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Designation F3292 − 19Standard Practice forInspection of Spinal Implants Undergoing Testing1This standard is issued under the fixed designation F3292; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon ´ indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice provides guidance for non-destructivephotographic analysis of spinal implants prior to, during, andafter testing. The purpose of this practice is to provide methodsfor documenting notable changes in implant characteristicse.g., surface defects, cracks, plastic deformation that haveoccurred during the course of a mechanical test. Documentingthese changes may assist in understanding if mechanical failurehas occurred, and how.1.2 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.3 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade TBT Committee.2. Referenced Documents2.1 ASTM Standards2F1582 Terminology Relating to Spinal ImplantsF1717 Test Methods for Spinal Implant Constructs in aVertebrectomy ModelF1798 Test Method for Evaluating the Static and FatigueProperties of Interconnection Mechanisms and Subassem-blies Used in Spinal Arthrodesis ImplantsF2077 Test Methods For Intervertebral Body Fusion DevicesF2193 Specifications and Test Methods for ComponentsUsed in the Surgical Fixation of the Spinal SkeletalSystemF2267 Test Method for Measuring Load Induced Subsidenceof Intervertebral Body Fusion Device Under Static AxialCompressionF2346 Test Methods for Static and Dynamic Characteriza-tion of Spinal Artificial DiscsF2423 Guide for Functional, Kinematic, and Wear Assess-ment of Total Disc ProsthesesF2624 Test Method for Static, Dynamic, and Wear Assess-ment of Extra-Discal Single Level Spinal ConstructsF2694 Practice for Functional and Wear Evaluation ofMotion-Preserving Lumbar Total Facet ProsthesesF2706 Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Verte-brectomy ModelF2789 Guide for Mechanical and Functional Characteriza-tion of Nucleus DevicesF2790 Practice for Static and Dynamic Characterization ofMotion Preserving Lumbar Total Facet Prostheses3. Terminology3.1 Definitions of Terms Specific to This Standard3.1.1 areas of interest, nregions of the implant identifiedby the user to be inspected. Note that all areas may not beeasily visualized by the naked eye e.g., mating surfaces, holes,internal components.3.1.2 failure mode, nhow the test specimen physicallyfailed, e.g., fracture, plastic deformation, wear.3.1.3 feature, na specific part of a test specimen, such asa crack, bend, scratch, vacancy, bulge, etc.3.1.4 mechanical failure, nthe onset of a material defect,initiation of a fatigue crack, or failure to maintain constructintegrity e.g., polyaxial screw slippage.3.1.5 test specimen, nan individual spinal implant or acollection of parts that have been or are intended to be used ortested together as an assembled spinal implant construct.4. Summary of Practice4.1 This practice provides guidance for evaluating anddocumenting physical changes in spinal devices tested accord-ing to other ASTM standards under the jurisdiction of Sub-committee F04.25.14.2 This practice does not determine if a failure has oc-curred.1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.25 on Spinal Devices.Current edition approved March 1, 2019. Published April 2019. DOI 10.1520/F3292-19.2The boldface numbers in parentheses refer to a list of references at the end ofthis standard.Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade TBT Committee.15. Significance and Use5.1 ASTM standards under the jurisdiction of Subcommit-tee F04.25 such as, Test Methods F1717, F1798, F2077,F2267, F2346, F2624, and F2706, Specifications and TestMethods F2193, Guides F2423 and F2789, Practices F2694and F2790 describe test methods and prescribe guidelines forevaluating different types of spinal implants as defined inTerminology F1582. Adherence to many of these standardsmay result in mechanical failure. In some cases, however, thefailure may not be obvious. Because none of these standardsdiscuss, describe, or provide methods for inspecting the de-vices for failure, this practice provides guidelines for inspec-tion such that the end user can effectively identify andcharacterize physical changes in test parts.5.2 The reporting of a mechanical failure and/or changes indevice characteristics is one source of error in precision andbias. Varying levels and types of characterization have thepotential to affect data reporting. This practice may reduce biasby providing guidance that can aid in effectively analyzingchanges in test parts.5.3 Non-destructive evaluation allows continued testing of aspecimen if performed mid-test and preserves the specimen forpost-test examination. Examination may also be limited tonon-destructive evaluation in a limited permission environ-ment.6. Apparatus6.1 For visual inspection, equipment must be able to pro-vide the right kind and amount of lighting, and an image sizewith sufficient pixel density magnification.6.2 Equipment6.2.1 Appropriate Lighting.6.2.2 Non-marring Forceps or Similar Instrument, forhandling test specimens.6.2.3 Stereomicroscope.6.3 Image Acquisition6.3.1 Digital Camera and/or Digital Microscope.7. Procedure7.1 General7.1.1 Inspect/examine each test specimen using a stereomi-croscope with a minimum of 10 magnification to explore anyareas of interest. Note that by use of the terms “inspect” and/or”examine,” the standard dictates a practice of surveying theentire test specimen before any images are captured. If a failurecan be seen at 10, then an appropriate magnification shall beused to capture/photograph/document the defect. Whileinspection/examination occurs at 10, the user of this practicemust determine the appropriate magnification to adequatelyand clearly capture/photograph/document any areas of interest.For example, 2.5 magnification may be adequate for docu-menting a gross failure, while 10 magnification may berequired for documenting a fatigue crack.7.1.2 All photographic records of test specimens must haveeither a scale contained in the image, or a fixture, entirecomponent, or similar reference of known size.7.1.3 The investigator may introduce fixtures in order toalter the orientation of the constructs to optimize visualization.The fixtures should not be used in such a way that wouldinitiate or cause additional plastic deformation for example,clamping.7.2 Pre-test Inspection7.2.1 If the implants are packaged and labeled “For ClinicalUse,” then Section is optional.NOTE 1The rationale for not including further pre-test inspection forthese implants is due to the prior final inspection as part of themanufacturing process.7.2.2 Inspect each test specimen according to . Note anyplastic deformations, machine/surface markings, or any addi-tional anomalies that are of interest prior to testing.7.2.3 At a minimum, a pre-test specimen image shall betaken using a digital camera or a digital camera mounted on astereomicroscope, or equivalent, to capture the overall condi-tion of each test specimen or representative specimen prior totesting.7.2.4 Capture additional images of areas of interest fordocumentation.NOTE 2Since this is a pre-inspection image capture, the user shouldcapture images that represent the pre-test disposition of the test specimen,with particular attention to areas of predicted or probable failure.7.3 During Testing7.3.1 While it is not recommended to remove test specimensduring testing unless specifically directed to do so under thetest methods section for the particular standard, the investiga-tors should make an effort to identify any abnormalities thatmay be present during testing, for example, debris, screwrotation, screw pull-out, crack initiations, fractures. To thedegree possible, inspect and document the test specimenaccording to 7.1.NOTE 3Depending on the test set up and fixtures employed, obtaining10 magnification may not be possible.7.3.2 In the event that the investigator notes any abnormali-ties prior to removing the test specimen from the test frame, animage using a digital camera will be taken in order to capturethe overall condition of each test specimen. This image may ormay not be with magnification.7.3.3 The investigator shall determine the frequency andtiming of any digital images that should be taken duringtesting.7.3.4 A high speed video camera focused on areas ofinterest, while not required, may be useful to understand anddocument specimen failure.7.3.5 If for any reason the test is stopped, the post-testprocedure should be followed, as outlined in 7.4.7.4 Post-Test Procedure7.4.1 Each test specimen shall be visually inspected accord-ing to 7.3.1 on the test frame prior to removal.7.4.2 Care shall be taken to identify any abnormalities thatmay be affected by removing the test specimen for example,debris, screw rotation, screw pull-out, fractures, etc..7.4.3 Any noted abnormalities shall be recorded for the finalreport.F3292 − 1927.4.4 Remove the test specimen from the test frame.7.4.5 For test specimens that were submerged in liquidmedia, excess liquid may be wiped off using a Kimwipe™ taskwiper or equivalent. The user shall not use any chemicalcleaners that affect surface finish or material properties of theimplant. Compressed air may also be used to remove anyexcess liquid from the device.7.4.6 Inspect and document test specimens according to 7.1.7.4.7 A complete investigation of the test specimen mayrequire disassembly of the components comprising the testspecimen. As a result, additional images of the individualcomponents of the test specimen after disassembly may berequired to document and characterize the test specimen.7.5 Physical Measurements7.5.1 Along with visual records, macro-measurements mayalso be taken of the test specimen using calipers, micrometers,digital imaging analysis, etc. Coordinate measurementmachines, white light interferometers, and profilometers mayalso be used to generate more precise records, especially ofsurface geometry.8. Report8.1 Report the following information8.1.1 Photographs taken during inspection with scale barsor other suitable measurement reference object documentingcharacteristics of the device that have changed during testing.Representative photographs are acceptable.9. Keywords9.1 cervical; extra-discal spinal constructs; fatigue testmethods; intervertebral body fusion device; intervertebral discprosthesis; lumbar; lumbar facet prosthesis; lumbosacral;nucleus devices; occipital-cervical-thoracic spinal implant con-struct; spinal arthrodesis; spinal artificial disc; spinal devices;spinal implant assembly; spinal implant construct; static testmethods; subsidence; thoracic; thoracolumbar pedicle screwsystem; total disc prosthesis; vertebrectomy; wearAPPENDIXESNonmandatory InformationX1. RATIONALEX1.1 Standards under the jurisdiction of ASTM Subcom-mittee F04.25 pertain to spinal implants and spinal implantassemblies comprising many different designs that can beassembled into a wide variety of configurations and combina-tions for different clinical indications dependent on the clinicalrequirements, intended clinical location, and intended methodof application. While these standards provide the frameworkfor a comprehensive series of mechanical tests that can be usedto compare different spinal implant designs in a consistentmanner, they do not prescribe inspection methods for evaluat-ing the implants.X1.2 This practice purports to provide minimum baselinecriteria for documenting mechanical failure. The user is cau-tioned that more detailed inspection criteria, including the useof additional equipment not listed herein, may be required tofully characterize the failure of the spinal implant.X1.3 This practice is not intended to be an all-encompassingguide for failure analysis of spinal implants undergoing testing.As such, there are other tests and standards that the user maywish to consider in evaluating failure such as scanning electronmicroscopy, computed tomography, FTIR analysis, dyepenetrant, or similar to further characterize any abnormalitiesor defects. Other useful evaluations may include such mini-mally disruptive tests as surface indentation, sampling fordifferential scanning calorimetry, or other tests that cause apermanent change to a very limited area of the device.X1.4 At this time, the analysis of spinal implants manufac-tured using additive manufacturing processes including but notlimited to material extrusion, material jetting, vat photopolymerization, powder bed fusion, and direct energy deposi-tion may require additional analysis techniques not detailedherein to fully characterize the disposition of the implant.F3292 − 193X2. MISCELLANEOUS GOOD PRACTICESX2.1 Lighting should be adjusted to capture fine details.Highly diffuse light provided by fiberoptic backlights facilitateidentifying scratches in bright white surfaces such as, UHM-WPE whereas concentrated beams may be necessary to reachinto small holes.X2.2 Many cameras and tabletop photographic systemsallow the date and time of the acquisition to be entered into thephotograph; this feature can be helpful if available.X2.3 Users may need to be previously informed of specificlocations for failure, and be provided with visual standardsregarding what constitutes a visual anomaly and what does not.X2.4 In some instances, timing marks marks across com-ponent interfaces to indicate the initial relationship betweencomponents before testing may be added across componentsof an implant assembly to assist in ascertaining failure, such asslippage or plastic deformation.X2.5 Some specimens must be inspected in a specializedcondition, such as heated, or under load in order to identify thefailure location. For example, tensile cracks may not be visi
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