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.
"synopsis" may belong to another edition of this title.
`This is a good textbook for engineers who intend to develop medical devices and for students who wish to study biomedical engineering.'
Frontiers Medical and Biological Engineering
This text presents a detailed review of the current use of biomaterials, providing an analysis of their short and long term evaluation. After an opening chapter investigating the scope and potential market for medical implants, each subsequent chapter focuses on a separate area of tissue replacement and discusses in depth materials in current clinical use as well as new materials under development.
"About this title" may belong to another edition of this title.
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Hardcover. Condition: new. Hardcover. The use of polymers, metals, ceramics and composite materials in the formulation of medical devices dates back centuries to when plant and animal skins were used for the amelioration of pathological conditions that resulted from mechanical, chemical or pathogenic trauma to tissues and organs. This text presents a detailed review of the current use of materials for the replacement of a range of body tissues, providing an analysis of the short and long term evaluation of each material. After an opening chapter investigating the scope and potential market for medical implants, each subsequent chapter focuses on a separate area of tissue replacement and discusses in depth materials currently used clinically as well as new materials now under development. Would dressings and skin replacement are reviewed followed by replacement skeletal tissues, biomaterials used in ophthalmology, cardiovascular implants, facial implants, dental implants and breast implants. The two primary pathways used to gain market approval in the USA, 510(k) and PMA, are also desceibed.Each of these tissue replacements are analyzed in terms of physico-chemical requirements and biocompatability assessment and the advantages and disadvantages of each material are summarized. The book is aimed at the reader who has an understanding of the basic concepts of polymers, metals and ceramics as well as biocompatability assessessment and will be of interest to all those in university biomaterials and biomechanics departments or medical schools, orthopaedic surgeons, industrial researchers and implant manufacturers. This text presents a detailed review of the current use of biomaterials, providing an analysis of their short and long term evaluation. Shipping may be from multiple locations in the US or from the UK, depending on stock availability. Seller Inventory # 9780412412608
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