ASTM F2346-05

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.
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 its use. It i...

General Information

• Status: Historical
• Publication Date: 31-Dec-2004
• 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

• Replaced By: ASTM F2346-05(2011) - Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
• Effective Date: 01-Dec-2011
• Referred By: ASTM F3292-19 - Standard Practice for Inspection of Spinal Implants Undergoing Testing
• Effective Date: 01-Jan-2005
• Referred By: ASTM F2694-16(2020) - Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
• Effective Date: 01-Jan-2005
• Referred By: ASTM F2789-10(2020) - Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
• Effective Date: 01-Jan-2005

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
Standard Test Methods for
Static and Dynamic Characterization of Spinal Artificial
1
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 to establish appropriate safety and health practices and
determine the applicability of regulatory limitations prior to
1.1 These test methods specify the materials and methods
use.
for the static and dynamic testing of artificial intervertebral
discs.
2. Referenced Documents
1.2 These test methods are intended to provide a basis for
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2.1 ASTM Standards:
the mechanical comparison among past, present, and future
E4 Practices for Force Verification of Testing Machines
non-biologic artificial intervertebral discs. These test methods
E6 TerminologyRelatingtoMethodsofMechanicalTesting
allowcomparisonofartificialintervertebraldiscswithdifferent
E466 Practice for Conducting Force Controlled Constant
intended spinal locations (cervical, thoracic, and lumbar) and
Amplitude Axial Fatigue Tests of Metallic Materials
methods of application to the intervertebral spaces. These test
E467 Practice for Verification of Constant Amplitude Dy-
methods are intended to enable the user to mechanically
namic Forces in an Axial Fatigue Testing System
compare artificial intervertebral discs and do not purport to
E468 Practice for Presentation of Constant Amplitude Fa-
provide performance standards for artificial intervertebral
tigue Test Results for Metallic Materials
discs.
E1823 Terminology Relating to Fatigue and Fracture Test-
1.3 These test methods describe static and dynamic tests by
ing
specifying load types and specific methods of applying these
F1582 Terminology Relating to Spinal Implants
loads. These tests are designed to allow for the comparative
F2077 Test Methods For Intervertebral Body Fusion De-
evaluation of artificial intervertebral discs.
vices
1.4 These test methods do not purport to address all clini-
cally relevant failure modes for artificial intervertebral discs,
3. Terminology
some of which will be device specific. For example, these test
3.1 Definitions—All definitions below supersede definitions
methodsdonotaddresstheimplant’sresistancetoexpulsionor
contained within Terminologies E6, E1823, F1582, and Prac-
implant wear resistance under expected in vivo loads and
tices E466, E467.
motions.Inaddition,thebiologicresponsetoweardebrisisnot
3.1.1 artificial intervertebral disc—a synthetic structure
addressed in these test methods.
that is permanently implanted in the disc space between two
1.5 Requirements are established for measuring displace-
adjacent vertebral bodies to provide spinal column support and
ments, determining the yield load or moment, and evaluating
allow intervertebral motion.
the stiffness of artificial intervertebral discs.
3.1.2 coordinate system/axes—three orthogonal axes are
1.6 Some artificial intervertebral discs may not be testable
defined by Terminology F1582. The center of the coordinate
in all test configurations.
system is located at the geometric center of the artificial
1.7 The values stated in SI units are to be regarded as the
intervertebraldisc.Alternativecoordinatesystemsmaybeused
standard with the exception of angular measurements, which
with justification. The XY-plane is to bisect the superior and
may be reported in terms of either degrees or radians.
inferior surfaces that are intended to simulate the adjacent
1.8 The use of this standard may involve the operation of
vertebral end plates. The positive Z-axis is to be directed
potentially hazardous equipment. This standard does not pur-
perpendicular to the bisector of the disc space, oriented in the
port to address all of the safety concerns, if any, associated
superior direction. The positive X-axis is parallel to the
with its use. It is the responsibility of the user of this standard
intervertebral space, oriented in the anterior direction and the
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These test methods are under the jurisdiction of ASTM Committee F04 on
2
Medical and Surgical Materials and Devices and is the direct responsibility of For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Subcommittee F04.25 on Spinal Devices. contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Current edition approved Jan. 1, 2005. Published January 2005. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F2346-05. the ASTM website.
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