11.040.40 (Implants for surgery, prothetics and or 标准查询与下载

ASTM F703-07 可植入假乳房标准规范

1.1 This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast.1.2 Limitations8212;This specification does not cover custom fabricated implantable breast prostheses.1.3 Single-use saline-inflatable, smooth, and textured silicone shell implantable breast prostheses are addressed in Specification F 2051.1.4 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.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.

Standard Specification for Implantable Breast Prostheses

ASTM F543-07 金属医疗骨螺钉的标准规范和试验方法

1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:1.2.1 Annex A1 - Test Method for Determining the Torsional Properties of Metallic Bone Screws.1.2.2 Annex A 2 - Test Method for Driving Torque of Medical Bone Screws.1.2.3 Annex A3 - Test Method for Determining the Axial Pullout Strength of Medical Bone Screws.1.2.4 Annex A4 - Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.1.2.5 Annex A5 - Specifications for Type HA and Type HB Metallic Bone Screws.1.2.6 Annex A6 - Specifications for Type HC and Type HD Metallic Bone Screws.1.2.7 Annex A7 - Specifications for Metallic Bone Screw Drive Connections.1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.1.4 Unless otherwise indicated, the values stated in SI units are to be regarded as standard. The values in parentheses are given for information only.This standard may involve the use of hazardous materials, operations, and 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.1.5 This annex specifies the requirements for a variety of drive connections that can be implemented in metallic medical bone screws. The screw's drive connection supplies the interconnection that is typically used in orthopedic surgery for inserting and removing bone screws.

Standard Specification and Test Methods for Metallic Medical Bone Screws

ASTM F2119-07(2013) 评定无源植入物磁共振图像产物的标准试验方法

5.1 This test method provides a quantified measure of the image artifact produced under a standard set of scanning conditions. 5.2 This test method applies only to passive implants that have been established to be MR-Safe or MR-Conditional. 1.1 This test method characterizes the distortion and signal loss artifacts produced in a magnetic resonance (MR) image by a passive implant (implant that functions without the supply of electrical or external power). Anything not established to be MR-Safe or MR-Conditional is excluded. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

ASTM F2229-07 外科植入物用锻制氮增强23锰-21铬-1钼低镍不锈钢合金棒材和线材的标准规范(UNS S29108)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 23manganese-21chromium-1molybdenum low-nickel stainless steel alloy bar and wire for surgical implants.1.2 The values stated in inch-pound units are to be regarded as the standard. The SI equivalents of the inch-pound units may be approximate.

Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)

ASTM F2580-07 最接近固定股骨髋假体标准接头的评估用标准试验方法

This test method can be used to describe the effects of materials, manufacturing, and design variables on the fatigue performance of metallic femoral hip prostheses subject to cyclic loading for large numbers of cycles. The loading of femoral hip designs in vivo will, in general, differ from the loading defined in this test method. The results obtained here cannot be used to directly predict in vivo performance. However, this test method is designed to allow for comparisons between the fatigue performance of different metallic femoral hip designs, when tested under similar conditions. In order for fatigue data on femoral hip prostheses to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established.1.1 This test method covers a procedure for the fatigue testing of metallic femoral hip prostheses used in hip joint replacements. This test method covers the procedures for the performance of fatigue tests on metallic femoral hip stems using a cyclic, constant-amplitude force. It applies to hip prostheses that utilize proximal metaphyseal fixation and are of a modular construct, and it is intended to evaluate the fatigue performance of the modular connections in the metaphyseal filling (that is, proximal body) region of the stem.1.2 This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic hip prostheses while held in a proximally fixated manner, with the distal end not held by a potting medium.1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis

ASTM F2694-07 活动腰椎全椎间盘假体的功能及磨损评定的标准实施规程

Total Facet Prosthesis Components8212;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. Spinal Testing Apparatus: Test Chambers8212;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. Component Clamping/Fixturing8212;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. The device should be securely (rigidly) attached at its bone-implant interface to the mating test fixtures. 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. Load and Motion: Facet loads (fx) are initially applied in the direction of the positive X-axis. Flexion load and motion are positive moment and rotation about the Y-axis. Extension load and motion are negative moment and rotation about the Y-axis. Lateral bend load and motion are positive and negative moments and rotations about the X-axis. Axial rotation load and motion are positive and negative moments and rotations about the Z-axis. Frequency8212;Test frequency is to 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. Cycle Counter8212;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. Note8212;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 Loading

Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses

ASTM F1580-07 外科植入物覆层用钛和钛-6铝-4钒合金粉末的标准规范

1.1 This specification covers the requirements for unalloyed titanium and Ti-6Al-4V alloy powders for use in fabricating coatings on titanium alloy implants. 1.2 Powders covered under this specification may be used to form coatings by sintering or thermal spraying techniques. 1.3 This specification covers powder requirements only. It does not address properties of the coatings formed from them. 1.4 Finely divided titanium powder may be considered pyrophoric and should be handled in accordance with the appropriate guidelines.

Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants

ASTM F560-07 外科植入物用非合金钽的标准规范(UNS R05200、UNS R05400)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for unalloyed tantalum plate, sheet, strip, rod, and wire used in the manufacture of surgical implants.1.2 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.

Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)

ASTM F648-07 外科植入物用超高分子量聚乙烯粉末和制造形态的标准规范

1.1 This specification covers ultra-high molecular weight polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants.1.2 The requirements of this specification apply to UHMWPE in two forms. One is virgin polymer powder (Section 4). The second is any form fabricated from this powder from which a finished product is subsequently produced (Section 5). This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant.1.3 The provisions of Specification D 4020 apply. Special requirements detailed in this specification are added to describe material which will be used in surgical implants.1.4 The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use (1, 2, 3) and by laboratory studies (4,5 6, ).The following precautionary caveat pertains only to the test method portion, Section 7, of this specification: 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.

Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

ASTM F562-07 外科植入用锻制35钴-35镍-20铬-10钼合金标准规范(UNS R30035)

1.1 This specification covers requirements of wrought 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the form of bar and wire, used for the manufacture of surgical implants. This alloy depends on combinations of work-strengthening, and work-strengthening and aging to attain a variety of combinations of strength and ductility.1.2 The values stated in inch-pound units are to be regarded as the standard. The SI equivalents of the inch-pound units may be approximate.

Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)

ASTM F2695-07 与外科植入物用α维生素E(维他命E)混合的超高分子量聚乙烯粉末的标准规范

1.1 This specification covers ultra-high molecular weight polyethylene (UHMWPE) powder blended with alpha-tocopherol (vitamin E) intended for use in surgical implants. 1.2 The requirements of this specification apply to alpha-tocopherol-containing UHMWPE in two forms. One is virgin polymer powder blended with alpha-tocopherol prior to consolidation (Section 4). The second is any form fabricated from this blended, alpha-tocopherol-containing powder from which a finished product is subsequently produced (Section 5). This specification does not apply to finished or semi-finished products that are doped with vitamin E after consolidation. 1.3 Aside from blending with alpha-tocopherol, the provisions of Specifications F 648 and D 4020 apply. Special requirements detailed in this specification are added to describe powders containing alpha-tocopherol that will be used in surgical implants. This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant. This specification also does not apply to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation. 1.4 The following precautionary caveat pertains only to the fabricated forms portion, Section 5, of this specification. 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.

Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications

ASTM F2146-07 外科移植物用锻造钛-3铝-2.5钒合金无缝管的标准规范(UNS R56320)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought and annealed or cold-worked and stress-relieved titanium-3aluminum-2.5vanadium alloy (UNS R56320) seamless tubing to be used in the manufacture of surgical implants. See Section for size limitations.1.2 The values stated in inch pound units are to be regarded as the standard. The SI equivalents in parentheses are for information only.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 requirements prior to use.

Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)

ASTM F2694-07(2013) 活动腰椎全椎间盘假体的功能及磨损评定的标准实施规程

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 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 Loading 5.2.5 Load and Motion:

Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses

ASTM F543-07e2 医用金属接骨螺钉的标准规范和试验方法

A1.1. Significance and Use A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products. 1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification. 1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included: 1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws. 1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws. 1.2.3 Annex A3—Test Method for Determining the Axial Pullout Strength of Medical Bone Screws. 1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws. 1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws. 1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws. 1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections. 1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard may involve the use of hazardous materials, operations, and equipment.

Standard Specification and Test Methods for Metallic Medical Bone Screws

ASTM F75-07 外科植入术用钴28铬6钼铸件和铸造合金的标准规范

1.1 This specification covers the requirements for cobalt-28 chromium-6 molybdenum alloy unfinished investment product castings for surgical implant applications and casting alloy in the form of shot, bar, or ingots to be used in the manufacture of surgical implants. This specification does not apply to completed surgical implants made from castings.1.2 The values stated in inch-pound units are to be regarded as the standard. The SI equivalents in parentheses are for information only.

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

ASTM F384-06e1 金属斜角整形外科骨折固定设备的标准规范和试验方法

A2.5.1 The test method establishes a uniform cantilever bending fatigue test to characterize and compare the fatigue performance of different angled device designs. This test method may be used to determine an angled device''s fatigue life at either a specific or over a range of maximum bending moment conditions. Additionally, this test method may be alternatively used to estimate an angled device''s fatigue strength for a specified number of fatigue cycles. A2.5.2 The test method utilizes a simplified angled device cantilever bending load model that may not be exactly representative of the in-situ loading configuration. The user should note that the test results generated by this test method can not be used to directly predict the in-vivo performance of the angled device being tested. The data generated from this test method can be used to conduct relative comparisons of different angled device designs. A2.5.3 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential application. A2.5.4 This test method assumes that the angled device is manufactured from a material that exhibits linear-elastic material behavior; therefore, this test method is not applicable for testing angled devices made from materials that exhibit nonlinear elastic behavior. A2.5.5 This test method is restricted to the testing of angled devices within the material''s linear-elastic range; therefore, this test method is not applicable for testing angled devices under conditions that would approach or exceed the bending strength of the angled device being tested.1.1 These specifications and test methods provide a comprehensive reference for angled devices used in the surgical internal fixation of the skeletal system. This standard establishes consistent methods to classify and define the geometric and performance characteristics of angled devices. This standard also presents a catalog of standard specifications that specify material, labeling, and handling requirements, and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of angled devices. 1.2 It is not the intention of this standard to define levels of performance of case-specific clinical performance for angled devices, as insufficient knowledge is available to predict the consequences of their use in individual patients for specific activities of daily living. Futhermore, this standard does not describe or specify specific designs for angled devices used in the surgical internal fixation of the skeletal system. 1.3 This standard may not be appropriate for all types of angled devices. The user is cautioned to consider the appropriateness of this standard in view of a particular angled device and its potential application. Note 18212;This standard is not intended to address intramedullary hip screw nails or other angled devices without a sideplate. 1.4 This standard includes the following test methods used in determining the following angled device mechanical performance characteristics: 1.4.1 Standard test method for single cycle compression bend testing of metallic angled orthopedic fracture fixation devices (see Annex A1). 1.4.2 Standard test method for determining the bending fatigue properties of metallic angled orthopedic fracture fixation devices (see Annex A2). 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

ASTM F2083-06 全膝假体标准规范

1.1 This specification covers total knee replacement (TKR) prostheses used to provide functioning articulation by employing femoral and tibial components, allowing a minimum of 110 of flexion to high flexion. Although a patellar component may be considered an integral part of a TKR, the detailed description of this component is excluded here since it is provided in Specification F 1672.1.2 Included within the scope of this specification are replaceable components of modular designs, for example, tibial articulating surfaces and all components labeled for or capable of being used with cement, regardless of whether the same components can also be used without cement. This includes primary and revision prostheses and also covers fixed and mobile bearing knee designs.1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. Additionally, those characteristics determined to be important to in vivo performance of the prosthesis are defined.1.4 Excluded from the scope are hemiarthroplasty devices that replace only the femoral or tibial surface, but not both; unicompartmental designs, which replace the articulating surfaces of only one condyle; and patellofemoral prostheses. Also excluded are devices designed for custom applications.

Standard Specification for Total Knee Prosthesis

ASTM F2083-06a 全膝假体标准规范

1.1 This specification covers total knee replacement (TKR) prostheses used to provide functioning articulation by employing femoral and tibial components, allowing a minimum of 110 of flexion to high flexion. Although a patellar component may be considered an integral part of a TKR, the detailed description of this component is excluded here since it is provided in Specification F 1672.1.2 Included within the scope of this specification are replaceable components of modular designs, for example, tibial articulating surfaces and all components labeled for or capable of being used with cement, regardless of whether the same components can also be used without cement. This includes primary and revision prostheses and also covers fixed and mobile bearing knee designs.1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. Additionally, those characteristics determined to be important to in vivo performance of the prosthesis are defined.1.4 Excluded from the scope are hemiarthroplasty devices that replace only the femoral or tibial surface, but not both; unicompartmental designs, which replace the articulating surfaces of only one condyle; and patellofemoral prostheses. Also excluded are devices designed for custom applications.

Standard Specification for Total Knee Prosthesis

ASTM F2083-06b 全膝假体标准规范

1.1 This specification covers total knee replacement (TKR) prostheses used to provide functioning articulation by employing femoral and tibial components, allowing a minimum of 110 of flexion to high flexion. Although a patellar component may be considered an integral part of a TKR, the detailed description of this component is excluded here since it is provided in Specification F 1672.1.2 Included within the scope of this specification are replaceable components of modular designs, for example, tibial articulating surfaces and all components labeled for or capable of being used with cement, regardless of whether the same components can also be used without cement. This includes primary and revision prostheses and also covers fixed and mobile bearing knee designs.1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. Additionally, those characteristics determined to be important to in vivo performance of the prosthesis are defined.1.4 Excluded from the scope are hemiarthroplasty devices that replace only the femoral or tibial surface, but not both; unicompartmental designs, which replace the articulating surfaces of only one condyle; and patellofemoral prostheses. Also excluded are devices designed for custom applications.

Standard Specification for Total Knee Prosthesis

ASTM F2025-06 磨损评定用聚合物元件重力测量的标准规程

This practice uses a weight-loss method of wear determination for the polymeric components or materials used in human joint prostheses, using serum or demonstrated equivalent fluid for lubrication, and running under a load profile representative of the appropriate human joint application (1,2).4 The basis for this weight-loss method for wear measurement was originally developed (3) for pin-on-disk wear studies (Practice F 732) and has been extended to total hip replacements (4, 5, ISO 14242–2, and Guide F 1714) and to femoro-tibial knee prostheses (6 and ISO 14243–2), and to femoro-patellar knee prostheses (6,7). While wear results in a change in the physical dimensions of the specimen, it is distinct from dimensional changes due to creep or plastic deformation, in that wear results in the removal of material in the form of polymeric debris particles, causing a loss in weight of the specimen. This practice for measuring wear of the polymeric component is suitable for various simulator devices. These techniques can be used with metal, ceramic, carbon, polymeric, and composite counter faces bearing against a polymeric material (for example, polyethylene, polyacetal, and so forth). Thus, this weight-loss method has universal application for wear studies of human joint replacements which feature polymeric bearings. This weight-loss method has not been validated for non-polymeric material bearing systems, such as metal-metal, carbon-carbon, or ceramic-ceramic. Progressive wear of such rigid bearing combinations has generally been monitored using a linear, variable-displacement transducers, or by other profilometric techniques.1.1 This practice describes a laboratory method using a weight-loss (that is, mass-loss; see X1.4) technique for evaluating the wear properties of polymeric materials or devices which are being considered for use as bearing surfaces of human joint replacement prostheses, or both. The test specimens are evaluated in a device intended to simulate the tribological conditions encountered in the human joint; for example, use of a fluid such as bovine serum, or equivalent pseudosynovial fluid shown to simulate similar wear mechanisms and debris generation as found in vivo.

Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment