And Healthcare

Author : Elena P. Ivanova
ISBN : 9781782422662
Genre : Technology & Engineering
File Size : 58.42 MB
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New Functional Biomaterials for Medicine and Healthcare provides a concise summary of the latest developments in key types of biomaterials. The book begins with an overview of the use of biomaterials in contemporary healthcare and the process of developing novel biomaterials; the key issues and challenges associated with the design of complex implantable systems are also highlighted. The book then reviews the main materials used in functional biomaterials, particularly their properties and applications. Individual chapters focus on both natural and synthetic polymers, metallic biomaterials, and bio-inert and bioactive ceramics. Advances in processing technologies and our understanding of materials and their properties have made it possible for scientists and engineers to develop more sophisticated biomaterials with more targeted functionality. New Functional Biomaterials for Medicine and Healthcare provides an ideal one-volume summary of this important field that represents essential reading for scientists, engineers, and clinicians, and a useful reference text for undergraduate and postgraduate students. Provides a concise summary of the latest developments in key types of biomaterials Highlights key issues and challenges associated with the design of complex implantable systems Chapters focus on both natural and synthetic polymers, metallic biomaterials, and bio-inert and bioactive ceramics
Category: Technology & Engineering