Biomaterials, Medical Devices and Tissue Engineering

An Integrated Approach : An integrated approach

By: Frederick Silver

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Hardcover | 30 November 1993

At a Glance

Hardcover
312 Pages

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23.39 x 15.6 x 1.91

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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.

Industry Reviews

`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

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You Can Find This Book In

Non-Fiction Medicine Surgery Plastic & Reconstructive Surgery Pre-Clinical Medicine & Basic Sciences Engineering & Technology Mechanical Engineering & Materials Materials Science Nursing & Ancillary Services Biomedical Engineering Gardening Technology in General

Engineering in General Medicine in General Health Systems & Services General Practice

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Paperback

Published: 17th September 2012

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Scope and markets for medical implants	p. 1
Wound dressings and skin replacement	p. 46
Replacement of skeletal tissues	p. 92
Biomaterials used in ophthalmology	p. 120
Cardiovascular implants	p. 153
Facial implants	p. 194
Dental implants	p. 220
Breast implants	p. 236
510 (k) and PMA regulatory filings in the US	p. 250
References	p. 262
Index	p. 301
Table of Contents provided by Blackwell. All Rights Reserved.

Biomaterials, Medical Devices and Tissue Engineering

An Integrated Approach : An integrated approach

At a Glance

Hardcover

Industry Reviews

Shipping

How to return your order

Defective items

You Can Find This Book In

Other Editions and Formats

Paperback

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