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Author: F.H. Silver Publisher: Springer Science & Business Media ISBN: 9401107351 Category : Technology & Engineering Languages : en Pages : 310
Book Description
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.
Author: F.H. Silver Publisher: Springer Science & Business Media ISBN: 9401107351 Category : Technology & Engineering Languages : en Pages : 310
Book Description
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.
Author: David Hill Publisher: Wiley ISBN: 9780471967088 Category : Medical Languages : en Pages : 0
Book Description
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.
Author: Donald L. Wise Publisher: Springer Science & Business Media ISBN: 1592591973 Category : Technology & Engineering Languages : en Pages : 350
Book Description
The medical device and drug industries standards in analytical methodology and are consistently among the strongest techno- quality control. logical performers. Materials are a key The users of Biomaterials Engineering ingredient in their dynamic growth. Devel- and Devices: Human Applications will r- opment of these materials is in a constant resent a broad base of backgrounds ranging state of activity, with the challenge of re- from the basic sciences (e. g. , polymer placing old materials that cannot withstand chemistry and biochemistry) to more the tests of time, and the new materials’ applied disciplines (e. g. , mechanical/ needs coming to the forefront in modern chemical engineering, orthopedics, and applications. This new reference text, pharmaceutics). To meet varied needs, each Biomaterials Engineering and Devices: chapter provides clear ancd fully detailed Human Applications, focuses on materials discussions. This in-depth, but practical, used in or on the human body—materials coverage should also assist recent indu- that define the world of “biomaterials. ” ees to the biomaterials circle. The editors Biomaterials Engineering and Devices: trust that this reference textbook conveys Human Applications focuses on mate- the intensity of this fast moving field in an rials development and characterization. enthusastic presentation. Chapters deal with issues in the selection of Donald L. Wise, PHD proper biomaterials from biocompatibility Debra J. Trantolo, PHD to biostability to structure/function relation- Kai-Uwe Lewandrowski, MD ships. Chapters also focus on the use of Joseph D. Gresser, PHD specific biomaterials based on their physio- Mario V.
Author: Ferdyansyah Mahyudin Publisher: Springer ISBN: 3319148451 Category : Technology & Engineering Languages : en Pages : 242
Book Description
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.
Author: Yaser Dahman Publisher: CRC Press ISBN: 0429878354 Category : Medical Languages : en Pages : 358
Book Description
Biomaterials Science and Technology: Fundamentals and Developments presents a broad scope of the field of biomaterials science and technology, focusing on theory, advances, and applications. It reviews the fabrication and properties of different classes of biomaterials such as bioinert, bioactive, and bioresorbable, in addition to biocompatibility. It further details traditional and recent techniques and methods that are utilized to characterize major properties of biomaterials. The book also discusses modifications of biomaterials in order to tailor properties and thus accommodate different applications in the biomedical engineering fields and summarizes nanotechnology approaches to biomaterials. This book targets students in advanced undergraduate and graduate levels in majors related to fields of Chemical Engineering, Materials Engineering and Science, Biomedical Engineering, Bioengineering, and Life Sciences. It assists in understanding major concepts of fabrication, modification, and possible applications of different classes of biomaterials. It is also intended for professionals who are interested in recent advances in the emerging field of biomaterials.
Author: Swee Hin Teoh Publisher: World Scientific ISBN: 9812560610 Category : Medical Languages : en Pages : 347
Book Description
The success of any implant or medical device depends very much on the biomaterial used. Synthetic materials (such as metals, polymers and composites) have made significant contributions to many established medical devices. The aim of this book is to provide a basic understanding on the engineering and processing aspects of biomaterials used in medical applications. Of paramount importance is the tripartite relationship between material properties, processing methods and design. As the target audiences cover a wide interdisciplinary field, each chapter is written with a detailed background so that audience of another discipline will be able to understand. For the more knowledgeable reader, a detailed list of references is included.
Author: Yitzhak Rosen Publisher: CRC Press ISBN: 1439804052 Category : Medical Languages : en Pages : 330
Book Description
"This book is essential when designing, developing and studying biomedical materials. provides an excellent review-from a patient, disease, and even genetic point of view-of materials engineering for the biomedical field. This well presented book strongly insists on how the materials can influence patients' needs, the ultimate drive for biomedic
Author: William R Wagner Publisher: Academic Press ISBN: 0128161388 Category : Medical Languages : en Pages : 1612
Book Description
The revised edition of the renowned and bestselling title is the most comprehensive single text on all aspects of biomaterials science from principles to applications. Biomaterials Science, fourth edition, provides a balanced, insightful approach to both the learning of the science and technology of biomaterials and acts as the key reference for practitioners who are involved in the applications of materials in medicine.This new edition incorporates key updates to reflect the latest relevant research in the field, particularly in the applications section, which includes the latest in topics such as nanotechnology, robotic implantation, and biomaterials utilized in cancer research detection and therapy. Other additions include regenerative engineering, 3D printing, personalized medicine and organs on a chip. Translation from the lab to commercial products is emphasized with new content dedicated to medical device development, global issues related to translation, and issues of quality assurance and reimbursement. In response to customer feedback, the new edition also features consolidation of redundant material to ensure clarity and focus. Biomaterials Science, 4th edition is an important update to the best-selling text, vital to the biomaterials’ community. The most comprehensive coverage of principles and applications of all classes of biomaterials Edited and contributed by the best-known figures in the biomaterials field today; fully endorsed and supported by the Society for Biomaterials Fully revised and updated to address issues of translation, nanotechnology, additive manufacturing, organs on chip, precision medicine and much more. Online chapter exercises available for most chapters
Author: Lia Stanciu Publisher: Academic Press ISBN: 0128095245 Category : Medical Languages : en Pages : 369
Book Description
Introductory Biomaterials enables undergraduate students in Biomedical, Chemical, Materials and other relevant Engineering disciplines to become familiar with the key concepts of Biomaterials principles: biocompatibility, structure-property-applications relationships, mechanical response of natural tissues, and cellular pathways for tissue-material ingrowth. Written in a clear, concise manner that weds theory with applications, this book helps students to understand the often intricate relationships between materials the implant devices that are made from them, and how the human body reacts to them. The book includes such concepts as requirements for metals, alloys, and ceramic materials to be used in load bearing implants (corrosion concepts, stress shielding, mechanical properties, composition), what properties of polymers impact their use in medicine (leaching and swelling, creep and stress relaxation); the tissue response to biomaterials, concepts related to drug delivery applications (polymer degradation, encapsulation), and tissue engineering (scaffold porosity, diffusion of nutrients, mechanical properties). Begins with structure-properties, followed immediately by their impact on actual biomaterials classes and devices, thus directly relating theory to applications (e.g. polymers to polymeric stents; metals to fracture fixation devices) Explains concepts in a clear, progressive manner, with numerous examples and figures to enhance student learning Covers all key biomaterials classes: metallic, ceramic, polymeric, composite and biological Includes a timely chapter on medical device regulation