F04.25 - Spinal Devices

SIGNIFICANCE AND USE
5.1 Intervertebral body fusion devices are generally simple geometric-shaped devices, which are often 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 This test method is designed to quantify the subsidence characteristics of different designs of intervertebral body fusion devices since this is a potential clinical failure mode. These tests are conducted in vitro in order to simplify the comparison of simulated vertebral body subsidence induced by the intervertebral body fusion devices.  
5.3 The static axial compressive loads that will be applied to the intervertebral body fusion devices and test blocks will differ from the complex loading seen in vivo, and therefore, the results from this test method may not be used to directly predict in vivo performance. The results, however, can be used to compare the varying degrees of subsidence between different intervertebral body fusion device designs for a given density of simulated bone.  
5.4 The location within the simulated vertebral bodies and position of the intervertebral body fusion device with respect to the loading axis will be dependent upon the design and manufacturer's recommendation for implant placement.
SCOPE
1.1 This test method specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices, spinal implants designed to promote arthrodesis at a given spinal motion segment.  
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future non-biologic intervertebral body fusion devices. This test method is intended to enable the user to mechanically compare intervertebral body fusion devices and does not purport to provide performance standards for intervertebral body fusion devices.  
1.3 This test method describes a static test method by specifying a load type and a specific method of applying this load. This test method is designed to allow for the comparative evaluation of intervertebral body fusion devices.  
1.4 Guidelines are established for measuring test block deformation and determining the subsidence of intervertebral body fusion devices.  
1.5 Since some intervertebral body fusion devices require the use of additional implants for stabilization, the testing of these types of implants may not be in accordance with the manufacturer's recommended usage.  
1.6 Units—The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians.  
1.7 The use of this standard may involve the operation of potentially hazardous equipment. 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 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.

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.

SIGNIFICANCE AND USE
5.1 Intervertebral body fusion device assemblies are generally simple geometric-shaped devices which are often porous or hollow in nature. Their function is to support the anterior column of the spine 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 intervertebral body fusion device assemblies so that comparisons can be made between different designs.  
5.2 This test method is designed to quantify the static and dynamic characteristics of different designs of intervertebral body fusion device assemblies. These tests are conducted in vitro to allow for analysis and comparison of the mechanical performance of intervertebral body fusion device assemblies to specific force modalities.  
5.3 The forces applied to the intervertebral body fusion assemblies 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 intervertebral body fusion device assemblies.  
5.4 Since the environment may affect the dynamic performance of intervertebral body fusion device assemblies, dynamic testing in a saline environment may be considered. 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 desired, the investigator should consider testing in a saline environmental bath at 37 °C (for example, 0.9 g NaCl per 100 mL water) at a rate of 1 Hz or less. 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.  
5.5 If the devices are known to be temperature and environment dependent, testing should be conducted in physiologic solution as described in 5.4. Devices that require...
SCOPE
1.1 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment.  
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies.  
1.3 The test method describes 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 intervertebral body fusion device assemblies.  
1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.  
1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).  
1.6 Guidelines are established for measuring displacements, determining the yield force or moment, and evaluating the stiffness and strength of the intervertebral body fusion device assemblies.  
1.7 Some intervertebral body fusion device assemblies may not be testable in all test configurations.  
1.8 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.  
1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is ...

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...

SIGNIFICANCE AND USE
5.1 Spinal implants are generally composed of several components that, when connected together, form a spinal implant construct. Spinal implant constructs are designed to provide some stability to the spine while arthrodesis takes place. This test method outlines standardized evaluations of different interconnection mechanisms to facilitate comparison between different designs. Comparisons must be made cautiously and with careful analysis, taking into account the effects that design differences can have on the loading configurations.  
5.2 This test method is used to quantify the static and fatigue properties of different implant interconnection designs. The mechanical tests are conducted in vitro using simplified, unidirectional loads and moments. Fatigue testing in a simulated body fluid or saline may have a fretting, corrosive, or lubricating effect on the interconnection and thereby affect the relative performance of tested devices. Hence, the test environment, whether a simulated body fluid, saline (9 g NaCl per 1000 mL H2O), with a saline drip, or dry, is an important characteristic of the test and must be reported accurately.  
5.3 The loading of spinal implant constructs in vivo will, in general, differ from the loading configurations used in this test method. The results obtained here cannot be used directly to predict in vivo performance. However, the results can be used to compare different component designs in terms of relative mechanical parameters.
SCOPE
1.1 This test method covers the measurement of uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of spinal arthrodesis implants.  
1.2 The purpose of this test method is to provide a means of mechanically characterizing different designs of spinal implant interconnections. Ultimately, the various components and interconnections should be combined for static and fatigue testing of the spinal implant construct. It is not the intention of this test method to address the analysis of spinal implant constructs or subconstructs or to define levels of performance of spinal implants, as insufficient knowledge is available to predict the consequences of the use of particular spinal implant designs.  
1.3 This standard defines test methods to measure the strength of spinal implant component interconnections and how to report test results.  
1.4 The values stated in SI units are to be regarded as 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.

SIGNIFICANCE AND USE
5.1 Spinal implants are generally composed of several components which, when connected together, form a spinal implant assembly. Spinal implant assemblies are designed to provide some stability to the spine while arthrodesis takes place. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies so that comparison between different designs may be facilitated.  
5.2 These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the spine.  
5.3 The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in-vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters.  
5.4 Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz.  
5.5 The location of the longitudinal elements is determined by where the anchors are clinically placed against bony structures. The perpendicular distance to the load direction (block moment arm) between the axis of a hinge pin and the anchor’s attachment points to a UHMWPE block is independent of anchor type. The distance between the anchor’s attachment point to the UHMWPE block an...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific, depending on the intended spinal location and intended method of application to the spine.  
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.  
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies.  
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly.  
1.5 Some spinal constructs 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 measurement are included in this standard.  
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 recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World T...

SIGNIFICANCE AND USE
5.1 Total Facet Prosthesis Components—The total facet replacement may comprise a variety of shapes and configurations. Its forms may include, but are not limited to: ball-and-socket articulating joints, joints having a free-floating or semi-constrained third body, metallic load-bearing surfaces, and spring and dampening mechanisms. Additionally, it may have a unilateral or bilateral design.  
5.2 Spinal Testing Apparatus:  
5.2.1 Test Chambers—In case of a multispecimen machine, each chamber shall be isolated to prevent cross-contamination of the test specimens. The chamber shall be made entirely of corrosion-resistant materials, such as acrylic plastic or stainless steel, and shall be removable from the machine for thorough cleaning between tests.  
5.2.2 Component Clamping/Fixturing—Since the purpose of the test is to characterize the wear and kinematic function of the total facet prosthesis, the method for mounting components in the test chamber shall not compromise the accuracy of assessment of the weight loss or stiffness variation during the test. For example, prostheses having complicated superior and inferior surfaces for contacting bone (for example, sintered beads, hydroxylapatite (HA) coating, plasma spray) may be specially manufactured to modify that surface in a manner that does not affect the wear simulation.  
5.2.3 The device should be securely (rigidly) attached at its bone-implant interface to the mating test fixtures.  
5.2.4 The motion of the superior test fixture (more posterior fixture in Figs. 1 and 2) relative to the inferior testing fixture shall be constrained in three-dimensional space except for the components in the direction of specified test motions/loads.  
FIG. 1 Diagrams of Possible Test Apparatus for Allowing Simultaneous Lateral Bending and Axial Rotation Motions with Anterior-Posterior Directed Facet Loading
Note 1: This setup would require two rotational actuators and one translational actuator.  
FIG. 2 Diagrams of Po...
SCOPE
1.1 This practice provides guidance for the functional, kinematic, and wear testing of motion-preserving total facet prostheses for the lumbar spine. These implants are intended to allow motion and lend support to the functional spinal unit(s) through replacement of the natural facets.  
1.2 This practice is not intended to address the bone implant interface or the static characteristics of the prosthesis components. Fatigue characteristics are included, but only as a by-product of cyclic wear testing under facet load and thus are not addressed in the typical process of generating a Stress-Life (S-N) characterization.  
1.3 Biocompatibility of the materials used in a total facet prosthesis are not addressed in this practice.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4.1 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in 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.

ABSTRACT
This test method deals with static, dynamic, and wear testing of extra-discal motion preserving implants. These implants are intended to augment spinal stability without significant tissue removal while allowing motion of the functional spinal unit(s). Wear is assessed using a weight loss method and a dimensional analysis for determining wear of components used in extra-discal spinal motion preserving procedures, using testing medium as defined in this test method. This test method is not intended to address facet arthroplasty devices and any potential failure mode as it relates to the fixation of the device to its bony interfaces; and does not prescribe methods for assessing the mechanical characteristics of the device in translation. The static test includes the static flexion test, static extension test, static torsion test, static lateral bending test, and fatigue tests. Wear test includes flexion/extension wear assessment, rotational wear assessment, and bending wear assessment. The apparatus which shall be used includes implant components and spinal testing apparatus. The calculation and interpretation of wear results are also elaborated.
SIGNIFICANCE AND USE
4.1 This test method is designed to quantify the static and dynamic characteristics of different designs of single level spinal constructs. Wear may also be assessed for implants that allow motion using testing medium (see 6.1) for simulating the physiologic environment at 37 °C. Wear is assessed using a weight loss method in addition to dimensional analyses. Weight loss is determined after subjecting the implants to dynamic profiles specified in this test method. This information will allow the manufacturer or end user of the product to understand how the specific device in question performs under the test conditions prescribed in this test method.  
4.2 This test method is intended to be applicable for single level extra-discal spinal constructs. Three different types of fixtures are specified for testing single level extra-discal spinal constructs See Fig. 2, Fig. 4, and Fig. 5. See also Table 1.  
4.3 Implants may be designed using a variety of materials (for example, ceramics, metals, polymers, or combinations thereof), and it is the goal of this test method to enable a comparison of the static, dynamic, and wear properties generated by these devices, regardless of material and type of device.
SCOPE
1.1 This test method describes methods to assess the static and dynamic properties of single level spinal constructs.  
1.2 An option for assessing wear using a weight loss method and a dimensional analysis is given. This method, described herein, is used for the analysis of devices intended for motion preservation, using testing medium as defined in this standard (6.1).  
1.3 This test method is not intended to address any potential failure mode as it relates to the fixation of the device to its bony interfaces.  
1.4 It is the intent of this test method to enable single level extra-discal spinal constructs with regard to kinematic, functional, and wear characteristics when tested under the specified conditions.  
1.5 This test method is not intended to address facet arthroplasty devices.  
1.6 In order that the data be reproducible and comparable within and between laboratories, it is essential that uniform procedures be established. This test method is intended to facilitate uniform testing methods and data reporting.  
1.7 The motion profiles specified by this test method do not necessarily accurately reproduce those occurring in vivo. Rather this method provides useful boundary/endpoint conditions for evaluating implant designs in a functional manner.  
1.8 This test method is not intended to be a performance standard. It is the responsibility of the user of this test method to characterize the safety and effectiveness of the device under evaluation.  
1.9 Multiple test methods are included in this standard. However, it mu...

SIGNIFICANCE AND USE
4.1 This guide can be used to determine the fatigue and wear behavior of IVD prostheses subjected to functional and kinematic cyclic loading/motion for relatively large numbers of cycles (for example, various designs of IVD prostheses, as well as the effects of materials, manufacturing techniques and other design variables on one particular design can be determined using this guide).  
4.2 This guide is intended to be applicable to IVD prostheses that support load and transmit motion by means of an articulating joint or by use of compliant materials. Ceramics, metals, or polymers, or combination thereof, are used in IVD prostheses, and it is the goal of this guide to enable a kinematic wear and/or fatigue comparison of these devices, regardless of material and type of device.
SCOPE
1.1 This guide provides guidance for wear and/or fatigue testing of total disc prostheses under functional and kinematic conditions and, to this end, describes test methods for assessment of the wear or functional characteristics, or both, of total disc prostheses.  
1.2 Both lumbar and cervical prostheses are addressed.  
1.3 Load and kinematic profiles for lumbar and cervical devices are not identical and, therefore, are addressed separately in the guide.  
1.4 Partial disc replacements, such as nucleus replacements or facet joint replacements, are not intended to be addressed.  
1.5 Wear is assessed using a weight loss method in a testing medium as defined in this guide.  
1.6 This guide does not address any potential failure mode as it relates to the fixation of the implant to its bony interfaces.  
1.7 It is the intent of this guide to enable comparison of intervertebral disc (IVD) prostheses with regard to wear and fatigue characteristics when tested under the specified conditions. It must be recognized, however, that there are many possible variations in in-vivo conditions. A single laboratory simulation with a fixed set of parameters might not be universally representative.  
1.8 Most IVD prostheses primarily fall into two classifications: articulating ball-in-socket type prostheses, and elastomeric or compliant type prostheses. For the former, this guide primarily addresses Mode 1 wear (defined in 3.2.17.1); whereas for the latter, this guide addresses potential failure of the prosthesis when the implant is subjected to a range of motion and/or loads that fall within the full range of possible physiologic motions and loads.  
1.9 For articulating components, this guide predominantly describes a Mode 1 test. The user is cautioned that other modes of wear may occur and may have significant influence on the functionality and performance of an articulating IVD prosthesis; therefore, the user should consider the effects of other wear modes on the performance of the prosthesis.  
1.10 In order that the data be reproducible and comparable within and between laboratories, it is essential that uniform procedures are established. This guide is intended to facilitate uniform methods for testing and reporting of data for total disc replacement prostheses.  
1.11 Without a substantial clinical retrieval history of IVD prostheses, actual loading profiles and patterns cannot be delineated at the time of the writing of this guide. It therefore follows that the load and motion conditions specified by this guide do not necessarily accurately reproduce those occurring in vivo. Rather, this guide provides useful boundary/endpoint conditions for evaluating prosthesis designs in a functional manner.  
1.12 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in either degrees or radians.  
1.13 This guide is not intended to be a performance standard. It is the responsibility of the user of this guide to characterize the safety and effectiveness of the prosthesis under evaluation.  
1.14 This standard does not purport to address all of t...

ABSTRACT
These specifications and test methods provide standard specifications that specify material, labeling, and handling requirements for components used in surgical fixation of the spinal skeletal system such as metallic spinal screws, spinal plates, and spinal rods. The specifications and test methods establish (1) common terminology that can be used to describe the size and other physical characteristics of spinal components and performance definitions related to the performance of spinal components, and (2) performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components. It is not the intention of these specifications and test methods to define levels of performance or case-specific clinical performance for spinal components and to describe or specify specific designs for the individual components. For these specifications and test methods may not be appropriate for all types of spinal surgical fixation systems, the appropriateness of these specifications in view of the particular implant system and its potential application shall be considered. The test methods include static and fatigue bending strength tests. Requirements for marking and packaging are specified as well.
SIGNIFICANCE AND USE
4.1 Spinal implant constructs are typically a compilation of several components. Screws, plates, and rods are integral components of many spinal implant constructs. These components are designed to transfer load between the bone and the longitudinal or transverse element, or both. These specifications and test methods identify specifications for such components and define standard equivalent test methods that can be used when evaluating different related component designs.  
4.2 Since the loading of spinal components in-vivo  may differ from the loading configurations addressed in these specifications and test methods, the results obtained from this document may not predict  in-vivo performance of either the components or the construct as a whole. Such tests can, however, be used to compare different component designs in terms of relevant mechanical performance characteristics.  
4.3 The performance-related mechanical characteristics determined by these specifications and test methods will supply the user with information that may be used to predict the mechanical performance of different design variations of similar (function and indication) spinal construct components.
SCOPE
1.1 These specifications and test methods are intended to provide a comprehensive reference for the components of systems used in the surgical fixation of the spinal skeletal system. The document catalogs standard specifications that specify material, labeling, and handling requirements. The specifications and test methods also establish common terminology that can be used to describe the size and other physical characteristics of spinal components and performance definitions related to the performance of spinal components. Additionally, the specifications and test methods establish performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components.  
1.2 These specifications and test methods are part of a series of standards addressing systems used in the surgical fixation of the spinal skeletal system. These specifications and test methods concentrate on the individual components, which are found in many spinal fixation systems. If the user is interested in evaluating the next level in the spinal fixation system chain, the interconnections between individual components and subassemblies (two or more components), the user should consult Guide F1798. At the highest level in this chain is Test Methods F1717, which is used to evaluate an entire construct assembled from many components and involves numerous interconnections and several subassemblies.  
1.3 It is not the intention of th...

SIGNIFICANCE AND USE
5.1 Nucleus devices are generally designed to augment the mechanical function of native degenerated nucleus material or to replace tissue that has been removed during a surgical procedure. This guide outlines methods for evaluating many different types of devices. Comparisons between devices must be made cautiously and with careful analysis, taking into account the effects that design and functional differences can have on the testing configurations and overall performance, and the possibility that mechanical failure may not be related to clinical failure and inversely, that mechanical success may not be related to clinical success.  
5.2 These tests are conducted in vitro to allow for analysis of the mechanical performance of the nucleus device under specific testing modalities. The loads applied may differ from the complex loading seen in vivo, and therefore the results from these tests may not directly predict in vivo performance.  
5.3 These tests are used to quantify the static and dynamic properties and performance of different implant designs. The mechanical tests are conducted in vitro using simplified loads and moments. Fatigue testing in a simulated body fluid or saline may have fretting, aging, corroding, or lubricating effects on the device and thereby affect the relative performance of tested devices. Hence, the test environment and the effect of that environment, whether a simulated body fluid, normal saline bath (9 g NaCl per 1000 mL H2O), or dry, is an important characteristic of the test and must be reported accurately.  
5.4 Dynamic testing methods should be designed to answer the following questions, including but not limited to: Does the device still function as intended after cycling? Does it retain adequate performance characteristics (for example, mechanical and kinematic properties such as ROM)? Did the device wear or degrade? If there is evidence of wear or degradation of the device, it should be identified and quantified with reasonable ...
SCOPE
1.1 This guide describes various forms of nucleus replacement and nucleus augmentation devices. It further outlines the types of testing that are recommended in evaluating the performance of these devices.  
1.2 Biocompatibility of the materials used in a nucleus replacement device is not addressed in this guide. However, users should investigate the biocompatibility of their device separately (see X1.1).  
1.3 While it is understood that expulsion and endplate fractures represent documented clinical failures, this guide does not specifically address them, although some of the factors that relate to expulsion have been included (see X1.3).  
1.4 Multiple tests are described in this guide; however, the user need not use them all. It is the responsibility of the user of this guide to determine which tests are appropriate for the devices being tested and their potential application. Some tests may not be applicable for all types of devices. Moreover, some nucleus devices may not be stable in all test configurations. However, this does not necessarily mean that the test methods described are unsuitable.  
1.5 The science of nucleus device design is still very young and includes technology that is changing more quickly than this guide can be modified. Therefore, the user must carefully consider the applicability of this guide to the user’s particular device; the guide may not be appropriate for every device. For example, at the time of publication, this guide does not address the nucleus replacement and nucleus augmentation devices that are designed to be partially or completely resorbable in the body. However, some of the test recommended in this guide may be applicable to evaluate such devices. It has not been demonstrated that mechanical failure of nucleus devices is related to adverse clinical results. Therefore this standard should be used with care in evaluating proposed nucleus devices.  
1.6 This guide is not int...

SCOPE
1.1 This specification covers standards a manufacturer shall meet in the performance testing of neurosurgical head holder devices (skull clamps).  
1.2 This specification covers neurosurgical head holder devices (skull clamps) made of metal (nonradiolucent) as well as neurosurgical head holder devices (skull clamps) made of plastic material (radiolucent).  
1.3 This specification represents the best currently available test procedures and is a minimum safety and performance standard.  
1.4 This specification covers only those neurosurgical head holders (skull clamps) intended for use on humans for neurosurgical and spinal clinical applications. This specification assumes the user is well trained in the procedures and use of these devices including selection of the correct device type and accessories.  
1.5 This specification describes those devices commonly known as skull clamps and accessories, such as skull pins, attachments, and various adaptors.  
1.6 This specification only describes head holder devices that provide rigid skeletal fixation of the skull by means of three skull pins that penetrate the outer surface or outer layers of the patient’s head during neurosurgical or spinal procedures (compare with Ref (1)).2 Two pins are typically located in a 2-pin rocker, whereas the force delivery component is equipped with a single pin.  
1.7 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. The values given in parentheses are for information only.  
1.8 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.  
FIG. 1 Skull Clamp Device Achieving 3-Pin Rigid Fixation
FIG. 2 Skull Clamp System (Skull Clamp, Base Unit, Adaptor, and Skull Pins)  
1.9 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.

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.

SIGNIFICANCE AND USE
5.1 This guide can be used to develop test parameters for evaluating fatigue and wear behavior of IVD prostheses under impingement loading. It must be recognized, however, that there are likely many possible impingement conditions for a given IVD prosthesis.  
5.2 The user should attempt to determine the clinically relevant and geometrically possible impingement conditions and dictated by the design and impingement wear test parameters that may result in wear and fatigue damage for the IVD prosthesis. The user should also attempt to select the device size which will represent a worst case for the impingement conditions and parameters selected.  
5.3 The user should reference and utilize existing sources of information to identify the impingement test parameters that produce the clinically relevant impingement wear and damage for their IVD prosthesis. Prior clinical experience with the device design may aid in the development of impingement test parameters through analysis of device retrievals and radiographs. However, prior clinical experience with the IVD being tested should not be considered as a prerequisite for performing impingement testing.  
5.4 This guide details a three-step process for assessing device impingement under a selected set of conditions:  
5.4.1 The user selects previously identified impingement conditions, one at a time, or clinically observed conditions.  
5.4.2 The user selects the worst-case size of device to apply the selected conditions.  
5.4.3 Solid modeling and the quasistatic test method should be employed to assess the impingement condition and determine the impingement test parameters – most importantly, the angular displacement limits to be used in the impingement wear test.  
5.4.4 The impingement wear test is then conducted using the impingement test parameters.  
5.5 This guide serves to evaluate devices with various designs, materials (i.e., metal-on-metal versus polymer-on-polymer), and stiffness in the impingement reg...
SCOPE
1.1 This standard is intended to provide guidance on the evaluation of wear and fatigue characteristics of total disc prostheses under cyclic impingement conditions.  
1.2 This guide describes impingement testing of devices with articulating components. The user is cautioned that the methods described herein are intended to produce an impingement condition which may or may not be indicative of clinical performance and which may or may not be consistent with the intended use of the device, and that this should be considered when interpreting the data. Clinically, total disc prostheses should always be implanted per labeling and the manufacturer’s instructions for use.  
1.3 Impingement has been observed in retrievals among several total disc prosthesis designs; however, impingement is not necessarily associated with device or clinical failure. It is the intent of this guide to investigate possible impingement-induced wear and mechanical failure modes associated with device design, as well as potential mechanical failure modes associated with clinical events such as subsidence, malpositioning, and improper implant sizing. Note that mechanical failure may or may not be associated with functional failure.  
1.4 It is recommended that the user define the bearing and non-bearing features of the intervertebral disc (IVD) prosthesis and evaluate the performance of the IVD prosthesis under Mode 1 wear by using Guide F2423 or ISO 18192-1 prior to use of this guide. This standard is not intended to provide guidance on Mode I testing.  
1.5 The goal of this guide is to evaluate impingement in IVD prostheses regardless of the intended region of the spine (cervical or lumbar), material or material combinations (ceramic, metal, polymer), and bearing type (fixed or mobile).  
1.6 It is the intent of this guide to enable comparison of IVD prostheses with regard to wear and fatigue characteristics when tested under the specified cond...

SIGNIFICANCE AND USE
5.1 Artificial intervertebral discs are orthopaedic implants that replace degenerated natural intervertebral discs. Their function is to support the anterior column of the spine while allowing motion at the operated level. These test methods outline materials and methods for the characterization of the mechanical performance of different artificial intervertebral discs so that comparisons can be made between different designs.  
5.2 These test methods are designed to quantify the static and dynamic characteristics of different designs of artificial intervertebral discs. These tests are conducted in vitro in order to allow for analysis of individual disc replacement devices and comparison of the mechanical performance of multiple artificial intervertebral disc designs in a standard model.  
5.3 The loads applied to the artificial intervertebral discs 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 artificial intervertebral discs.  
5.4 Fatigue tests should be conducted in a 0.9 % saline environmental bath at 37°C at a rate of 2 Hz or less. Other test environments such as a simulated body fluid, a saline drip or mist, distilled water, or other type of lubrication could also be used with adequate justification. Likewise, alternative test frequencies may be used with adequate justification.  
5.5 It is well known that the failure of materials is dependent upon stress, test frequency, surface treatments, and environmental factors. Therefore, when determining the effect of changing one of these parameters (for example, frequency, material, or environment), all others should be kept constant to facilitate interpretation of the results. In particular, it may be necessary to assess the influence of test frequency on device fracture while holding the test environment, implant materials and processing, ...
SCOPE
1.1 These test methods specify the materials and methods for the static and dynamic testing of artificial intervertebral discs.  
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future non-biologic artificial intervertebral discs. These test methods allow comparison of artificial intervertebral discs with different intended spinal locations (cervical, thoracic, and lumbar) and methods of application to the intervertebral spaces. These test methods are intended to enable the user to mechanically compare artificial intervertebral discs and do not purport to provide performance standards for artificial intervertebral discs.  
1.3 These test methods describe static and dynamic tests by specifying load types and specific methods of applying these loads. These tests are designed to allow for the comparative evaluation of artificial intervertebral discs.  
1.4 These test methods do not purport to address all clinically relevant failure modes for artificial intervertebral discs, some of which will be device specific. For example, these test methods do not address the implant's resistance to expulsion or implant wear resistance under expected in vivo loads and motions. In addition, the biologic response to wear debris is not addressed in these test methods.  
1.5 Requirements are established for measuring displacements, determining the yield load or moment, and evaluating the stiffness of artificial intervertebral discs.  
1.6 Some artificial intervertebral discs may not be testable in all test configurations.  
1.7 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians.  
1.8 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 approp...

SIGNIFICANCE AND USE
5.1 Occipital-cervical and occipital-cervical-thoracic spinal implants are generally composed of several components which, when connected together, form either an occipital-cervical spinal implant assembly or an occipital-cervical-thoracic spinal implant assembly. Occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are designed to provide some stability to the spine during the process of arthrodesis. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies to facilitate comparisons between different designs.  
5.2 These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the occipital-cervical and occipital-cervical-thoracic spine.  
5.3 The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters.  
5.4 Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of the environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz.  
5.5 The location of the longitudinal elements is determined by the intended in vivo location of the ...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of occipital-cervical and occipital-cervical-thoracic spinal implant components can be specific depending on the intended location and intended method of attachment.  
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future occipital-cervical and occipital-cervical-thoracic spinal implant assemblies. They allow comparison of occipital-cervical and occipital-cervical-thoracic spinal implant constructs with different methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.  
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and two fatigue tests for the comparative evaluation of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are defined.  
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of occipital-cervical or occipital-cervical-thoracic spinal implant assemblies.  
1.5 It may not be possible to test some occipital-cervical and some occipital-cervical-thoracic spinal constructs in all test configurations.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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 th...

SCOPE
1.1 This terminology covers basic terms and considerations for spinal implant devices and their mechanical analyses.

SIGNIFICANCE AND USE
5.1 Facet Prosthesis Components—The facet replacement may comprise a variety of shapes and configurations. Its forms may include, but are not limited to, ball and socket articulating joints, joints having a free-floating or semi-constrained third body, metallic load-bearing surfaces, and spring and dampening mechanisms. Additionally, it may have a unilateral or bilateral design.  
5.2 These test methods are designed to quantify the static and dynamic characteristics of different designs of FPs. The tests are conducted in vitro in order to allow for analysis of individual devices and comparison of the mechanical performance of multiple designs.  
5.3 The loads applied to the FP 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 in different devices.  
5.4 Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be conducted in a 0.9 % saline environmental bath at 37°C at a maximum rate of 10 Hz for metallic devices and 2 Hz for non-metallic devices. Other test environments such as a simulated body fluid, a saline drip or mist, distilled water, other type of lubrication or dry could also be used with adequate justification. Likewise, alternative test frequencies may be used with adequate justification to ensure that they do not impact the device performance.  
5.5 It is well known that the failure of materials is dependent upon stress, test frequency, surface treatments, and environmental factors. Therefore, when determining the effect of changing these parameters (for example, frequency, material, or environment), care should be taken to allow for appropriate interpretation of the results. In particular, it may be necessary to assess the influence of test frequency on dev...
SCOPE
1.1 This practice provides guidance for the static and dynamic testing of Lumbar Total Facet Prostheses (FPs). These implants are intended to allow motion and lend support to one or more functional spinal unit(s) through replacement of the natural facets.  
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future non-biologic FPs. These test methods allow comparison of devices with different methods of application to the lumbar spine. These test methods are intended to enable the user to mechanically compare devices and do not purport to provide performance standards for them.  
1.3 These test methods describe static and dynamic tests by specifying load types and specific methods of applying these loads.  
1.4 These test methods do not purport to address all clinically relevant failure modes for FPs, some of which will be device-specific. For example, these test methods do not address implant wear resistance under expected in vivo loads and motions. In addition, the biologic response to wear debris is not addressed in these test methods.  
1.5 Requirements are established for measuring displacements and evaluating the stiffness of an FP.  
1.6 Some devices may not be testable in all test configurations.  
1.7 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians.  
1.8 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.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Developme...

SIGNIFICANCE AND USE
5.1 Intervertebral body fusion devices are generally simple geometric-shaped devices, which are often 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 This test method is designed to quantify the subsidence characteristics of different designs of intervertebral body fusion devices since this is a potential clinical failure mode. These tests are conducted in vitro in order to simplify the comparison of simulated vertebral body subsidence induced by the intervertebral body fusion devices.  
5.3 The static axial compressive loads that will be applied to the intervertebral body fusion devices and test blocks will differ from the complex loading seen in vivo, and therefore, the results from this test method may not be used to directly predict in vivo performance. The results, however, can be used to compare the varying degrees of subsidence between different intervertebral body fusion device designs for a given density of simulated bone.  
5.4 The location within the simulated vertebral bodies and position of the intervertebral body fusion device with respect to the loading axis will be dependent upon the design and manufacturer's recommendation for implant placement.
SCOPE
1.1 This test method specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices, spinal implants designed to promote arthrodesis at a given spinal motion segment.  
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future non-biologic intervertebral body fusion devices. This test method is intended to enable the user to mechanically compare intervertebral body fusion devices and does not purport to provide performance standards for intervertebral body fusion devices.  
1.3 This test method describes a static test method by specifying a load type and a specific method of applying this load. This test method is designed to allow for the comparative evaluation of intervertebral body fusion devices.  
1.4 Guidelines are established for measuring test block deformation and determining the subsidence of intervertebral body fusion devices.  
1.5 Since some intervertebral body fusion devices require the use of additional implants for stabilization, the testing of these types of implants may not be in accordance with the manufacturer's recommended usage.  
1.6 Units—The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians.  
1.7 The use of this standard may involve the operation of potentially hazardous equipment. 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 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.

SIGNIFICANCE AND USE
5.1 Intervertebral body fusion device assemblies are generally simple geometric-shaped devices which are often porous or hollow in nature. Their function is to support the anterior column of the spine 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 intervertebral body fusion device assemblies so that comparisons can be made between different designs.  
5.2 This test method is designed to quantify the static and dynamic characteristics of different designs of intervertebral body fusion device assemblies. These tests are conducted in vitro to allow for analysis and comparison of the mechanical performance of intervertebral body fusion device assemblies to specific force modalities.  
5.3 The forces applied to the intervertebral body fusion assemblies 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 intervertebral body fusion device assemblies.  
5.4 Since the environment may affect the dynamic performance of intervertebral body fusion device assemblies, dynamic testing in a saline environment may be considered. 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 desired, the investigator should consider testing in a saline environmental bath at 37°C (for example, 0.9-g NaCl per 100-mL water) at a rate of 1 Hz or less. 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.  
5.5 If the devices are known to be temperature and environment dependent, testing should be conducted in physiologic solution as described in 5.4. Devices that require p...
SCOPE
1.1 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment.  
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies.  
1.3 The test method describes 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 intervertebral body fusion device assemblies.  
1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.  
1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).  
1.6 Guidelines are established for measuring displacements, determining the yield force or moment, evaluating the stiffness, and strength of the intervertebral body fusion device assemblies.  
1.7 Some intervertebral body fusion device assemblies may not be testable in all test configurations.  
1.8 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.  
1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the...

SIGNIFICANCE AND USE
5.1 Spinal implants are generally composed of several components which, when connected together, form a spinal implant assembly. Spinal implant assemblies are designed to provide some stability to the spine while arthrodesis takes place. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies so that comparison between different designs may be facilitated.  
5.2 These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the spine.  
5.3 The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters.  
5.4 Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz.  
5.5 The location of the longitudinal elements is determined by where the anchors are clinically placed against bony structures. The perpendicular distance to the load direction (block moment arm) between the axis of a hinge pin and the anchor’s attachment-points to a UHMWPE block is independent of anchor-type. The distance between the anchor’s attachment point to the UHMWPE block an...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific, depending on the intended spinal location and intended method of application to the spine.  
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.  
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies.  
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly.  
1.5 Some spinal constructs 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 measurement are included in this standard.  
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 recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World T...

ABSTRACT
These specifications and test methods provide standard specifications that specify material, labeling, and handling requirements for components used in surgical fixation of the spinal skeletal system such as metallic spinal screws, spinal plates, and spinal rods. The specifications and test methods establish (1) common terminology that can be used to describe the size and other physical characteristics of spinal components and performance definitions related to the performance of spinal components, and (2) performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components. It is not the intention of these specifications and test methods to define levels of performance or case-specific clinical performance for spinal components and to describe or specify specific designs for the individual components. For these specifications and test methods may not be appropriate for all types of spinal surgical fixation systems, the appropriateness of these specifications in view of the particular implant system and its potential application shall be considered. The test methods include static and fatigue bending strength tests. Requirements for marking and packaging are specified as well.
SIGNIFICANCE AND USE
4.1 Spinal implant constructs are typically a compilation of several components. Screws, plates, and rods are integral components of many spinal implant constructs. These components are designed to transfer load between the bone and the longitudinal or transverse element, or both. These specifications and test methods identify specifications for such components and define standard equivalent test methods that can be used when evaluating different related component designs.  
4.2 Since the loading of spinal components in-vivo  may differ from the loading configurations addressed in these specifications and test methods, the results obtained from this document may not predict  in-vivo performance of either the components or the construct as a whole. Such tests can, however, be used to compare different component designs in terms of relevant mechanical performance characteristics.  
4.3 The performance-related mechanical characteristics determined by these specifications and test methods will supply the user with information that may be used to predict the mechanical performance of different design variations of similar (function and indication) spinal construct components.
SCOPE
1.1 These specifications and test methods are intended to provide a comprehensive reference for the components of systems used in the surgical fixation of the spinal skeletal system. The document catalogs standard specifications that specify material, labeling, and handling requirements. The specifications and test methods also establish common terminology that can be used to describe the size and other physical characteristics of spinal components and performance definitions related to the performance of spinal components. Additionally, the specifications and test methods establish performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components.  
1.2 These specifications and test methods are part of a series of standards addressing systems used in the surgical fixation of the spinal skeletal system. These specifications and test methods concentrate on the individual components, which are found in many spinal fixation systems. If the user is interested in evaluating the next level in the spinal fixation system chain, the interconnections between individual components and subassemblies (two or more components), the user should consult Guide F1798. At the highest level in this chain is Test Methods F1717, which is used to evaluate an entire construct assembled from many components and involves numerous interconnections and several subassemblies.  
1.3 It is not the intention of th...

ABSTRACT
These specifications and test methods provide standard specifications that specify material, labeling, and handling requirements for components used in surgical fixation of the spinal skeletal system such as metallic spinal screws, spinal plates, and spinal rods. The specifications and test methods establish (1) common terminology that can be used to describe the size and other physical characteristics of spinal components and performance definitions related to the performance of spinal components, and (2) performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components. It is not the intention of these specifications and test methods to define levels of performance or case-specific clinical performance for spinal components and to describe or specify specific designs for the individual components. For these specifications and test methods may not be appropriate for all types of spinal surgical fixation systems, the appropriateness of these specifications in view of the particular implant system and its potential application shall be considered. The test methods include static and fatigue bending strength tests. Requirements for marking and packaging are specified as well.
SIGNIFICANCE AND USE
4.1 Spinal implant constructs are typically a compilation of several components. Screws, plates, and rods are integral components of many spinal implant constructs. These components are designed to transfer load between the bone and the longitudinal or transverse element, or both. These specifications and test methods identify specifications for such components and define standard equivalent test methods that can be used when evaluating different related component designs.  
4.2 Since the loading of spinal components in-vivo  may differ from the loading configurations addressed in these specifications and test methods, the results obtained from this document may not predict  in-vivo performance of either the components or the construct as a whole. Such tests can, however, be used to compare different component designs in terms of relevant mechanical performance characteristics.  
4.3 The performance-related mechanical characteristics determined by these specifications and test methods will supply the user with information that may be used to predict the mechanical performance of different design variations of similar (function and indication) spinal construct components.
SCOPE
1.1 These specifications and test methods are intended to provide a comprehensive reference for the components of systems used in the surgical fixation of the spinal skeletal system. The document catalogs standard specifications that specify material, labeling, and handling requirements. The specifications and test methods also establish common terminology that can be used to describe the size and other physical characteristics of spinal components and performance definitions related to the performance of spinal components. Additionally, the specifications and test methods establish performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components.  
1.2 These specifications and test methods are part of a series of standards addressing systems used in the surgical fixation of the spinal skeletal system. These specifications and test methods concentrate on the individual components, which are found in many spinal fixation systems. If the user is interested in evaluating the next level in the spinal fixation system chain, the interconnections between individual components and subassemblies (two or more components), the user should consult Guide F1798. At the highest level in this chain is Test Methods F1717, which is used to evaluate an entire construct assembled from many components and involves numerous interconnections and several subassemblies.  
1.3 It is not the intention of th...

SIGNIFICANCE AND USE
5.1 Intervertebral body fusion devices are generally simple geometric shaped devices, which are often 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 This test method is designed to quantify the subsidence characteristics of different designs of intervertebral body fusion devices since this is a potential clinical failure mode. These tests are conducted in vitro in order to simplify the comparison of simulated vertebral body subsidence induced by the intervertebral body fusion devices.  
5.3 The static axial compressive loads that will be applied to the intervertebral body fusion devices and test blocks will differ from the complex loading seen in vivo, and therefore, the results from this test method may not be used to directly predict in vivo performance. The results, however, can be used to compare the varying degrees of subsidence between different intervertebral body fusion device designs for a given density of simulated bone.  
5.4 The location within the simulated vertebral bodies and position of the intervertebral body fusion device with respect to the loading axis will be dependent upon the design and manufacturer's recommendation for implant placement.
SCOPE
1.1 This test method specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices, spinal implants designed to promote arthrodesis at a given spinal motion segment.  
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future non-biologic intervertebral body fusion devices. This test method is intended to enable the user to mechanically compare intervertebral body fusion devices and does not purport to provide performance standards for intervertebral body fusion devices.  
1.3 This test method describes a static test method by specifying a load type and a specific method of applying this load. This test method is designed to allow for the comparative evaluation of intervertebral body fusion devices.  
1.4 Guidelines are established for measuring test block deformation and determining the subsidence of intervertebral body fusion devices.  
1.5 Since some intervertebral body fusion devices require the use of additional implants for stabilization, the testing of these types of implants may not be in accordance with the manufacturer's recommended usage.  
1.6 Units—The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians.  
1.7 The use of this standard may involve the operation of potentially hazardous equipment. 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 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.

SIGNIFICANCE AND USE
5.1 Intervertebral body fusion device assemblies are generally simple geometric-shaped devices which are often porous or hollow in nature. Their function is to support the anterior column of the spine 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 intervertebral body fusion device assemblies so that comparisons can be made between different designs.  
5.2 This test method is designed to quantify the static and dynamic characteristics of different designs of intervertebral body fusion device assemblies. These tests are conducted in vitro to allow for analysis and comparison of the mechanical performance of intervertebral body fusion device assemblies to specific force modalities.  
5.3 The forces applied to the intervertebral body fusion assemblies 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 intervertebral body fusion device assemblies.  
5.4 Since the environment may affect the dynamic performance of intervertebral body fusion device assemblies, dynamic testing in a saline environment may be considered. 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 desired, the investigator should consider testing in a saline environmental bath at 37°C (for example, 0.9-g NaCl per 100-mL water) at a rate of 1 Hz or less. 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.  
5.5 If the devices are known to be temperature and environment dependent, testing should be conducted in physiologic solution as described in 5.4. Devices that require p...
SCOPE
1.1 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment.  
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies.  
1.3 The test method describes 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 intervertebral body fusion device assemblies.  
1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.  
1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).  
1.6 Guidelines are established for measuring displacements, determining the yield force or moment, evaluating the stiffness, and strength of the intervertebral body fusion device assemblies.  
1.7 Some intervertebral body fusion device assemblies may not be testable in all test configurations.  
1.8 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.  
1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the...

SIGNIFICANCE AND USE
5.1 Occipital-cervical and occipital-cervical-thoracic spinal implants are generally composed of several components which, when connected together, form either an occipital-cervical spinal implant assembly or an occipital-cervical-thoracic spinal implant assembly. Occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are designed to provide some stability to the spine during the process of arthrodesis. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies to facilitate comparisons between different designs.  
5.2 These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the occipital-cervical and occipital-cervical-thoracic spine.  
5.3 The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters.  
5.4 Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of the environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz.  
5.5 The location of the longitudinal elements is determined by the intended in vivo location of the ...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of occipital-cervical and occipital-cervical-thoracic spinal implant components can be specific depending on the intended location and intended method of attachment.  
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future occipital-cervical and occipital-cervical-thoracic spinal implant assemblies. They allow comparison of occipital-cervical and occipital-cervical-thoracic spinal implant constructs with different methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.  
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and two fatigue tests for the comparative evaluation of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are defined.  
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of occipital-cervical or occipital-cervical-thoracic spinal implant assemblies.  
1.5 It may not be possible to test some occipital-cervical and some occipital-cervical-thoracic spinal constructs in all test configurations.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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 and health practices and determine the applicability ...

SIGNIFICANCE AND USE
4.1 This guide can be used to determine the fatigue and wear behavior of IVD prostheses subjected to functional and kinematic cyclic loading/motion for relatively large numbers of cycles (for example, various designs of IVD prostheses, as well as the effects of materials, manufacturing techniques and other design variables on one particular design can be determined using this guide).  
4.2 This guide is intended to be applicable to IVD prostheses, that support load and transmit motion by means of an articulating joint or by use of compliant materials. Ceramics, metals, or polymers, or combination thereof, are used in IVD prostheses, and it is the goal of this guide to enable a kinematic wear and/or fatigue comparison of these devices, regardless of material and type of device.
SCOPE
1.1 This guide provides guidance for wear and/or fatigue testing of total disc prostheses under functional and kinematic conditions and, to this end, describes test methods for assessment of the wear or functional characteristics, or both, of total disc prostheses.  
1.2 Both lumbar and cervical prostheses are addressed.  
1.3 Load and kinematic profiles for lumbar and cervical devices are not identical and, therefore, are addressed separately in the guide.  
1.4 Partial disc replacements, such as nucleus replacements or facet joint replacements, are not intended to be addressed.  
1.5 Wear is assessed using a weight loss method in a testing medium as defined in this guide.  
1.6 This guide does not address any potential failure mode as it relates to the fixation of the implant to its bony interfaces.  
1.7 It is the intent of this guide to enable comparison of intervertebral disc (IVD) prostheses with regard to wear and fatigue characteristics when tested under the specified conditions. It must be recognized, however, that there are many possible variations in in vivo conditions. A single laboratory simulation with a fixed set of parameters might not be universally representative.  
1.8 Most IVD prostheses primarily fall into two classifications: articulating ball-in-socket type prostheses, and elastomeric or compliant type prostheses. For the former, this guide primarily addresses Mode 1 wear (defined herein); whereas for the latter, this guide addresses potential failure of the prosthesis when the implant is subjected to a range of motion and/or loads that fall within the full range of possible physiologic motions and loads.  
1.9 For articulating components, this guide predominantly describes a Mode 1 test. The user is cautioned that other modes of wear may occur and may have significant influence on the functionality and performance of an articulating IVD prosthesis, and therefore the user should consider the effects of other wear modes on the performance of the prosthesis.  
1.10 In order that the data be reproducible and comparable within and between laboratories, it is essential that uniform procedures are established. This guide is intended to facilitate uniform methods for testing and reporting of data for total disc replacement prostheses.  
1.11 Without a substantial clinical retrieval history of IVD prostheses, actual loading profiles and patterns cannot be delineated at the time of the writing of this guide. It therefore follows that the load and motion conditions specified by this guide do not necessarily accurately reproduce those occurring in vivo. Rather, this guide provides useful boundary/endpoint conditions for evaluating prosthesis designs in a functional manner.  
1.12 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in either degrees or radians.  
1.13 This guide is not intended to be a performance standard. It is the responsibility of the user of this guide to characterize the safety and effectiveness of the prosthesis under evaluation.  
1.14 This standard does not purport to address all of th...

SIGNIFICANCE AND USE
5.1 Total Facet Prosthesis Components—The total facet replacement may comprise a variety of shapes and configurations. Its forms may include, but are not limited to, ball and socket articulating joints, joints having a free-floating or semi-constrained third body, metallic load-bearing surfaces, and spring and dampening mechanisms. Additionally, it may have a unilateral or bilateral design.  
5.2 Spinal Testing Apparatus:  
5.2.1 Test Chambers—In case of a multispecimen machine, each chamber shall be isolated to prevent cross-contamination of the test specimens. The chamber shall be made entirely of corrosion-resistant materials, such as acrylic plastic or stainless steel, and shall be removable from the machine for thorough cleaning between tests.  
5.2.2 Component Clamping/Fixturing—Since the purpose of the test is to characterize the wear and kinematic function of the total facet prosthesis, the method for mounting components in the test chamber shall not compromise the accuracy of assessment of the weight loss or stiffness variation during the test. For example, prostheses having complicated superior and inferior surfaces for contacting bone (for example, sintered beads, hydroxylapatite (HA) coating, plasma spray) may be specially manufactured to modify that surface in a manner that does not affect the wear simulation.  
5.2.3 The device should be securely (rigidly) attached at its bone-implant interface to the mating test fixtures.  
5.2.4 The motion of the superior test fixture (more posterior fixture in Figs. 1 and 2) relative to the inferior testing fixture shall be constrained in three-dimensional space except for the components in the direction of specified test motions/loads. .  
5.2.5 Load and Motion:  
5.2.5.1 Facet loads (fx) are initially applied in the direction of the positive X-axis.
5.2.5.2 Flexion load and motion are positive moment and rotation about the Y-axis.
5.2.5.3 Extension load and motion are negative moment and rotation about...
SCOPE
1.1 This practice provides guidance for the functional, kinematic, and wear testing of motion-preserving total facet prostheses for the lumbar spine. These implants are intended to allow motion and lend support to the functional spinal unit(s) through replacement of the natural facets.  
1.2 This test method is not intended to address the bone implant interface or the static characteristics of the prosthesis components. Fatigue characteristics are included, but only as a by-product of cyclic wear testing under facet load and thus are not addressed in the typical process of generating a Stress-Life (S-N) characterization.  
1.3 Biocompatibility of the materials used in a total facet prosthesis are not addressed in this practice.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4.1 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in 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 and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This test method deals with static, dynamic, and wear testing of extra-discal motion preserving implants. These implants are intended to augment spinal stability without significant tissue removal while allowing motion of the functional spinal unit(s). Wear is assessed using a weight loss method and a dimensional analysis for determining wear of components used in extra-discal spinal motion preserving procedures, using testing medium as defined in this test method. This test method is not intended to address facet arthroplasty devices and any potential failure mode as it relates to the fixation of the device to its bony interfaces; and does not prescribe methods for assessing the mechanical characteristics of the device in translation. The static test includes the static flexion test, static extension test, static torsion test, static lateral bending test, and fatigue tests. Wear test includes flexion/extension wear assessment, rotational wear assessment, and bending wear assessment. The apparatus which shall be used includes implant components and spinal testing apparatus. The calculation and interpretation of wear results are also elaborated.
SIGNIFICANCE AND USE
4.1 This test method is designed to quantify the static and dynamic characteristics of different designs of single level spinal constructs. Wear may also be assessed for implants that allow motion using testing medium (see 6.1) for simulating the physiologic environment at 37°C. Wear is assessed using a weight loss method in addition to dimensional analyses. Weight loss is determined after subjecting the implants to dynamic profiles specified in this test method. This information will allow the manufacturer or end user of the product to understand how the specific device in question performs under the test conditions prescribed in this test method.  
4.2 This test method is intended to be applicable for single level extra-discal spinal constructs. Three different types of fixtures are specified for testing single level extra-discal spinal constructs (See Fig. 2, Fig. 4, and Fig. 5). See also Table 1.Figure  
Loading Mode  
Rotational  
Fig. 2  
Flexion  
Extension  
Lateral Bending  
Axial Rotation  
Fig. 2 and Fig. 6  
Offset Flexion and Offset Extension  
Shear  
Fig. 4  
Anterior/Posterior Shear  
Compression Bending  
Fig. 5  
Compression Bending  
4.3 Implants may be designed using a variety of materials (for example, ceramics, metals, polymers, or combinations thereof), and it is the goal of this test method to enable a comparison of the static, dynamic, and wear properties generated by these devices, regardless of material and type of device.
SCOPE
1.1 This test method describes methods to assess the static and dynamic properties of single level spinal constructs.  
1.2 An option for assessing wear using a weight loss method and a dimensional analysis is given. This method, described herein, is used for the analysis of devices intended for motion preservation, using testing medium as defined in this standard (6.1).  
1.3 This test method is not intended to address any potential failure mode as it relates to the fixation of the device to its bony interfaces.  
1.4 It is the intent of this test method to enable single level extra-discal spinal constructs with regard to kinematic, functional, and wear characteristics when tested under the specified conditions.  
1.5 This test method is not intended to address facet arthroplasty devices.  
1.6 In order that the data be reproducible and comparable within and between laboratories, it is essential that uniform procedures be established. This test method is intended to facilitate uniform testing methods and data reporting.  
1.7 The motion profiles specified by this test method do not necessarily accurately reproduce those occurring in vivo. Rather this method provides useful bo...

SIGNIFICANCE AND USE
5.1 Spinal implants are generally composed of several components which, when connected together, form a spinal implant assembly. Spinal implant assemblies are designed to provide some stability to the spine while arthrodesis takes place. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies so that comparison between different designs may be facilitated.  
5.2 These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the spine.  
5.3 The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters.  
5.4 Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz.  
5.5 The location of the longitudinal elements is determined by where the anchors are clinically placed against bony structures. The perpendicular distance to the load direction (block moment arm) between the axis of a hinge pin and the anchor’s attachment-points to a UHMWPE block is independent of anchor-type. The distance between the anchor’s attachment point to the UHMWPE block an...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific, depending on the intended spinal location and intended method of application to the spine.  
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.  
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies.  
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly.  
1.5 Some spinal constructs 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 measurement are included in this standard.  
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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
5.1 Nucleus devices are generally designed to augment the mechanical function of native degenerated nucleus material or to replace tissue that has been removed during a surgical procedure. This guide outlines methods for evaluating many different types of devices. Comparisons between devices must be made cautiously and with careful analysis, taking into account the effects that design and functional differences can have on the testing configurations and overall performance, and the possibility that mechanical failure may not be related to clinical failure and inversely, that mechanical success may not be related to clinical success.  
5.2 These tests are conducted in vitro to allow for analysis of the mechanical performance of the nucleus device under specific testing modalities. The loads applied may differ from the complex loading seen in vivo, and therefore the results from these tests may not directly predict in vivo performance.  
5.3 These tests are used to quantify the static and dynamic properties and performance of different implant designs. The mechanical tests are conducted in vitro using simplified loads and moments. Fatigue testing in a simulated body fluid or saline may have fretting, aging, corroding, or lubricating effects on the device and thereby affect the relative performance of tested devices. Hence, the test environment and the effect of that environment, whether a simulated body fluid, normal saline bath (9 g NaCl per 1000 mL H2O), or dry, is an important characteristic of the test and must be reported accurately.  
5.4 Dynamic testing methods should be designed to answer the following questions, including but not limited to: Does the device still function as intended after cycling? Does it retain adequate performance characteristics (for example, mechanical and kinematic properties such as ROM)? Did the device wear or degrade? If there is evidence of wear or degradation of the device, it should be identified and quantified with reasonable ...
SCOPE
1.1 This guide describes various forms of nucleus replacement and nucleus augmentation devices. It further outlines the types of testing that are recommended in evaluating the performance of these devices.  
1.2 Biocompatibility of the materials used in a nucleus replacement device is not addressed in this guide. However, users should investigate the biocompatibility of their device separately (see X1.1).  
1.3 While it is understood that expulsion and endplate fractures represent documented clinical failures, this guide does not specifically address them, although some of the factors that relate to expulsion have been included (see X1.3).  
1.4 Multiple tests are described in this guide; however, the user need not use them all. It is the responsibility of the user of this guide to determine which tests are appropriate for the devices being tested and their potential application. Some tests may not be applicable for all types of devices. Moreover, some nucleus devices may not be stable in all test configurations. However, this does not necessarily mean that the test methods described are unsuitable.  
1.5 The science of nucleus device design is still very young and includes technology that is changing more quickly than this guide can be modified. Therefore, the user must carefully consider the applicability of this guide to the user’s particular device; the guide may not be appropriate for every device. For example, at the time of publication, this guide does not address the nucleus replacement and nucleus augmentation devices that are designed to be partially or completely resorbable in the body. However, some of the test recommended in this guide may be applicable to evaluate such devices. It has not been demonstrated that mechanical failure of nucleus devices is related to adverse clinical results. Therefore this standard should be used with care in evaluating proposed nucleus devices.  
1.6 This guide is not int...

SIGNIFICANCE AND USE
5.1 Facet Prosthesis Components—The facet replacement may comprise a variety of shapes and configurations. Its forms may include, but are not limited to, ball and socket articulating joints, joints having a free-floating or semi-constrained third body, metallic load-bearing surfaces, and spring and dampening mechanisms. Additionally, it may be a unilateral or bilateral design.  
5.2 These test methods are designed to quantify the static and dynamic characteristics of different designs of FP. The tests are conducted in vitro in order to allow for analysis of individual devices and comparison of the mechanical performance of multiple designs.  
5.3 The loads applied to the FP 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 in different devices.  
5.4 Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be conducted in a 0.9 % saline environmental bath at 37°C at a maximum rate of 10 Hz for all metallic devices and 2 Hz for non-metallic devices. Other test environments such as a simulated body fluid, a saline drip or mist, distilled water, other type of lubrication or dry could also be used with adequate justification. Likewise, alternative test frequencies may be used with adequate justification to ensure that it does not impact the device performance.  
5.5 It is well known that the failure of materials is dependent upon stress, test frequency, surface treatments, and environmental factors. Therefore, when determining the effect of changing these parameters (for example, frequency, material, or environment), care should be taken to allow for appropriate interpretation of the results. In particular, it may be necessary to assess the influence of test frequency on de...
SCOPE
1.1 This practice provides guidance for the static and dynamic testing of Lumbar Total Facet Prostheses (FP). These implants are intended to allow motion and lend support to one or more functional spinal unit(s) through replacement of the natural facets.  
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future non-biologic FP. These test methods allow comparison of devices with different methods of application to the lumbar spine. These test methods are intended to enable the user to mechanically compare devices and do not purport to provide performance standards for them.  
1.3 These test methods describe static and dynamic tests by specifying load types and specific methods of applying these loads.  
1.4 These test methods do not purport to address all clinically relevant failure modes for FP, some of which will be device specific. For example, these test methods do not address implant wear resistance under expected in vivo loads and motions. In addition, the biologic response to wear debris is not addressed in these test methods.  
1.5 Requirements are established for measuring displacements and evaluating the stiffness of FP.  
1.6 Some devices may not be testable in all test configurations.  
1.7 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians.  
1.8 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

SIGNIFICANCE AND USE
5.1 Occipital-cervical and occipital-cervical-thoracic spinal implants are generally composed of several components which, when connected together, form either an occipital-cervical spinal implant assembly or an occipital-cervical-thoracic spinal implant assembly. Occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are designed to provide some stability to the spine during the process of arthrodesis. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies to facilitate comparisons between different designs.  
5.2 These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the occipital-cervical and occipital-cervical-thoracic spine.  
5.3 The loads applied to the spinal implant assemblies  in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters.  
5.4 Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of the environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz.  
5.5 The location of the longitudinal elements is determined by the intended in vivo location of the...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of occipital-cervical and occipital-cervical-thoracic spinal implant components can be specific depending on the intended location and intended method of attachment.  
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future occipital-cervical and occipital-cervical-thoracic spinal implant assemblies. They allow comparison of occipital-cervical and occipital-cervical-thoracic spinal implant constructs with different methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.  
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and two fatigue tests for the comparative evaluation of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are defined.  
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of occipital-cervical or occipital-cervical-thoracic spinal implant assemblies.  
1.5 It may not be possible to test some occipital-cervical and some occipital-cervical-thoracic spinal constructs in all test configurations.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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 and health practices and determine the applicability ...

ABSTRACT
These specifications and test methods provide standard specifications that specify material, labeling, and handling requirements for components used in surgical fixation of the spinal skeletal system such as metallic spinal screws, spinal plates, and spinal rods. The specifications and test methods establish (1) common terminology that can be used to describe the size and other physical characteristics of spinal components and performance definitions related to the performance of spinal components, and (2) performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components. It is not the intention of these specifications and test methods to define levels of performance or case-specific clinical performance for spinal components and to describe or specify specific designs for the individual components. For these specifications and test methods may not be appropriate for all types of spinal surgical fixation systems, the appropriateness of these specifications in view of the particular implant system and its potential application shall be considered. The test methods include static and fatigue bending strength tests. Requirements for marking and packaging are specified as well.
SIGNIFICANCE AND USE
4.1 Spinal implant constructs are typically a compilation of several components. Screws, plates, and rods are integral components of many spinal implant constructs. These components are designed to transfer load between the bone and the longitudinal or transverse element, or both. These specifications and test methods identify specifications for such components and define standard equivalent test methods that can be used when evaluating different related component designs.  
4.2 Since the loading of spinal components in-vivo  may differ from the loading configurations addressed in these specifications and test methods, the results obtained from this document may not predict  in-vivo performance of either the components or the construct as a whole. Such tests can, however, be used to compare different component designs in terms of relevant mechanical performance characteristics.  
4.3 The performance-related mechanical characteristics determined by these specifications and test methods will supply the user with information that may be used to predict the mechanical performance of different design variations of similar (function and indication) spinal construct components.
SCOPE
1.1 These specifications and test methods are intended to provide a comprehensive reference for the components of systems used in the surgical fixation of the spinal skeletal system. The document catalogs standard specifications that specify material, labeling, and handling requirements. The specifications and test methods also establish common terminology that can be used to describe the size and other physical characteristics of spinal components and performance definitions related to the performance of spinal components. Additionally, the specifications and test methods establish performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components.  
1.2 These specifications and test methods are part of a series of standards addressing systems used in the surgical fixation of the spinal skeletal system. These specifications and test methods concentrate on the individual components, which are found in many spinal fixation systems. If the user is interested in evaluating the next level in the spinal fixation system chain, the interconnections between individual components and subassemblies (two or more components), the user should consult Guide F1798. At the highest level in this chain is Test Methods F1717, which is used to evaluate an entire construct assembled from many components and involves numerous interconnections and several subassemblies.  
1.3 It is not the intention of th...

SIGNIFICANCE AND USE
5.1 Intervertebral body fusion device assemblies are generally simple geometric-shaped devices which are often porous or hollow in nature. Their function is to support the anterior column of the spine 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 intervertebral body fusion device assemblies so that comparisons can be made between different designs.  
5.2 This test method is designed to quantify the static and dynamic characteristics of different designs of intervertebral body fusion device assemblies. These tests are conducted in vitro to allow for analysis and comparison of the mechanical performance of intervertebral body fusion device assemblies to specific force modalities.  
5.3 The forces applied to the intervertebral body fusion assemblies 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 intervertebral body fusion device assemblies.  
5.4 Since the environment may affect the dynamic performance of intervertebral body fusion device assemblies, dynamic testing in a saline environment may be considered. 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 desired, the investigator should consider testing in a saline environmental bath at 37°C (for example, 0.9-g NaCl per 100-mL water) at a rate of 1 Hz or less. 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.  
5.5 If the devices are known to be temperature and environment dependent, testing should be conducted in physiologic solution as described in 5.4. Devices that require p...
SCOPE
1.1 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment.  
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies.  
1.3 The test method describes 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 intervertebral body fusion device assemblies.  
1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.  
1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).  
1.6 Guidelines are established for measuring displacements, determining the yield force or moment, evaluating the stiffness, and strength of the intervertebral body fusion device assemblies.  
1.7 Some intervertebral body fusion device assemblies may not be testable in all test configurations.  
1.8 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.  
1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the...

SIGNIFICANCE AND USE
5.1 Spinal implants are generally composed of several components which, when connected together, form a spinal implant assembly. Spinal implant assemblies are designed to provide some stability to the spine while arthrodesis takes place. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies so that comparison between different designs may be facilitated.  
5.2 These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the spine.  
5.3 The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters.  
5.4 Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz.  
5.5 The location of the longitudinal elements is determined by where the anchors are clinically placed against bony structures. The perpendicular distance to the load direction (block moment arm) between the axis of a hinge pin and the anchor’s attachment-points to a UHMWPE block is independent of anchor-type. The distance between the anchor’s attachment point to the UHMWPE block an...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific, depending on the intended spinal location and intended method of application to the spine.  
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.  
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies.  
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly.  
1.5 Some spinal constructs 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 measurement are included in this standard.  
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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
5.1 Spinal implants are generally composed of several components that, when connected together, form a spinal implant construct. Spinal implant constructs are designed to provide some stability to the spine while arthrodesis takes place. This test method outlines standardized evaluations of different interconnection mechanisms to facilitate comparison between different designs. Comparisons must be made cautiously and with careful analysis, taking into account the effects that design differences can have on the loading configurations.  
5.2 This test method is used to quantify the static and fatigue properties of different implant interconnection designs. The mechanical tests are conducted in vitro using simplified, unidirectional loads and moments. Fatigue testing in a simulated body fluid or saline may have a fretting, corrosive, or lubricating effect on the interconnection and thereby affect the relative performance of tested devices. Hence, the test environment, whether a simulated body fluid, saline (9g NaCl per 1000 mL H2O), with a saline drip, or dry, is an important characteristic of the test and must be reported accurately.  
5.3 The loading of spinal implant constructs in vivo will, in general, differ from the loading configurations used in this test method. The results obtained here cannot be used directly to predict in vivo performance. However, the results can be used to compare different component designs in terms of relative mechanical parameters.
SCOPE
1.1 This test method covers the measurement of uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of spinal arthrodesis implants.  
1.2 The purpose of this test method is to provide a means of mechanically characterizing different designs of spinal implant interconnections. Ultimately, the various components and interconnections should be combined for static and fatigue testing of the spinal implant construct. It is not the intention of this test method to address the analysis of spinal implant constructs or subconstructs or to define levels of performance of spinal implants as insufficient knowledge is available to predict the consequences of the use of particular spinal implant designs.  
1.3 This test method sets out definitions for use in measuring the strength of component interconnections of spinal implants, possible test methods themselves, and the reporting of test results.  
1.4 The values stated in SI units are to be regarded as 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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
5.1 Total Facet Prosthesis Components—The total facet replacement may comprise a variety of shapes and configurations. Its forms may include, but are not limited to, ball and socket articulating joints, joints having a free-floating or semi-constrained third body, metallic load-bearing surfaces, and spring and dampening mechanisms. Additionally, it may be a unilateral or bilateral design.  
5.2 Spinal Testing Apparatus:
5.2.1 Test Chambers—In case of a multispecimen machine, each chamber shall be isolated to prevent cross-contamination of the test specimens. The chamber shall be made entirely of corrosion resistant materials, such as acrylic plastic or stainless steel, and shall be removable from the machine for thorough cleaning between tests.  
5.2.2 Component Clamping/Fixturing—Since the purpose of the test is to characterize the wear and kinematic function of the total facet prosthesis, the method for mounting components in the test chamber shall not compromise the accuracy of assessment of the weight loss or stiffness variation during the test. For example, prostheses having complicated superior and inferior surfaces for contacting bone (for example, sintered beads, hydroxylapatite (HA) coating, plasma spray) may be specially manufactured to modify that surface in a manner that does not affect the wear simulation.  
5.2.3 The device should be securely (rigidly) attached at its bone-implant interface to the mating test fixtures.  
5.2.4 The motion of the superior test fixture (more posterior fixture in Figs. 1 and 2) relative to the inferior testing fixture shall be constrained in three-dimensional space except for the components in the direction of specified test motions/loads. Note 1—This setup would require two rotational actuators and one translational actuator.
FIG. 1 Diagrams of Possible Test Apparatus for Allowing Simultaneous Lateral Bending and Axial Rotation Motions with Anterior-Posterior Directed Facet LoadingNote 1—This setup would requ...
SCOPE
1.1 This practice provides guidance for the functional, kinematic and wear testing of motion-preserving total facet prostheses for the lumbar spine. These implants are intended to allow motion and lend support to the functional spinal unit(s) through replacement of the natural facets.  
1.2 This test method is not intended to address the bone implant interface or the static characteristics of the prosthesis components. Fatigue characteristics are included, but only as a by-product of cyclic wear testing under facet load and thus are not addressed in the typical process of generating an S-N characterization.  
1.3 Biocompatibility of the materials used in a total facet prosthesis are not addressed in this practice.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4.1 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in 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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
5.1 Spinal implants are generally composed of several components which, when connected together, form a spinal implant assembly. Spinal implant assemblies are designed to provide some stability to the spine while arthrodesis takes place. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies so that comparison between different designs may be facilitated.  
5.2 These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the spine.  
5.3 The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters.  
5.4 Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz.  
5.5 The location of the longitudinal elements is determined by where the anchors are clinically placed against bony structures. The perpendicular distance to the load direction (block moment arm) between the axis of a hinge pin and the anchor’s attachment-points to a UHMWPE block is independent of anchor-type. The distance between the anchor’s attachment point to the UHMWPE block an...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific, depending on the intended spinal location and intended method of application to the spine.  
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.  
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies.  
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly.  
1.5 Some spinal constructs 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 measurement are included in this standard.  
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 and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This test method deals with static, dynamic, and wear testing of extra-discal motion preserving implants. These implants are intended to augment spinal stability without significant tissue removal while allowing motion of the functional spinal unit(s). Wear is assessed using a weight loss method and a dimensional analysis for determining wear of components used in extra-discal spinal motion preserving procedures, using testing medium as defined in this test method. This test method is not intended to address facet arthroplasty devices and any potential failure mode as it relates to the fixation of the device to its bony interfaces; and does not prescribe methods for assessing the mechanical characteristics of the device in translation. The static test includes the static flexion test, static extension test, static torsion test, static lateral bending test, and fatigue tests. Wear test includes flexion/extension wear assessment, rotational wear assessment, and bending wear assessment. The apparatus which shall be used includes implant components and spinal testing apparatus. The calculation and interpretation of wear results are also elaborated.
SIGNIFICANCE AND USE
This test method is designed to quantify the static and dynamic characteristics of different designs of single level spinal constructs. Wear may also be assessed for implants that allow motion using testing medium (see 6.1) for simulating the physiologic environment at 37°C. Wear is assessed using a weight loss method in addition to dimensional analyses. Weight loss is determined after subjecting the implants to dynamic profiles specified in this test method. This information will allow the manufacturer or end user of the product to understand how the specific device in question performs under the test conditions prescribed in this test method.
This test method is intended to be applicable for single level extra-discal spinal constructs. Three different types of fixtures are specified for testing single level extra-discal spinal constructs (See Fig. 2, Fig. 4, and Fig. 5). See also Table 1.
Implants may be designed using a variety of materials (for example, ceramics, metals, polymers, or combinations thereof), and it is the goal of this test method to enable a comparison of the static, dynamic, and wear properties generated by these devices, regardless of material and type of device.
TABLE 1 Loading Modes and Associated Apparatus Listing Possible Tests That May Be Conducted (see 1.9)
Note 1—For all loading modes, static, dynamic, and wear tests are described in this test method.
Note 2—“Offset” refers to 8 mm of offset induced in the spinal construct (see Fig. 6) before subjecting the construct to rotational flexion/extension moments (see Fig. 2).  Associated
ApparatusAssociated
FigureLoading Mode RotationalFig. 2Flexion Extension Lateral Bending Axial Rotation  Fig. 2 and Fig. 6Offset Flexion and Offset Extension  ShearFig. 4Anterior/Posterior Shear  Compression BendingFig. 5Compression Bending
FIG. 4 Schematic of Anterior/Posterior Shear Testing Apparatus
FIG. 5 Schematic of Single Level Compression Bending Test
SCOPE
1.1 This test method describes methods to assess the static and dynamic properties of single level spinal constructs.
1.2 An option for assessing wear using a weight loss method and a dimensional analysis is given. This method, described herein, is used for the analysis of devices intended for motion preservation, using testing medium as defined in this standard (6.1).
1.3 This test method is not intended to address any potential failure mode as it relates to the fixation of the device to its bony interfaces.
1.4 It is the intent of this test method to enable single level extra-discal spinal constructs with regard to kinematic, functional, and wear characteristics when tested under the specified conditions.
1.5 This test method is not intended to address facet arthroplasty devices.
1.6 In or...

SIGNIFICANCE AND USE
5.1 Spinal implants are generally composed of several components which, when connected together, form a spinal implant assembly. Spinal implant assemblies are designed to provide some stability to the spine while arthrodesis takes place. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies so that comparison between different designs may be facilitated.  
5.2 These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the spine.  
5.3 The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters.  
5.4 Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz.  
5.5 The location of the longitudinal elements is determined by where the anchors are clinically placed against bony structures. The perpendicular distance to the load direction (block moment arm) between the axis of a hinge pin and the anchor's attachment-points to a UHMWPE block is independent of anchor-type. The distance between the anchor's attachment point to the UHMWPE block an...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific, depending on the intended spinal location and intended method of application to the spine.  
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.  
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies.  
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly.  
1.5 Some spinal constructs 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 measurement are included in this standard.  
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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
Spinal implants are generally composed of several components which, when connected together, form a spinal implant assembly. Spinal implant assemblies are designed to provide some stability to the spine while arthrodesis takes place. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies so that comparison between different designs may be facilitated.
These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the spine.
The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters.
Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz.
The location of the longitudinal elements is determined by where the anchors are clinically placed against bony structures. The perpendicular distance to the load direction (block moment arm) between the axis of a hinge pin and the anchor's attachment-points to a UHMWPE block is independent of anchor-type. The distance between the anchor's attachment point to the UHMWPE block and the center of the long...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific, depending on the intended spinal location and intended method of application to the spine.
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies.
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly.
1.5 Some spinal constructs 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 measurement are included in this standard.
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 and health practices and determine the applicability of regulatory limitations prior to use.

SCOPE
1.1 This terminology covers basic terms and considerations for spinal implant devices and their mechanical analyses.

SIGNIFICANCE AND USE
Intervertebral body fusion devices are generally simple geometric shaped devices, which are often porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment.  
This test method is designed to quantify the subsidence characteristics of different designs of intervertebral body fusion devices since this is a potential clinical failure mode. These tests are conducted in vitro in order to simplify the comparison of simulated vertebral body subsidence induced by the intervertebral body fusion devices.
The static axial compressive loads that will be applied to the intervertebral body fusion devices and test blocks will differ from the complex loading seen in vivo, and therefore, the results from this test method may not be used to directly predict in vivo performance. The results, however, can be used to compare the varying degrees of subsidence between different intervertebral body fusion device designs for a given density of simulated bone.
The location within the simulated vertebral bodies and position of the intervertebral body fusion device with respect to the loading axis will be dependent upon the design and manufacturer's recommendation for implant placement.
SCOPE
1.1 This test method specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices, spinal implants designed to promote arthrodesis at a given spinal motion segment.
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future non-biologic intervertebral body fusion devices. This test method is intended to enable the user to mechanically compare intervertebral body fusion devices and does not purport to provide performance standards for intervertebral body fusion devices.
1.3 This test method describes a static test method by specifying a load type and a specific method of applying this load. This test method is designed to allow for the comparative evaluation of intervertebral body fusion devices.
1.4 Guidelines are established for measuring test block deformation and determining the subsidence of intervertebral body fusion devices.
1.5 Since some intervertebral body fusion devices require the use of additional implants for stabilization, the testing of these types of implants may not be in accordance with the manufacturer's recommended usage.
1.6 Units—The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians.
1.7 The use of this standard may involve the operation of potentially hazardous equipment. 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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
Artificial intervertebral discs are orthopaedic implants that replace degenerated natural intervertebral discs. Their function is to support the anterior column of the spine while allowing motion at the operated level. These test methods outline materials and methods for the characterization of the mechanical performance of different artificial intervertebral discs so that comparisons can be made between different designs.
These test methods are designed to quantify the static and dynamic characteristics of different designs of artificial intervertebral discs. These tests are conducted in vitro in order to allow for analysis of individual disc replacement devices and comparison of the mechanical performance of multiple artificial intervertebral disc designs in a standard model.
The loads applied to the artificial intervertebral discs 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 artificial intervertebral discs.
Fatigue tests should be conducted in a 0.9 % saline environmental bath at 37°C at a rate of 2 Hz or less. Other test environments such as a simulated body fluid, a saline drip or mist, distilled water, or other type of lubrication could also be used with adequate justification. Likewise, alternative test frequencies may be used with adequate justification.
It is well known that the failure of materials is dependent upon stress, test frequency, surface treatments, and environmental factors. Therefore, when determining the effect of changing one of these parameters (for example, frequency, material, or environment), all others should be kept constant to facilitate interpretation of the results. In particular, it may be necessary to assess the influence of test frequency on device fracture while holding the test environment, implant materials and processing, and implant geometry con...
SCOPE
1.1 These test methods specify the materials and methods for the static and dynamic testing of artificial intervertebral discs.
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future non-biologic artificial intervertebral discs. These test methods allow comparison of artificial intervertebral discs with different intended spinal locations (cervical, thoracic, and lumbar) and methods of application to the intervertebral spaces. These test methods are intended to enable the user to mechanically compare artificial intervertebral discs and do not purport to provide performance standards for artificial intervertebral discs.
1.3 These test methods describe static and dynamic tests by specifying load types and specific methods of applying these loads. These tests are designed to allow for the comparative evaluation of artificial intervertebral discs.
1.4 These test methods do not purport to address all clinically relevant failure modes for artificial intervertebral discs, some of which will be device specific. For example, these test methods do not address the implant's resistance to expulsion or implant wear resistance under expected in vivo loads and motions. In addition, the biologic response to wear debris is not addressed in these test methods.
1.5 Requirements are established for measuring displacements, determining the yield load or moment, and evaluating the stiffness of artificial intervertebral discs.
1.6 Some artificial intervertebral discs may not be testable in all test configurations.
1.7 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians.
1.8 The use of this standard may involve the operation of potentially hazardous equipment. This standard does not purport to address all of the safety concerns, if any, associated with it...

SIGNIFICANCE AND USE
Intervertebral body fusion device assemblies are generally simple geometric-shaped devices which are often porous or hollow in nature. Their function is to support the anterior column of the spine 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 intervertebral body fusion device assemblies so that comparisons can be made between different designs.
This test method is designed to quantify the static and dynamic characteristics of different designs of intervertebral body fusion device assemblies. These tests are conducted in vitro to allow for analysis and comparison of the mechanical performance of intervertebral body fusion device assemblies to specific force modalities.
The forces applied to the intervertebral body fusion assemblies 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 intervertebral body fusion device assemblies.
Since the environment may affect the dynamic performance of intervertebral body fusion device assemblies, dynamic testing in a saline environment may be considered. 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 desired, the investigator should consider testing in a saline environmental bath at 37°C (for example, 0.9-g NaCl per 100-mL water) at a rate of 1 Hz or less. 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.
If the devices are known to be temperature and environment dependent, testing should be conducted in physiologic solution as described in 5.4. Devices that require physiologic solution for ...
SCOPE
1.1 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment.
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies.
1.3 The test method describes 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 intervertebral body fusion device assemblies.
1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.
1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).  
1.6 Guidelines are established for measuring displacements, determining the yield force or moment, evaluating the stiffness, and strength of the intervertebral body fusion device assemblies.
1.7 Some intervertebral body fusion device assemblies may not be testable in all test configurations.
1.8 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.
1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the respon...

SIGNIFICANCE AND USE
This guide can be used to determine the fatigue and wear behavior of IVD prostheses subjected to functional and kinematic cyclic loading/motion for relatively large numbers of cycles (for example, various designs of IVD prostheses, as well as the effects of materials, manufacturing techniques and other design variables on one particular design can be determined using this guide).
This guide is intended to be applicable to IVD prostheses that support load and transmit motion by means of an articulating joint or by use of compliant materials. Ceramics, metals, or polymers, or combination thereof, are used in IVD prosthesis, and it is the goal of this guide to enable a kinematic wear and/or fatigue comparison of these devices, regardless of material and type of device.
SCOPE
1.1 This guide provides guidance for wear and/or fatigue testing of total disc prostheses under functional and kinematic conditions and, to this end, describes test methods for assessment of the wear or functional characteristics, or both, of total disc prostheses.
1.2 Both lumbar and cervical prostheses are addressed.
1.3 Load and kinematic profiles for lumbar and cervical devices are not identical and, therefore, are addressed separately in the guide.
1.4 Partial disc replacements, such as nucleus replacements or facet joint replacements, are not intended to be addressed.
1.5 Wear is assessed using a weight loss method in a testing medium as defined in this guide.
1.6 This guide does not address any potential failure mode as it relates to the fixation of the implant to its bony interfaces.
1.7 It is the intent of this guide to enable comparison of intervertebral disc (IVD) prostheses with regard to wear and fatigue characteristics when tested under the specified conditions. It must be recognized, however, that there are many possible variations in the in vivo conditions. A single laboratory simulation with a fixed set of parameters might not be universally representative.
1.8 Most IVD prostheses primarily fall into two classifications: articulating ball-in-socket type prostheses, and elastomeric or compliant type prostheses. For the former, this guide primarily addresses Mode 1 wear (defined herein); whereas for the latter, this guide addresses potential failure of the prosthesis when the implant is subjected to a range of motion and/or loads that fall within the full range of possible physiologic motions and loads.
1.9 For articulating components, this guide predominantly describes a Mode 1 test. The user is cautioned that other modes of wear may occur and may have significant influence on the functionality and performance of an articulating IVD prosthesis, and therefore the user should consider the effects of other wear modes on the performance of the prosthesis.
1.10 In order that the data be reproducible and comparable within and between laboratories, it is essential that uniform procedures are established. This guide is intended to facilitate uniform methods for testing and reporting of data for total disc replacement prostheses.  
1.11 Without a substantial clinical retrieval history of IVD prostheses, actual loading profiles and patterns cannot be delineated at the time of the writing of this guide. It therefore follows that the load and motion conditions specified by this guide do not necessarily accurately reproduce those occurring in vivo. Rather, this guide provides useful boundary/endpoint conditions for evaluating prosthesis designs in a functional manner.
1.12 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in either degrees or radians.
1.13 This guide is not intended to be a performance standard. It is the responsibility of the user of this guide to characterize the safety and effectiveness of the prosthesis under evaluation.
1.14 This standard does not purport to address all of the safety concerns,...

SIGNIFICANCE AND USE
Spinal implants are generally composed of several components which, when connected together, form a spinal implant assembly. Spinal implant assemblies are designed to provide some stability to the spine while arthrodesis takes place. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies so that comparison between different designs may be facilitated.
These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the spine.
The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters.
Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz.
The location of the longitudinal elements is determined by where the anchors are clinically placed against bony structures. The perpendicular distance to the load direction (block moment arm) between the axis of a hinge pin and the anchor's attachment-points to a UHMWPE block is independent of anchor-type. The distance between the anchor's attachment point to the UHMWPE block and the center of the long...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific depending on the intended spinal location and intended method of application to the spine.
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies.
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly.
1.5 Some spinal constructs 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 measurement are included in this standard.
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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
Spinal implants are generally composed of several components which, when connected together, form a spinal implant assembly. Spinal implant assemblies are designed to provide some stability to the spine while arthrodesis takes place. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies so that comparison between different designs may be facilitated.
These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the spine.
The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters.
Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz.
The location of the longitudinal elements is determined by where the anchors are clinically placed against bony structures. The perpendicular distance to the load direction (block moment arm) between the axis of a hinge pin and the anchor's attachment-points to a UHMWPE block is independent of anchor-type. The distance between the anchor's attachment point to the UHMWPE block and the center of the long...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific depending on the intended spinal location and intended method of application to the spine.
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies.
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly.
1.5 Some spinal constructs 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 measurement are included in this standard.
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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
Spinal implants are generally composed of several components which, when connected together, form a spinal implant assembly. Spinal implant assemblies are designed to provide some stability to the spine while arthrodesis takes place. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies so that comparison between different designs may be facilitated.
These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the spine.
The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters.
Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz.
The location of the longitudinal elements is determined by where the anchors are clinically placed against bony structures. The perpendicular distance to the load direction (block moment arm) between the axis of a hinge pin and the anchor's attachment-points to a UHMWPE block is independent of anchor-type. The distance between the anchor's attachment point to the UHMWPE block and the center of the long...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific depending on the intended spinal location and intended method of application to the spine.
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies.
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly.
1.5 Some spinal constructs 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 measurement are included in this standard.
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 and health practices and determine the applicability of regulatory limitations prior to use.