HANDBOOK OF MATERIALS FOR MEDICAL DEVICES
2003 ASM International. All Rights Reserved.Handbook of Materials for Medical Devices (#06974G)www.asminternational.orgHANDBOOK OFMATERIALS FORMEDICAL DEVICESEdited byJ.R. DavisDavis & AssociatesASM InternationalMaterials Park, OH 44073-0002www.asminternational.org
2003 ASM International. All Rights Reserved.Handbook of Materials for Medical Devices (#06974G)www.asminternational.orgCopyright 2003byASM International All rights reservedNo part of this book may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means,electronic, mechanical, photocopying, recording, or otherwise, without the written permission of the copyrightowner.First printing, December 2003Great care is taken in the compilation and production of this book, but it should be made clear that NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHAN ILITY OR FITNESS FOR A PARTICULAR PURPOSE, ARE GIVEN IN CONNECTION WITHTHIS PUBLICATION. Although this information is believed to be accurate by ASM, ASM cannot guaranteethat favorable results will be obtained from the use of this publication alone. This publication is intended for useby persons having technical skill, at their sole discretion and risk. Since the conditions of product or material useare outside of ASM’s control, ASM assumes no liability or obligation in connection with any use of this information. No claim of any kind, whether as to products or information in this publication, and whether or not basedon negligence, shall be greater in amount than the purchase price of this product or publication in respect ofwhich damages are claimed. THE REMEDY HEREBY PROVIDED SHALL BE THE EXCLUSIVE ANDSOLE REMEDY OF BUYER, AND IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR SPECIAL,INDIRECT OR CONSEQUENTIAL DAMAGES WHETHER OR NOT CAUSED BY OR RESULTINGFROM THE NEGLIGENCE OF SUCH PARTY. As with any material, evaluation of the material under end-useconditions prior to specification is essential. Therefore, specific testing under actual conditions is recommended.Nothing contained in this book shall be construed as a grant of any right of manufacture, sale, use, or reproduction, in connection with any method, process, apparatus, product, composition, or system, whether or not covered by letters patent, copyright, or trademark, and nothing contained in this book shall be construed as a defenseagainst any alleged infringement of letters patent, copyright, or trademark, or as a defense against liability forsuch infringement.Comments, criticisms, and suggestions are invited and should be forwarded to ASM International.ASM International staff who worked on this project include Scott Henry, Assistant Director of Reference Publications; Bonnie Sanders, Manager of Production; and Nancy Hrivnak, Jill Kinson, and Carol Polakowski, Production Editors.Library of Congress Cataloging-in-Publication DataHandbook of materials for medical devices / edited by J.R. Davis.p. ; cm.Includes bibliographical references and index.1. Biomedical materials—Handbooks, manuals, etc. I. Davis, J. R. (Joseph R.) II. ASM International.[DNLM: 1. Biomedical and Dental Materials. QT 37 H2366 2003]R857.M3H355 2003610′.28′4—dc222003057730ISBN: 0-87170-790-XSAN:204-7586ASM International Materials Park, OH 44073-0002www.asminternational.orgPrinted in the United States of America
2003 ASM International. All Rights Reserved.Handbook of Materials for Medical Devices (#06974G)www.asminternational.orgContentsPreface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viiIntroductionChapter 1Overview of Biomaterials and Their Use in Medical Devices . . . . . . . . . . . . . . . .Uses for Biomaterials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Types of Biomaterials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Examples of Biomaterials Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Chapter 2Physical and Mechanical Requirements for Medical Device Materials . . . . . . .Biomaterials: A Brief Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Body Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Biocompatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Mechanical Behavior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Elastic Modulus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Corrosion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Sterilization of Implants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11351313131415161618Medical ApplicationsChapter 3Metallic Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Stainless Steels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Cobalt-Base Alloys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Titanium and Titanium-Base Alloys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Comparison of Orthopedic Implant Materials . . . . . . . . . . . . . . . . . . . . . . . . . . .Shape Memory Alloys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Other Metallic Materials Used for Medical Devices . . . . . . . . . . . . . . . . . . . . . .21223138454547Chapter 4Corrosion of Metallic Implants and Prosthetic Devices . . . . . . . . . . . . . . . . . . .Historical Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Types of Metals Used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Significance of Corrosion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Surface Effects and Ion Release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Electrochemistry and Basic Corrosion Processes . . . . . . . . . . . . . . . . . . . . . . . .Forms of Corrosion in Implant Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5151525960606063iii
2003 ASM International. All Rights Reserved.Handbook of Materials for Medical Devices (#06974G)www.asminternational.orgSynthetic Physiological Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67Corrosion Tests for Evaluating Implant Metals . . . . . . . . . . . . . . . . . . . . . . . . . . 67Chapter 5Failure Analysis of Metallic Orthopedic Implants . . . . . . . . . . . . . . . . . . . . . . . . 75Types of Orthopedic Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75Complications Related to Implants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78Metallic Implant Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79The Body Environment and Its Interactions with Implants . . . . . . . . . . . . . . . . . 79Design of Internal Fixation Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82Analysis of Failed Internal Fixation Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . 83Failure Analysis Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83Failures Related to Implant Deficiencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84Failures Related to Mechanical or Biomechanical Conditions . . . . . . . . . . . . . . 98Fatigue Properties of Implant Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106Failures Related to Implant Degradation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112Failures Related to Inadequate Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118Fractures of Total Hip Joint Prostheses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124Fractures of Total Knee Joint Prostheses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125Chapter 6Ceramic Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Tissue Attachment Mechanisms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Nearly Inert Crystalline Ceramics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Porous Ceramics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Bioactive Glasses and Glass Ceramics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Calcium Phosphate Ceramics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Resorbable Calcium Phosphates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Carbon-Base Implant Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .137137140142143145147148Chapter 7Polymeric Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Characteristics and Classification of Polymers . . . . . . . . . . . . . . . . . . . . . . . . .Historical Development of Polymeric Biomaterials . . . . . . . . . . . . . . . . . . . . .Applications Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .151151154158Chapter 8Adhesives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Adhesive Bonding Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Surface Pretreatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Adhesives for Device Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Pressure-Sensitive Adhesives for Medical Applications . . . . . . . . . . . . . . . . . .Adhesives in Medical Electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Regulatory Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .171171172174175176176Chapter 9Coatings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Porous Coatings for Orthopedic Implants . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Ion Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Ion-Beam-Assisted Deposition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Vapor Deposition Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Polymer Coatings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .179179185185188190Dental ApplicationsChapter 10 Biomaterials for Dental Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195Dental Amalgam Alloys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195iv
2003 ASM International. All Rights Reserved.Handbook of Materials for Medical Devices (#06974G)www.asminternational.orgNoble Metals and Base Metals Used in Dentistry . . . . . . . . . . . . . . . . . . . . . . .Noble Metal Casting Alloys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Crown and Bridge and Partial Denture Base Metal Alloys . . . . . . . . . . . . . . . .Porcelain-Fused-to-Metal Alloys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Wrought Alloys for Orthodontic Wires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Alloys for Dental Implants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Soldering Alloys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Alloys for Dental Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Ceramics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Glass-Ceramic Prosthetics Formed by a Casting Process . . . . . . . . . . . . . . . . .Glass Implant Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Composite Dental Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Dental Cements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Polymers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .197198199201204205206207208210212213215216Chapter 11 Tarnish and Corrosion of Dental Alloys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Overview of Dental Devices and Alloys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Tarnish and Corrosion Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Interstitial versus Oral Fluid Environments and Artificial Solutions . . . . . . . .Effect of Saliva Composition on Alloy Tarnish and Corrosion . . . . . . . . . . . .Oral Corrosion Pathways and Electrochemical Properties . . . . . . . . . . . . . . . .Oral Corrosion Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Nature of the Intraoral Surface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Classification and Characterization of Dental Alloys . . . . . . . . . . . . . . . . . . . .Tarnish and Corrosion under Simulated or Accelerated Conditions . . . . . . . . .221221224228232233237242245264Chapter 12 Friction and Wear of Dental Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Human Dental Tissues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Wear Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Dental Amalgam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Composite Restorative Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Pit and Fissure Sealants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Dental Cements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Noble and Base Metal Alloys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Porcelain and Plastic Denture Teeth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Denture Acrylics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Dental Feldspathic Porcelain and Ceramics . . . . . . . . . . . . . . . . . . . . . . . . . . .Die Materials (Stone, Resin, and Metal) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Endodontic Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Periodontal Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Orthodontic Wires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 317v
2003 ASM International. All Rights Reserved.Handbook of Materials for Medical Devices (#06974G)www.asminternational.orgPrefaceIn January of 2000, the National Institutes of Health (NIH) estimated that 8 to 10% of Americans,or about 20 to 25 million people, had some sort of medical device implanted in their bodies (refer tothe NIH Technology Assessment Conference on Implants, held 10–12 Jan 2000 in Bethesda, MD).In the United States, the market for orthopedic implant devices such as total knee and hip replacements, spinal implants, and bone fixation devices, exceeds two billion dollars per year. Worldwide,this market exceeds 4.3 billion per year. These numbers, which clearly demonstrate the economicimpact of the medical device industry, should continue to rise due to the combination of advances inthe medical and materials science fields and an aging population (particularly in the United States,where some “baby boomers” are now in their sixties).Humans have sought to restore function to the human body stricken by trauma or disease for thousands of years. For example, ancient civilizations such as the Phoenicians, Etruscans, Greeks, Romans,Chinese, and Aztecs used gold in dentistry as far back as 2700 bc. The use of sutures made from linencan be traced back to the Egyptians in circa 2000 bc. However, it has only been during the past 100years that man-made materials and devices have been developed to the point where they can be usedextensively to replace parts of living systems in the human body. These special materials—able tofunction in intimate contact with living tissue, with minimal adverse reaction or rejection by thebody—are called biomaterials. Today, biomaterials play a major role in replacing or improving thefunction of every major body system (skeletal, circulatory, nervous, etc.). Some common implantsinclude the orthopedic devices mentioned earlier; cardiac implants such as artificial heart valves andpacemakers; soft tissue implants such as breast implants and injectable collagen for soft tissue augmentation; and dental implants to replace teeth/root systems and bony tissue in the oral cavity.Recognizing the growing importance of biomaterials and bioengineering, ASM International haspublished a number of reviews during the past 20 years that document the properties and failuremechanisms of metallic implant materials. The majority of these reviews can be found in various volumes of the Metals/ASM Handbook series. Until now, however, there was no single definitive sourcepublished by ASM that described the many important topics associated with the use of variousimplant materials (including metals, ceramics, polymers, composites, and coatings). These materialsinclude: Implant material selection and applicationsThe body/oral environment and its impact on implant material performanceThe basic concepts of biocompatibilityTissue attachment mechanismsBiophysical and biomechanical requirements of implant materialsCorrosion and wear behavior, including degradation of polymeric materialsvii
2003 ASM International. All Rights Reserved.Handbook of Materials for Medical Devices (#06974G) www.asminternational.orgCoatings technology, including the use of coatings to facilitate implant fixation and bone ingrowth,wear-resistant coatings, coatings to enhance blood clot resistance, antimicrobial action, and lubricity, and coatings for delivery of drugsDesign considerations, particularly failures related to inadequate designEach of these subjects is addressed in the Handbook of Materials for Medical Devices.The genesis of this handbook can be attributed to the input of the ASM Handbook and TechnicalBooks Committees, the ASM editorial staff (most notably, Scott Henry and Don Baxter), and theASM Materials and Processes for Medical Devices Task Force. In particular, thanks are due to thefollowing Task Force members for their thorough critique of the outline of the handbook at the outset of the project: Farrokh Farzin-Nia (Ormco Corporation), Darel E. Hodgson (Shape MemoryApplications, Johns
Each of these subjects is addressed in the Handbook of Materials for Medical Devices. The genesis of this handbook can be attributed to the input of the ASM Handbook and Technical Books Committees, the ASM editorial staff (most notably, Scott Henry and Don Baxter), and the ASM Materials and P
Bruksanvisning för bilstereo . Bruksanvisning for bilstereo . Instrukcja obsługi samochodowego odtwarzacza stereo . Operating Instructions for Car Stereo . 610-104 . SV . Bruksanvisning i original
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