Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach.pdf

Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach PDF

F. H. Silver

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 Tissue …

9401043167 ISBN
Englisch SPRACHE
Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach.pdf


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Going far beyond the coverage in most standard books on the subject, Biomaterials Science: An Integrated Clinical and Engineering Approach offers a solid overview of the use of biomaterials in medical devices, drug delivery, and tissue engineering.

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Biomaterials, Tissue Engineering and … More recently, tissue engineering strategies have been applied to medical device development programs, with particular focus on soft tissue, cardiovascular and orthopaedic applications. Such devices and therapies revolve around use of living cells and/or active agents delivered by scaffolds and other systems to promote tissue repair, replacement or regeneration.

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