ASTM F3631-24

Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices

SIGNIFICANCE AND USE
5.1 IBFDs can be single-piece or multicomponent designs and can be porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment.  
5.2 Intra-operative IBFD assembly failures can result in significant clinical consequences.4 This test method outlines materials and methods for the comparative characterization and evaluation of the intra-operative impact performance of IBFD assemblies.  
5.3 The impact forces applied during a surgical procedure may be highly variable 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 IBFD assemblies. The tests may also identify the weakest, most likely to fail points in particular IBFD-inserter combinations, thus enabling design improvements.  
5.4 Intra-operative clinical failures may be due to several factors, some of which may not be simulated in the current method. For example, off-axis impact loads applied to the IBFD assembly are not simulated in the current method yet may contribute to intra-operative clinical failures in some designs. The user of this standard should consider incorporating such factors into their evaluations.
SCOPE
1.1 This test method covers the materials and methods for impact testing of lumbar intervertebral body fusion devices (IBFD).  
1.2 This test method is intended to provide a basis for the mechanical comparison among nonbiologic IBFD assemblies (the IBFD and associated inserter tool). This test method is intended to enable the user to compare these IBFD assemblies under impact loads to simulate the intra-operative surgical technique used to insert the IBFD.  
1.3 The test method describes the impact test by specifying impact energies and specific methods for applying these energies. The tests are designed to allow for the comparative evaluation of IBFD assemblies.  
1.4 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.  
1.5 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.  
1.6 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.

General Information

• Status: Published
• Publication Date: 14-Mar-2024
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.25 - Spinal Devices

Standards Content (Sample)

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: F3631 − 24
Standard Test Method for
Assessment of Intra-operative Durability of Intervertebral
1
Body Fusion Devices
This standard is issued under the fixed designation F3631; 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 E4 Practices for Force Calibration and Verification of Test-
ing Machines
1.1 This test method covers the materials and methods for
E177 Practice for Use of the Terms Precision and Bias in
impact testing of lumbar intervertebral body fusion devices
ASTM Test Methods
(IBFD).
E691 Practice for Conducting an Interlaboratory Study to
1.2 This test method is intended to provide a basis for the
Determine the Precision of a Test Method
mechanical comparison among nonbiologic IBFD assemblies
F1582 Terminology Relating to Spinal Implants
(the IBFD and associated inserter tool). This test method is
F1839 Specification for Rigid Polyurethane Foam for Use as
intended to enable the user to compare these IBFD assemblies
a Standard Material for Testing Orthopaedic Devices and
under impact loads to simulate the intra-operative surgical
Instruments
technique used to insert the IBFD.
F2077 Test Methods for Intervertebral Body Fusion Devices
1.3 The test method describes the impact test by specifying
F2267 Test Method for Measuring Load-Induced Subsid-
impact energies and specific methods for applying these
ence of Intervertebral Body Fusion Device Under Static
energies. The tests are designed to allow for the comparative
Axial Compression
evaluation of IBFD assemblies.
F3292 Practice for Inspection of Spinal Implants Undergo-
ing Testing
1.4 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
3. Terminology
standard, with the exception of angular measurements, which
may be reported in terms of either degrees or radians.
3.1 For definitions of terms, refer to terminology in Prac-
1.5 This standard does not purport to address all of the
tices E4, Terminology F1582, Specification F1839, and Prac-
safety concerns, if any, associated with its use. It is the
tice F3292.
responsibility of the user of this standard to establish appro-
3.2 Definitions of Terms Specific to This Standard:
priate safety, health, and environmental practices and deter-
3.2.1 coordinate system/axes, n—for the Insertion Between
mine the applicability of regulatory limitations prior to use.
Foam Blocks method (Annex A1), the center of the coordinate
1.6 This international standard was developed in accor-
system is located at the geometric center of the foam block
dance with internationally recognized principles on standard-
assembly. The XY plane is to bisect the sagittal plane angle
ization established in the Decision on Principles for the
across the foam blocks that are intended to simulate the
Development of International Standards, Guides and Recom-
adjacent vertebral end plates. The positive Z-axis is to be
mendations issued by the World Trade Organization Technical
directed superiorly and should be collinear with the long axis
Barriers to Trade (TBT) Committee.
of the inserter instrument and the guide rod. The compressive
intraspinal force is defined to be the component in the positive
2. Referenced Documents
X direction. Impact force is defined to be the force along the
2
2.1 ASTM Standards:
negative Z-axis, Fig. 1(a). For the Static Rigid Block method
(Annex A2), the XY plane is coplanar with the bottom surface
1 of the pocket that mates with the tip of the IBFD. The positive
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 Z-axis is to be directed superiorly and should be collinear with
F04.25 on Spinal Devices.
the long axis of the inserter instrument and the guide rod, Fig.
Current edition approved March 15, 2024. Published April 2024. DOI: 10.1520/
1(b).
F3631-24.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
3.2.2 crack, n—an externally visible physical discontinuity
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
in the form of a narrow opening that arises from mechanical
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. impact forces.
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