ASTM F1717-01

Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

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 Values stated in SI units are to be regarded as 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.

General Information

• Status: Historical
• Publication Date: 09-Dec-2001
• 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 F1717-96 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
• Effective Date: 10-Dec-2001
• Replaced By: ASTM F1717-04 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
• Effective Date: 01-Apr-2004
• Referred By: ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• Effective Date: 10-Dec-2001
• Referred By: ASTM F1798-21 - Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
• Effective Date: 10-Dec-2001
• Referred By: ASTM F2624-12(2020) - Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
• Effective Date: 10-Dec-2001
• Referred By: ASTM F2706-18 - Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
• Effective Date: 10-Dec-2001
• Referred By: ASTM F3292-19 - Standard Practice for Inspection of Spinal Implants Undergoing Testing
• Effective Date: 10-Dec-2001

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Please contact ASTM International (www.astm.org) for the latest information.
Designation:F1717–01
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 (ϵ) indicates an editorial change since the last revision or reapproval.
1. Scope E739 Practice for Statistical Analysis of Linear or Linear-
3
ized Stress-Life (S-N) and Strain-Life (ϵ-N) Fatigue Data
1.1 These test methods cover the materials and methods for
3
E1150 Definitions of Terms Relating to Fatigue
the static and fatigue testing of spinal implant assemblies in a
4
F1582 Terminology Relating to Spinal Implants
vertebrectomymodel.Thetestmaterialsformostcombinations
ofspinalimplantcomponentscanbespecificdependingonthe
3. Terminology
intended spinal location and intended method of application to
3.1 Definitions:
the spine.
3.1.1 For definitions of terms relating to these test methods,
1.2 These test methods are intended to provide a basis for
see Terminology E6E6, Terminology F1582F1582, and
the mechanical comparison among past, present, and future
Definitions E1150E1150.
spinal implant assemblies. They allow comparison of spinal
3.2 Definitions of Terms Specific to This Standard:
implant constructs with different intended spinal locations and
3.2.1 active length of the longitudinal element—the straight
methodsofapplicationtothespine.Thesetestmethodsarenot
line distance between the center of attachment of the superior
intended to define levels of performance, since sufficient
anchor and the center of attachment of the inferior anchor.
knowledge is not available to predict the consequences of the
3.2.2 angular displacement at 2 % offset yield (degrees)—
use of a particular device.
the angular displacement of a construct measured via the
1.3 These test methods set out guidelines for load types and
actuatorthatproducesapermanentangulardisplacementinthe
methods of applying loads. Methods for three static load types
X-Y plane equal to 0.020 times the torsional aspect ratio (see
and one fatigue test are defined for the comparative evaluation
Point A in Fig. 1).
of spinal implant assemblies.
3.2.3 block moment arm—the perpendicular to the applied
1.4 These test methods establish guidelines for measuring
load between the insertion point of an anchor and the axis of
displacements, determining the yield load, and evaluating the
the hinge pin.
stiffness and strength of the spinal implant assembly.
3.2.4 compressive or tensile bending stiffness (N/mm)—the
1.5 Some spinal constructs may not be testable in all test
compressive or tensile bending yield force divided by elastic
configurations.
displacement (see the initial slope of line BC in Fig. 1).
1.6 Values stated in SI units are to be regarded as standard.
3.2.5 compressive or tensile bending ultimate load (N)—the
1.7 This standard does not purport to address all of the
maximum compressive or tensile force in X-Z plane applied to
safety concerns, if any, associated with its use. It is the
a spinal implant assembly (see the force at Point E in Fig. 1).
responsibility of the user of this standard to establish appro-
Theultimateloadshouldbeafunctionofthedeviceandnotof
priate safety and health practices and determine the applica-
the load cell or testing machine.
bility of regulatory limitations prior to use.
3.2.6 compressive or tensile bending yield load (N)—the
2. Referenced Documents compressive or tensile bending force in X-Z plane necessary to
produce a permanent deformation equal to 0.020 times the
2.1 ASTM Standards:
2 activelengthofthelongitudinalelement(seetheforceatPoint
D638 Test Method for Tensile Properties of Plastic
3
Din Fig. 1).
E4 Practices for Force Verification of Testing Machines
3.2.7 coordinate system/axes—three orthogonal axes are
E6 Terminology Relating to Methods of Mechanical Test-
3
defined in Fig. 2 and Fig. 3. The anterior-posterior axis is X
ing
with positive being anterior. The medial-lateral axis is Y with
left being positive when viewed posteriorly. The superior-
1 inferior axis is Z with superior being positive.
These test methods are under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and are the direct responsibility of 3.2.8 displacement at 2 % offset yield (mm)—the displace-
Subcommittee F04.25 on Spinal Devices.
ment of a construct measured via the actuator that produces a
Current edition approved Dec. 10, 2001. Published April 2002. Originally
published as F1717-96. Last previous edition F1717-96.
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Annual Book of ASTM Standards, Vol 08.01.
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Annual Book of ASTM Standards, Vol 03.01. Annual Book of ASTM Standards, Vol 13.01.
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