ASTM F2706-18
(Test Method)Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
SIGNIFICANCE AND USE
5.1 Occipital-cervical and occipital-cervical-thoracic spinal implants are generally composed of several components which, when connected together, form either an occipital-cervical spinal implant assembly or an occipital-cervical-thoracic spinal implant assembly. Occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are designed to provide some stability to the spine during the process of arthrodesis. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies to facilitate comparisons between different designs.
5.2 These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of occipital-cervical and occipital-cervical-thoracic 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 occipital-cervical and occipital-cervical-thoracic spine.
5.3 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.
5.4 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 the 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.
5.5 The location of the longitudinal elements is determined by the intended in vivo location of the ...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of occipital-cervical and occipital-cervical-thoracic spinal implant components can be specific depending on the intended location and intended method of attachment.
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future occipital-cervical and occipital-cervical-thoracic spinal implant assemblies. They allow comparison of occipital-cervical and occipital-cervical-thoracic spinal implant constructs with different 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 two fatigue tests for the comparative evaluation of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are defined.
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of occipital-cervical or occipital-cervical-thoracic spinal implant assemblies.
1.5 It may not be possible to test some occipital-cervical and some occipital-cervical-thoracic spinal constructs 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, health, and environmental practices and determine th...
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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: F2706 − 18
Standard Test Methods for
Occipital-Cervical and Occipital-Cervical-Thoracic Spinal
1
Implant Constructs in a Vertebrectomy Model
This standard is issued under the fixed designation F2706; 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 responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
1.1 These test methods cover the materials and methods for
mine the applicability of regulatory limitations prior to use.
thestaticandfatiguetestingofoccipital-cervicalandoccipital-
1.8 This international standard was developed in accor-
cervical-thoracic spinal implant assemblies in a vertebrectomy
dance with internationally recognized principles on standard-
model. The test materials for most combinations of occipital-
ization established in the Decision on Principles for the
cervical and occipital-cervical-thoracic spinal implant compo-
Development of International Standards, Guides and Recom-
nents can be specific depending on the intended location and
mendations issued by the World Trade Organization Technical
intended method of attachment.
Barriers to Trade (TBT) Committee.
1.2 These test methods are intended to provide a basis for
the mechanical comparison among past, present, and future 2. Referenced Documents
2
occipital-cervical and occipital-cervical-thoracic spinal im-
2.1 ASTM Standards:
plant assemblies. They allow comparison of occipital-cervical
E4Practices for Force Verification of Testing Machines
and occipital-cervical-thoracic spinal implant constructs with
E6Terminology Relating to Methods of Mechanical Testing
different methods of application to the spine. These test
E739PracticeforStatisticalAnalysisofLinearorLinearized
methodsarenotintendedtodefinelevelsofperformance,since
Stress-Life (S-N) and Strain-Life (ε-N) Fatigue Data
sufficient knowledge is not available to predict the conse-
E1823TerminologyRelatingtoFatigueandFractureTesting
quences of the use of a particular device.
F1582Terminology Relating to Spinal Implants
1.3 These test methods set out guidelines for load types and F1717Test Methods for Spinal Implant Constructs in a
methods of applying loads. Methods for three static load types Vertebrectomy Model
and two fatigue tests for the comparative evaluation of F2077Test Methods for Intervertebral Body Fusion Devices
occipital-cervical and occipital-cervical-thoracic spinal im-
3. Terminology
plant assemblies are defined.
3.1 Definitions—For definitions of terms relating to these
1.4 These test methods establish guidelines for measuring
test methods, see Terminologies E6, F1582, and E1823.
displacements, determining the yield load, and evaluating the
stiffnessandstrengthofoccipital-cervicaloroccipital-cervical-
3.2 Definitions of Terms Specific to This Standard:
thoracic spinal implant assemblies. 3.2.1 active length of the longitudinal element, n—the
straight line distance between the centers of rotation of the test
1.5 Itmaynotbepossibletotestsomeoccipital-cervicaland
blocks.
some occipital-cervical-thoracic spinal constructs in all test
configurations. 3.2.2 block moment arm, n—the perpendicular to the ap-
pliedloadbetweentheinsertionpointofananchorandtheaxis
1.6 The values stated in SI units are to be regarded as
of the hinge pin.
standard. No other units of measurement are included in this
3.2.3 compressive or tensile bending stiffness (N/mm),
standard.
n—the compressive or tensile bending yield force divided by
1.7 This standard does not purport to address all of the
elastic displacement (see the initial slope of line BC in Fig. 1).
safety concerns, if any, associated with its use. It is the
3.2.4 compressive or tensile bending ultimate load (N),
n—the maximum compressive or tensile force in the X-Z plane
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
Current edition approved April 1, 2018. Published May 2018. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2008. Last previous edition approved in 2017 as F2706 – 17. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2706-18. the ASTM website.
Copyright © ASTM International, 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: F2706 − 17 F2706 − 18
Standard Test Methods for
Occipital-Cervical and Occipital-Cervical-Thoracic Spinal
1
Implant Constructs in a Vertebrectomy Model
This standard is issued under the fixed designation F2706; 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 cover the materials and methods for the static and fatigue testing of occipital-cervical and
occipital-cervical-thoracic spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of
occipital-cervical and occipital-cervical-thoracic spinal implant components can be specific depending on the intended location and
intended method of attachment.
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future
occipital-cervical and occipital-cervical-thoracic spinal implant assemblies. They allow comparison of occipital-cervical and
occipital-cervical-thoracic spinal implant constructs with different 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
two fatigue tests for the comparative evaluation of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are
defined.
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness
and strength of occipital-cervical or occipital-cervical-thoracic spinal implant assemblies.
1.5 It may not be possible to test some occipital-cervical and some occipital-cervical-thoracic spinal constructs 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.8 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
E739 Practice for Statistical Analysis of Linear or Linearized Stress-Life (S-N) and Strain-Life (ε-N) Fatigue Data
E1823 Terminology Relating to Fatigue and Fracture Testing
F1582 Terminology Relating to Spinal Implants
F1717 Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
F2077 Test Methods for Intervertebral Body Fusion Devices
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 Subcommittee
F04.25 on Spinal Devices.
Current edition approved March 1, 2017April 1, 2018. Published April 2017May 2018. Originally approved in 2008. Last previous edition approved in 20142017 as F2706
– 08 (2014). 17. DOI: 10.1520/F2706-17.10.1520/F2706-18.
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
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F2706 − 18
3. Terminology
3.1 Definitions—For definitions of terms relating to these test methods, see Terminologies E6, F1582, and E1823.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 active length of the longitudinal element, n—the straight line distance between the centers of rotation of the test blocks.
3.2.2 block moment arm, n—the perpen
...
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