ASTM F3292-19

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
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).
2.1 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
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.
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
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 should not be used in such a way that would
tee F04.25 (such as, Test Methods F1717, F1798, F2077,
initiate or cause additional plastic deformation (for example,
F2267, F2346, F2624, and F2706, Specifications and Test
clamping).
Methods F2193, Guides F2423 and F2789, Practices F2694
and F2790) describe test methods and prescribe guidelines for 7.2 Pre-test Inspection:
evaluating different types of spinal implants (as defined in
7.2.1 Iftheimplantsarepackagedandlabeled“ForClinical
Terminology F1582). Adherence to many of these standards
Use,” then Section is optional.
may result in mechanical failure. In some cases, however, the
NOTE 1—The rationale for not including further pre-test inspection for
failure may not be obvious. Because none of these standards
these implants is due to the prior final inspection as part of the
discuss, describe, or provide methods for inspecting the de-
manufacturing process.
vices for failure, this practice provides guidelines for inspec-
7.2.2 Inspect each test specimen according to . Note any
tion such that the end user can effectively identify and
plastic deformations, machine/surface markings, or any addi-
characterize physical changes in test parts.
tional anomalies that are of interest prior to testing.
5.2 The reporting of a mechanical failure and/or changes in
7.2.3 At a minimum, a pre-test specimen image shall be
device characteristics is one source of error in precision and
taken using a digital camera or a digital camera mounted on a
bias. Varying levels and types of characterization have the
stereomicroscope, or equivalent, to capture the overall condi-
potentialtoaffectdatareporting.Thispracticemayreducebias
tion of each test specimen or representative specimen prior to
by providing guidance that can aid in effectively analyzing
testing.
changes in test parts.
7.2.4 Capture additional images of areas of interest for
documentation.
5.3 Non-destructiveevaluationallowscontinuedtestingofa
specimenifperformedmid-testandpreservesthespecimenfor
NOTE 2—Since this is a pre-inspection image capture, the user should
post-test examination. Examination may also be limited to
captureimagesthatrepresentthepre-testdispositionofthetestspecimen,
non-destructive evaluation in a limited permission environ- with particular attention to areas of predicted or probable failure.
ment.
7.3 During Testing:
7.3.1 Whileitisnotrecommendedtoremovetestspecimens
6. Apparatus
during testing (unless specifically directed to do so under the
test methods section for the particular standard), the investiga-
6.1 For visual inspection, equipment must be able to pro-
tors should make an effort to identify any abnormalities that
vide the right kind and amount of lighting, and an image size
may be present during testing, for example, debris, screw
with sufficient pixel density (magnification).
rotation, screw pull-out, crack initiations, fractures. To the
6.2 Equipment:
degree possible, inspect and document the test specimen
6.2.1 Appropriate Lighting.
according to 7.1.
6.2.2 Non-marring Forceps (or Similar Instrument), for
handling test specimens. NOTE3—Dependingonthetestsetupandfixturesemployed,obtaining
10× magnification may not be possible.
6.2.3 Stereomicroscope.
7.3.2 In the event that the investigator notes any abnormali-
6.3 Image Acquisition:
tiespriortoremovingthetestspecimenfromthetestframe,an
6.3.1 Digital Camera and/or Digital Microscope.
image using a digital camera will be taken i
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