Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach

Lingua: inglese

Editore: Springer Netherlands, Springer Netherlands Nov 1993, 1993

0412412608 / 9780412412608

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This item is printed on demand - Print on Demand Titel. Neuware -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.Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg 312 pp. Englisch.

Codice articolo 9780412412608

Titolo
Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach
Autore
F. H. Silver
Editore
Springer Netherlands, Springer Netherlands Nov 1993
Anno di pubblicazione
1993
Condizione
Neu
Rilegatura
Buch
Lingua
inglese
ISBN 10
0412412608
ISBN 13
9780412412608
Peso dell'articolo
635 grammi
Dimensioni
241x160x21 mm

buchversandmimpf2000

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