定价： 1656元 / 折扣价： 1474 元 加购物车

定价： 590元 加购物车

This specification covers shoulder prostheses for total or hemiarthroplasty used to provide functioning articulation by employing glenoid and humeral components. The prostheses may be constrained, partially constrained, or unconstrained. Modular prostheses are included in this specification, but devices for custom applications are not covered. The prostheses are required to meet the prescribed mechanical strength, corrosion resistance, biocompatibility, wear of alternative, and range of motion.1.1 This specification covers shoulder prostheses for total or hemiarthroplasty used to provide functioning articulation by employing glenoid and humeral components.1.2 Devices for custom applications are not covered by this specification. Modular prostheses are included in this specification.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.FIG. 1 Glenosphere Thickness1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 590元 加购物车

1.1 This specification covers total elbow replacement (TER) prostheses and hemi-elbow replacement (“hemi”) prostheses used to provide functioning articulation by employing humeral, ulnar, and/or radial components that allow for the restoration of motion of the human elbow joint complex.1.2 Included within the scope of this specification are elbow prosthesis components for primary and revision surgery with linked and non-linked designs and components implanted with or without use of bone cement.1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those characteristics determined to be important to the in vivo performance of the prosthesis are defined. However, compliance with this specification does not itself mean that a device will provide satisfactory clinical performance.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 international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 590元 加购物车

This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast. Breast prosthesis are classified into three types: type I breast prosthesis, n - implantable breast prosthesis containing a single lumen containing a fixed amount of silicone gel, Type II breast prosthesis, n - implantable breast prosthesis comprised of two complete lumens, one inside the other, and type III breast prosthesis, n - implantable breast prosthesis comprised of two complete lumens, one inside the other. Elongation, breaking strength, tensile set, critical fused or adhered joints, shell rupture, and shell leakage shall be tested to meet the requirements prescribed. Gel cohesion, gel bleeding, and gel penetration shall be tested to meet the requirements prescribed.1.1 This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast.1.2 Limitations—This specification does not cover custom fabricated implantable breast prostheses.1.3 Single-use saline-inflatable, smooth and textured silicone shell implantable breast prostheses are addressed in Specification F2051.1.4 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 590元 加购物车

定价： 590元 加购物车

定价： 590元 加购物车

定价： 646元 加购物车

定价： 590元 加购物车

5.1 This guide can be used to develop test parameters for evaluating fatigue and wear behavior of IVD prostheses under impingement loading. It must be recognized, however, that there are likely many possible impingement conditions for a given IVD prosthesis.5.2 The user should attempt to determine the clinically relevant and geometrically possible impingement conditions and dictated by the design and impingement wear test parameters that may result in wear and fatigue damage for the IVD prosthesis. The user should also attempt to select the device size which will represent a worst case for the impingement conditions and parameters selected.5.3 The user should reference and utilize existing sources of information to identify the impingement test parameters that produce the clinically relevant impingement wear and damage for their IVD prosthesis. Prior clinical experience with the device design may aid in the development of impingement test parameters through analysis of device retrievals and radiographs. However, prior clinical experience with the IVD being tested should not be considered as a prerequisite for performing impingement testing.5.4 This guide details a three-step process for assessing device impingement under a selected set of conditions:5.4.1 The user selects previously identified impingement conditions, one at a time, or clinically observed conditions.5.4.2 The user selects the worst-case size of device to apply the selected conditions.5.4.3 Solid modeling and the quasistatic test method should be employed to assess the impingement condition and determine the impingement test parameters – most importantly, the angular displacement limits to be used in the impingement wear test.5.4.4 The impingement wear test is then conducted using the impingement test parameters.5.5 This guide serves to evaluate devices with various designs, materials (i.e., metal-on-metal versus polymer-on-polymer), and stiffness in the impingement region using the same axial force and angular displacement control.5.5.1 In the case where the device has no limit in a given direction or does not allow motion in a given direction, a rationale for excluding that condition should be provided (e.g., intended design or function of the device).5.6 Impingement occurs over a range between an initial and an ultimate angle rather than at a discrete angle and location because both design (e.g., mobile bearings) and material combinations (e.g., inclusion of polymeric materials) may lead to compliance, deformation and wear, which in turn may lead to a change in the angular displacement at which contact occurs over the course of the test. A range of angular displacement is therefore prescribed to ensure that the impingement region is fully loaded during each impingement cycle.5.7 The suggested test parameters in Table 1 have been provided with the objective of minimizing Mode I wear at the bearing surface while providing sufficient motion to fully offload the bearing surface for each cycle. Given that the intended function of the devices is typically to articulate, it may be impossible to fully eliminate Mode 1 wear at the intended bearing interface.5.8 The point of impingement (POI) is a simplification for the purpose of determining an impingement moment arm and thus calculating the theoretical ultimate moment (Mt). Mt may be useful for comparing device designs.5.9 The contribution of axial rotation to impingement damage is still under-studied. However, retrieval analysis has provided evidence that it may contribute to impingement damage. Many total disc replacements are unconstrained in axial rotation. Therefore, unlike flexion-extension or lateral bending where a moment versus angular displacement response can be readily developed, axial rotation will have a near-zero moment response. The axial rotation parameters provided in Section 15 are based on the Mode 1 wear test methods and should be assessed and altered if justification (e.g., wear patterns from retrievals, scientific literature, etc.) exists.1.1 This standard is intended to provide guidance on the evaluation of wear and fatigue characteristics of total disc prostheses under cyclic impingement conditions.1.2 This guide describes impingement testing of devices with articulating components. The user is cautioned that the methods described herein are intended to produce an impingement condition which may or may not be indicative of clinical performance and which may or may not be consistent with the intended use of the device, and that this should be considered when interpreting the data. Clinically, total disc prostheses should always be implanted per labeling and the manufacturer’s instructions for use.1.3 Impingement has been observed in retrievals among several total disc prosthesis designs; however, impingement is not necessarily associated with device or clinical failure. It is the intent of this guide to investigate possible impingement-induced wear and mechanical failure modes associated with device design, as well as potential mechanical failure modes associated with clinical events such as subsidence, malpositioning, and improper implant sizing. Note that mechanical failure may or may not be associated with functional failure.1.4 It is recommended that the user define the bearing and non-bearing features of the intervertebral disc (IVD) prosthesis and evaluate the performance of the IVD prosthesis under Mode 1 wear by using Guide F2423 or ISO 18192-1 prior to use of this guide. This standard is not intended to provide guidance on Mode I testing.1.5 The goal of this guide is to evaluate impingement in IVD prostheses regardless of the intended region of the spine (cervical or lumbar), material or material combinations (ceramic, metal, polymer), and bearing type (fixed or mobile).1.6 It is the intent of this guide to enable comparison of IVD prostheses with regard to wear and fatigue characteristics when tested under the specified conditions.1.7 The values stated in SI units are to be regarded as the standard with the exception of angular measurements which should be reported in degrees.1.8 The use of this standard may involve the operation of potentially hazardous 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 646元 加购物车

5.1 Once implanted, active fixation systems are subjected to cyclic loading that can be caused by blood flow, musculoskeletal motion, and other sources. The focus of this document is on axial loading caused by hemodynamics. However, depending on the device design other loading modes could influence AFC or attachment mechanism durability (e.g., radial dilatation could lead to longitudinal foreshortening and axial loading on an active fixation system). Damage to AFCs and/or attachment mechanisms may not necessarily lead to device malfunction, but could cause embolization of portions of the device, device migration, endoleaks, or other patient complications (1-4).4 Therefore, durability testing of AFCs and attachment mechanisms is important to ensure that these components are capable of maintaining structural integrity for a defined lifetime.5.1.1 A test method developed following this standard guide can be used to determine the durability of AFCs and/or attachment mechanisms under the desired loading which can be used to assess conformance to product specifications, consensus standards, and guidance documents as well as to support regulatory submissions, quality control, and manufacturing.5.2 This guide provides examples and recommendations so that users can develop an appropriate active fixation durability test for their device design that mechanically challenges either the AFC, the attachment mechanism, or both simultaneously. It should be recognized that both AFCs and attachment mechanisms need to be evaluated to fully characterize active fixation system durability for design verification testing. While testing of the entire active fixation system may typically be preferable, this guide recognizes that there might be situations where this is not practical or desired and allows for independent testing of AFCs and attachment mechanisms. This guide does not contain an exhaustive list of test methods for active fixation durability and methods not included herein may be acceptable for evaluating active fixation durability. Furthermore, this guide does not include information on how to handle all patient complexities such as calcium deposits or weakened aortic tissue. For assistance regarding super-physiological testing, the user is referred to ASTM F3211.5.2.1 The success of an active fixation durability test method depends on the ability of the test apparatus to consistently induce the desired loading (force and/or displacement) to the test specimen at the applied test frequency for the entire duration of the test.5.3 For most devices, active fixation durability testing will need to be complemented by other types of durability testing such as pulsatile, axial, bending, or torsional. ASTM F2477 addresses pulsatile durability testing, ASTM F2942 addresses axial, bending, and torsional durability testing, and ISO 25539-1, in part, addresses general in vitro testing and durability testing of endovascular prostheses.1.1 This guide addresses how to conduct in vitro durability testing on active fixation components (AFCs) and attachment mechanisms of endovascular prostheses. It does not address the durability of fixation systems that reside solely within the vessel lumen to resist device migration (e.g, radial force and friction, adhesives, or geometric fit).1.2 This guide was developed to address active fixation durability for aortic stent grafts. It is not intended to address fixation durability for other endovascular prostheses such as inferior vena cava filters, transcatheter heart valves, barbed venous stents, ancillary fixation devices (e.g, staples or adhesives), or cardiac devices (e.g., left atrial appendage device or mitral repair device). However, some of the techniques and guidance within may be applicable to the in vitro testing of those other devices.1.3 This guide does not directly apply to implants with absorbable AFCs although many aspects of this standard are applicable to those products.1.4 This guide does not provide the in vivo physiologic loading conditions for endovascular prostheses. It is the responsibility of the user to determine the loading or deformation conditions for their particular device and indication. Typically, an axial loading (force or displacement) mode caused by hemodynamics is used, although other modes are possible and should be considered.1.5 This guide does not recommend any specific test method or apparatus for evaluating active fixation durability. It is recognized that there are multiple valid ways to conduct active fixation durability testing and as such this guide provides general recommendations and topics to consider so that users can successfully develop a test plan for their device.1.6 Units—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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 590元 加购物车

定价： 590元 加购物车

This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses, intended for use in surgical reconstruction, augmentation, or replacement of the breast. This specification does not cover custom fabricated implantable breast prostheses and other gel-saline type implants. The silicone elastomer compositions for use as primary material of construction of the shell including the exterior (tissue contact) surface shall include: (1) polymer types MQ or VMQ, (2) fillers A, B, or C, (3) additive J (for radiopacity), and (4) catalysts B, G, J, or K. The requirements for the following are specified: (1) fabrication including vulcanization and postcure, (2) volume and dimension of saline filled prostheses, (3) fixation sites, and (4) orientation means. The following tests shall be performed: (1) physical property tests such as shell leakage and tension tests (2) biocompatibility test, (3) shell rupture or failure test, (4) valve competence, and (5) abrasion test. The physical property requirements are specified for (1) shell percent elongation, breaking strength, and tensile set, and (2) critical and non-critical fused or adhered joints. Illustrations for testing fused or adhered joints are provided. Requirements for sterilization, packaging, labeling, and package inserts are detailed as well.1.1 This specification covers the requirements for single-use, saline inflatable, smooth and textured silicone shell implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast.1.2 Limitations: 1.2.1 This specification does not cover custom fabricated implantable breast prostheses.1.2.2 This specification does not cover gel/saline type implants, which are within the scope of Specification F703.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 590元 加购物车

4.1 This guide can be used to determine the fatigue and wear behavior of IVD prostheses subjected to functional and kinematic cyclic loading/motion for relatively large numbers of cycles (for example, various designs of IVD prostheses, as well as the effects of materials, manufacturing techniques and other design variables on one particular design can be determined using this guide).4.2 This guide is intended to be applicable to IVD prostheses that support load and transmit motion by means of an articulating joint or by use of compliant materials. Ceramics, metals, or polymers, or combination thereof, are used in IVD prostheses, and it is the goal of this guide to enable a kinematic wear and/or fatigue comparison of these devices, regardless of material and type of device.1.1 This guide provides guidance for wear and/or fatigue testing of total disc prostheses under functional and kinematic conditions and, to this end, describes test methods for assessment of the wear or functional characteristics, or both, of total disc prostheses.1.2 Both lumbar and cervical prostheses are addressed.1.3 Load and kinematic profiles for lumbar and cervical devices are not identical and, therefore, are addressed separately in the guide.1.4 Partial disc replacements, such as nucleus replacements or facet joint replacements, are not intended to be addressed.1.5 Wear is assessed using a weight loss method in a testing medium as defined in this guide.1.6 This guide does not address any potential failure mode as it relates to the fixation of the implant to its bony interfaces.1.7 It is the intent of this guide to enable comparison of intervertebral disc (IVD) prostheses with regard to wear and fatigue characteristics when tested under the specified conditions. It must be recognized, however, that there are many possible variations in in-vivo conditions. A single laboratory simulation with a fixed set of parameters might not be universally representative.1.8 Most IVD prostheses primarily fall into two classifications: articulating ball-in-socket type prostheses, and elastomeric or compliant type prostheses. For the former, this guide primarily addresses Mode 1 wear (defined in 3.2.17.1); whereas for the latter, this guide addresses potential failure of the prosthesis when the implant is subjected to a range of motion and/or loads that fall within the full range of possible physiologic motions and loads.1.9 For articulating components, this guide predominantly describes a Mode 1 test. The user is cautioned that other modes of wear may occur and may have significant influence on the functionality and performance of an articulating IVD prosthesis; therefore, the user should consider the effects of other wear modes on the performance of the prosthesis.1.10 In order that the data be reproducible and comparable within and between laboratories, it is essential that uniform procedures are established. This guide is intended to facilitate uniform methods for testing and reporting of data for total disc replacement prostheses.1.11 Without a substantial clinical retrieval history of IVD prostheses, actual loading profiles and patterns cannot be delineated at the time of the writing of this guide. It therefore follows that the load and motion conditions specified by this guide do not necessarily accurately reproduce those occurring in vivo. Rather, this guide provides useful boundary/endpoint conditions for evaluating prosthesis designs in a functional manner.1.12 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in either degrees or radians.1.13 This guide is not intended to be a performance standard. It is the responsibility of the user of this guide to characterize the safety and effectiveness of the prosthesis under evaluation.1.14 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.15 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 590元 加购物车

定价： 590元 加购物车