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Description of ASTM-F1831 2024ASTM F1831-24Active Standard: Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization DevicesASTM F1831Scope 1.1 This specification covers standards a manufacturer shall meet in the designing, manufacturing, testing, labeling, and documenting of halo and tong external spinal immobilization devices, but it is not to be construed as production methods, quality control techniques, manufacturer's lot criteria, or clinical recommendations. 1.2 This specification represents the best currently available test procedures at this time and is a minimum safety and performance standard. 1.3 This specification covers only those halo and tong devices intended for use on humans for therapeutic purposes. This specification assumes the user is well trained in the procedures and maintenance of halo and tong application and has the ability to determine if an abnormality is treatable by these procedures. 1.4 This specification describes those devices commonly known as halo external fixation devices and what is known as cranial traction tongs. 1.5 Cranial traction tongs and halo devices are used to achieve and maintain optimal spinal alignment, in order to enhance fusion and decrease neurological deficit. 1.6 Monitoring the progress of treatment after application of these devices is important, this should be done in accordance with the manufacturer's recommendation and guidelines pertaining to the specific device. 1.7 The values stated in both inch-pound and SI units are to be regarded separately as the standard. The values given in parentheses are for information only. 1.8 The following precautionary statement pertains only to the test method portions, Sections 10 – 13: 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. 1.9 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 cranial traction tongs; halo external fixation device; magnetic resonance imaging (MRI) compatibility; ICS Code ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics) DOI: 10.1520/F1831-24 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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