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This volume details current developments in industry practices and standards relating to medical device packaging. This edition offers entirely new as well as revised chapters on packaging materials, package validation and methods and integrity testing, bar-coding technology, environmentally sound packaging and disposal procedures, storage autoclave sytems, international standards, customer needs, regulatory aspects, and more.
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Medical Device Packaging Handbook Packaging and Converting Technology ; 8
author
:
Sherman, Max
publisher
:
CRC Press
isbn10 | asin
:
0824701992
print isbn13
:
9780824701994
ebook isbn13
:
9780585374154
language
:
English
subject
Medical instruments and apparatus--Packaging--Handbooks, manuals, etc, Medical instruments and apparatus--Labeling--Handbooks, manuals, etc.
publication date
:
1998
lcc
:
R857.P33M43 1998eb
ddc
:
681/.761
subject
:
Medical instruments and apparatus--Packaging--Handbooks, manuals, etc, Medical instruments and apparatus--Labeling--Handbooks, manuals, etc.
Medical Device Packaging Handbook
Packaging and Converting Technology
A Series of Reference Books
edited by
Harold A. Hughes Director, School of Packaging Michigan State University East Lansing, Michigan
1. Packaging: Specifications, Purchasing, and Quality Control: Third Edition, Revised and Expanded, Edmund A. Leonard
2. Medical Device Packaging Handbook, edited by Joseph D. O'Brien
3. Integrated Packaging Systems for Transportation and Distribution, Charles W. Ebeling
4. Quality Control of Packaging Materials in the Pharmaceutical Industry, Kenneth Harburn
5. Plastics in Food Packaging: Properties, Design, and Fabrication, William E. Brown
6. Food Packaging: Principles and Practice, Gordon L. Robertson
7. Packaging: Specifications, Purchasing, and Quality Control: Fourth Edition, Revised and Expanded, Edmund A. Leonard
8. Medical Device Packaging Handbook: Second Edition, Revised and Expanded, edited by Max Sherman
Additional Volumes in Preparation
Page i
Medical Device Packaging Handbook
Second Edition, Revised and Expanded
Edited by Max Sherman
Sherman Consulting Services, Inc. Warsaw, Indiana
Page ii
Library of Congress Cataloging-in-Publication Data
Medical device packaging handbook / edited by Max Sherman.2nd ed., rev. & expanded. p. cm.(Packaging and converting technology; v. 8) Includes bibliographical references and index. ISBN 0-8247-0199-2 (alk. paper) 1. Medical instruments and apparatusPackagingHandbooks, manuals, etc. 2. Medical instruments and apparatusLabelingHandbooks, manuals, etc. I. Sherman, Max. II. Series: Packaging and converting technology; 8. R857.P33M43 1998 681'.761dc21 98-36296 CIP
First edition edited by Joseph O'Brien, 1990.
This book is printed on acid-free paper.
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Copyright 1998 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.
When the Medical Device Packaging Handbook was initially published in 1990, the editor and the authors understood its temporal nature. The packaging field is dynamicinternational and domestic regulatory requirements are added periodically, new sterilization methods appear, packaging materials change, new standards are written, packaging and bar-coding equipment become more sophisticated, and concern for the environment increases. All of these changes were considered and were instrumental in the decision to revise the first edition.
Fortunately, authors were found who were experts in their disciplines, international standards, validation, and environmental issues, and these three topics are included in new chapters in this handbook. The chapters describing package sterilization methods, regulatory aspects, packaging materials, and customer needs have been updated and rewritten by the original authors. New authors have provided new chapters on bar-code technology and storage autoclave case systems, topics that were included in the earlier edition. Only the chapter on specifications remains basically the same.
All of the authors graciously consented to contribute to the specialized field of medical device packaging. Their knowledge and experience should help to promote a greater understanding of this important endeavor.
The handbook is designed to be used by packaging engineers; designers; validation engineers; regulatory, quality assurance, and research and development personnel; government and health-care employees; and packaging engineering students. The chapters on regulatory aspects, standards, and validation should be particularly helpful in addressing the new FDA Quality Systems requirements and in complying with the European Medical Device Directive.
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