ASTM F1717-96

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

• Replaced By: ASTM F1717-01 - Standard Test Methods for 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
• 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 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

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1717 – 96
Standard Test Methods for
Static and Fatigue for Spinal Implant Constructs in a
1
Corpectomy Model
This standard is issued under the fixed designation F 1717; 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 (e) indicates an editorial change since the last revision or reapproval.
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1. Scope ized Stress-Life (S-N) and Strain-Life (e-N) Fatigue Data
3
E 1150 Definitions of Terms Relating to Fatigue
1.1 This standard covers the materials and methods for the
4
F 1582 Terminology Relating to Spinal Implants
static and fatigue testing of spinal implant assemblies in a
corpectomy model. The test materials for most combinations of
3. Terminology
spinal implant components can be specific depending on the
3.1 Definitions:
intended spinal location and intended method of application to
3.1.1 For definitions of terms relating to the test method, see
the spine.
Terminology E 6, Terminology F 1582 and Definitions E 1150.
1.2 This standard is intended to provide a basis for the
3.2 Definitions of Terms Specific to This Standard:
mechanical comparison among past, present and future spinal
3.2.1 active length of the longitudinal element—the straight
implant assemblies. It allows comparison of spinal implant
line distance between the center of attachment of the superior
constructs with different intended spinal locations and methods
anchor and the center of attachment of the inferior anchor.
of application to the spine. These test methods are not intended
3.2.2 angular displacement at 2 % offset yield (degrees)—
to define levels of performance, since sufficient knowledge is
the angular displacement of a construct measured via the
not available to predict the consequences of the use of a
actuator that produces a permanent angular displacement in the
particular device.
X-Y plane equal to 0.020 times the torsional aspect ratio (see
1.3 The standard sets out guidelines for load types and
Point A in Fig. 1).
methods of applying loads. Methods for three static load types
3.2.3 block moment arm—the perpendicular to the applied
and one fatigue test are defined for the comparative evaluation
load between the insertion point of an anchor and the axis of
of spinal implant assemblies.
the hidge pin.
1.4 This standard establishes guidelines for measuring dis-
3.2.4 compressive or tensile bending stiffness (N/mm)—the
placements, determining the yield load, evaluating the stiffness
compressive or tensile bending yield force divided by elastic
and strength of the spinal implant assembly.
displacement (see the initial slope of line BC in Fig. 1).
1.5 Some spinal constructs may not be testable in all test
3.2.5 compressive or tensile bending ultimate load (N)—the
configurations.
maximum compressive or tensile force in X-Z plane applied to
1.6 Values stated in SI units are to be regarded as standard.
a spinal implant assembly (see the force at Point E in Fig. 1).
1.7 This standard does not purport to address all of the
The ultimate load should be a function of the device and not of
safety concerns, if any, associated with its use. It is the
the load cell or testing machine.
responsibility of the user of this standard to establish appro-
3.2.6 compressive or tensile bending yield load (N)—the
priate safety and health practices and determine the applica-
compressive or tensile bending force in X-Z plane necessary to
bility of regulatory limitations prior to use.
produce a permanent deformation equal to 0.020 times the
2. Referenced Documents active length of the longitudinal element (see the force at Point
D in Fig. 1).
2.1 ASTM Standards:
2
3.2.7 coordinate system/axes—three orthogonal axes are
D 638 Test Method for Tensile Properties of Plastic
3 defined in Fig. 2 and Fig. 3. The anterior-posterior axis is X
E 4 Practices for Force Verification of Testing Machines
with positive being anterior. The medial-lateral axis is Y with
E 6 Terminology Relating to Methods of Mechanical Test-
3 left being positive when viewed posteriorly. The superior-
ing
inferior axis is Z with superior being positive.
E 739 Practice for Statistical Analysis of Linear or Linear-
3.2.8 displacement at 2 % offset yield (mm)—the displace-
ment of a construct measured via the actuator that produces a
1
These test methods are under the jurisdiction of ASTM Committee F-4 on
permanent deformation equal to 0.020 times the active length
Medical and Surgical Materials and Devices and are the direct responsibility of
of the longitudinal element (see Point A in Fig. 1).
Subcommittee F04.25on Spinal Devices.
Current edition approved June 10, 1996. Published December 1996.
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Annual Book of ASTM Standards, Vol 08.01.
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Annual Boo
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