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 device fracture while holding the test environment, implant materials and processing, and implant geometry constant.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 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 is intended to be performed in conjunction with pin-on-flat wear machines or similar machines that are designed to evaluate simplified specimen geometries.NOTE 1: See Haider & Baykal (1)3 for useful considerations and potential pitfalls in conducting pin on disk testing, interpreting test results and the complex and sometimes conflicting effects of lower stress and higher contact area on wear.4.2 This test method is designed to evaluate combinations of materials with respect to the amount of polymer wear, where quantifiable wear occurs primarily on the polymeric component. With some combinations of materials, significant wear of the counterface may occur, with subsequent embedding of counterface debris particles in the polymer. Such an occurrence will render the weight loss of the polymer specimen unreliable as an indicator of the polymer wear.4.3 Wear is reported as volume loss of the polymeric specimen as a function of sliding distance; however, if the sliding distance is not constant across the polymeric specimen surface due to complex motion patterns, wear may be reported as volume loss of the polymeric specimen as a function of wear cycles (in which case a “wear cycle” shall be defined). Volume loss of the polymer specimen is determined by dividing the experimental weight loss by the density of the polymer. For ease of interpretation, wear should be reported as a function of both the number of wear cycles and the sliding distance, when possible.4.4 The reference for the comparative evaluation of candidate materials shall be the wear rate of ultra-high-molecular-weight polyethylene (UHMWPE) conforming to Specification F648 bearing against counterfaces of cobalt-chromium-molybdenum alloy (in accordance with Specifications F75, F799, or F1537), having prosthetic-quality surface finish and lubricated with bovine blood serum (see 5.2).1.1 This test method describes a laboratory method for evaluating the wear properties of combinations of materials that are being considered for use as bearing surfaces of human total joint prostheses. The body of this test method contains general methods which apply to all types of prosthesis wear applications while individual annexes describe specific wear test methods and clinical validation criteria tailored to each distinct wear application (for example, linear reciprocating motion, ball-cup (“hip-type”) wear, delamination wear, and so forth). It is the intent of this test method to rank materials, within each wear application, for polymer wear rates under simulated physiological conditions. It must be recognized, however, that contact geometries and wear motions are simplified using such methods. This test method, therefore, represents only an initial stage in the full wear characterization of a candidate material.1.2 All candidate materials should be tested in an appropriate joint simulator apparatus using prototype prostheses before being used in clinical trials in patients. The tests described in this test method are used to quickly and reliably screen material combinations for wear performance in different orthopaedic wear applications prior to committing them to more expensive and time-consuming joint simulator testing. In addition, these simplified tests can be used to relate material, surface finish, or other parameters to wear behavior on a more practical basis than is possible in joint simulator tests.1.3 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.1.4 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.

定价： 646元 加购物车

定价： 646元 加购物车

定价： 590元 加购物车

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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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This test method covers the procedure for determining the durability of ballon-expandable and self- expanding metal or alloy vascular stents. Tests are performed by exposing specimens to physiologically relevant diametric distention levels using hydrodynamic pulsatile loading. Specimens should have been deployed into a mock or elastically simulated vessel prior to testing. The test methods are valid for determining stent failure due to typical cyclic blood vessel diametric distention and include physiological pressure tests and diameter control tests. These do not address other modes of failure such as dynamic bending, torsion, extension, crushing, or abrasion. Test apparatus include a pressure measurement system, dimensional measurement devices, a cycle counting system, and a temperature control system.1.1 These test methods cover the determination of the durability of a vascular stent or endoprosthesis by exposing it to diametric deformation by means of hydrodynamic pulsatile loading. This testing occurs on a test sample that has been deployed into a mock (elastically simulated) vessel. The test is conducted for a number of cycles to adequately establish the intended fatigue resistance of the sample.1.2 These test methods are applicable to balloon-expandable and self-expanding stents fabricated from metals and metal alloys and endovascular prostheses with metal stents. This standard does not specifically address any attributes unique to coated stents, polymeric stents, or biodegradable stents, although the application of this test method to those products is not precluded.1.3 These test methods may be used for assessing stent and endovascular prosthesis durability when exposed to blood vessel cyclic diametric change. These test methods do not address other cyclic loading modes such as bending, torsion, extension, or compression.1.4 These test methods are primarily intended for use with physiologically relevant diametric change, however guidance is provided for hyper-physiologic diametric deformation (that is, fatigue to fracture).1.5 These test methods do address test conditions for curved mock vessels, however might not address all concerns.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 Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 646元 加购物车

定价： 515元 加购物车

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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 LoadingNOTE 1: This setup would require two rotational actuators and one translational actuator.FIG. 2 Diagrams of Possible Test Apparatus for Allowing Simultaneous Flexion-Extension and Lateral Bending Motions with Anterior-Posterior Directed Facet LoadingNOTE 1: This setup would require two rotational actuators and one translational actuator.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 the Y-axis.5.2.5.4 Lateral bend load and motion are positive and negative moments and rotations about the X-axis.5.2.5.5 Axial rotation load and motion are positive and negative moments and rotations about the Z-axis.5.2.6 Frequency—Test frequency shall be determined and justified by the user of this practice, and shall not exceed 2 Hz without adequate justification ensuring that the applied motion (load) profiles remain within specified tolerances and that the total facet prosthesis’s wear and functional characteristics are not significantly affected. See X1.6.5.2.7 Cycle Counter—One complete motion is the entire range from starting position through the range of motion (or load when in load control) and returning to the starting position (load). Cycles are to be counted using an automated counting device.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.

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1.1 This guide specifies a method to measure the surface and estimate the in-vivo material loss from the conical taper junctions, such as the femoral head/stem junction or adapter sleeve from explanted modular hip prosthesis, modular knee or shoulder joints. This guide is applicable to any articulating bearing material, stem material and conical taper size. The principles in this guide may be applied to other designs of taper junction, such as the modular stem/neck junction found in some hip joints.1.2 This guide covers the measurement of the surface and estimation of depth of material loss and volume of material loss and taper geometry using a Roundness Machine (1-4), Coordinate Measuring Machine (CMM) (5) and Optical Coordinate Measuring Machine (6, 7).2 Other measurement equipment may be used to measure the surface if the resolution and accuracy of the measurements are comparable with the instruments detailed in this standard. The measurement and analysis protocols should be based on those described in this standard.NOTE 1: The maximum depth of material loss is sensitive to the number and spacing of data points.1.3 The measurement techniques in this standard guide use measurements taken on the surface of the taper using stylus instruments. The material loss/corrosion mechanisms in the taper junction may lead to oxide layers or corrosion products deposited on the surface of the taper. These layers may lead to an underestimation of the volume of material loss.1.4 The explants may have debris or biological deposits on the surfaces of the taper junctions. These deposits will prevent the measurement of the actual surface of the taper junction and their effect on the measurement must be considered when deciding the cleaning protocol. Normally, the taper surfaces will be cleaned before measurements are taken.1.5 This standard may involve hazardous materials, operations and equipment. As a precautionary measure, explanted devices should be sterilized or minimally disinfected by an appropriate means that does not adversely affect the implant or the associated tissue that may be the subject of subsequent analysis. A detailed discussion of precautions to be used in handling human tissues can be found in ISO 12891-1. 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.

定价： 590元 加购物车

定价： 590元 加购物车

定价： 590元 加购物车

1.1 This standard guide provides options and a compendium of information for measuring the bearing surface and estimating the in-vivo wear of explanted Metal-on-Metal (MoM) and other “hard” (for example, ceramic) hip components. The guide covers the measurement of acetabular cups and femoral heads using a dimensional change method and is applicable to all prosthetic hip types, including stemmed (modular) and resurfacing hip systems.1.2 The methods specified in this guide are not applicable for measuring the in-vivo wear from non-articulating surfaces, for example modular connections (at the stem/neck, neck/head, or cup liner/shell interface) or at the acetabular cup rim.1.3 The parameters (wear depth and volumetric wear) evaluated and reported in this guide are estimated from the assumed as-manufactured shape of the components. The wear volume is calculated using a numerical integration method and the wear depth is the difference between the assumed as-manufactured shape and the measured surface.1.4 This guide covers the measurement of the depth of wear and the volumetric wear using a Coordinate Measuring Machine (CMM) and the depth of wear using an Roundness Machine. Other metrology measurement equipment may be used to measure the wear depth or volume if the resolution and accuracy of the measurements are comparable with the instruments detailed in this standard. The measurement and analysis protocols should be based on those described in this standard.1.5 This guide is applicable to hip joints which are nominally spherical at the time of manufacture. Form deviations resulting from manufacturing or deformation may occur and may necessitate the use of a non-spherical surface to represent the unworn surface of the component. Hip joints designed with asymmetry are considered beyond the scope of this guide, although the principles and techniques may be applicable to the characterization of wear from the articulating surfaces.1.6 This guide is intended as an extension to Practice F561 as a Stage II nondestructive test.1.7 This standard may involve hazardous materials, operations, and equipment. As a precautionary measure, explanted devices should be sterilized or disinfected by an appropriate means that does not adversely affect the implant or the associated tissue that may be the subject of subsequent analysis. A detailed discussion of precautions to be used in handling human tissues can be found in ISO 12891-1. 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.

定价： 590元 加购物车

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