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

ASTM F1717-09 脊骨切除术模型中脊骨植入结构的标准试验方法

Spinal implants are generally composed of several components which, when connected together, form a spinal implant assembly. Spinal implant assemblies are designed to provide some stability to the spine while arthrodesis takes place. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies so that comparison between different designs may be facilitated. These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the spine. 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 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 where the anchors are clinically placed against bony structures. The perpendicular distance to the load direction (block moment arm) between the axis of a hinge pin and the anchor''s attachment-points to a UHMWPE block is independent of anchor-type. The distance between the anchor''s attachment point to the UHMWPE block and the center of the longitudinal element is a function of the interface design between the screw, hook, wire, cable, and so forth, and the rod, plate, and so forth.1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific depending on the intended spinal location and intended method of application to the spine. 1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device. 1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies. 1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly. 1.5 Some spinal constructs may not be testable in all test configurations. 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......

Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

ASTM F2224-09(2014) 医用高纯水合硫酸钙或二水硫酸钙的标准规范

1.1 This specification covers material requirements for unfabricated and fabricated forms of hydrated calcium sulfate intended for surgical implants. Fabricated forms may include pressed and cast surgical implants in various geometric shapes. The calcium sulfate hemihydrate in the unfabricated form can be converted with the addition of water or other water-containing solutions to a fabricated calcium sulfate dihydrate form. 1.2 The requirements of this specification apply to calcium sulfate combined with two molecules of water or two calcium sulfate molecules sharing one water molecule. Approximate chemical formulae: Calcium Sulfate Dihydrate CaSO4·2H2O   Calcium Sulfate Hemihydrate CaSO4·1/2H2O or CaSO4·H2O·CaSO4 1.3 This specification specifically excludes calcium sulfate anhydrite and calcium sulfate forms that contain additives such as reinforcing phases, medicaments, biological agents, and so forth. 1.4 The presence of processing aids does not exclude a product from the physical and mechanical requirements of this specification. 1.5 Some provisions of Specification C59/C59M and Test Methods C472 apply. Special requirements that are detailed in this specification are included to characterize the material which will be used in surgical implants. 1.6 The biological response to calcium sulfate in bone tissue has been well characterized by a history of clinical use (1-14)2 and by laboratory studies (15-18). 1.7 The following precautionary caveat pertains only to the test method portion, Sections 4, 5, and 6, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.

Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants

ASTM F2224-09 医用高纯水合硫酸钙或二水硫酸钙规范

1.1 This specification covers material requirements for unfabricated and fabricated forms of hydrated calcium sulfate intended for surgical implants. Fabricated forms may include pressed and cast surgical implants in various geometric shapes. The calcium sulfate hemihydrate in the unfabricated form can be converted with the addition of water or other water-containing solutions to a fabricated calcium sulfate dihydrate form. 1.2 The requirements of this specification apply to calcium sulfate combined with two molecules of water or two calcium sulfate molecules sharing one water molecule.Approximate chemical formulae: Calcium Sulfate Dihydrate CaSO4·2H2O Calcium Sulfate Hemihydrate CaSO4·1/2H2O or CaSO4·H2O·CaSO4 1.3 This specification specifically excludes calcium sulfate anhydrite and calcium sulfate forms that contain additives such as reinforcing phases, medicaments, biological agents, and so forth. 1.4 The presence of processing aids does not exclude a product from the physical and mechanical requirements of this specification. 1.5 Some provisions of Specification C 59/C 59M and Test Methods C 472 apply. Special requirements that are detailed in this specification are included to characterize the material which will be used in surgical implants. 1.6 The biological response to calcium sulfate in bone tissue has been well characterized by a history of clinical use (1-14) and by laboratory studies (15-18). 1.7 The following precautionary caveat pertains only to the test method portion, Sections 4, 5, and 6, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.

Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants

ASTM F1357-09 全腕关节植入物的标准规范

1.1 This specification describes total wrist implants, including solid ceramic implants, used to provide functioning articulation by employing radial and carpal components. 1.2 This specification excludes those implants with ceramic-coated or porous-coated surfaces, one-piece elastomeric implants (with or without grommets), and those devices used for custom applications. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Specification for Articulating Total Wrist Implants

ASTM F602-09 可植入的热固性环氧塑料标准

1.1 These criteria cover thermoset plastics based on diglycidyl ethers of bisphenol A (DGEBPA) and appropriate curing agents or catalysts as opposed to thermoplastics based on epoxy structures. 1.2 These criteria are generic and are intended to provide definitions and a standard description of epoxy plastics used in implantable devices. It is also intended to serve as a standard guide for the preparation of more specific documents with values and limits covering specific end uses. 1.3 Compliance with these criteria shall not be construed as an endorsement of implantability. The biocompatibility of epoxy plastics as a class has not been established. Epoxy plastic is a generic term relating to the class of polymers formed from epoxy resins, certain curing agents or catalysts, and various additives. Since many compositions and formulations fall under this class, it is essential that the formulator or fabricator ensure biocompatibility of the specific composition or formulation in its intended end use. Since these criteria provide guidance for the preparation of more specific documents covering specific end uses, these documents will provide bases for standardized evaluation of biocompatibility appropriate for a specific end use. 1.4 Each of the properties listed shall be considered in selecting materials for specific end uses. A list of selected properties with limiting values assigned is suggested for separate product specifications. 1.5 All of the properties and test methods listed may not be pertinent in any specific situation, nor may all of the tests outlined be required. 1.6 These criteria are limited to functionally or fully cured epoxy plastics. Uncured or incompletely cured formulations are specifically excluded. 1.7 The epoxy plastics covered by this standard are those to be evaluated for use in implantable biomedical devices. The term implantable is herein considered to include devices used in vivo for time periods in excess of 30 days. 1.8 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 Criteria for Implantable Thermoset Epoxy Plastics

ASTM F641-09 可植入的环氧树脂电子胶囊密封材料标准规范

1.1 This specification covers thermoset plastics based on diglycidyl ethers of bisphenol A and amino functional curing agents or amine catalysts. 1.2 The epoxy encapsulants covered by this specification are intended to provide a tissue-compatible protective covering for implantable medical devices such as pulse generators, telemetry devices and RF receivers. The biocompatibility of epoxy plastics has not been established. Epoxy plastic is a generic term relating to the class of polymers formed from epoxy resins, certain curing agents or catalysts and various additives. Since many compositions and formulations fall under this category, it is essential that the fabricator assure safety of implantability of the specific composition or formulation for the intended use by current state-of-the-art test methods. This specification can be used as a basis for standardized evaluation of biocompatibility for such implantable encapsulants. 1.3 The encapsulants covered by this specification are for use in devices intended as long-term implants. 1.4 Limitations8212;This specification covers only the initial qualification of epoxy encapsulants for implantable electronic circuitry. Some of the requirements are not applicable to routine lot-to-lot quality control. 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 Implantable Epoxy Electronic Encapsulants

ASTM F665-09 生物医学用氯乙烯塑料的标准分类

This classification was developed to permit the addition of descriptive symbols and values for further new formulations with improved properties without complete reorganization of the standard and to facilitate the incorporation of future new test methods to keep pace with changing industry requirements.1.1 This classification provides guidance to engineers and users in the selection of practical vinyl chloride plastics for medical applications and further provides a method for specifying these materials by use of a simple line call-out designation. This classification excludes vinyl chloride plastics used in long-term implants. 1.2 Use is made of a classification scheme based on the premise that the composition of vinyl chloride plastics, copolymers, fillers, plasticizers, stabilizers, and other additives in these systems can be arranged into characteristic material designations. 1.3 In all cases where the provisions of this classification system would conflict with those of the detailed specification for a particular device, the latter shall take precedence. Note 18212;For cases in which the vinyl chloride plastic may be used for purposes where the requirements are too specific to be completely described by this classification system, it is advisable for the purchaser to consult the supplier to secure adjustment of the properties to suit the actual conditions to which the device is to be subjected. 1.4 The biocompatibility of vinyl chloride plastics as a class of materials has not been established. Since many compositions and formulations fall under this class, it is essential that the fabricators/device manufacturers assure the safety and efficacy of the specific composition or formulation, in its intended application, using state-of-the-art test methods. 1.5 This classification is to assist the interface between the material supplier and the device manufacturer (fabricator) who purchases a formulated vinyl chloride plastic for a component. For those device manufacturers (fabricators) who do their own formulating, compounding, extrusion, molding, and so forth, this classification does not apply. 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 Classification for Vinyl Chloride Plastics Used in Biomedical Application

ASTM F2182-09 磁共振成像时测量射频感应加热接近被动性植入物的标准试验方法

This test method describes a test procedure for evaluating the RF-induced temperature rise associated with an MR procedure involving a specific frequency of RF irradiation of an implant. The heating measurements are made twice, once with the implant and then repeated at the same location without the implant. These two measurements estimate the local SAR and the local additional temperature rise with the implant. If there is a significant temperature rise associated with the implant, the results may be used as an input to a computational model for estimating temperature rise in a patient. The combination of the test results and the computational model results may then be provided to regulatory bodies and physicians to assess the safety of a patient with the implant during an MR scan. 1.1 This test method covers measurement of radio frequency (RF) induced heating on or near a passive medical implant and its surroundings during magnetic resonance imaging (MRI). 1.2 This test method is one of those required to determine if the presence of a passive implant may cause injury to the patient with the implant during an MR procedure. Other safety issues that should be addressed include magnetically induced displacement force and torque. 1.3 The amount of RF-induced temperature rise for a given specific absorption rate (SAR) will depend on the RF frequency, which is dependent on the static magnetic field strength of the MR system. Because of possible additional heating, particularly when implant dimensions approaches or exceeds onequarter of the wavelength of the RF field inside the phantom, conclusions from measurements made at one static magnetic field strength do not apply to other field strengths and frequencies. While the focus in this test method is on 1.5 T or 3 Tesla cylindrical bore MR systems, the RF-induced temperature rise for an implant in open MR systems can be evaluated by suitable modification of the method described herein. 1.4 This test method assumes that testing is done on devices that will be entirely inside the body. For other implantation conditions (for example, external fixation devices, percutaneous needles, catheters or tethered devices such as ablation probes), modifications of this test method are necessary. 1.5 This test method applies to whole body magnetic resonance equipment, as defined in section 2.2.103 of the IEC Standard 60601-2-33, Ed. 2.0, with a whole body RF transmit coil as defined in section 2.2.100. The RF coil is assumed to have quadrature excitation. 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 Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging

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 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 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 F2723-08 评价活动衬垫膝关节胫骨基座/轴承抗动态分离的标准试验方法

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. 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. 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 regarded as 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

ASTM F2582-08 髋臼假体冲击的标准试验方法

The test method may be used to evaluate and compare acetabular prostheses to assess the relative degree of constraint for the prosthesis and the damage tolerance under controlled laboratory conditions. It is recognized that there are several clinical failure modes for acetabular prostheses and that this test method may or may not be capable of reproducing them.1.1 This test method covers a procedure for measuring the range of motion, impingement, and dislocation of a femoral head assembly and acetabular prosthesis. 1.2 This test method covers the procedure for static and cyclic fatigue tests. 1.3 This test method may be used to evaluate single piece acetabular prostheses, modular prostheses, and constrained prostheses manufactured from polymeric, metallic, or ceramic materials. 1.4 The values stated in SI units are regarded as the 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 Impingement of Acetabular Prostheses

ASTM F2083-08 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 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 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 F2027-08 组织工程医学产品对原料或生物材料的特性和测试的标准指南

The physico-chemical characteristics of the raw or starting biomaterial used in regenerative medicine scaffolds carries significant potential to affect product performance by influencing cell behavior and/or the release of bioactive molecules or drugs. This guide describes recommended specifications or characterizations of raw or starting biomaterials to ensure reproducibility prior to their fabrication into implantable tissue engineering scaffolds and/or controlled release matrices. 1.1 This document provides guidance on writing a materials specification for raw or starting biomaterials intended for use in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules. This guide does not apply to biomaterials that are already in a scaffold form or are finished tissue-engineered medical products. 1.2 The purpose of this guide is to provide a compendium of relevant existing standards and test methods for biomaterials already commonly used within medical products and to provide characterization guidance for interim use of raw biomaterials for which a standard does not exist. 1.3 This guide covers specifications and characterizations of all the major classes of materials including polymers, ceramics, metals, composites, and natural tissues of human, animal, or plant origin. This guide does not apply to pharmaceuticals. 1.4 This guide is focused on specification of chemical, physical, and mechanical properties of the raw or starting material. It does not include safety and biocompatibility requirements since safety and biocompatibility testing is typically done on materials fabricated into a final form to include all possible effects of fabrication and sterilization techniques. 1.5 Compliance with materials specifications developed in accordance with this standard may not necessarily result in a material suitable for its intended purpose. Additional testing specific to the intend use may be required.

Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products

ASTM F2724-08 活动衬垫膝关节置换的标准试验方法

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. Similar to constraint testing of total knees (see Test Method F 1223), 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. 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 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 F1350-08 锻造18铬-14镍-2.5钼不锈钢外科固定用线标准规范(UNS S31673)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for the manufacture of wrought 18 chromium-14 nickel-2.5 molybdenum stainless steel in the form of surgical fixation wire. 1.2 The values stated in SI units are to be regarded as the standard. The inch-pound values in parentheses are for information only.

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