TAILIEUCHUNG - Safety Evaluation of Medical Devices Second Edition Revised and Expanded

The second edition of Safety Evaluation of Medical Devices continues to focus on the objective of the first edition—to serve as a single-volume practical guide for those who are responsible for or concerned with ensuring safety in the use and manufacture of medical devices. It benefits from recognition of the limitations and shortcomings of the previous edition, and also reflects the changes in regulations, science, and the marketplace. Foremost, this new edition has been recast throughout to address the fact that device markets are global, and that their regulation has also become so. Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), | Safety Evaluation of Medical Devices Second Edition Revised and Expanded Shayne Cox Gad Gad Consulting Services Cary North Carolina MARCEL DEKKER Marcel Dekker Inc. New York Basel Copyright 2002 by Marcel Dekker. All Rights ISBN 0-8247-0617-X This book is printed on acid-free paper. Headquarters Marcel Dekker Inc. 270 Madison Avenue New York NY 10016 tel 212-696-9000 fax 212-685-4540 Eastern Hemisphere Distribution Marcel Dekker AG Hutgasse 4 Postfach 812 CH-4001 Basel Switzerland tel 41-61-261-8482 fax 41-61-261-8896 World Wide Web http The publisher offers discounts on this book when ordered in bulk quantities. For more information write to Special Sales Professional Marketing at the headquarters address above. Copyright 2002 by Marcel Dekker Inc. All Rights Reserved. Neither this book nor any part may be reproduced or transmitted in any form or by any means electronic or mechanical including photocopying microfilming and recording or by any information storage and retrieval system without permission in writing from the publisher. Current printing last digit 10 987654321 PRINTED IN THE UNITED STATES OF AMERICA Copyright 2002 by Marcel Dekker. All Rights To Joyce my wife partner and best friend for all the light and joy that she has brought into my world. Copyright 2002 by Marcel Dekker. All Rights .

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