• ASTM F 2346 : 2018

    Current The latest, up-to-date edition.

    Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-06-2018

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    These test methods specify the materials and methods for the static and dynamic testing of artificial intervertebral discs.

    Scope - (Show below) - (Hide below)

    1.1These test methods specify the materials and methods for the static and dynamic testing of artificial intervertebral discs.

    1.2These test methods are intended to provide a basis for the mechanical comparison among past, present, and future non-biologic artificial intervertebral discs. These test methods allow comparison of artificial intervertebral discs with different intended spinal locations (cervical, thoracic, and lumbar) and methods of application to the intervertebral spaces. These test methods are intended to enable the user to mechanically compare artificial intervertebral discs and do not purport to provide performance standards for artificial intervertebral discs.

    1.3These test methods describe static and dynamic tests by specifying load types and specific methods of applying these loads. These tests are designed to allow for the comparative evaluation of artificial intervertebral discs.

    1.4These test methods do not purport to address all clinically relevant failure modes for artificial intervertebral discs, some of which will be device specific. For example, these test methods do not address the implant's resistance to expulsion or 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.

    1.5Requirements are established for measuring displacements, determining the yield load or moment, and evaluating the stiffness of artificial intervertebral discs.

    1.6Some artificial intervertebral discs may not be testable in all test configurations.

    1.7The 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.

    1.8This 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.

    1.9This 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.

    General Product Information - (Show below) - (Hide below)

    Committee F 04
    Document Type Test Method
    Publisher American Society for Testing and Materials
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ASTM F 3292 : 2019 Standard Practice for Inspection of Spinal Implants Undergoing Testing
    ASTM F 2789 : 2010 : R2015 Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
    ASTM F 2694 : 2016 Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses

    Standards Referencing This Book - (Show below) - (Hide below)

    ASTM E 1823 : 2024 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 1582 : 1998 : R2016 Standard Terminology Relating to Spinal Implants
    ASTM F 2077 : 2003 Test Methods For Intervertebral Body Fusion Devices
    ASTM E 1823 : 2024 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 1823 : 2012 : REV : EDT 0 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 1823 : 2007 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 468 : 1990 : R2004 Standard Practice for Presentation of Constant Amplitude Fatigue Test Results for Metallic Materials
    ASTM E 1823 : 2009 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 2077 : 2022 Standard Test Methods for Intervertebral Body Fusion Devices
    ASTM F 1582 : 1998 : R2003 Standard Terminology Relating to Spinal Implants
    ASTM E 6 : 2002 Standard Terminology Relating to Methods of Mechanical Testing
    ASTM E 466 : 1996 Standard Practice for Conducting Force Controlled Constant Amplitude Axial Fatigue Tests of Metallic Materials
    ASTM F 2077 : 2017 Test Methods For Intervertebral Body Fusion Devices
    ASTM F 2077 : 2000 Test Methods For Intervertebral Body Fusion Devices
    ASTM E 1823 : 2005 : REV A : EDT 1 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 1823 : 2010 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 1823 : 2021 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 1823 : 2009 : REV B Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 2077 : 2018 Test Methods For Intervertebral Body Fusion Devices
    ASTM E 1823 : 2012 : REV D Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 1823 : 2012 : REV B Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 466 : 2021 Standard Practice for Conducting Force Controlled Constant Amplitude Axial Fatigue Tests of Metallic Materials
    ASTM E 466 : 2015 Standard Practice for Conducting Force Controlled Constant Amplitude Axial Fatigue Tests of Metallic Materials
    ASTM F 2077 : 2001 Test Methods For Intervertebral Body Fusion Devices
    ASTM E 6 : 2015 : EDT 3 Standard Terminology Relating to Methods of Mechanical Testing
    ASTM F 2077 : 2011 Test Methods For Intervertebral Body Fusion Devices
    ASTM E 6 : 2023 : REV A Standard Terminology Relating to Methods of Mechanical Testing
    ASTM E 4 : 2021 Standard Practices for Force Calibration and Verification of Testing Machines
    ASTM F 1582 : 1998 : R2011 Standard Terminology Relating to Spinal Implants
    ASTM E 1823 : 1996 : R2002 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 1823 : 1996 : EDT 1 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 467 : 2008 : R2014 Standard Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
    ASTM E 1823 : 2012 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 1823 : 2007 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 6 : 2015 : EDT 4 : REDLINE Standard Terminology Relating to Methods of Mechanical Testing
    ASTM E 468 : 2018 Standard Practice for Presentation of Constant Amplitude Fatigue Test Results for Metallic Materials
    ASTM E 1823 : 2023 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 6 : 2015 : EDT 4 Standard Terminology Relating to Methods of Mechanical Testing
    ASTM E 6 : 2023 Standard Terminology Relating to Methods of Mechanical Testing
    ASTM E 467 : 2021 Standard Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
    ASTM E 1823 : 2013 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 1823 : 2012 : REV C Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 1823 : 2020 : REV B Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 1823 : 2005 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 1582 : 1998 Standard Terminology Relating to Spinal Implants
    ASTM F 2077 : 2014 Test Methods For Intervertebral Body Fusion Devices
    ASTM E 1823 : 2011 Standard Terminology Relating to Fatigue and Fracture Testing
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