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

ASTM F601-13 金属外科植入物荧光渗透检查的标准实施规程

3.1 This practice is intended to confirm the method of obtaining and evaluating the fluorescent penetrant indications on metallic surgical implants. 3.2 The product acceptance and rejection criteria will be as agreed upon between the purchaser and the supplier. 1.1 This practice is intended as a guide for fluorescent penetrant inspection of metallic surgical implants. 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

ASTM F1314-13ae1 外科植入物用锻制氮增强22铬-13镍-5锰-2.5钼不锈钢合金棒材及线材的标准规范 (UNS S20910)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 22 chromium – 13 nickel – 5 manganese – 2.5 molybdenum stainless steel alloy bar and wire for surgical implants. 1.2 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.

Standard Specification for Wrought Nitrogen Strengthened 22 Chromiumndash;13 Nickelndash;5 Manganesendash;2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)

ASTM F67-13 外科植入物应用非合金钛(UNS R50250, UNS R50400, UNS R50550, UNS R50700)的标准规范

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for four grades of unalloyed titanium strip, sheet, plate, bar, billet, forging, and wire used for the manufacture of surgical implants. 1.2 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.

Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

ASTM F136-13 外科植入物用锻制钛-6铝-4钒ELI (超低间质) 合金的标准规范 (UNS R56401)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be 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 Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

ASTM F3036-13 可吸收支架试验用标准指南

4.1 Absorbable cardiovascular stents provide temporary support to the vasculature and are intended to degrade and absorb over time after being implanted into the vasculature. 4.2 The test methods used to evaluate the mechanical performance of absorbable devices are similar to those used to evaluate permanent (non-absorbable) cardiovascular devices. The absorbable-specific pre-test conditioning requirements, handling requirements before and during the test, and time-dependent mechanical property evaluations for absorbable devices are addressed here. 4.3 As the absorbable implant degrades, the mechanical performance of the device also deteriorates. The key to achieving effective revascularization with absorbable devices is to provide an adequate level of luminal support for the time frame needed for vessel stabilization. 1.1 This Guide covers select physical and mechanical characterizations of vascular stents with one or more absorbable components. Such absorbable stents (also referred to as vascular scaffolds) are used to provide temporary luminal support of the coronary and peripheral vasculature following interventional revascularization procedures. This Guide covers devices that are fabricated from one or more degradable polymers and/or metals (from this point on referred to as “absorbable”). This Guide provides a framework for evaluating the change in select physical and mechanical characteristics of absorbable stents from manufacture through their intended degradation in vivo. Specific testing recommendations are limited to existing ASTM standards for stent evaluation. 1.2 Recommendations specific to non-absorbable stents with absorbable coatings are not within scope. 1.3 Recommendations specific to testing absorbable stent grafts are not provided here, however this standard has many elements applicable to testing absorbable stent grafts. 1.4 Clinical need dictates that absorbable stents initially possess the same general dimensions and mechanical function as their non-absorbable counterparts. Thus, utilization of already established mechanical stent evaluation methods is possible when absorbable test specimens are previously conditioned under physiologically relevant temperature and humidity. As a result, this standard addresses absorbable-specific testing issues related to the mechanical and physical evaluation of these devices. This standard is limited to providing absorbable-specific testing recommendations for evaluations where an ASTM method for durable (i.e., non-absorbable) stents is already available. Specifically, this standard provides testing recommendations for adapting the elastic recoil (ASTM F2079), securement/dislodgement (ASTM F2394), and three-point bending (ASTM F2606) tests to fully absorbable devices. This guide generally describes specimen conditioning, as appropriate, for absorbable devices, which can range from none to extensive – depending on the measured attribute and relevant clinical exposure conditions, including time in the in-use environment. There are additional stent evaluation methods that are not addressed explicitly in this guide, e.g., chronic durability, that may require absorbable-specific provisions. The user should justify the appropriate testing for the specific polymer and device. 1.4.1 While the primary purpose of this guide is to address absorbable stent-related issues specific to the tests described in Section

Standard Guide for Testing Absorbable Stents

ASTM F2102-13 评估预期供外科植入物使用的聚乙烯制品氧化程度的标准指南

1.1 This guide covers a method for the measurement of the relative extent of oxidation present in HDPE homopolymers and ultra-high-molecular-weight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy. The intensity (area) of the carbonyl absorptions (gt;C=O) centered near 1720 cm-1 is related to the amount of chemically bound oxygen present in the material. Other forms of chemically bound oxygen (C-O-C, C-O-O-C, C-O-H, and so forth) are not captured by this guide. 1.2 Although this guide may give the investigator a means to compare the relative extent of carbonyl oxidation present in various UHMWPE samples, it is recognized that other forms of chemically bound oxygen may be important contributors to these materials' characteristics. 1.3 FIG. 1 Typical FTIR Spectra of Oxidized UHMWPE, Showing the Definition of an Area-Based Oxidation Index Based on Normalization Using the 1370-cm -1 PeakFIG. 2 FTIR Spectra Showing the Carbonyl Absorption Bands Note 1—Note that both reagents effectively extracted the lipids (the lipid absorption peak is centered at approximately 1740 cm-1). The tibial insert was fabricated from highly crosslinked and remelted UHMWPE followed by terminal sterilization in EtO gas (Ref. 1).The applicability of the infrared method has been demonstrated by many literature reports. This particular method, using the intensity (area) of the C-H absorption centered near 1370 cm-1 to normalize for the sample's thickness, has been validated by an Interlaboratory Study (ILS) conducted according to Practice E691. 1.4 The following precautionary caveat pertains only to the test method portion, Section 5, of this specification: This standard may involve 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 requirements prior to use.

Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants

ASTM F1798-13 评估脊柱关节固定用植入物采用互联机制和部件的静态和疲劳特性的评估标准试验方法

5.1 Spinal implants are generally composed of several components that, when connected together, form a spinal implant construct. Spinal implant constructs are designed to provide some stability to the spine while arthrodesis takes place. This test method outlines standardized evaluations of different interconnection mechanisms to facilitate comparison between different designs. Comparisons must be made cautiously and with careful analysis, taking into account the effects that design differences can have on the loading configurations. 5.2 This test method is used to quantify the static and fatigue properties of different implant interconnection designs. The mechanical tests are conducted in vitro using simplified, unidirectional loads and moments. Fatigue testing in a simulated body fluid or saline may have a fretting, corrosive, or lubricating effect on the interconnection and thereby affect the relative performance of tested devices. Hence, the test environment, whether a simulated body fluid, saline (9g NaCl per 1000 mL H2O), with a saline drip, or dry, is an important characteristic of the test and must be reported accurately. 5.3 The loading of spinal implant constructs in vivo will, in general, differ from the loading configurations used in this test method. The results obtained here cannot be used directly to predict in vivo performance. However, the results can be used to compare different component designs in terms of relative mechanical parameters. 1.1 This test method covers the measurement of uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of spinal arthrodesis implants. 1.2 The purpose of this test method is to provide a means of mechanically characterizing different designs of spinal implant interconnections. Ultimately, the various components and interconnections should be combined for static and fatigue testing of the spinal implant construct. It is not the intention of this test method to address the analysis of spinal implant constructs or subconstructs or to define levels of performance of spinal implants as insufficient knowledge is available to predict the consequences of the use of particular spinal implant designs. 1.3 This test method sets out definitions for use in measuring the strength of component interconnections of spinal implants, possible test methods themselves, and the reporting of test results. 1.4 The values stated in SI units are to be regarded as standard, with the exception of angular measurements, which may be reported in terms of either degrees or radians. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

ASTM F2943-13 展示关节置换术用骨科植入物的最终用户标识信息的标准指南

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 Current 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 individual stakeholders (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 compared with 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 represented 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 ......

Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty

ASTM F2146-13 外科植入物用锻制3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 4 for size limitations. 1.2 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. 1.3 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 requirements prior to use.

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

ASTM F543-13 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 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using all of the described ......

Standard Specification and Test Methods for Metallic Medical Bone Screws

ASTM F138-13 外科植入物用锻制18铬-14镍-2.5钼不锈钢棒材及线材的标准规范 (UNS S31673)

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

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

ASTM F1314-13 外科植入物用锻制氮增强22铬-13镍-5锰-2.5钼不锈钢合金棒材及线材的标准规范 (UNS S20910)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 22 chromium – 13 nickel – 5 manganese – 2.5 molybdenum stainless steel alloy bar and wire for surgical implants. 1.2 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.

Standard Specification for Wrought Nitrogen Strengthened 22 Chromiumndash;13 Nickelndash;5 Manganesendash;2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)

ASTM F86-13 金属外科植入物表面制备和标记的标准实施规程

3.1 The surface treatments documented in this practice are intended to improve the corrosion resistance of metallic surgical implants manufactured from iron, cobalt, titanium, and tantalum base materials. 3.2 Iron particles, ceramic media, and other foreign particles may become smeared over or imbedded into the surface of implants during processing operations such as forming, machining, tumbling, bead blasting, and so forth. These particles should be removed to minimize localized rust formation and superficial blemishes. 3.3 The various chemical and electrochemical surface treatments specified in this practice are intended to remove objectionable surface contaminants and to restore maximum corrosion resistance to the passive oxide film. 3.4 The need for an additional implant surface treatment such as secondary passivation in nitric acid should be evaluated for localized implant surfaces that have electrochemical or laser product markings created after the final surface treatment. 1.1 This practice provides a description of surface characteristics, methods of surface preparation, and methods of marking for metallic surgical implants. Marking nomenclature and neutralization of endotoxin are not specified in this practice (see X1.3). Surface requirements and marking methods included in the implant specification shall take precedence over requirements listed in this practice, where appropriate. 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. 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 Surface Preparation and Marking of Metallic Surgical Implants

ASTM F543-13e1 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 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design. In most instances, only a subset of the herein described test methods will be required. 1.6 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.

Standard Specification and Test Methods for Metallic Medical Bone Screws

ASTM F561-13 对医疗器械及相关职责和液体进行回收和分析的标准实施规程

5.1 The investigation of retrieved implantable medical devices and adjacent tissues can be of value in the assessment of clinical complications associated with the use of a specific prosthetic device design; can expand the knowledge of clinical implant performance and interactions between implants and the body; provide information on implant performance and safety; and thus further the development of biocompatible implant materials and devices with improved performance. Comparison of wear patterns and wear particle morphology observed with retrievals and those observed with in vitro joint simulator tests can provide valuable insight into the validity of the in vitro simulation. 5.2 A significant portion of the information associated with a retrieved implant is obtained with detailed studies of the device-tissue interface. Appropriate methods are provided to facilitate a study of the particles in the tissues, and chemical analysis for the byproducts of degradation of the implant, and histologic evaluation of the cellular response to the implant. 5.3 For the analysis to be accurate, it is essential that the device and associated tissues be removed without alteration of their form and structure. It is also essential that the tissues be handled in such a way as to avoid microbial contamination of the work place or the investigator. Standard protocols for the examination and collection of data are provided for retrieval and handling of implantable medical devices, as well as for specific types of materials in relation to their typical applications. For particular investigational programs, additional, more specific, protocols may be required. If special analytical techniques are employed, the appropriate procedures must be specified. 5.4 In order to interpret the analysis of materials and tissues, it is also essential to capture a minimum data set regarding the clinical findings and laboratory studies documenting device performance and reasons for removal. 5.5 Any destructive analysis of implants must be done so as to not destroy any features that may become the subject of litigation, as per Practice E860. This standard recommendation should be applied in accordance with state or national regulations or legal requirements regarding the handling and analysis of retrieved implants and tissues. 1.1 This practice covers recommendations for the retrieval, handling, and analysis of implanted medical devices and associated specimens that are removed from patients during revision surgery, at postmortem, or as part of animal studies. This practice can also be used for analysis of specimens and lubrication fluids from in vitro wear tests and joint simulators. The aim is to provide guidance in preventing damage to the associated specimens which could obscure the investigational results, and in gathering data at the proper time and circumstance to validate the study. 1.2 This practice offers guidelines for the analysis of retrieved implants to limit damage to them, and to allow comparisons between investigational results from different studies. The protocols are divided into three stages, where Stage I is the minimum non-destructive analysis, Stage II is more complete non-destructive analysis, and Stage III is destructive analysis. Standard protocols for the examination and collection of data are provided for specific types of materials in relati......

Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

ASTM F2942-13 血管支架体外轴向, 弯曲和扭转耐久性试验的标准指南

5.1 It is important to consider the durability of stent designs in deformation modes that are intended to model in vivo conditions. The appropriate amplitude and number of cycles in each of the modes has to be determined independently for the particular clinical use proposed for the stent. These tests do not replicate all varieties and aspects of the deployment process and the in vivo mechanical environment so they cannot be proofs of durability. Instead, the tests provide evidence of durability. The durability tests can also provide a means of assessing design, material or processing changes. 5.1.1 This guide might be useful for development testing, specification acceptance testing, and regulatory submission testing and filings as it provides a basic assurance that the tests are designed, executed, and reported in a suitable fashion. 5.1.2 If the tests are conducted using a well-defined FTF methodology, they can be useful in: 5.1.2.1 Potential design improvement through identification of better and worse geometries, materials, and manufacturing processes; 5.1.2.2 Understanding product durability by estimating the effects of changes in geometry, materials, or manufacturing processes; 5.1.2.3 Estimating the safety factor relative to the amplitudes and other factors in use conditions; and 5.1.2.4 Validating finite element analysis (FEA) and fatigue life models. 5.1.3 As stated in the scope, this guide is not intended to provide the in vivo physiologic deformation conditions that a vascular stent can be subjected. Reliable clinical data characterizing cyclic vascular deformation may be lacking for some indications. The user should develop and justify the boundary conditions (e.g., literature review, in vivo studies, cadaver studies, or modeling of stent vessel interaction) for the chosen durability bench tests. Additional conditions that may be considered include vessel calcification, vessel taper, eccentric lesions, deformation excursions (e.g., exercise), and vessel remodeling. 5.1.4 Test methods other than those provided in the annexes of this document might be appropriate, depending upon stent design. However, these methods are beyond the scope of this guide. 1.1 This guide includes three separate cyclic deformation durability guides related to vascular stents: bending, axial, and torsional. 1.2 This guide does not address flat plate, local crush durability, or multi-mode testing. 1.3 This guide applies to balloon-expandable and self-expanding stents fabricated from metals and metal alloys. It does not specifically address any attributes unique to coated stents (i.e., stent with a surface layer of an additional material(s)), monolithically polymeric stents, or absorbable stents, although the application of this standard to those products is not precluded. 1.4 This guide is applicable to testing of stent(s) (or a representative portion of a stent). While durability testing of coupon samples (e.g., a scaled-u......

Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

ASTM F560/F560M-13 外科植入物应用非合金钽(UNS R05200, UNS R05400)的标准规范

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for unalloyed tantalum plate, sheet, strip, bar, and wire used in the manufacture of surgical implants. 1.2 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 of the two systems may result in non-conformance with this standard.

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

ASTM F2977-13 外科植入物用高分子生物材料的小型冲孔测试的标准试验方法

4.1 Miniature specimen testing techniques are used to characterize the mechanical behavior of polymer stock materials and surgical implants after manufacture, sterilization, shelf aging, radiation crosslinking, thermal treatment, filler incorporation, and implantation (1-3). Furthermore, experimental materials can be evaluated after accelerated aging, fatigue testing, and hip, knee, or spine wear simulation. Consequently, the small punch test makes it possible to examine relationships between wear performance and mechanical behavior. This test method can also be used to rank the mechanical behavior relative to a reference control material. 4.2 Small punch testing results may vary with specimen preparation and with the speed and environment of testing. Consequently, where precise comparative results are desired, these factors must be carefully controlled. 1.1 This test method covers the determination of mechanical behavior of polymeric biomaterials by small punch testing of miniature disk specimens (0.5 mm in thickness and 6.4 mm in diameter). The test method has been established for characterizing surgical materials after ram extrusion or compression molding (1-3)2; for evaluating as-manufactured implants and sterilization method effects (4, 5); as well as for testing of implants that have been retrieved (explanted) from the human body (6, 7). 1.2 The results of the small punch test, namely the peak load, ultimate displacement, ultimate load, and work to failure, provide metrics of the yielding, ultimate strength, ductility, and toughness under multiaxial loading conditions. Because the mechanical behavior can be different when loaded under uniaxial and multiaxial loading conditions (8), the small punch test provides a complementary mechanical testing technique to the uniaxial tensile test. However, it should be noted that the small punch test results may not correlate with uniaxial tensile test results. 1.3 In addition to its use as a research tool in implant retrieval analysis, the small punch test can be used as a laboratory screening test to evaluate new materials with minimal material waste (1). 1.4 The small punch test has been applied to other polymers, including polymethyl methacrylate (PMMA) bone cement, polyacetal, and high density polyethylene (HDPE), ultra high molecular weight polyethylene (UHMWPE), and polyetheretherketone (PEEK)

Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants

ASTM F2989-13 外科植入物应用的金属注射成型的非合金钛部件的标准规范

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for three grades of metal injection molded (MIM) unalloyed titanium components in two types to be used in the manufacture of surgical implants. 1.2 The Type 1 MIM components covered by this specification may have been densified beyond their as-sintered density by post-sinter processing. 1.3 Values in either inch-pound or SI are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore each system shall be used independent of the other. Combining values from the two systems may result in non-conformance with the specification. 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 Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications

ASTM F2723-13 评定活动衬垫膝关节胫骨板/支座耐动态脱位的标准试验方法

4.1 This test method includes the use of static and fatigue shear and bending force conditions to evaluate the bearing retention mechanism of a mobile bearing knee design and its ability to prevent disassociation. 4.2 In general, disassociation does not occur during activities where the contact locations are within the boundaries of the bearing surfaces. Disassociation is most likely to occur with forces at the edges of the bearing component or with large AP shear forces on a posterior stabilized knee tibial component post. Extreme bearing rotation, bone/bearing impingement, severe varus or valgus moments, high flexion or any combination of the above can increase the likelihood of disassociation. 4.3 The test method described is applicable to any bicompartmental mobile bearing knee with a bearing retention mechanism. With modification, the test can be applied to a unicompartmental mobile bearing knee with a bearing retention mechanism. 1.1 This test method describes a laboratory method for evaluating the potential for mobile bearing knee tibial baseplate/bearing disassociation under repeated forces. 1.2 The test described is applicable to any bicompartmental mobile bearing knee with a bearing retention mechanism. With modification, the test can be applied to a unicompartmental mobile bearing knee with a bearing retention mechanism. 1.3 Although the methodology described does not replicate all physiological force conditions, it is a means of in vitro comparison of mobile bearing knee designs and the strength of the bearing retention mechanism between the tibial baseplate and bearing components under the stated test conditions. 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 Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation