ASTM F2077-18

Test Methods For Intervertebral Body Fusion Devices

SIGNIFICANCE AND USE
5.1 Intervertebral body fusion device assemblies are generally simple geometric-shaped devices which are often porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment. This test method outlines materials and methods for the characterization and evaluation of the mechanical performance of different intervertebral body fusion device assemblies so that comparisons can be made between different designs.  
5.2 This test method is designed to quantify the static and dynamic characteristics of different designs of intervertebral body fusion device assemblies. These tests are conducted in vitro to allow for analysis and comparison of the mechanical performance of intervertebral body fusion device assemblies to specific force modalities.  
5.3 The forces applied to the intervertebral body fusion assemblies 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 intervertebral body fusion device assemblies.  
5.4 Since the environment may affect the dynamic performance of intervertebral body fusion device assemblies, dynamic testing in a saline environment may be considered. Fatigue tests should first be conducted in air (at ambient temperature) for comparison purposes since the environmental effects could be significant. If a simulated in vivo environment is desired, the investigator should consider testing in a saline environmental bath at 37°C (for example, 0.9-g NaCl per 100-mL water) at a rate of 1 Hz or less. A simulated body fluid, a saline drip or mist, distilled water, or other type of lubrication at 37°C could also be used with adequate justification.  
5.5 If the devices are known to be temperature and environment dependent, testing should be conducted in physiologic solution as described in 5.4. Devices that require p...
SCOPE
1.1 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment.  
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies.  
1.3 The test method describes static and dynamic tests by specifying force types and specific methods of applying these forces. These tests are designed to allow for the comparative evaluation of intervertebral body fusion device assemblies.  
1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.  
1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).  
1.6 Guidelines are established for measuring displacements, determining the yield force or moment, evaluating the stiffness, and strength of the intervertebral body fusion device assemblies.  
1.7 Some intervertebral body fusion device assemblies may not be testable in all test configurations.  
1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, with the exception of angular measurements, which may be reported in terms of either degrees or radians.  
1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the...

General Information

• Status: Historical
• Publication Date: 31-May-2018
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.25 - Spinal Devices

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2077 − 18
Test Methods For
1
Intervertebral Body Fusion Devices
This standard is issued under the fixed designation F2077; 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 1.9 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This test method covers the materials and methods for
responsibility of the user of this standard to establish appro-
the static and dynamic testing of intervertebral body fusion
priate safety, health, and environmental practices and deter-
deviceassemblies,spinalimplantsdesignedtopromotearthro-
mine the applicability of regulatory limitations prior to use.
desis at a given spinal motion segment.
1.10 This international standard was developed in accor-
1.2 This test method is intended to provide a basis for the
dance with internationally recognized principles on standard-
mechanical comparison among past, present, and future non-
ization established in the Decision on Principles for the
biologicintervertebralbodyfusiondeviceassemblies.Thistest
Development of International Standards, Guides and Recom-
methodallowscomparisonofintervertebralbodyfusiondevice
mendations issued by the World Trade Organization Technical
assemblies with different intended spinal locations and meth-
Barriers to Trade (TBT) Committee.
ods of application to the intradiscal spaces.This test method is
intended to enable the user to compare intervertebral body
2. Referenced Documents
fusion device assemblies mechanically and does not purport to
2
2.1 ASTM Standards:
provide performance standards for intervertebral body fusion
E4Practices for Force Verification of Testing Machines
device assemblies.
E6Terminology Relating to Methods of MechanicalTesting
1.3 The test method describes static and dynamic tests by
E177Practice for Use of the Terms Precision and Bias in
specifying force types and specific methods of applying these
ASTM Test Methods
forces. These tests are designed to allow for the comparative
E691Practice for Conducting an Interlaboratory Study to
evaluation of intervertebral body fusion device assemblies.
Determine the Precision of a Test Method
E1823TerminologyRelatingtoFatigueandFractureTesting
1.4 These tests are designed to characterize the structural
E2309Practices forVerification of Displacement Measuring
integrity of the device and are not intended to test the
Systems and Devices Used in Material Testing Machines
bone-implant interface.
F1582Terminology Relating to Spinal Implants
1.5 This test method does not address expulsion testing of
intervertebral body fusion device assemblies (see 1.4).
3. Terminology
1.6 Guidelinesareestablishedformeasuringdisplacements,
3.1 For definition of terms refer toTerminology E6, E1823,
determiningtheyieldforceormoment,evaluatingthestiffness,
and F1582.
and strength of the intervertebral body fusion device assem-
3.2 Definitions of Terms Specific to This Standard:
blies.
3.2.1 coordinate system/axes, n—Three orthogonal axes are
1.7 Some intervertebral body fusion device assemblies may
defined by Terminology F1582. The center of the coordinate
not be testable in all test configurations.
system is located at the geometric center of the intervertebral
body fusion device assembly. The XY plane is to bisect the
1.8 The values stated in SI units are to be regarded as
sagittal plane angle between superior and inferior lines (sur-
standard. No other units of measurement are included in this
faces) that are intended to simulate the adjacent vertebral end
standard, with the exception of angular measurements, which
plates. The positive Z axis is to be directed superiorly. Force
may be reported in terms of either degrees or radians.
components parallel to the XY plane are shear components of
loading. The compressive axial force is defined to be the
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee
2
F04.25 . 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 [e-mail]. For Annual Book of ASTM
published in 2000. Last previous edition approved in 2017 as F2077–17. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2077-18. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2077 − 18
component
...

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: F2077 − 17 F2077 − 18
Test Methods forFor
1
Intervertebral Body Fusion Devices
This standard is issued under the fixed designation F2077; 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 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device
assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment.
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic
intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies
with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable
the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance
standards for intervertebral body fusion device assemblies.
1.3 The test method describes static and dynamic tests by specifying force types and specific methods of applying these forces.
These tests are designed to allow for the comparative evaluation of intervertebral body fusion device assemblies.
1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant
interface.
1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).
1.6 Guidelines are established for measuring displacements, determining the yield force or moment, evaluating the stiffness, and
strength of the intervertebral body fusion device assemblies.
1.7 Some intervertebral body fusion device assemblies may not be testable in all test configurations.
1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard,
with the exception of angular measurements, which may be reported in terms of either degrees or radians.
1.9 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 the applicability of
regulatory limitations prior to use.
1.10 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
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
E1823 Terminology Relating to Fatigue and Fracture Testing
E2309 Practices for Verification of Displacement Measuring Systems and Devices Used in Material Testing Machines
F1582 Terminology Relating to Spinal Implants
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.25 .
Current edition approved Oct. 1, 2017June 1, 2018. Published October 2017August 2018. Originally published in 2000. Last previous edition approved in 20142017 as
F2077 – 14F2077 – 17. DOI: 10.1520/F2077-17.10.1520/F2077-18.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. 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 ----------------------
F2077 − 18
3. Terminology
3.1 For definition of terms refer to Terminology E6, E1823, and F1582.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 coordinate system/axes, n—Three orthogonal axes are defined by Terminology F1582. The center of the coordinate system
is located at the geomet
...