Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach

An integrated approach

Authors: Silver, Frederick

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About this book

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.

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`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

Table of contents (9 chapters)

Table of contents (9 chapters)

Buy this book

eBook $169.00
price for USA in USD
  • ISBN 978-94-011-0735-8
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase Institutional customers should get in touch with their account manager
Hardcover $279.99
price for USA in USD
Softcover $219.99
price for USA in USD
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Bibliographic Information

Bibliographic Information
Book Title
Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach
Book Subtitle
An integrated approach
Authors
Copyright
1994
Publisher
Springer Netherlands
Copyright Holder
Chapman & Hall
eBook ISBN
978-94-011-0735-8
DOI
10.1007/978-94-011-0735-8
Hardcover ISBN
978-0-412-41260-8
Softcover ISBN
978-94-010-4316-8
Edition Number
1
Number of Pages
VII, 303
Topics