ASTM F2346-05(2011)

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

SIGNIFICANCE AND USE
Artificial intervertebral discs are orthopaedic implants that replace degenerated natural intervertebral discs. Their function is to support the anterior column of the spine while allowing motion at the operated level. These test methods outline materials and methods for the characterization of the mechanical performance of different artificial intervertebral discs so that comparisons can be made between different designs.
These test methods are designed to quantify the static and dynamic characteristics of different designs of artificial intervertebral discs. These tests are conducted in vitro in order to allow for analysis of individual disc replacement devices and comparison of the mechanical performance of multiple artificial intervertebral disc designs in a standard model.
The loads applied to the artificial intervertebral discs may differ from the complex loading seen in vivo, and therefore, the results from these tests may not directly predict in vivo performance. The results, however, can be used to compare mechanical performance of different artificial intervertebral discs.
Fatigue tests should be conducted in a 0.9 % saline environmental bath at 37°C at a rate of 2 Hz or less. Other test environments such as a simulated body fluid, a saline drip or mist, distilled water, or other type of lubrication could also be used with adequate justification. Likewise, alternative test frequencies may be used with adequate justification.
It is well known that the failure of materials is dependent upon stress, test frequency, surface treatments, and environmental factors. Therefore, when determining the effect of changing one of these parameters (for example, frequency, material, or environment), all others should be kept constant to facilitate interpretation of the results. In particular, it may be necessary to assess the influence of test frequency on device fracture while holding the test environment, implant materials and processing, and implant geometry con...
SCOPE
1.1 These test methods specify the materials and methods for the static and dynamic testing of artificial intervertebral discs.
1.2 These 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.
1.3 These 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.
1.4 These 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.
1.5 Requirements are established for measuring displacements, determining the yield load or moment, and evaluating the stiffness of artificial intervertebral discs.
1.6 Some artificial intervertebral discs 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 use of this standard may involve the operation of potentially hazardous equipment. This standard does not purport to address all of the safety concerns, if any, associated with it...

General Information

• Status: Historical
• Publication Date: 30-Nov-2011
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.25 - Spinal Devices

Relations

• Replaces: ASTM F2346-05 - Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
• Effective Date: 01-Dec-2011
• Replaced By: ASTM F2346-18 - Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
• Effective Date: 01-Jun-2018
• Referred By: ASTM F2694-16(2020) - Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
• Effective Date: 01-Dec-2011
• Referred By: ASTM F2789-10(2020) - Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
• Effective Date: 01-Dec-2011
• Referred By: ASTM F3292-19 - Standard Practice for Inspection of Spinal Implants Undergoing Testing
• Effective Date: 01-Dec-2011

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F2346 −05 (Reapproved 2011)
Standard Test Methods for
Static and Dynamic Characterization of Spinal Artificial
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Discs
This standard is issued under the fixed designation F2346; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.8 The use of this standard may involve the operation of
potentially hazardous equipment. This standard does not pur-
1.1 These test methods specify the materials and methods
port to address all of the safety concerns, if any, associated
for the static and dynamic testing of artificial intervertebral
with its use. It is the responsibility of the user of this standard
discs.
to establish appropriate safety and health practices and
1.2 These test methods are intended to provide a basis for
determine the applicability of regulatory limitations prior to
the mechanical comparison among past, present, and future
use.
non-biologic artificial intervertebral discs. These test methods
allowcomparisonofartificialintervertebraldiscswithdifferent
2. Referenced Documents
intended spinal locations (cervical, thoracic, and lumbar) and
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2.1 ASTM Standards:
methods of application to the intervertebral spaces. These test
E4 Practices for Force Verification of Testing Machines
methods are intended to enable the user to mechanically
E6 Terminology Relating to Methods of Mechanical Testing
compare artificial intervertebral discs and do not purport to
E466 Practice for Conducting Force Controlled Constant
provide performance standards for artificial intervertebral
Amplitude Axial Fatigue Tests of Metallic Materials
discs.
E467 Practice for Verification of Constant Amplitude Dy-
1.3 These test methods describe static and dynamic tests by namic Forces in an Axial Fatigue Testing System
specifying load types and specific methods of applying these E468 Practice for Presentation of Constant Amplitude Fa-
loads. These tests are designed to allow for the comparative
tigue Test Results for Metallic Materials
evaluation of artificial intervertebral discs. E1823 TerminologyRelatingtoFatigueandFractureTesting
F1582 Terminology Relating to Spinal Implants
1.4 These test methods do not purport to address all clini-
F2077 TestMethodsForIntervertebralBodyFusionDevices
cally relevant failure modes for artificial intervertebral discs,
some of which will be device specific. For example, these test
3. Terminology
methodsdonotaddresstheimplant’sresistancetoexpulsionor
3.1 All definitions below supersede definitions contained
implant wear resistance under expected in vivo loads and
within Terminologies E6, E1823, F1582, and Practices E466,
motions.Inaddition,thebiologicresponsetoweardebrisisnot
E467.
addressed in these test methods.
3.2 Definitions:
1.5 Requirements are established for measuring
3.2.1 artificial intervertebral disc—a synthetic structure that
displacements, determining the yield load or moment, and
is permanently implanted in the disc space between two
evaluating the stiffness of artificial intervertebral discs.
adjacent vertebral bodies to provide spinal column support and
1.6 Some artificial intervertebral discs may not be testable
allow intervertebral motion.
in all test configurations.
3.2.2 coordinate system/axes—three orthogonal axes are
1.7 The values stated in SI units are to be regarded as the
defined by Terminology F1582. The center of the coordinate
standard with the exception of angular measurements, which
system is located at the geometric center of the artificial
may be reported in terms of either degrees or radians.
intervertebraldisc.Alternativecoordinatesystemsmaybeused
with justification. The XY-plane is to bisect the superior and
inferior surfaces that are intended to simulate the adjacent
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These test methods are under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devicesand is the direct responsibility of
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Subcommittee F04.25 on Spinal Devices. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Dec. 1, 2011. Published January 2012. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 2005. Last previous edition approved in 2005 as F2346 – 05. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2346-05R11. the ASTM website.
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F2346−05 (2011)
FIG. 1Intervertebral Height Diagram
vertebral end plates. The positive Z-axis is to be directed vertebral bodies
...