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

ASTM F2579-08 外科植入物用无定型的聚丙交酯和丙交酯乙交酯共聚物树脂的标准规范

1.1 This specification covers virgin poly(lactide) and poly(lactide-co-glycolide) resins able to be fully solvated at 30°C by either methylene chloride (dichloromethane) or chloroform (trichloromethane). The poly(d,l-lactide) homopolymers covered by this specification are considered to be amorphous (that is, void of crystallinity) and are polymerized either from meso-lactide or from equimolar (racemic) combinations of d-lactide and l-lactide. The poly(d,l-lactide-co-glycolide) copolymers covered by this specification are also considered to be amorphous and are co-polymerized from a combination of glycolide and either meso-lactide or racemic quantities of d-lactide and l-lactide, and typically possess nominal mole fractions that equal or exceed 50 % lactide. 1.2 Since poly(glycolide) is commonly abbreviated as PGA for poly(glycolic acid) and poly(lactide) is commonly abbreviated as PLA for poly(lactic acid), these polymers are commonly referred to as PGA, PLA, and PLA:PGA resins for the hydrolytic byproducts to which they respectively degrade. PLA is a term that carries no enantiomeric specificity and therefore also encompasses the isotactic d-PLA and l-PLA moieties, each of which carries potential for crystallization. Therefore, specific reference to d,l-PLA is essential to appropriately differentiate the amorphous atactic/syndiotactic d,l-lactide based polymers and copolymers covered by this specification. 1.3 This specification is not applicable to lactide based polymers or copolymers that possess isotactic polymeric segments sufficient in size to deliver potential for lactide based crystallization. This specification is not applicable to lactide-co-glycolide copolymers that possess glycolide segments sufficient in size to deliver potential for glycolide based crystallization, thereby requiring fluorinated solvents for complete dissolution under room temperature conditions. This specification is specifically not applicable to lactide-co-glycolide copolymers with glycolide mole fractions greater than or equal to 70 % (65.3 % in mass fraction). This specification is not applicable to block copolymers or to polymers or copolymers synthesized from combinations of d-lactide and l-lactide that differ by more than 1.5 total mole percent (1.5 % of total moles). 1.4 This specification addresses material characteristics of both poly(lactide) and poly(lactide-co-glycolide) resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from these materials. 1.5 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, etc.) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated independently using appropriate test methods to assure safety and efficacy. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants

ASTM F2083-08e1 膝关节置换假体的标准规范

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. 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 Specification for Total Knee Prosthesis

ASTM F138-08 外科植入物用锻造18铬-14镍-2.5钼不锈钢条和线材的标准规范(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 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 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

ASTM F2313-08e1 摩尔分数大于或等于70%乙二醇的外科植入物用聚乙二醇和聚乙二醇聚乳酸树脂的标准规范

1.1 This specification covers both virgin poly(glycolide) resin and poly(glycolide-co-lactide) resin with mole fractions greater than or equal to 70 % glycolide. This specification is not applicable to glycolide:lactide copolymers with mole fractions exceeding 30 % lactide. 1.2 Since poly(glycolide) is commonly abbreviated as PGA for poly(glycolic acid) and poly(lactide) is commonly abbreviated as PLA for poly(lactic acid), these polymers are commonly referred to as PGA and PLA:PGA resins for the hydrolytic byproducts to which they respectively degrade. 1.3 This specification addresses material characteristics of both virgin poly(glycolide) and poly(>70 % glycolide-co-lactide) resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from these materials. 1.4 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated independently using appropriate test methods to ensure safety and efficacy. 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 may suggest 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 for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide

ASTM F2129-08 进行循环动电位极化测量以测定小型植入装置的腐蚀敏感性的标准试验方法

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. 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. To accommodate the wide variety of device shapes and sizes encountered, a variety of holding devices can be used. 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 be necessarily 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 F 1828), 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 G 5 and Test Method G 61 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. 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. ^REFERENCE: ASTM Standards: D 1193 Specification for Reagent Water E 177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods E 691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method F 1828 Specification for Ureteral Sten......

Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

ASTM F1581-08(2012) 外科植入物用无机骨料成分的标准规范

1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix X1). 1.2 The biological response to apatite in soft tissue and bone has been characterized by a history of clinical use and by laboratory studies (1, 2, 3).2 Xenogeneic bone, with organic components present, has been shown to be antigenic in the human host (4) whereas the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in human clinical use (5, 6, 7). 1.3 This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. 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 Warning???Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA???s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law. 1.6 This standard does not purport to address all of the safety concerns, such as health concerns due to the presence of transmissible disease, 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. (See Appendix X2).

Standard Specification for Composition of Anorganic Bone for Surgical Implants

ASTM F136-08 薄膜设备用铬溅射极的标准规范

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-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

ASTM F1223-08 整个膝部复位固定情况测定的标准试验方法

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 to aid the physician in making a more informed total knee replacement (TKR) selection. A proper matching of TKR functional restorative capabilities and the recipient's (patient's) needs is more likely provided for by a rational testing protocol of the implant in an effort to reveal certain device characteristics pertinent to the selection process. 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. 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. The methodology, utility, and limitations of constraint/laxity testing are discussed. 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 E 4.) 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 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 Determination of Total Knee Replacement Constraint

ASTM F2514-08 承受均布径向的金属血管支架有限元分析(FEA) 的标准指南

Finite element analysis is a valuable method for evaluating the performance of metallic stents and in quantifying quantities such as internal stresses, internal strains, and deformation patterns due to applied external loads and boundary conditions. Many times an analysis is performed to correlate to and plan experimental tests. A finite element analysis is especially valuable in determining quantities that cannot be readily measured.1.1 Purpose8212;This guide establishes general requirements and considerations for the development of finite element models used in the evaluation of the performance of a metallic vascular stent design under uniform radial loading. Suggested criteria are provided for evaluating the typical cases of metallic stents under uniform radially oriented and pulsatile loading. Recommended procedures for checking and validating the finite element model(s) are provided as a means to assess the model and analysis results. Finally, the recommended content of an engineering report covering the mechanical simulations is presented. 1.2 Limits: 1.2.1 This guide is limited in discussion to the finite element structural analysis of metallic stents of the following types: 1.2.1.1 Plastically deformable metal stents. 1.2.1.2 Self-expanding metal stents. 1.2.1.3 Plastically deformable metal portions of covered stents. 1.2.1.4 Metal portions of self-expanding covered metal stents. 1.2.2 The emphasis of the techniques described in this guide is intended for both elasto-plastic materials such as stainless steel, and superelastic materials such as nitinol. Unique concerns associated with stents designed for shape memory behavior are not addressed within this guide. 1.2.3 This guide does not consider changes to possible time varying conditions or different loadings related to vascular remodeling. 1.2.4 This guide is restricted to cases that involve the application of uniform radially oriented loading. 1.2.5 This guide does not provide guidance in the application or interpretation of FEA in determining fatigue life. 1.2.6 This guide is not intended to include complete descriptions of the finite element method, nor its theoretical basis and formulation. 1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

ASTM F2313-08 摩尔分数大于或等于70%乙交酯的外科植入物用聚（乙交酯）和聚（乙交酯-丙交酯）树脂的标准规范

1.1 This specification covers both virgin poly(glycolide) resin and poly(glycolide-co-lactide) resin with mole fractions greater than or equal to 70 % glycolide. This specification is not applicable to glycolide:lactide copolymers with mole fractions exceeding 30 % lactide. 1.2 Since poly(glycolide) is commonly abbreviated as PGA for poly(glycolic acid) and poly(lactide) is commonly abbreviated as PLA for poly(lactic acid), these polymers are commonly referred to as PGA and PLA:PGA resins for the hydrolytic byproducts to which they respectively degrade. 1.3 This specification addresses material characteristics of both virgin poly(glycolide) and poly(>70 % glycolide-co-lactide) resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from these materials. 1.4 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated independently using appropriate test methods to ensure safety and efficacy. 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 may suggest 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 for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide

ASTM F136-08e1 外科植入设备用锻制钛6和铝4钒特低杂质合金的标准规范(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-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

ASTM F2119-07 评定被动植入物MR图象制品的标准试验方法

This test method provides a quantified measure of the image artifact produced under a standard set of scanning conditions. 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.

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

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 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 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 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 F1314-07 外科植入物用锻造氮加强的22铬-13镍-5锰-2.5钼不锈钢棒材和线材用标准规范(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 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 22 Chromium - 13 Nickel - 5 Manganese - 2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)

ASTM F1537-07 外科植入物用钴-28铬-6钼合金的标准规范(UNS R31537、UNS R31538和UNS R31539)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for three wrought cobalt-28chromium-6molybdenum alloys used for surgical implants. The properties specified apply specifically to wrought bar, rod, and wire.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 Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

ASTM F90-07 外科植入物用锻造钴-20铬-15钨-10镍合金的标准规范

1.1 This specification covers the requirements for wrought cobalt-20chromium-15tungsten-10nickel alloy used for surgical implants. The properties specified apply specifically to wrought bar, rod, wire, sheet, and strip, but do not apply to surgical fixation wire (see Specification F 1091).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 Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

ASTM F2581-07 外科植入物用锻制氮增强的11锰-17铬-3钼低镍不锈钢合金棒材和金属丝的标准规范

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 11manganese-17chromium-3molybdenum low-nickel stainless steel alloy bar and wire for surgical implants.1.2 As of the time of the original approval of this specification no product utilizing this alloy had been approved through a 510(k) submission.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 Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)