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Description of ASTM-F3047M 2015ASTM F3047M-15Historical Standard: Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard ArticulationsASTM F3047MScope 1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard on hard articulations. This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. Device articulating components manufactured from other metallic alloys, ceramics or with coated or elementally modified surfaces could possibly be evaluated with this guide. However such materials may include risks and failure mechanisms which are not adressed in this guide. 1.2 Hard-on-hard hip bearing systems include metal-on-metal, ceramic-on-ceramic, ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements. 1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal on polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement. 1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6). 1.5 The values stated in SI units are to be regarded as the standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Keywords ceramic-on-ceramic; hard-on-hard; high demand wear; hip simulator testing; insert/shell angle; metal-on-metal; third body wear; ICS Code ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics) DOI: 10.1520/F3047M-15 The following editions for this book are also available...This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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