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

ASTM F2514-08(2014) 承受均布径向荷载的金属血管支架有限元分析 (FEA) 的标准指南

4.1 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 Purpose—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 40;FEA41; of Metallic Vascular Stents Subjected to Uniform Radial Loading

ASTM F2606-08(2014) 三点弯曲血管球囊膨胀型支架和支架装置的标准指南

3.1 This guide can be used to obtain force versus deflection or midspan bending moment versus midspan curvature curves for stents and stent systems subjected to three-point bending conditions. Bending flexibility of a stent system may be a factor in its ability to track through the vascular anatomy, and may be a factor in vascular trauma along the delivery pathway distal to the guide catheter. Bending flexibility of a deployed stent may be one measure of its ability to flex with a vessel, or to conform to the natural curvature of a vessel. Bending flexibility of a delivery system may also be of interest if it is desired to assess the separate contributions of the delivery system and the mounted stent to the overall flexibility of the stent system. 3.2 This guide is not intended to determine material properties, stent system trackability (ability of a stent system to follow a guide wire and/or guide catheter through vascular tortuosity), or stent system deliverability (ability of a stent system to deliver a stent to the implantation site(s) or through particular level(s) of vascular tortuosity). While this guide does not determine stent system trackability or deliverability, it can provide quantitative insight into how stent system bending flexibility affects trackability and deliverability. Similarly, while this guide does not determine conformability of a deployed stent, it can provide quantitative insight into how stent and/or stent system bending flexibility affects deployed stent conformability. Since this guide quantifies bending flexibility, it may be useful in determining the magnitude of bending flexibility effects on bending-related performance differences between the test article and control devices. 3.3 The three-point bending procedures provided in this guide are intended to be used to characterize balloon-expandable stent and stent system flexibility during product development. They may not necessarily satisfy any particular requirements of national or international regulatory bodies. 1.1 This guide provides guidelines for quantitatively characterizing balloon-expandable stent and stent system flexibility using three-point bending procedures. Guidelines are provided for characterizing deployed stent flexibility, and for characterizing pre-deployment stent system flexibility in the region of the stent and balloon. 1.2 This guide is not recommended for test articles that cannot be appropriately evaluated using a span length to stent outer diameter (as tested) ratio of at least 4:1. Test articles that do not meet this requirement are likely to exhibit appreciable deformation by modes other than bending. 1.3 This guide does not provide procedures for characterizing the bending flexibility of self-expanding stents, self-expanding stent systems, endoprostheses (stent-grafts), or endoprostheses systems. However, some aspects of this guide may be useful for developing appropriate three-point bending characterization procedures for these devices. While this guide was developed with vascular stents and stent systems in mind, it may be useful for characterizing the bending flexibility of balloon-expandable stents and stent systems used in non-vascular applications. 1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.

Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems

ASTM F1926/F1926M-08 磷酸钙颗粒及其制品和涂料的环境稳定性评价的标准试验方法

1.1 This test method covers calcium phosphate materials intended for use in surgical implant applications. 1.2 Aspects of the biological response to calcium phosphate materials in soft tissue and bone have been reported from laboratory studies and clinical use (1-10). 1.3 The requirements of this specification apply to calcium phosphate materials such as calcium hydroxyapatite (see Specification F 1185), beta-tricalcium phosphate (see Specification F 1088), and biphasic mixtures thereof with or without intentional addition of other minor components (<10 %). 1.4 The material(s) shall be representative of that produced for sale. It shall have been produced and processed under standard manufacturing conditions. 1.5 The materials may be in the form of powders, granules, fabricated forms or coatings; and may be porous, nonporous, textured, and other implantable topographical substrate form representative of the end-use product. 1.6 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. 1.7 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. 1.8 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. 1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings

ASTM F560-08 外科植入设备用非合金钽的标准规范(UNS R05200,UNS R05400)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for unalloyed tantalum plate, sheet, strip, rod, and wire used in the manufacture of surgical implants. 1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

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

ASTM F1713-08(2013) 外科植入物用锻制钛-13铌-13锆合金的标准规范 (UNS R58130)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-13niobium-13zirconium alloy to be used in the manufacture of surgical implants (1).2 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-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)

ASTM F1537-08 外科移植物用锻造钴28铬6钼合金锻件(UNS R31537、R31538、R31539)标准规范

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 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 Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

ASTM F2181-08 用于手术植入物的锻造无缝不锈钢管的标准规范

1.1 This specification covers the requirements for five compositions of wrought seamless stainless steel tubing for the manufacture of surgical implants. Material shall conform to the applicable requirements of Specifications F 138, F 1314, F 1586, F 2229, or F 2581. This specification addresses those product variables that differentiate wrought seamless tubing from the bar and wire product forms covered in these specifications. 1.2 This specification applies to cold finished, straight length tubing from 0.125 to 1.315 in. (3.18 to 33.4 mm) nominal outside diameter (OD) and 0.018 in. (0.46 mm) and greater nominal wall thickness. 1.3 The specifications in 2.1 will be referred to as the ASTM material standard(s) in this specification. 1.4 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 Seamless Stainless Steel Tubing for Surgical Implants

ASTM F2606-08 三点弯曲血管球囊膨胀型支架和支架装置的标准指南

This guide can be used to obtain force versus deflection or midspan bending moment versus midspan curvature curves for stents and stent systems subjected to three-point bending conditions. Bending flexibility of a stent system may be a factor in its ability to track through the vascular anatomy, and may be a factor in vascular trauma along the delivery pathway distal to the guide catheter. Bending flexibility of a deployed stent may be one measure of its ability to flex with a vessel, or to conform to the natural curvature of a vessel. Bending flexibility of a delivery system may also be of interest if it is desired to assess the separate contributions of the delivery system and the mounted stent to the overall flexibility of the stent system. This guide is not intended to determine material properties, stent system trackability (ability of a stent system to follow a guide wire and/or guide catheter through vascular tortuosity), or stent system deliverability (ability of a stent system to deliver a stent to the implantation site(s) or through particular level(s) of vascular tortuosity). While this guide does not determine stent system trackability or deliverability, it can provide quantitative insight into how stent system bending flexibility affects trackability and deliverability. Similarly, while this guide does not determine conformability of a deployed stent, it can provide quantitative insight into how stent and/or stent system bending flexibility affects deployed stent conformability. Since this guide quantifies bending flexibility, it may be useful in determining the magnitude of bending flexibility effects on bending-related performance differences between the test article and control devices. The three-point bending procedures provided in this guide are intended to be used to characterize balloon-expandable stent and stent system flexibility during product development. They may not necessarily satisfy any particular requirements of national or international regulatory bodies.1.1 This guide provides guidelines for quantitatively characterizing balloon-expandable stent and stent system flexibility using three-point bending procedures. Guidelines are provided for characterizing deployed stent flexibility, and for characterizing pre-deployment stent system flexibility in the region of the stent and balloon. 1.2 This guide is not recommended for test articles that cannot be appropriately evaluated using a span length to stent outer diameter (as tested) ratio of at least 4:1. Test articles that do not meet this requirement are likely to exhibit appreciable deformation by modes other than bending. 1.3 This guide does not provide procedures for characterizing the bending flexibility of self-expanding stents, self-expanding stent systems, endoprostheses (stent-grafts), or endoprostheses systems. However, some aspects of this guide may be useful for developing appropriate three-point bending characterization procedures for these devices. While this guide was developed with vascular stents and stent systems in mind, it may be useful for characterizing the bending flexibility of balloon-expandable stents and stent systems used in non-vascular applications. 1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.

Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems

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 F2724-08(2014) 评估活动衬垫膝关节置换的标准试验方法

4.1 This test method is designed to provide a standardized method to determine the constraint of mobile-bearing knee designs with regards to spin-out and spit-out of the mobile bearing. 4.2 Similar to constraint testing of total knees (see Test Method F1223), it is important to note that the test method does not simulate the soft tissues and laxity of the knee joint, which may be key factors related to the occurrence of spin-out or spit-out.3 For instance, a patient with good soft tissue restraints will perhaps require a lower spin-out/spit-out resistance whereas a patient with major bone loss or destroyed ligamentous structures will likely require an implant with a higher spin-out/spit-out resistance. Therefore, the results from the test should be taken into account along with the condition of the patient’s soft tissues to determine the relative safety for the device. 1.1 This test method is designed to provide a standardized method to determine the dislocation resistance of mobile-bearing knee designs with regard to femoral component disassociation and spin-out/spit-out of the mobile bearing insert. 1.2 Although the methodology described does not replicate all physiological loading conditions, it is a means of in-vitro comparison of mobile bearing knee designs and their ability to resist dislocation of the mobile bearing from the femoral or tibial components under stated test conditions. 1.3 The test method applies only to mobile bearing total knee designs. 1.4 The values stated in SI units are regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered 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 Dislocation

ASTM F961-08 外科植入用锻制35钴-35镍-20铬-10钼合金锻件的标准规范(UNS R30035)

1.1 This specification covers the requirements for 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the form of forgings, 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 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)

ASTM F2028-08(2012)e1 关节窝松动或分离的动态评定的标准试验方法

1.1). 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 glenoid component rocks or pivots following cyclic displacement of the humeral head to opposing glenoid rims (for example, superior-inferior or anterior-posterior). Performance is judged by the tensile displacement opposite each loaded rim after dynamic rocking. 1.2 The same setup can be used to test the locking mechanism of modular glenoid components, for example, for disassociation. 1.3 These test methods cover shoulder replacement designs with monolithic or modular glenoid components for cemented 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 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 F2706-08 在椎骨切除术模型中枕颈和枕颈-胸椎植入构造的标准试验方法

Occipital-cervical and occipital-cervical-thoracic spinal implants are generally composed of several components which, when connected together, form either an occipital-cervical spinal implant assembly or an occipital-cervical-thoracic spinal implant assembly. Occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are designed to provide some stability to the spine during the process of arthrodesis. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies to facilitate comparisons between different designs. These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of occipital-cervical and occipital-cervical-thoracic 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 occipital-cervical and occipital-cervical-thoracic spine. 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. 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 the 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. The location of the longitudinal elements is determined by the intended in vivo location of the anchors. The perpendicular distance to the load direction between the axis of a hinge pin and the anchor''s attachment points to a polyacetal block is independent of anchor-type for the cervical block, but dependent on the design for the occipital test block. The distance between the polyacetal block and the center of the longitudinal element is a function of the design of the implant.1.1 These test methods cover the materials and methods for the static and fatigue testing of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of occipital-cervical and occipital-cervical-thoracic spinal implant components can be specific depending on the intended location and intended method of attachment. 1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future occipital-cervical and occipital-cervical-thoracic spinal implant assemblies. They allow comparison of occipital-cervical and occipital-cervical-thoracic spinal implant constructs with different 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 two fatigue tests for the comparative evaluation of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are defined. 1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of occipital-cervical or occipital-cervical-thoracic spinal implant asse......

Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model

ASTM F1377-08 骨科植入物涂层用钴-28铬-6钼粉的标准规范(UNS R30075)

1.1 This specification covers the requirements for cobalt-28chromium-6molybdenum alloy powders for use in fabricating coatings on cobalt-28chromium-6molybdenum alloy orthopedic 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 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 Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)

ASTM F451-08 丙烯酸骨水泥标准规范

1.1 This specification covers self-curing resins used primarily for the fixation of internal orthopedic prostheses. The mixture may be used in either the predough or dough stage in accordance with the manufacturer''s recommendations. 1.2 Units of premeasured powder and liquid are supplied in a form suitable for mixing. The mixture then sets in place. 1.3 While a variety of copolymers and comonomers may be incorporated, the composition of the set cement shall contain poly(methacrylic acid esters) as its main ingredient. 1.4 This specification covers compositional, physical performance, and biocompatibility as well as packaging requirements. The biocompatibility of acrylic bone cement as it has been traditionally formulated and used has been reported in the literature (1, 2). 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 Specification for Acrylic Bone Cement

ASTM F1581-08 外科植入用无机骨料成分标准规范

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). 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 This standard does not pruport 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 F2212-08 作为组织工程医疗产品（TEMP）外科植入物和基质起始材料的I型胶原蛋白特性的标准指南

The objective of this guide is to provide guidance in the characterization of Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs). This guide contains a listing of physical and chemical parameters that are directly related to the function of collagen. This guide can be used as an aid in the selection and characterization of the appropriate collagen starting material for the specific use. Not all tests or parameters are applicable to all uses of collagen. The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) medical devices, tissue engineered medical products (TEMPs) or cell, drug, or DNA delivery devices for implantation. The use of collagen in a practical application should be based, among other factors, on biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application. The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs. These are source of collagen, chemical and physical characterization and testing, and impurities profile. The following documents relating to the production, regulation and regulatory approval of TEMPs products should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs: FDA CFR: 21 CFR 3: Product Jurisdiction: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=3 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=58 FDA/CDRH CFR and Guidances: 21 CFR Part 803: Medical Device Reporting: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=803 21 CFR 812: Investigational Device Exemptions: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=812 21 CFR 814: Premarket Approval of Medical Devices : http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=814 21 CFR 820: Quality System Regulation: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=820 Design Control Guidance for Medical Device Manufacturers: http://www.fda.gov/cdrh/comp/designgd.pdf Preproduction Quality Assurance Planning Recommendations for Medical Device Manufacturers (FDA 90-4236): http://www.fda.gov/cdrh/manual/appende.html The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program—Draft Guidance for Industry and FDA Staff:

Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

ASTM F1223-08(2012) 测定全膝关节置换约束的标准试验方法

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......

Standard Test Method for Determination of Total Knee Replacement Constraint

ASTM F1609-08(2014) 可植入材料用磷酸钙涂层的标准规范

1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications. 1.2 In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response (1,2)2 and laboratory characterization (2-4). Several publications (5-10) have documented the in vitro and in vivo properties of selected calcium phosphate coating systems. 1.3 This specification includes hydroxylapatite coatings, tricalcium phosphate coatings, or combinations thereof, with or without intentional minor additions of other ceramic or metallic,3 and applied by methods including, but not limited to, the following: (1) mechanical capture, (2) plasma spray deposition, (3) dipping/sintering, (4) electrophoretic deposition, (5) porcelainizing, and (6) sputtering. 1.4 Substrates may include smooth, porous, textured, and other implantable topographical forms. 1.5 This specification excludes organic coatings that may contain calcium and phosphate ionic species. 1.6 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.

Standard Specification for Calcium Phosphate Coatings for Implantable Materials