ASTM F3574-22
(Test Method)Standard Test Methods for Sacroiliac Joint Fusion Devices
Standard Test Methods for Sacroiliac Joint Fusion Devices
SIGNIFICANCE AND USE
4.1 The function of the SIJ fusion device assembly is to stabilize the SIJ 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 SIJ fusion device assemblies so that comparisons can be made between different designs.
4.2 These test methods are designed to quantify the static and dynamic characteristics of different designs of SIJ fusion device assemblies. These tests are conducted in vitro to allow for analysis and comparison of the mechanical performance of SIJ fusion device assemblies to specific force modalities.
4.3 The forces applied to the SIJ fusion device assemblies during the tests described herein 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 SIJ fusion device assemblies.
4.4 Since the environment may affect the dynamic performance of SIJ fusion device assemblies, dynamic testing in a saline environment may be considered for implants with wearing surfaces or with movable components or for implants with components that are temperature dependent. 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 necessary, the investigator should consider testing in a saline environmental bath at 37 °C (for example, 0.9 g NaCl per 100 mL water). 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.
4.5 If the devices are known to be temperature and environment dependent, testing should be conducted in physiologic solution as described in 4.4. Devices that require physiologic solution for testing should be tested in the same type of soluti...
SCOPE
1.1 These test methods cover the materials and methods for the static and dynamic testing of sacroiliac joint (SIJ) fusion device assemblies, SIJ implants designed to promote arthrodesis at the sacroiliac joint.
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic SIJ fusion device assemblies. These test methods allow for comparison of SIJ fusion device assemblies intended to be implanted with a trajectory in line with the joint space (in-line implant) or for comparison of SIJ fusion devices intended for implantation across the joint space (transverse implant). These test methods are intended enable the user to compare SIJ fusion device assemblies mechanically and do not purport to provide performance standards for SIJ fusion device assemblies.
1.3 These tests describe 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 SIJ device assemblies.
1.4 Guidelines are established for measuring displacements, determining the yield force or moment, and evaluating the stiffness and strength of the SIJ fusion device assemblies.
1.5 Some SIJ fusion device assemblies may not be testable in all test configurations.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurements are included in this standard, with the exception of angular measurements, which may be reported in terms of either degrees or radians.
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 the applicability of regulatory limitations prior to use.
1.8 This international standard was developed in accordance with internationally recogniz...
General Information
Relations
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: F3574 − 22
Standard Test Methods for
1
Sacroiliac Joint Fusion Devices
This standard is issued under the fixed designation F3574; 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 ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 These test methods cover the materials and methods for
mendations issued by the World Trade Organization Technical
the static and dynamic testing of sacroiliac joint (SIJ) fusion
Barriers to Trade (TBT) Committee.
device assemblies, SIJ implants designed to promote arthrod-
esis at the sacroiliac joint.
2. Referenced Documents
1.2 These test methods are intended to provide a basis for
2
2.1 ASTM Standards:
the mechanical comparison among past, present, and future
E4Practices for Force Calibration and Verification of Test-
nonbiologic SIJ fusion device assemblies. These test methods
ing Machines
allow for comparison of SIJ fusion device assemblies intended
E6Terminology Relating to Methods of Mechanical Testing
to be implanted with a trajectory in line with the joint space
E691Practice for Conducting an Interlaboratory Study to
(in-line implant) or for comparison of SIJ fusion devices
Determine the Precision of a Test Method
intended for implantation across the joint space (transverse
E1823TerminologyRelatingtoFatigueandFractureTesting
implant). These test methods are intended enable the user to
E2309/E2309MPractices for Verification of Displacement
compareSIJfusiondeviceassembliesmechanicallyanddonot
Measuring Systems and Devices Used in MaterialTesting
purporttoprovideperformancestandardsforSIJfusiondevice
Machines
assemblies.
F543Specification and Test Methods for Metallic Medical
1.3 These tests describe static and dynamic tests by speci-
Bone Screws
fying force types and specific methods of applying these
F1582Terminology Relating to Spinal Implants
forces. These tests are designed to allow for the comparative
F1839SpecificationforRigidPolyurethaneFoamforUseas
evaluation of SIJ device assemblies.
a Standard Material for Testing Orthopaedic Devices and
Instruments
1.4 Guidelinesareestablishedformeasuringdisplacements,
F2077TestMethodsForIntervertebralBodyFusionDevices
determining the yield force or moment, and evaluating the
F2193Specifications and Test Methods for Components
stiffness and strength of the SIJ fusion device assemblies.
Used in the Surgical Fixation of the Spinal Skeletal
1.5 Some SIJ fusion device assemblies may not be testable
System
in all test configurations.
1.6 The values stated in SI units are to be regarded as 3. Terminology
standard. No other units of measurements are included in this
3.1 For definitions of terms, refer to Terminologies E6,
standard, with the exception of angular measurements, which
E1823, and F1582, and the Terminology section in Specifica-
may be reported in terms of either degrees or radians.
tions F543 and F2193.
1.7 This standard does not purport to address all of the
3.2 Definitions of Terms Specific to This Standard:
safety concerns, if any, associated with its use. It is the
3.2.1 axial pullout strength, n—the maximum tensile force
responsibility of the user of this standard to establish appro-
perAnnexA2requiredtofailorremoveatransversesacroiliac
priate safety, health, and environmental practices and deter-
joint fusion implant from a material into which the device has
mine the applicability of regulatory limitations prior to use.
been inserted.
1.8 This international standard was developed in accor-
3.2.2 bending fatigue runout moment (N-m), n—valueofthe
dance with internationally recognized principles on standard-
maximum moment under dynamic cantilever bending per
1
These test methods are under the jurisdiction of ASTM Committee F04 on
2
Medical and Surgical Materials and Devices and are the direct responsibility of For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Subcommittee F04.25 on Spinal Devices. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved June 1, 2022. Published June 2022. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F3574-22. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F3574 − 22
Annex A2 that can be applied t
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.