1.1 This test method covers the test procedure for determining the axial pull-out strength of medical bone screws. 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 and health practices and determine the applicability of regulatory limitations prior to use.

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4.1 The bi-directional axial compressive load test provides separate, direct measurements of the pile side shear mobilized above an embedded jack assembly and the pile end bearing plus any side shear mobilized below the jack assembly. The maximum mobilized pile resistance equals two times the maximum load applied by the jack assembly. Test results may also provide information used to assess the distribution of side shear resistance along the pile, the amount of end bearing mobilized at the pile bottom, and the long-term load-displacement behavior.4.2 The specified maximum test load should be consistent with the engineer’s desired test outcome. For permanent (working) piles, the engineer may require that the magnitude of applied test load be limited in order to measure the pile movement at a predetermined proof load as part of a quality control or quality assurance program. Tests that attempt to fully mobilize the axial compressive resistance of the test pile may allow the engineer to improve the efficiency of the pile design by reducing the piling length, quantity, or size.4.3 The engineer and other interested parties may analyze the results of a bi-directional axial compressive load test to estimate the load versus movement behavior and the pile capacity that would be measured during axial static compressive or tensile loading applied at the pile top (see Notes 1-3). Factors that may affect the pile response to axial static loading during a static test include, but are not limited to the:(1) pile installation equipment and procedures,(2) elapsed time since initial installation,(3) pile material properties and dimensions,(4) type, density, strength, stratification, and groundwater conditions both adjacent to and beneath the pile,(5) test procedure,(6) prior load cycles.NOTE 1: To estimate the load displacement curve for the pile as if it were loaded in compression at the top (as in Test Methods D1143/D1143M), the engineer may use strain and movement compatibility to sum the pile capacity mobilized above and below the embedded jack assembly for a given pile-top movement. This “top-load” curve will be limited by the lesser of the displacement measured above or below the embedded jack assembly. To obtain adequate minimum displacement during the test, the engineer may wish to specify a maximum test load greater than the desired equivalent “top load”.NOTE 2: A bi-directional load test applies the test load within the pile, resulting in internal pile stresses and pile displacements that differ from those developed during a load test applied at the pile top. Bi-directional testing will generally not test the structural suitability of a pile to support a load as typically placed at the pile top. Structural defects near the pile top may go undetected unless separate integrity tests are performed prior to or after bi-directional testing (see Note 8). The analysis of bi-directional load test results to estimate the pile-top movement that would be measured by applying a compressive load at the top of the pile should consider strain compatibility and load-displacement behavior. ASTM D1143/D1143M provides a standard test method for the direct measurement of pile top movement during an axial static compressive load applied at the pile top.NOTE 3: The analysis of bi-directional load test results to estimate pile displacements that would be measured by applying a tensile (uplift) load at the top of the pile should consider strain and movement compatibility. Users of this standard are cautioned to interpret conservatively the tensile capacity estimated from the analysis of a compressive load. ASTM D3689/D3689M provides a standard test method for the direct measurement of axial static tensile capacity.4.4 For the purpose of fully mobilizing the axial compressive capacity, the engineer will usually locate the jack assembly at a location within pile where the capacity above the assembly equals the capacity below it. A poorly chosen assembly location may result in excessive movement above or below the jack assembly, limiting the applied load and reducing the usefulness of the test result. Determination of the assembly’s location requires suitable site characterization, consideration of construction methods, and the proper application of engineering principles and judgement (see Note 4). More complex test configurations, using multiple levels of jack assemblies, may provide a higher probability that the full resistance of the pile along its entire length may be determined. Details regarding such complex arrangements are beyond the scope of this standard.NOTE 4: The bi-directional load test may not fully mobilize the axial compressive pile resistance in all sections of the pile. Practical, economical, or code considerations may also result in bi-directional load tests that are not intended to fully mobilize the axial resistance in some or all sections of the pile. In these cases, interpretation of the bi-directional test may under-predict the total axial compressive capacity of the pile.NOTE 5: The quality of the results produced by this test method are dependent on the competence of the personnel performing it, and the suitability of the equipment and facilities used. Agencies that meet the criteria of Practice D3740 are generally considered capable of competent and objective testing/sampling/ inspection/etc. Users of this test method are cautioned that compliance with Practice D3740 does not in itself assure reliable results. Reliable results depend on many factors; Practice D3740 provides a means of evaluating some of those factors.1.1 The test methods described in this standard measure the axial displacement of a single, deep foundation element when loaded in bi-directional static axial compression using an embedded bi-directional jack assembly. These methods apply to all deep foundations, referred to herein as “piles,” which function in a manner similar to driven piles, cast in place piles, or barrettes, regardless of their method of installation. The test results may not represent the long-term performance of a deep foundation.1.2 This standard provides minimum requirements for testing deep foundations under bi-directional static axial compressive load. Plans, specifications, and/or provisions prepared by a qualified engineer may provide additional requirements and procedures as needed to satisfy the objectives of a particular test program. The engineer in charge of the foundation design, referred to herein as the engineer, shall approve any deviations, deletions, or additions to the requirements of this standard.1.3 This standard provides the following test procedures:Procedure A Quick Test 9.2.1Procedure B Extended Test (optional) 9.2.21.4 Apparatus and procedures herein designated “optional” may produce different test results and may be used only when approved by the engineer. The word “shall” indicates a mandatory provision, and the word “should” indicates a recommended or advisory provision. Imperative sentences indicate mandatory provisions.1.5 The engineer may use the results obtained from the test procedures in this standard to predict the actual performance and adequacy of piles used in the constructed foundation. See Appendix X1 for comments regarding some of the factors influencing the interpretation of test results.1.6 A qualified engineer (specialty engineer, not to be confused with the foundation engineer as defined above) shall design and approve the load test configuration and test procedures. The text of this standard references notes and footnotes which provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of the standard. This standard also includes illustrations and appendixes intended only for explanatory or advisory use.1.7 Units—The values stated in either SI units or inch-pound units (presented in brackets) are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. Reporting of test results in units other than SI shall not be regarded as nonconformance with this test method.1.8 The gravitational system of inch-pound units is used when dealing with inch-pound units. In this system, the pound (lbf) represents a unit of force (weight), while the unit for mass is slugs. The rationalized slug unit is not given, unless dynamic (F=ma) calculations are involved.1.9 All observed and calculated values shall conform to the guidelines for significant digits and rounding established in Practice D6026.1.9.1 The procedures used to specify how data are collected, recorded and calculated in this standard are regarded as the industry standard. In addition, they are representative of the significant digits that should generally be retained. The procedures used do not consider material variation, purpose for obtaining the data, special purpose studies, or any considerations for the user’s objectives; and it is common practice to increase or reduce significant digits of reported data to be commensurate with these considerations. It is beyond the scope of this standard to consider significant digits used in analysis methods for engineering design.1.10 This standard offers an organized collection of information or a series of options and does not recommend a specific course of action. This document cannot replace education or experience and should be used in conjunction with professional judgment. Not all aspects of this guide may be applicable in all circumstances. This ASTM standard is not intended to represent or replace the standard of care by which the adequacy of a given professional service must be judged, nor should this document be applied without consideration of a project's many unique aspects. The word “Standard” in the title of this document means only that the document has been approved through the ASTM consensus process.1.11 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.1.12 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.

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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.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.

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4.1 This test method will provide a relationship between time to failure, creep rate, and displacement to failure for specific failure loads at specific test temperatures as well as a relationship between creep rate and applied load at specific test temperatures for loads less than failure loads.4.2 Pile design for specific soil temperatures may be controlled by either limiting long-term stress to below long-term strength or by limiting allowable settlement over the design life of the structure. It is the purpose of this test method to provide the basic information from which the limiting strength or long-term settlement may be evaluated by geotechnical engineers.4.3 Data derived from pile tests at specific ground temperatures that differ from the design temperatures must be corrected to the design temperature by the use of data from additional pile tests, laboratory soil strength tests, or published correlations, if applicable, to provide a suitable means of correction.4.4 For driven piles or grouted piles, failure will occur at the pile/soil interface. For slurry piles, failure can occur at either the pile/slurry interface or the slurry/soil interface, depending on the strength and deformation properties of the slurry material and the adfreeze bond strength. Location of the failure surface must be taken into account in the design of the test program and in the interpretation of the test results. Dynamic loads must be evaluated separately.NOTE 1: The quality of the results produced by application of this standard is dependent on the competence of the personnel performing it, and the suitability of the equipment and facilities. Agencies that meet the criteria of Practice D3740 are generally considered capable of competent and objective testing/sampling/inspection/etc. Users of this standard are cautioned that compliance with Practice D3740 does not in itself assure reliable results. Reliable results depend on many factors; Practice D3740 provides a means of evaluating some of those factors.1.1 The test methods described in this standard measure the axial deflection of a vertical or inclined deep foundation when loaded in static axial compression. These methods apply to all deep foundations, referred to herein as piles, that function in a manner similar to driven piles or cast-in-place piles, regardless of their method of installation, and may be used for testing single piles or pile groups. The test results may not represent the long-term performance of a deep foundation.1.2 This standard provides minimum requirements for testing deep foundations under static axial compressive load. Plans, specifications, and/or provisions prepared by a qualified engineer may provide additional requirements and procedures as needed to satisfy the objectives of a particular test program. The engineer in responsible charge of the foundation design, referred to herein as the Engineer, shall approve any deviations, deletions, or additions to the requirements of this standard.1.3 This standard allows the following test procedures:Procedure A Quick Test 8.1.2Procedure B Maintained Test (Optional) 8.1.3Procedure C Loading in Excess of Maintained Test (Optional) 8.1.4Procedure D Constant Time Interval Test (Optional) 8.1.5Procedure E Constant Rate of Penetration Test (Optional) 8.1.6Procedure F Constant Movement Increment Test (Optional) 8.1.7Procedure G Cyclic Loading Test (Optional) 8.1.81.4 Apparatus and procedures herein designated “optional” may produce different test results and may be used only when approved by the Engineer. The word “shall” indicates a mandatory provision, and the word “should” indicates a recommended or advisory provision. Imperative sentences indicate mandatory provisions.1.5 A qualified geotechnical engineer should interpret the test results obtained from the procedures of this standard so as to predict the actual performance and adequacy of piles used in the constructed foundation. See Appendix X1 for comments regarding some of the factors influencing the interpretation of test results.1.6 A qualified engineer shall design and approve all loading apparatus, loaded members, support frames, and test procedures. The text of this standard references notes and footnotes which provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of the standard. This standard also includes illustrations and appendixes intended only for explanatory or advisory use.1.7 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.1.8 The gravitational system of inch-pound units is used when dealing with inch-pound units. In this system, the pound [lbf] represents a unit of force [weight], while the unit for mass is slugs. The rationalized slug unit is not given, unless dynamic [F=ma] calculations are involved.1.9 All observed and calculated values shall conform to the guidelines for significant digits and rounding established in Practice D6026.1.10 The method used to specify how data are collected, calculated, or recorded in this standard is not directly related to the accuracy to which the data can be applied in design or other uses, or both. How one applies the results obtained using this standard is beyond its scope.1.11 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. Specific precautionary statements are given in Section 9.1.12 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.

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4.1 The axial force fatigue test is used to determine the effect of variations in material, geometry, surface condition, stress, and so forth, on the fatigue resistance of metallic materials subjected to direct stress for relatively large numbers of cycles. The results may also be used as a guide for the selection of metallic materials for service under conditions of repeated direct stress.4.2 In order to verify that such basic fatigue data generated using this practice is comparable, reproducible, and correlated among laboratories, it may be advantageous to conduct a round-robin-type test program from a statistician's point of view. To do so would require the control or balance of what are often deemed nuisance variables; for example, hardness, cleanliness, grain size, composition, directionality, surface residual stress, surface finish, and so forth. Thus, when embarking on a program of this nature it is essential to define and maintain consistency a priori, as many variables as reasonably possible, with as much economy as prudent. All material variables, testing information, and procedures used should be reported so that correlation and reproducibility of results may be attempted in a fashion that is considered reasonably good current test practice.4.3 The results of the axial force fatigue test are suitable for application to design only when the specimen test conditions realistically simulate service conditions or some methodology of accounting for service conditions is available and clearly defined.1.1 This practice covers the procedure for the performance of axial force controlled fatigue tests to obtain the fatigue strength of metallic materials in the fatigue regime where the strains are predominately elastic, both upon initial loading and throughout the test. This practice is limited to the fatigue testing of axial unnotched and notched specimens subjected to a constant amplitude, periodic forcing function in air at room temperature.1.2 The use of this test method is limited to specimens and does not cover testing of full-scale components, structures, or consumer products.1.3 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.1.4 The text of this standard references notes and footnotes that provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of the standard.NOTE 1: The following documents, although not directly referenced in the text, are considered important enough to be listed in this practice:E739 Practice for Statistical Analysis of Linear or Linearized Stress-Life (S-N) and Strain-Life (ε-N) Fatigue DataSTP 566 Handbook of Fatigue Testing2STP 588 Manual on Statistical Planning and Analysis for Fatigue Experiments3STP 731 Tables for Estimating Median Fatigue Limits41.5 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.

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4.1 It is well understood how to measure the forces applied to a specimen under static conditions. Practices E4 details the required process for verifying the static force measurement capabilities of testing machines. During dynamic operation however, additional errors may manifest themselves in a testing machine. Further verification is necessary to confirm the dynamic force measurement capabilities of testing machines.NOTE 1: The static machine verification accomplished by Practices E4 simply establishes the reference. Indicated forces measured from the force cell are compared with the dynamometer conditioned forces statically for confirmation and then dynamically for dynamic verification of the fatigue testing system's force output.NOTE 2: The dynamic accuracy of the force cell's output will not always meet the accuracy requirement of this standard without correction. Dynamic correction to the force cell output can be applied provided that verification is performed after the correction has been applied.NOTE 3: Overall test accuracy is a combination of measurement accuracy and control accuracy. This practice provides methods to evaluate either or both. As control accuracy is dependent on many more variables than measurement accuracy it is imperative that the test operator utilize appropriate measurement tools to confirm that the testing machine’s control behavior is consistent between verification activities and actual testing activities.4.2 Dynamic errors are primarily span dependent, not level dependent. That is, the error for a particular force endlevel during dynamic operation is dependent on the immediately preceding force endlevel. Larger spans imply larger absolute errors for the same force endlevel.4.3 Due to the many test machine factors that influence dynamic force accuracy, verification is recommended for every new combination of potential error producing factors. Primary factors are specimen design, machine configuration, test frequency, and loading span. Clearly, performing a full verification for each configuration is often impractical. To address this problem, dynamic verification is taken in two parts.4.3.1 First, one or more full verifications are performed at least annually. The main body of this practice describes that procedure. This provides the most accurate estimate of dynamic errors, as it will account for electronic as well as acceleration-induced sources of error.4.3.2 The second part, described in Annex A1, is a simplified verification procedure. It provides a simplified method of estimating acceleration-induced errors only. This procedure is to be used for common configuration changes (that is, specimen/grip/crosshead height changes).4.4 Dynamic verification of the fatigue system is recommended over the entire range of force and frequency over which the planned fatigue test series is to be performed. Endlevels are limited to the machine's verified static force as defined by the current static force verification when tested in accordance with Practices E4.NOTE 4: There is uncertainty as to whether or not the vibration in a frame will be different when operating in compression as opposed to tension. As a consequence, this practice recommends performing verifications at maximum tension and maximum compression endlevels. The total span does not need to be between those two levels, but can be performed as two tests.NOTE 5: Primary electronic characteristics affecting dynamic measurement accuracy are noise and bandwidth. Excessive noise is generally the dominant effect at the minimum test frequency. Insufficient bandwidth-induced errors are generally most significant at the maximum test frequency.1.1 This practice covers procedures for the dynamic verification of cyclic force amplitude control or measurement accuracy during constant amplitude testing in an axial fatigue testing system. It is based on the premise that force verification can be done with the use of a strain gaged elastic element. Use of this practice gives assurance that the accuracies of forces applied by the machine or dynamic force readings from the test machine, at the time of the test, after any user applied correction factors, fall within the limits recommended in Section 9. It does not address static accuracy which must first be addressed using Practices E4 or equivalent.1.2 Verification is specific to a particular test machine configuration and specimen. This standard is recommended to be used for each configuration of testing machine and specimen. Where dynamic correction factors are to be applied to test machine force readings in order to meet the accuracy recommended in Section 9, the verification is also specific to the correction process used. Finally, if the correction process is triggered or performed by a person, or both, then the verification is specific to that individual as well.1.3 It is recognized that performance of a full verification for each configuration of testing machine and specimen configuration could be prohibitively time consuming and/or expensive. Annex A1 provides methods for estimating the dynamic accuracy impact of test machine and specimen configuration changes that may occur between full verifications. Where test machine dynamic accuracy is influenced by a person, estimating the dynamic accuracy impact of all individuals involved in the correction process is recommended. This practice does not specify how that assessment will be done due to the strong dependence on owner/operators of the test machine.1.4 This practice is intended to be used periodically. Consistent results between verifications is expected. Failure to obtain consistent results between verifications using the same machine configuration implies uncertain accuracy for dynamic tests performed during that time period.1.5 This practice addresses the accuracy of the testing machine's force control or indicated forces, or both, as compared to a dynamometer's indicated dynamic forces. Force control verification is only applicable for test systems that have some form of indicated force peak/valley monitoring or amplitude control. For the purposes of this verification, the dynamometer's indicated dynamic forces will be considered the true forces. Phase lag between dynamometer and force transducer indicated forces is not within the scope of this practice.1.6 The results of either the Annex A1 calculation or the full experimental verification must be reported per Section 10 of this standard.1.7 This practice provides no assurance that the shape of the actual waveform conforms to the intended waveform within any specified tolerance.1.8 This standard is principally focused at room temperature operation. It is believed there are additional issues that must be addressed when testing at high temperatures. At the present time, this standard practice must be viewed as only a partial solution for high temperature testing.1.9 The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this standard.1.10 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.1.11 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.

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4.1 This test method helps to assess the axial locking force of a modular taper. Some types of devices that may utilize this type of connection are the modular shoulder and modular hip prostheses. Additional means of evaluating the locking mechanisms of tapers may be appropriate, depending upon the design of the device.4.2 This test method may not be appropriate for all implant applications. The user is cautioned to consider the appropriateness of the practice in view of the materials and design being tested and their potential application.4.3 While this test method may be used to measure the force required to disengage tapers, any comparison of such data for various component designs must take into consideration the size of the implant and the type of locking mechanism evaluated.1.1 This test method establishes a standard methodology for determining the force required, under laboratory conditions, to disassemble tapers of implants that are otherwise not intended to release. Some examples are the femoral components of a total or partial hip replacement or shoulder in which the head and base component are secured together by a self-locking taper.1.2 This test method has been developed primarily for evaluation of metal and ceramic head designs on metal tapers but may have application to other materials and designs.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4 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.1.5 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.

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5.1 It is important to consider the durability of stent designs in deformation modes that are intended to model in vivo conditions. The appropriate amplitude and number of cycles in each of the modes have to be determined independently for the particular clinical use proposed for the stent. These tests do not replicate all varieties and aspects of the deployment process nor the in vivo mechanical environment in its entirety, and as such they cannot be proofs of durability. Instead, the tests provide evidence of durability. The durability tests can also provide a means of assessing design, material or processing changes.5.1.1 This guide might be useful for development testing, specification acceptance testing, and regulatory submission testing and filings as it provides a basic assurance that the tests are designed, executed, and reported in a suitable fashion.5.1.2 If the tests are conducted using a well defined FTF methodology, they can be useful in:5.1.2.1 Potential design improvement through identification of better and worse geometries, materials, and manufacturing processes;5.1.2.2 Understanding product durability by estimating the effects of changes in geometry, materials, or manufacturing processes;5.1.2.3 Estimating the safety factor relative to the amplitudes and other factors in use conditions; and5.1.2.4 Validating finite element analysis (FEA) and fatigue life models.5.1.3 As stated in the scope, this guide is not intended to provide the in vivo physiologic deformation conditions to which a vascular stent can be subjected. Reliable clinical data characterizing cyclic vascular deformation may be lacking for some indications. The user should develop and justify the boundary conditions (e.g., by literature review, in vivo studies, cadaver studies, or modeling of stent vessel interaction) for the chosen durability bench tests. Additional conditions that may be considered include vessel calcification, vessel taper, eccentric lesions, deformation excursions (e.g., exercise), and vessel remodeling.5.1.4 Test methods other than those provided in the annexes of this document might be appropriate, depending upon stent design. However, these methods are beyond the scope of this guide.1.1 This guide includes three separate cyclic deformation durability guides related to vascular stents: bending, axial, and torsional.1.2 This guide does not address flat plate, local crush durability, or multi-mode testing. Although this guide does not address multi-mode testing, the information included herein could be applicable to developing this type of test.1.3 This guide applies to balloon-expandable and self-expanding stents fabricated from metals and metal alloys. It does not specifically address any attributes unique to coated stents (i.e., stents with a surface layer of an additional material(s)), monolithically polymeric stents, or absorbable stents, although the application of this standard to those products is not precluded.1.4 This guide applies to endovascular grafts (“stent-grafts”) and other conduit products commonly used to treat aneurismal disease, peripheral vessel trauma, or to provide vascular access. The information provided herein does not address all issues related to testing of these devices.1.5 This guide is applicable to testing of stent(s) (or a representative portion of a stent). While durability testing of coupon samples (e.g., a scaled-up portion of the stent structure) can provide useful information, it is not within the scope of this guide.1.6 This guide applies to in vitro modeling of stent durability from non-radial arterial motions. Such motions may arise from musculoskeletal activities, including walking and breathing, and cardiac motion. Test Methods F2477 addresses pulsatile (i.e., radial) durability of vascular stents.1.7 This guide does not provide the in vivo physiologic deformation conditions for a vascular stent. It is incumbent upon the user of the standard to develop and justify these boundary conditions (e.g., by literature review, in vivo studies, cadaver studies, or modeling of stent vessel interaction) in these durability bench tests. Additional conditions that may be considered include vessel calcification, vessel taper, eccentric lesions, loading excursions (e.g., exercise), and vessel remodeling.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 Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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4.1 Based on the measurements of force and displacement at the pile top, possibly combined with those from accelerometers or strain transducers located further down the pile, these test methods measure the pile top deflection in response to an axial compressive force pulse. The relatively long duration of the force pulse compared to the natural period of the test pile causes the pile to compress and translate approximately as a unit during a portion of the pulse, simultaneously mobilizing compressive axial static resistance and dynamic resistance at all points along the length of the pile for that portion of the test.4.2 The compressive axial static resistance is derived from the test data and is therefore an indirect result. Test Method D1143/D1143M provides a direct and therefore more reliable measurement of static resistance.4.3 The Engineer should ensure that the test as specified will generate the required peak force to meet the purpose of the test. In case that purpose is to establish geotechnical failure, the Engineer should also ensure that peak force results in significant permanent axial movement during the axial force pulse event.4.4 The Engineer may analyze the acquired data using engineering principles and judgment to evaluate the performance of the force pulse apparatus, and the characteristics of the pile's response to the force pulse loading. This analysis typically includes a reduction factor to account for the loading rate effect, that is, additional load resistance that occurs as a result of a faster rate of loading than used during a static test. Test results from piles installed in cohesive soils generally require a greater reduction. The Engineer should determine how the type, size, and shape of the pile, and the properties of the soil or rock beneath and adjacent to the pile, affect the rate-of-loading reduction factors and the amount of movement required to mobilize and accurately assess the static resistance by eliminating the dynamic component of the response.4.5 The scope of this standard does not include analysis for foundation capacity, but in order to analyze the test data appropriately it is important that information on factors that affect the derived axial static capacity is properly documented. These factors may include, but are not limited to, the: (1) pile installation equipment and procedures, (2) elapsed time since initial installation, (3) pile material properties and dimensions, (4) type, density, strength, stratification, and saturation of the soil, or rock, or both adjacent to and beneath the pile, (5) quality of force pulse test data, and (6) final foundation settlement.4.6 The accuracy of the derived results may improve when using additional strain transducers embedded in the pile. When combined with an appropriate method of analysis, the Engineer may use data from these optional transducers to estimate the relative contribution of side shear and end bearing to the mobilized axial static compressive resistance of the pile, or to infer the relative contribution of certain soil layers to the overall mobilized axial compressive resistance of the pile.NOTE 1: The quality of the result produced by these test methods is dependent on the competence of the personnel performing it, and the suitability of the equipment and facilities used. Agencies that meet the criteria of Practice D3740 are generally considered capable of competent and objective testing and inspection. Users of these test methods are cautioned that compliance with Practice D3740 does not in itself assure reliable results. Reliable results depend on many factors; Practice D3740 provides a means of evaluating some of those factors.1.1 These test methods, commonly referred to as Rapid Load Testing, cover procedures for testing an individual vertical or inclined deep foundation element to determine the displacement response to an axial compressive force pulse applied at its top. These non-static foundation test methods apply to all deep foundation units, referred to herein as “piles,” that function in a manner similar to driven or cast-in-place piles, regardless of their method of installation.1.2 Two alternative procedures are provided:1.2.1 Procedure A uses a combustion gas pressure apparatus to produce the required axial compressive force pulse.1.2.2 Procedure B uses a cushioned drop mass apparatus to produce the required axial compressive force pulse.1.3 This standard provides minimum requirements for testing deep foundations under an axial compressive force pulse. Plans, specifications, provisions (or combinations thereof) prepared by a qualified engineer, may provide additional requirements and procedures as needed to satisfy the objectives of a particular deep foundation test program. The engineer in responsible charge of the foundation design, referred to herein as the “Engineer,” shall approve any deviations, deletions, or additions to the requirements of this standard.1.4 The proper conduct and evaluation of the test requires special knowledge and experience. A qualified engineer should directly supervise the acquisition of field data and the interpretation of the test results so as to predict the actual performance and adequacy of deep foundations used in the constructed foundation. A qualified engineer shall approve the apparatus used for applying the force pulse, rigging and hoisting equipment, support frames, templates, and test procedures.1.5 The text of this standard references notes and footnotes which provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of the standard. The word “shall” indicates a mandatory provision, and the word “should” indicates a recommended or advisory provision. Imperative sentences indicate mandatory provisions.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 All observed and calculated values shall conform to the guidelines for significant digits and rounding established in Practice D6026.1.7.1 The procedures used to specify how data are collected/recorded or calculated in the standard are regarded as the industry standard. In addition, they are representative of the significant digits that generally should be retained. The procedures used do not consider material variation, purpose for obtaining the data, special purpose studies, or any considerations for the user’s objectives; and it is common practice to increase or reduce significant digits of reported data to be commensurate with these considerations. It is beyond the scope of this standard to consider significant digits used in analysis methods for engineering data1.8 The method used to specify how data are collected, calculated or recorded in this standard is not directly related to the accuracy to which the data can be applied in the design or other uses, or both. How one uses the results obtained using this standard is beyond its scope.1.9 ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentioned in this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk of infringement of such rights, are entirely their own responsibility.1.10 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. Section 7 provides a partial list of specific hazards and precautions.1.11 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.

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