ASTM F2346-18
(Test Method)Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
SIGNIFICANCE AND USE
5.1 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.
5.2 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.
5.3 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.
5.4 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.
5.5 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, ...
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 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 approp...
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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.
Designation:F2346 −18
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.Anumber 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 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 These test methods specify the materials and methods
responsibility of the user of this standard to establish appro-
for the static and dynamic testing of artificial intervertebral
priate safety, health, and environmental practices and deter-
discs.
mine the applicability of regulatory limitations prior to use.
1.2 These test methods are intended to provide a basis for
1.9 This international standard was developed in accor-
the mechanical comparison among past, present, and future
dance with internationally recognized principles on standard-
non-biologic artificial intervertebral discs. These test methods
ization established in the Decision on Principles for the
allowcomparisonofartificialintervertebraldiscswithdifferent
Development of International Standards, Guides and Recom-
intended spinal locations (cervical, thoracic, and lumbar) and
mendations issued by the World Trade Organization Technical
methods of application to the intervertebral spaces. These test
Barriers to Trade (TBT) Committee.
methods are intended to enable the user to mechanically
compare artificial intervertebral discs and do not purport to 2. Referenced Documents
provide performance standards for artificial intervertebral
2
2.1 ASTM Standards:
discs.
E4Practices for Force Verification of Testing Machines
1.3 These test methods describe static and dynamic tests by E6Terminology Relating to Methods of MechanicalTesting
specifying load types and specific methods of applying these E466Practice for Conducting Force Controlled Constant
loads. These tests are designed to allow for the comparative
Amplitude Axial Fatigue Tests of Metallic Materials
evaluation of artificial intervertebral discs. E467Practice for Verification of Constant Amplitude Dy-
namic Forces in an Axial Fatigue Testing System
1.4 These test methods do not purport to address all clini-
E468Practice for Presentation of Constant Amplitude Fa-
cally relevant failure modes for artificial intervertebral discs,
tigue Test Results for Metallic Materials
some of which will be device specific. For example, these test
E1823TerminologyRelatingtoFatigueandFractureTesting
methodsdonotaddresstheimplant’sresistancetoexpulsionor
F1582Terminology Relating to Spinal Implants
implant wear resistance under expected in vivo loads and
F2077Test Methods for Intervertebral Body Fusion Devices
motions.Inaddition,thebiologicresponsetoweardebrisisnot
addressed in these test methods.
3. Terminology
1.5 Requirements are established for measuring
3.1 All definitions below supersede definitions contained
displacements, determining the yield load or moment, and
within Terminologies E6, E1823, F1582, and Practices E466,
evaluating the stiffness of artificial intervertebral discs.
E467.
1.6 Some artificial intervertebral discs may not be testable
3.2 Definitions:
in all test configurations.
3.2.1 artificial intervertebral disc—asyntheticstructurethat
1.7 The values stated in SI units are to be regarded as the
is permanently implanted in the disc space between two
standard with the exception of angular measurements, which adjacentvertebralbodiestoprovidespinalcolumnsupportand
may be reported in terms of either degrees or radians.
allow intervertebral motion.
3.2.2 coordinate system/axes—three orthogonal axes are
defined by Terminology F1582. The center of the coordinate
1
These test methods are under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
2
Subcommittee F04.25 on Spinal Devices. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved June 1, 2018. Published August 2018. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2005. Last previous edition approved in 2011 as F2346–05 (2011). Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F2346-18. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 -------
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2346 − 05 (Reapproved 2011) F2346 − 18
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
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 its use. It is the responsibility of the user of this standard to establish
appropriate safety safety, health, and healthenvironmental practices and determine the applicability of regulatory limitations prior
to use.
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.
2. Referenced Documents
2
2.1 ASTM Standards:
E4 Practices for Force Verification of Testing Machines
E6 Terminology Relating to Methods of Mechanical Testing
E466 Practice for Conducting Force Controlled Constant Amplitude Axial Fatigue Tests of Metallic Materials
E467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
E468 Practice for Presentation of Constant Amplitude Fatigue Test Results for Metallic Materials
E1823 Terminology Relating to Fatigue and Fracture Testing
1
These test methods are under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.25 on Spinal Devices.
Current edition approved Dec. 1, 2011June 1, 2018. Published January 2012August 2018. Originally approved in 2005. Last previous edition approved in 20052011 as
F2346 – 05.F2346 – 05 (2011). DOI: 10.1520/F2346-05R11.10.1520/F2346-18.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2346 − 18
FIG. 1 Intervertebral Height Diagram
F1582 Terminology Relating to Spinal Implants
F2077 Test Methods For Intervertebral Body Fusion Devices
3. Terminology
3.1 All definitions below supersede definiti
...
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