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Biomaterials in the Design and Reliability of Medical Devices


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Michael N. Helmus
Boston Scientific Corporation


ISBN: 978-0-306-47690-7
Pub date: 2002-12-01
226 pages
33 figures
36 tables


About this book

This book highlights the responsibility of medical device designers and engineers to eliminate sites of failure and to test devices to demonstrate its ultimate safety and efficacy. It also evaluates biomaterials and their properties as related to the design and reliability of medical devices. The principals that are described are readily applicable to the biomaterial scaffolds used for generating tissue-engineered constructs.

Table of contents

Overview and Introduction: Unique Aspects of Biomaterials in the Safety and Efficacy of Medical Implant Devices
Michael N. Helmus

Standards and Guidelines for Biocompatibility for Medical Devices
Sharon Northup

Medical Device Regulation
Barry Sall

Medical Device Testing
Sharon Northup

Failure Analysis: Learning for the Future from the Past
Michael N. Helmus

Biomaterials Testing Issues in Small Business
Roger Snyder

Tissue Engineering Constructs and Commercialization
Kelvin Brockbank

Testing of Bioactive Biomaterial: A Case Study
Katherine Tweden