ASTM F3292-19
(Practice)Standard Practice for Inspection of Spinal Implants Undergoing Testing
Standard Practice for Inspection of Spinal Implants Undergoing Testing
SIGNIFICANCE AND USE
5.1 ASTM standards under the jurisdiction of Subcommittee F04.25 (such as, Test Methods F1717, F1798, F2077, F2267, F2346, F2624, and F2706, Specifications and Test Methods F2193, Guides F2423 and F2789, Practices F2694 and F2790) describe test methods and prescribe guidelines for evaluating different types of spinal implants (as defined in Terminology F1582). Adherence to many of these standards may result in mechanical failure. In some cases, however, the failure may not be obvious. Because none of these standards discuss, describe, or provide methods for inspecting the devices for failure, this practice provides guidelines for inspection such that the end user can effectively identify and characterize physical changes in test parts.
5.2 The reporting of a mechanical failure and/or changes in device characteristics is one source of error in precision and bias. Varying levels and types of characterization have the potential to affect data reporting. This practice may reduce bias by providing guidance that can aid in effectively analyzing changes in test parts.
5.3 Non-destructive evaluation allows continued testing of a specimen if performed mid-test and preserves the specimen for post-test examination. Examination may also be limited to non-destructive evaluation in a limited permission environment.
SCOPE
1.1 This practice provides guidance for non-destructive photographic analysis of spinal implants prior to, during, and after testing. The purpose of this practice is to provide methods for documenting notable changes in implant characteristics (e.g., surface defects, cracks, plastic deformation) that have occurred during the course of a mechanical test. Documenting these changes may assist in understanding if mechanical failure has occurred, and how.
1.2 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.
1.3 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
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: F3292 − 19
Standard Practice for
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Inspection of Spinal Implants Undergoing Testing
This standard is issued under the fixed designation F3292; 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 F2346Test Methods for Static and Dynamic Characteriza-
tion of Spinal Artificial Discs
1.1 This practice provides guidance for non-destructive
F2423Guide for Functional, Kinematic, and Wear Assess-
photographic analysis of spinal implants prior to, during, and
ment of Total Disc Prostheses
aftertesting.Thepurposeofthispracticeistoprovidemethods
F2624Test Method for Static, Dynamic, and Wear Assess-
for documenting notable changes in implant characteristics
ment of Extra-Discal Single Level Spinal Constructs
(e.g., surface defects, cracks, plastic deformation) that have
F2694Practice for Functional and Wear Evaluation of
occurred during the course of a mechanical test. Documenting
Motion-Preserving Lumbar Total Facet Prostheses
thesechangesmayassistinunderstandingifmechanicalfailure
F2706Test Methods for Occipital-Cervical and Occipital-
has occurred, and how.
Cervical-Thoracic Spinal Implant Constructs in a Verte-
1.2 This standard does not purport to address all of the
brectomy Model
safety concerns, if any, associated with its use. It is the
F2789Guide for Mechanical and Functional Characteriza-
responsibility of the user of this standard to establish appro-
tion of Nucleus Devices
priate safety, health, and environmental practices and deter-
F2790Practice for Static and Dynamic Characterization of
mine the applicability of regulatory limitations prior to use.
Motion Preserving Lumbar Total Facet Prostheses
1.3 This international standard was developed in accor-
dance with internationally recognized principles on standard-
3. Terminology
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
3.1 Definitions of Terms Specific to This Standard:
mendations issued by the World Trade Organization Technical
3.1.1 areas of interest, n—regions of the implant identified
Barriers to Trade (TBT) Committee.
by the user to be inspected. Note that all areas may not be
easilyvisualizedbythenakedeye(e.g.,matingsurfaces,holes,
2. Referenced Documents
internal components).
2
2.1 ASTM Standards:
3.1.2 failure mode, n—how the test specimen physically
F1582Terminology Relating to Spinal Implants
failed, (e.g., fracture, plastic deformation, wear).
F1717Test Methods for Spinal Implant Constructs in a
Vertebrectomy Model
3.1.3 feature, n—a specific part of a test specimen, such as
F1798Test Method for Evaluating the Static and Fatigue
a crack, bend, scratch, vacancy, bulge, etc.
PropertiesofInterconnectionMechanismsandSubassem-
3.1.4 mechanical failure, n—the onset of a material defect,
blies Used in Spinal Arthrodesis Implants
initiation of a fatigue crack, or failure to maintain construct
F2077TestMethodsForIntervertebralBodyFusionDevices
integrity (e.g., polyaxial screw slippage).
F2193Specifications and Test Methods for Components
Used in the Surgical Fixation of the Spinal Skeletal
3.1.5 test specimen, n—an individual spinal implant or a
System
collection of parts that have been or are intended to be used or
F2267TestMethodforMeasuringLoadInducedSubsidence
tested together as an assembled spinal implant construct.
of Intervertebral Body Fusion Device Under Static Axial
Compression
4. Summary of Practice
4.1 This practice provides guidance for evaluating and
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ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical
documenting physical changes in spinal devices tested accord-
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee
ing to other ASTM standards under the jurisdiction of Sub-
F04.25 on Spinal Devices.
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committee F04.25.
Current edition approved March 1, 2019. Published April 2019. DOI: 10.1520/
F3292-19.
2 4.2 This practice does not determine if a failure has oc-
The boldface numbers in parentheses refer to a list of references at the end of
this standard. curred.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F3292 − 19
5. Significance and Use 7.1.3 The investigator may introduce fixtures in order to
alter the orientation of the constructs to optimize visualization.
5.1 ASTM standards under the jurisdiction of Subcommit-
The fixtures shoul
...
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