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  • ASTM
    F2790-10(2014) Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses
    Edition: 2014
    $103.58
    Unlimited Users per year

Description of ASTM-F2790 2014

ASTM F2790-10-Reapproved2014

Historical Standard: Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses




ASTM F2790

Scope

1.1 This practice provides guidance for the static and dynamic testing of Lumbar Total Facet Prostheses (FP). These implants are intended to allow motion and lend support to one or more functional spinal unit(s) through replacement of the natural facets.

1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future non-biologic FP. These test methods allow comparison of devices with different methods of application to the lumbar spine. These test methods are intended to enable the user to mechanically compare devices and do not purport to provide performance standards for them.

1.3 These test methods describe static and dynamic tests by specifying load types and specific methods of applying these loads.

1.4 These test methods do not purport to address all clinically relevant failure modes for FP, some of which will be device specific. For example, these test methods do not address implant wear resistance under expected in vivo loads and motions. In addition, the biologic response to wear debris is not addressed in these test methods.

1.5 Requirements are established for measuring displacements and evaluating the stiffness of FP.

1.6 Some devices may not be testable in all test configurations.

1.7 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians.

1.8 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.


Keywords

dynamic stabilization; dynamic test; facet arthroplasty; posterior instrumentation; spinal implants; static test;


ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)


DOI: 10.1520/F2790-10R14

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About ASTM

ASTM 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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