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Description of ASTM-F3574 2022ASTM F3574-22Active Standard: Standard Test Methods for Sacroiliac Joint Fusion DevicesASTM F3574Scope 1.1 These test methods cover the materials and methods for the static and dynamic testing of sacroiliac joint (SIJ) fusion device assemblies, SIJ implants designed to promote arthrodesis at the sacroiliac joint. 1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic SIJ fusion device assemblies. These test methods allow for comparison of SIJ fusion device assemblies intended to be implanted with a trajectory in line with the joint space (in-line implant) or for comparison of SIJ fusion devices intended for implantation across the joint space (transverse implant). These test methods are intended enable the user to compare SIJ fusion device assemblies mechanically and do not purport to provide performance standards for SIJ fusion device assemblies. 1.3 These tests describe static and dynamic tests by specifying force types and specific methods of applying these forces. These tests are designed to allow for the comparative evaluation of SIJ device assemblies. 1.4 Guidelines are established for measuring displacements, determining the yield force or moment, and evaluating the stiffness and strength of the SIJ fusion device assemblies. 1.5 Some SIJ fusion device assemblies may not be testable in all test configurations. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurements are included in this standard, with the exception of angular measurements, which may be reported in terms of either degrees or radians. 1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. Keywords dynamic test methods; sacroiliac joint (SIJ) fusion device; SIJ implants; static test methods; ICS Code ICS Number Code 11.040.40 (Implants for surgery, prosthetics and orthotics) DOI: 10.1520/F3574-22 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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