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

ASTM F1854-15 医用植入物上多孔覆层的立体测量评价的标准试验方法

5.1 All these test methods are recommended for elementary quantification of the morphological properties of porous coatings bonded to solid substrates. 5.2 These test methods may be useful for comparative evaluations of different coatings or different lots of the same coating. 5.3 All the methods should be performed on the same set of images of fields. 5.4 A statistical estimate can be made of the distributions of the mean coating thickness and the volume percent void. No estimate can be made of the distribution of intercept lengths. 5.5 There are limits to the accurate characterization of porosity, depending on spacing between the lines in the line grid (or points in the point grid) and the individual and cumulative fields used for the measurements. Increasing the size of the fields, increasing the number of fields, or decreasing the grid spacing will increase the accuracy of the measurements obtained. 5.6 This method may be suitable for ceramic coatings if an accurate coating cross section can be produced. Producing an accurate ceramic coating cross section may require other techniques than standard metallographic techniques. 5.7 For coatings having a mean thickness less than 300 microns, it is not recommended to attempt to determine the volume percent void or the mean intercept length. 1.1 This test method covers stereological test methods for characterizing the coating thickness, void content, and mean intercept length of various porous coatings adhering to nonporous substrates. 1.2 A method to measure void content and intercept length at distinct levels (“Tissue Interface Gradients”) through the porous coating thickness is outlined in 9.4. 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants

ASTM F2895-15 铸造金属植入物数字射线照相术的标准实践

4.1 The requirements expressed in this practice are intended to control the quality of the digital radiographic image of cast metallic surgical implants. 1.1 This practice covers the procedure for digital radiographic testing of cast metallic surgical implants and related weldments. 1.2 Digital X-ray is an alternative method for radiography of cast metallic surgical implants and related weldments (see Practice F629). 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 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 Practice for Digital Radiography of Cast Metallic Implants

ASTM F2129-15 测定小型植入装置腐蚀敏感性的循环动电位极化测量的标准试验方法

5.1 Corrosion of implantable medical devices can have deleterious effects on the device performance or may result in the release of corrosion products with harmful biological consequences; therefore it is important to determine the general corrosion behavior as well as the susceptibility of the devices to localized corrosion. 5.2 The forming and finishing steps used to create an implantable device may have significant effects on the corrosion resistance of the material out of which the device is fabricated. During the selection process of a material for use as an implantable device, testing the corrosion resistance of the material is an essential step; however, it does not necessarily provide critical data regarding device performance. 5.3 To accommodate the wide variety of device shapes and sizes encountered, a variety of holding devices can be used. 5.4 Note that the method is intentionally designed to reach conditions that are sufficiently severe to cause breakdown and deterioration of the medical devices and that these conditions may not necessarily be encountered in vivo. The results of this corrosion test conducted in artificial physiological electrolytes can provide useful data for comparison of different device materials, designs, or manufacturing processes. However, note that this test method does not take into account the effects of cells, proteins, and so forth on the corrosion behavior in vivo. 1.1 This test method assesses the corrosion susceptibility of small, metallic, implant medical devices, or components thereof, using cyclic (forward and reverse) potentiodynamic polarization. Examples of device types that may be evaluated by this test method include, but are not limited to, vascular stents, ureteral stents (Specification F1828), filters, support segments of endovascular grafts, cardiac occluders, aneurysm or ligation clips, staples, and so forth. 1.2 This test method is used to assess a device in its final form and finish, as it would be implanted. These small devices should be tested in their entirety. The upper limit on device size is dictated by the electrical current delivery capability of the test apparatus (see Section 6). It is assumed that test methods, such as Reference Test Method G5 and Test Method G61 have been used for material screening. 1.3 Because of the variety of configurations and sizes of implants, this test method provides a variety of specimen holder configurations. 1.4 This test method is intended for use on implantable devices made from metals with a relatively high resistance to corrosion. 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 Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

ASTM F2091-15 髋臼假体标准规格

1.1 This specification covers acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur. 1.2 This specification is intended to provide basic descriptions of materials and device geometry. Additionally, those characteristics determined to be important to in vivo performance of the device are defined. 1.3 Acetabular prostheses included within the scope of this specification are intended for fixation by press-fit between the prosthesis and host bone, the use of bone cement, the use of bone screws or similar means of mechanical fixation, or through biological fixation of host bone and/or soft connective tissue into a porous surface. 1.4 Custom (designed explicitly for a single patient), revision, or constrained acetabular prostheses are not covered within the scope of this specification. 1.5 This specification does not cover the details for quality assurance, design control, production control contained in 21 CFR 820 (Quality System Regulation) and ISO 9001.

Standard Specification for Acetabular Prostheses

ASTM F2068-15 股骨假体标准规范&8212;金属植入物

1.1 This specification covers metallic stemmed femoral prostheses used to replace the natural hip joint by means of hemi-arthroplasty or total hip surgical procedures. Prostheses for hemi-arthroplasty are intended to articulate with the natural acetabulum of the patient. Prostheses for total hip replacement are intended to articulate with prosthetic acetabular cups. Prostheses may have integral femoral heads or cones designed to accept modular heads. 1.2 Modular femoral heads, which may be affixed to cones on implants covered by this specification, are not covered by this specification. The mechanical strength, corrosion resistance, and biocompatibility of the head portions of one-piece integral implants are covered by this specification. 1.3 Femoral prostheses included within the scope of this specification are intended for fixation by press fit between the prosthesis and host bone, the use of bone cement, or through the ingrowth of host bone into a porous coating. 1.4 Custom femoral prostheses, designed explicitly for a single patient, are not covered within the scope of this specification. 1.5 Prostheses incorporating nonmetallic (for example, polymer composite) implants, nonporous bioactive ceramic coatings, or porous-polymer coatings, are specifically excluded from the scope of this specification. 1.6 The requirements for modular connections of multicomponent modular femoral hip prostheses are not covered by this specification. 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

Standard Specification for Femoral Prostheses—Metallic Implants

ASTM F1350-15 锻造18铬-14镍-2.5钼不锈钢外科固定丝标准规范（UNS S31673）

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for the manufacture of wrought 18 chromium-14 nickel-2.5 molybdenum stainless steel in the form of surgical fixation wire. 1.2 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 this specification.

Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)

ASTM F2943-14 肌肉骨骼植入物终端用户标识信息展示的标准指南

4.1 Implantable medical device labeling often results in a variety of label formats and information prioritization. This variability can be seen not only across different manufacturers but also across different implant types.3 At present label design and layout is developed by a given manufacturer and represents balancing internal needs (such as manufacturing, distribution, and marketing), regulatory requirements within various markets, and end user needs (as identified by individual manufacturers performing “voice of the consumer” feedback on their label designs). 4.2 At no fault to any given manufacturer, this process, along with the manner in which label information competes for available “real estate” on a package, often leads to variable prioritization of label information and highly variable label designs. The impact of this variability on patient care is not well documented within the published literature. An article from AAOS Now in 2009 described potential issues around label variability and gave anecdotal evidence of its impact.3 4.3 No published literature demonstrating a clear and conclusive impact on patient safety resulting from implant label variability was identified. Despite this lack of evidence, anecdotal observations and input from various involved individuals and organizations (surgeons, operating room nurses, hospital administrators, product representatives, and manufacturers) suggests a potential, although unproven, benefit for an increased standardization of implant labeling. 4.4 The authors of this guide believe it is important to highlight that no universally accepted method for validation of a label’s effectiveness exists. Current validation methods consist of varying methods of customer feedback on an existing label design using formal customer questionnaires, informal customer feedback through individual polling, and internal manufacturer-driven studies. The label recommendations presented within this guide have not been validated as more or less effective than other existing implant labels currently in use. 4.5 These recommendations have been developed through the collaboration of an ASTM-sponsored task group with representation from large and small orthopedic implant manufacturers, orthopedic surgeons (specifically the Biomedical Engineering Committee from the American Academy of Orthopedic Surgeons), healthcare facility administrators, operating room nurses, the U.S. Food and Drug Administration (FDA), and the Canadian Healthcare System. The task group utilized “voice of consumer” feedback from previous manufacturer label initiatives combined with input from various end users on the task group. This process did not identify any given implant label format as being more or less effective but only attempts to prioritize information and recommend a universal format for this information. A manufacturer may determine that an alternative format may be more effective for its internal processes and elect not to follow these recommendations. 1.1 The goal of this guide is to recommend a universal label format (across manufacturers and various implants) of content and relative location of information necessary for final implant selection within an implant’s overall package labeling. 1.2 This guide recommends package labeling for musculoskeletal based implants......

Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants

ASTM F1223-14 整个膝部复位固定情况测定的标准试验方法

4.1 This test method, when applied to available products and proposed prototypes, is meant to provide a database of product functionality capabilities (in light of the suggested test regimens) that is hoped will aid the physician in making a more informed total knee replacement (TKR) selection. 4.2 A proper matching of TKR functional restorative capabilities and the recipient's (patient’s) needs is more likely to be provided by a rational testing protocol of the implant in an effort to reveal certain device characteristics pertinent to the selection process. 4.3 The TKR product designs are varied and offer a wide range of constraint (stability). The constraint of the TKR in the in vitro condition depends on several geometrical and kinematic interactions among the implant's components which can be identified and quantified. The degree of TKR's kinematic interactions should correspond to the recipient's needs as determined by the physician during clinical examination. 4.4 For mobile bearing knee systems, the constraint of the entire implant construct shall be characterized. Constraint of mobile bearings is dictated by design features at both the inferior and superior articulating interfaces. 4.5 The methodology, utility, and limitations of constraint/laxity testing are discussed.3, 4 The authors recognize that evaluating isolated implants (that is, without soft tissues) does not directly predict in vivo behavior, but will allow comparisons among designs. Constraint testing is also useful for characterizing implant performance at extreme ranges of motion which may be encountered in vivo at varying frequencies, depending on the patient’s anatomy, pre-operative capability, and post-operative activities and lifestyle. 1.1 This test method covers the establishment of a database of total knee replacement (TKR) motion characteristics with the intent of developing guidelines for the assignment of constraint criteria to TKR designs. (See the Rationale in Appendix X1.) 1.2 This test method covers the means by which a TKR constraint may be quantified according to motion delineated by the inherent articular design as determined under specific loading conditions in an in vitro environment. 1.3 Tests deemed applicable to the constraint determination are antero-posterior draw, medio-lateral shear, rotary laxity, valgus-varus rotation, and distraction, as applicable. Also covered is the identification of geometrical parameters of the contacting surfaces which would influence this motion and the means of reporting the test results. (See Practices E4.) 1.4 This test method is not a wear test. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of ......

Standard Test Method for Determination of Total Knee Replacement Constraint

ASTM F1926/F1926M-14 磷酸钙颗粒, 制作模型和涂层的溶出试验的标准试验方法

4.1 Aspects of the biological response to calcium phosphate materials in soft tissue and bone have been reported from laboratory studies and clinical use (1-11).3 4.2 The requirements of this test method apply to calcium phosphate materials such as calcium hydroxyapatite (see Specification F1185), beta-tricalcium phosphate (see Specification F1088), and biphasic mixtures thereof with or without intentional addition of other minor components (lt;10 %). 4.3 This test method is limited to the laboratory evaluation of the dissolution rate of a calcium phosphate material. No correlation of the results to in vivo performance is implied. Therefore, it is recommended that a control material be included in the evaluation. The control material can be a standardized material such as NIST SRM 2910 or a historical control. 1.1 This test method covers calcium phosphate materials intended for use in surgical implant applications. 1.2 The material(s) shall be representative of that produced for sale. It shall have been produced and processed under standard manufacturing conditions. 1.3 The materials may be in the form of powders, granules, spall material, fabricated forms or coatings; and may be porous, nonporous, textured, and other implantable topographical substrate form representative of the end-use product. 1.4 The calcium phosphate material may constitute the only material in a substrate or it may be one of multiple materials so long as all other materials present do not dissolve under the test conditions described in this test method. 1.5 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 nonconformance with the standard. 1.6 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 Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings

ASTM F2028-14 关节窝松动或分离的动态评定的标准试验方法

5.1 This test method is intended to investigate the resistance of a glenoid component to loosening. Glenoid loosening is the most common clinical complication in total shoulder arthroplasty (see X1.1). The method assumes that loosening occurs because of edge loading, often called the rocking-horse phenomenon. 5.2 This test method can be used both to detect potential problems and to compare design features. Factors affecting loosening performance include articular geometry, flange geometry, materials, fixation design, bone quality, and surgical technique. 1.1 These test methods measure how much a prosthetic anatomic glenoid component rocks or pivots following cyclic displacement of the humeral head to opposing glenoid rims (for example, superior-inferior or anterior-posterior). Motion is quantified by the tensile displacement opposite each loaded rim after dynamic rocking. Similarly, these test methods measure how much a prosthetic reverse glenoid component rocks or pivots following cyclic articulation with a mating humeral liner. Motion is quantified by the magnitude of displacement measured before and after cyclic loading. 1.2 The same setup can be used to test the locking mechanisms of modular glenoid components, for example, disassociation of both anatomic and reverse shoulder components. 1.3 These test methods cover shoulder replacement designs with monolithic or modular glenoid components for cemented fixation as well as reverse glenoid components for uncemented fixation. 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 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 Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

ASTM F1904-14 测试体内颗粒生物反应的标准实施规程

4.1 This practice is to be used to help assess the biocompatibility of materials used in medical devices. It is designed to test the effect of particles from the materials on the host tissues. 4.2 The appropriateness of the methods should be carefully considered by the user since not all materials or applications need to be tested by this practice. The validity of these studies in predicting the human response is not known at this time and studies such as those described here are needed. 4.3 Abbreviations Used: 4.3.1 CD—Cluster differentiation. 4.3.2 DNA—Deoxyribonucleic acid. 4.3.3 EDS—Energy dispersive X-ray spectroscopy. 4.3.4 EU—Endotoxin unit. 4.3.5 HLA—Human leukocyte antigens. 4.3.6 LAL—Limulus amebocyte lysate. 4.3.7 LPS—Lipopolysaccharide (endotoxin). 4.3.8 RNA—Ribonucleic acid. 1.1 This practice covers the production of wear particles and degradation products from implanted materials that may lead to a cascade of biological responses resulting in damage to adjacent and remote tissues. In order to ascertain the role of particles in stimulating such responses, the nature of the responses, and the consequences of the responses, established protocols are needed. This is an emerging, rapidly developing area and the information gained from standard protocols is necessary to interpret responses. Some of the procedures listed here may, on further testing, not prove to be predictive of clinical responses to particulate debris. However, only the use of standard protocols will establish which are useful techniques. Since there are many possible and established ways of determining responses, a single standard protocol is not stated. However, this recommended practice indicates which necessary information should be supplied with test results. For laboratories without established protocols, recommendations are given and indicated with an asterisk (*). 1.2 This standard is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material. 1.3 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 Practice for Testing the Biological Responses to Particles in vivo

ASTM F1672-14 膝假肢表面处理的标准规范

1.1 This specification covers patellar resurfacing devices used to provide a functioning articulation between the patella and the femur. 1.2 This specification is intended to provide basic descriptions of material and device geometry. Additionally, those characteristics determined to be important to in-vivo performance of the device are defined. 1.3 This specification does not cover the details for quality assurance, design control, and production control contained in 21 CFR 820 and ISO 9001. Note 1—Devices for custom applications are not covered by this specification.

Standard Specification for Resurfacing Patellar Prosthesis

ASTM F3044-14 评估医疗植入物用电化侵蚀电位的标准试验方法的试验方法

3.1 Implantable medical devices can be made of dissimilar metals or come into electrical contact with dissimilar metals leading to the potential for galvanic corrosion, which may result in the release of corrosion products with harmful biological consequences or a compromise of structural integrity of the device. Therefore, it is important to determine the susceptibility of these types of devices to galvanic corrosion. 3.2 Use of this test method is intended to provide information on the possible galvanic component of corrosion of two dissimilar metals in contact with one another. The dissimilar metals in contact may be on the same implantable medical device or as component parts of individual medical implant devices. 3.3 This test method has been designed to accommodate a wide variety of device shapes and sizes encountered by allowing the use of a variety of holding devices. 3.4 This standard is presented as a test method for conducting galvanic corrosion tests in a simulated physiological environment. Adherence to this test method should aid in avoiding some of the inherent difficulties in such testing. Other standards such as Guide G71 are general and, while they provide valuable background information, do not provide the necessary details or specificity for testing medical device implants. 1.1 This test method covers conducting galvanic corrosion tests to characterize the behavior of two dissimilar metals in electrical contact that are to be used in the human body as medical implants or as component parts to medical implants. Examples of the types of devices that might be assessed include overlapping stents of different alloys, stent and stent marker combinations, orthopedic plates and screws where one or more of the screws are of a different alloy than the rest of the device, and multi-part constructs where two or more alloys are used for the various component parts. Devices which are to be partially implanted, but in long-term contact within the body (such as external fixation devices) may also be evaluated using this method. 1.2 This test method covers the selection of specimens, specimen preparation, test environment, method of exposure, and method for evaluating the results to characterize the behavior of galvanic couples in an electrolyte. 1.3 Devices and device components are intended to be tested in their finished condition, as would be implanted (that is, the metallurgical and surface condition of the sample should be in or as close as possible to the same condition as in the finished device). 1.4 This test method does not address other types of corrosion and degradation damage that may occur in a device such as fretting, crevices, or the effect of any galvanically induced potentials on stress corrosion and corrosion fatigue. Surface modifications, such as from scratches (possibly introduced during implantation) or effects of welding (during manufacture), are also not addressed. These mechanisms are outside of the scope of this test method. 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.Note 1—Additional informati......

Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants

ASTM F2052-14 测量核磁共振环境中医疗设备的磁感应位移力的标准试验方法

5.1 This test method is one of those required to determine if the presence of a medical device may cause injury to individuals during an MR examination and in the MR environment. Other safety issues which should be addressed include but may not be limited to magnetically induced torque (see Test Method F2213) and RF heating (see Test Method F2182). The terms and icons in Practice F2503 should be used to mark the device for safety in the magnetic resonance environment. 5.2 If the device deflects less than 45°, then the magnetically induced deflection force is less than the force on the device due to gravity (its weight). For this condition, it is assumed that any risk imposed by the application of the magnetically induced force is no greater than any risk imposed by normal daily activity in the Earth's gravitational field. This statement does not constitute an acceptance criterion, however it is provided for a conservative reference point. It is possible that a greater magnetically induced deflection force can be acceptable and would not harm a patient. For forces greater than gravity the location of the implant and means of fixation must be considered. Magnetically induced deflection forces greater than the force of gravity may be acceptable when they can be justified for the specific case. 5.3 A deflection of less than 45° at the location of the maximum spatial gradient of the static magnetic field in one MR system does not preclude a deflection exceeding 45° in a system with a higher field strength or larger static field spatial gradients. 5.4 This test method alone is not sufficient for determining if a device is safe in the MR environment. 1.1 This test method covers the measurement of the magnetically induced displacement force produced by static magnetic field gradients on medical devices and the comparison of that force to the weight of the medical device. 1.2 This test method does not address other possible safety issues which include but are not limited to issues of magnetically induced torque, RF heating, induced heating, acoustic noise, interaction among devices, and the functionality of the device and the MR system. 1.3 This test method is intended for devices that can be suspended from a string. Devices which cannot be suspended from a string are not covered by this test method. The weight of the string from which the device is suspended during the test must be less than 18201;% of the weight of the tested device. 1.4 This test method shall be carried out in a horizontal bore MR system with a static magnetic filed oriented horizontally and parallel to the MR system bore. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, assoc......

Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment

ASTM F1717-14 椎骨切除术模型中脊骨植入结构的标准试验方法

5.1 Spinal implants are generally composed of several components which, when connected together, form a spinal implant assembly. Spinal implant assemblies are designed to provide some stability to the spine while arthrodesis takes place. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies so that comparison between different designs may be facilitated. 5.2 These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the spine. 5.3 The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters. 5.4 Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz. 5.5 The location of the longitudinal elements is determined by where the anchors are clinically placed against bony structures. The perpendicular distance to the load direction (block moment arm) between the axis of a hinge pin and the anchor’s attachment-points to a UHMWPE block is independent of anchor-type. The distance between the anchor’s attachment point to the UHMWPE block and the center of the longitudinal element is a function of the interface design between the screw, hook, wire, cable, and so forth, and the rod, plate, and so forth. 5.6 During static torsion testing, the rotation direction (clockwise or counter clockwise) may have an impact on the results. 1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific, depending on the intended spinal location and intended method of application to the spine. 1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device. 1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal imp......

Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

ASTM F648-14 外科植入用超高分子量聚乙烯粉末及成形件的标准规范

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 requirements of this specification do not apply to UHMWPE virgin powder or fabricated forms intentionally crosslinked or blended with other additives, for example, antioxidants. 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)2 and by laboratory studies (4, 5, 6). 1.5 The values stated in SI units are to be regarded as standard. 1.6 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 F2582-14 髋臼假体冲击的标准试验方法

5.1 This test method should be used to evaluate and compare acetabular prostheses to assess the relative degree of constraint for the prosthesis and the damage tolerance under controlled laboratory conditions. 5.2 Although the methodology described attempts to identify physiologically relevant motions and loading conditions, the interpretation of results is limited to an in vitro comparison between acetabular prosthesis designs regarding constraint and their ability to resist impingement fatigue, wear, deformation, and dislocation under the stated test conditions. 1.1 This test method covers a procedure to evaluate acetabular component fatigue, deformation, and wear and femoral head assembly dislocation under dynamic impingement conditions. 1.2 This test method can be used to evaluate single-piece acetabular prostheses, modular prostheses, and constrained prostheses manufactured from polymeric, metallic, or ceramic materials. 1.3 The values stated in SI units are regarded as the 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Impingement of Acetabular Prostheses

ASTM F2979-14 取出金属对金属及其他硬质对硬质髋关节假体关节表面磨损特征的标准指南

1.1 This guide specifies a method to measure the in-vivo wear of explanted Metal-on-Metal (MoM) and other “hard” (e.g., 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 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 ASTM 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses

ASTM F2565-13 外科植入物应用大剂量辐射交联超高分子量聚乙烯制品的标准指南

1.1 This guide covers extensively crosslinked ultra-high molecular weight polyethylene (UHMWPE) materials (fabricated forms) that are produced starting with virgin resin powders and consolidated forms meeting all the requirements of Test Method F648. 1.2 This guide does not cover fabricated forms of ultra-high molecular weight polyethylene which have received only gas plasma, ethylene oxide, or less than 40 kGy ionizing radiation treatments, that is, materials treated only by historical sterilization methods. 1.3 This guide pertains only to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation. 1.4 The specific relationships between these mechanical properties and the in vivo performance of a fabricated form have not been determined. While trends are apparent, specific property-polymer structure and polymer-design relationships are not well understood. These mechanical tests are frequently used to evaluate the reproducibility of a fabrication procedure and are applicable for comparative studies of different materials. 1.5 The following precautionary caveat pertains only to the test method portion, Section 5, of this guide. 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 Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications

ASTM F648-13 外科植入物用超高分子量聚乙烯粉末及组成形式的标准规范

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 requirements of this specification do not apply to UHMWPE virgin powder or fabricated forms intentionally crosslinked or blended with other additives, for example, antioxidants. 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)2 and by laboratory studies (4, 5, 6). 1.5 The values stated in SI units are to be regarded as standard. 1.6 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