ASTM F1717-10
(Test Method)Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
SIGNIFICANCE AND USE
Spinal implants are generally composed of several components which, when connected together, form a spinal implant assembly. Spinal implant assemblies are designed to provide some stability to the spine while arthrodesis takes place. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies so that comparison between different designs may be facilitated.
These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the spine.
The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters.
Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz.
The location of the longitudinal elements is determined by where the anchors are clinically placed against bony structures. The perpendicular distance to the load direction (block moment arm) between the axis of a hinge pin and the anchor's attachment-points to a UHMWPE block is independent of anchor-type. The distance between the anchor's attachment point to the UHMWPE block and the center of the long...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific depending on the intended spinal location and intended method of application to the spine.
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies.
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly.
1.5 Some spinal constructs may not be testable in all test configurations.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 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 and health practices and determine the applicability of regulatory limitations prior to use.
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Designation:F1717–10
Standard Test Methods for
1
Spinal Implant Constructs in a Vertebrectomy Model
This standard is issued under the fixed designation F1717; 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 2. Referenced Documents
2
1.1 These test methods cover the materials and methods for 2.1 ASTM Standards:
the static and fatigue testing of spinal implant assemblies in a D638 Test Method for Tensile Properties of Plastics
vertebrectomymodel.Thetestmaterialsformostcombinations E4 Practices for Force Verification of Testing Machines
ofspinalimplantcomponentscanbespecificdependingonthe E6 TerminologyRelatingtoMethodsofMechanicalTesting
intended spinal location and intended method of application to E177 Practice for Use of the Terms Precision and Bias in
the spine. ASTM Test Methods
1.2 These test methods are intended to provide a basis for E691 Practice for Conducting an Interlaboratory Study to
the mechanical comparison among past, present, and future Determine the Precision of a Test Method
spinal implant assemblies. They allow comparison of spinal E739 Practice for Statistical Analysis of Linear or Linear-
implant constructs with different intended spinal locations and ized Stress-Life ( S-N) and Strain-Life (e-N) Fatigue Data
methodsofapplicationtothespine.Thesetestmethodsarenot E1150 Definitions of Terms Relating to Fatigue
intended to define levels of performance, since sufficient F1582 Terminology Relating to Spinal Implants
knowledge is not available to predict the consequences of the F2077 Test Methods For Intervertebral Body Fusion De-
use of a particular device. vices
1.3 These test methods set out guidelines for load types and
3. Terminology
methods of applying loads. Methods for three static load types
and one fatigue test are defined for the comparative evaluation 3.1 Definitions:
3.1.1 For definitions of terms relating to these test methods,
of spinal implant assemblies.
1.4 These test methods establish guidelines for measuring see Terminology E6, Terminology F1582, and Definitions
E1150.
displacements, determining the yield load, and evaluating the
3.2 Definitions of Terms Specific to This Standard:
stiffness and strength of the spinal implant assembly.
1.5 Some spinal constructs may not be testable in all test 3.2.1 active length of the longitudinal element—the straight
line distance between the center of attachment of the superior
configurations.
1.6 The values stated in SI units are to be regarded as anchor and the center of attachment of the inferior anchor.
3.2.2 angular displacement at 2 % offset yield (degrees)—
standard. No other units of measurement are included in this
standard. the angular displacement of a construct measured via the
actuatorthatproducesapermanentangulardisplacementinthe
1.7 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the X-Y plane equal to 0.020 times the torsional aspect ratio (see
Point A in Fig. 1).
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica- 3.2.3 block moment arm—the perpendicular to the applied
load between the insertion point of an anchor and the axis of
bility of regulatory limitations prior to use.
the hinge pin.
1
These test methods are under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and are the direct responsibility of
2
Subcommittee F04.25 on Spinal Devices. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
CurrenteditionapprovedJuly1,2010.PublishedJuly2010.Originallyapproved contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
in 1996. Last previous edition approved in 2009 as F1717–09. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F1717-10. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F1717–10
FIG. 2 A Standard Bilateral Construct Containing Screw, Rod and
Screw
FIG. 1 Typical Load Displacement Curve or Torque Angulation
Curve
3.2.4 compressive or tensile bending stiffness (N/mm)—the
compressive or tensile bending yield force divided by elastic
displacement (see the initial slope of line BC in Fig. 1).
3.2.5 compressive or tensile bending ultimate load (N)—the
maximum compressive or tensile force in X-Z plane applied to
a spinal implant assembly (see the force at Point E in Fig. 1).
Theultimateloadshouldbeafunctionofthedev
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:F1717–09 Designation:F1717–10
Standard Test Methods for
1
Spinal Implant Constructs in a Vertebrectomy Model
This standard is issued under the fixed designation F1717; 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
1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a
vertebrectomy model. The test materials for most combinations of spinal implant components can be specific depending on the
intended spinal location and intended method of application to the spine.
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal
implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of
application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not
available to predict the consequences of the use of a particular device.
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and
one fatigue test are defined for the comparative evaluation of spinal implant assemblies.
1.4 Thesetestmethodsestablishguidelinesformeasuringdisplacements,determiningtheyieldload,andevaluatingthestiffness
and strength of the spinal implant assembly.
1.5 Some spinal constructs may not be testable in all test configurations.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
D638 Test Method for Tensile Properties of Plastics
E4 Practices for Force Verification of Testing Machines
E6 Terminology Relating to Methods of Mechanical Testing
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
E739 Practice for Statistical Analysis of Linear or Linearized Stress-Life ( S-N) and Strain-Life (-N) Fatigue Data
E1150 Definitions of Terms Relating to Fatigue
F1582 Terminology Relating to Spinal Implants
F2077 Test Methods For Intervertebral Body Fusion Devices
3. Terminology
3.1 Definitions:
3.1.1 For definitions of terms relating to these test methods, see Terminology E6, Terminology F1582, and Definitions E1150.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 active length of the longitudinal element—the straight line distance between the center of attachment of the superior
anchor and the center of attachment of the inferior anchor.
3.2.2 angular displacement at 2 % offset yield (degrees)—theangulardisplacementofaconstructmeasuredviatheactuatorthat
produces a permanent angular displacement in the X-Y plane equal to 0.020 times the torsional aspect ratio (see Point A in Fig.
1).
1
ThesetestmethodsareunderthejurisdictionofASTMCommitteeF04onMedicalandSurgicalMaterialsandDevices andarethedirectresponsibilityofSubcommittee
F04.25 on Spinal Devices.
Current edition approved Sept. 15, 2009. Published October 2009. Originally approved in 1996. Last previous edition approved in 2004 as F1717–04. DOI:
10.1520/F1717-09.
CurrenteditionapprovedJuly1,2010.PublishedJuly2010.Originallyapprovedin1996.Lastpreviouseditionapprovedin2009asF1717–09.DOI:10.1520/F1717-10.
2
ForreferencedASTMstandards,visittheASTMwebsite,www.astm.org,orcontactASTMCustomerServiceatservice@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 ----------------------
F1717–10
FIG. 1 Typical Load Displacement Curve or Torque Angulation
Curve
3.2.3 block moment arm—the perpendicular to the applied load between the insertion point of an anchor and the axis of the
hinge pin.
3.2.4 compressive or tensile bending stiffness (N/mm)
...
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