Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach

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November 1993



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.


Scope and markets for medical implants. Wound dressings and
skin replacement. Replacement of skeletal tissues. Biomaterials used
in opthalmology. Cardiovascular implants. Facial implants. Dental
implants. Breast implants. 510(k) and PMA regulatory fillings in the


`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

EAN: 9780412412608
ISBN: 0412412608
Untertitel: An integrated approach. 1994. Auflage. Book. Sprache: Englisch.
Verlag: Springer
Erscheinungsdatum: November 1993
Seitenanzahl: 312 Seiten
Format: gebunden
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