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Description of ASTM-F3395/F3395M 2019ASTM F3395/F3395M-19Active Standard: Standard Specification for Neurosurgical Head Holder DevicesASTM F3395/F3395MScope 1.1 This specification covers standards a manufacturer shall meet in the performance testing of neurosurgical head holder devices (skull clamps). 1.2 This specification covers neurosurgical head holder devices (skull clamps) made of metal (nonradiolucent) as well as neurosurgical head holder devices (skull clamps) made of plastic material (radiolucent). 1.3 This specification represents the best currently available test procedures and is a minimum safety and performance standard. 1.4 This specification covers only those neurosurgical head holders (skull clamps) intended for use on humans for neurosurgical and spinal clinical applications. This specification assumes the user is well trained in the procedures and use of these devices including selection of the correct device type and accessories. 1.5 This specification describes those devices commonly known as skull clamps and accessories, such as skull pins, attachments, and various adaptors. 1.6 This specification only describes head holder devices that provide rigid skeletal fixation of the skull by means of three skull pins that penetrate the outer surface or outer layers of the patient’s head during neurosurgical or spinal procedures (compare with Ref (1)).2 Two pins are typically located in a 2-pin rocker, whereas the force delivery component is equipped with a single pin. 1.7 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. The values given in parentheses are for information only. 1.8 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. FIG. 1 Skull Clamp Device Achieving 3-Pin Rigid Fixation FIG. 2 Skull Clamp System (Skull Clamp, Base Unit, Adaptor, and Skull Pins) 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 magnetic resonance imaging (MRI) compatibility; neurosurgical head hold devices; skull clamp; ICS Code ICS Number Code 11.040.30 (Surgical instruments and materials) DOI: 10.1520/F3395_F3395M-19 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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