5.1 Upon deployment of a stent or endovascular prosthesis, the device is intended to maintain the patency of the vascular vessel. In order to maintain vessel patency, the device must deform within the in-vivo loading environment without a flow-limiting loss in lumen area. Kinking induces a severe, localized loss of lumen area, typified by a slot-like lumen shape. Device resistance to kinking can be evaluated through multiple test methods, with the appropriate selection depending on the device.5.2 The purpose of this standard is to outline test methods to address the resistance to kinking of stents and endovascular prostheses. In the case where no kinking is observed, the radius at which a predefined narrowing criterion (for example, 50 % diameter reduction) occurs may be considered as the kink radius of the device.5.3 When kink resistance properties are expected to vary along the length of the stent or endovascular prosthesis, testing should be performed at each of these sections.5.4 This standard is not intended to evaluate the kink resistance of devices other than stents, endovascular prostheses, and scaffolds, although the specific procedures outlined here may be used if applicable.1.1 This standard addresses the kink resistance of stents and endovascular prostheses (for example, stent grafts). The standard may also be applicable to scaffolds.1.2 Test methods presented herein address the kink resistance of stents and endovascular protheses when exposed to bending in a single plane. While concurrent influences (for example, torque) are recognized to influence kinking properties, test methods other than single-plane bending are not addressed.1.3 Test methods presented herein do not specifically address kink resistance of branched (for example, bifurcated) or multicomponent endovascular prostheses, but some aspects of this standard may be applicable to their application.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, 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.

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3.1 The purpose of this guide is to provide a procedure for determining the appropriate attributes to evaluate in a shelf-life study for an endovascular device.1.1 This guide addresses the determination of appropriate device attributes for testing as part of a shelf-life study for endovascular devices. Combination and biodegradable devices (for example, drug devices, biologic devices, or drug biologics) may require additional considerations, depending on their nature.1.2 This guide does not directly provide any test methods for conducting shelf-life testing.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.

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4.1 The purpose of this guide is to provide guidance for selecting appropriate device size(s) and determining appropriate sample size(s) for design verification of endovascular devices. The device size(s) and sample size(s) for each design input requirement should be determined before testing. The device size(s) selected for verification testing should establish that the entire device matrix is able to achieve the design input requirements. If testing is not performed on all device sizes, justification should be provided.4.2 The sample size justification and statistical procedures used to analyze the data should be based on sound scientific principles and should be suitable for reaching a justifiable conclusion. Insufficient sample size may lead to erroneous conclusions more often than desired.4.3 Guidance regarding methodologies for determining device size selection and appropriate sample size is provided in Sections 5 and 6.1.1 This guide provides guidance for selecting an appropriate device size(s) and determining an appropriate sample size(s) (that is, number of samples) for design verification testing of endovascular devices. A methodology is presented to determine which device size(s) should be selected for testing to verify the device design adequately for each design input requirement (that is, test characteristic). Additionally, different statistical approaches are presented and discussed to help guide the developer to determine and justify sample size(s) for the design input requirement being verified. Alternate methodologies for determining device size selection and sample size selection may be acceptable for design verification.1.2 This guide applies to physical design verification testing. This guide addresses in-vitro testing; in-vivo/animal studies are outside the scope of this guide. This guide does not directly address design validation; however, the methodologies presented may be applicable to in-vitro design validation testing. Guidance for sampling related to computational simulation (for example, sensitivity analysis and tolerance analysis) is not provided. Guidance for using models, such as design of experiments (DOE), for design verification testing is not provided. This guide does not address sampling across multiple manufacturing lots as this is typically done as process validation. Special considerations are to be given to certain tests such as fatigue (see Practice E739) and shelf-life testing (see Section 8).1.3 Regulatory guidance may exist for endovascular devices that should be considered for design verification device size and sample size selection.1.4 Units—The values stated in SI units are to be regarded as the 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, 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.

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This test method covers the procedure for determining the durability of ballon-expandable and self- expanding metal or alloy vascular stents. Tests are performed by exposing specimens to physiologically relevant diametric distention levels using hydrodynamic pulsatile loading. Specimens should have been deployed into a mock or elastically simulated vessel prior to testing. The test methods are valid for determining stent failure due to typical cyclic blood vessel diametric distention and include physiological pressure tests and diameter control tests. These do not address other modes of failure such as dynamic bending, torsion, extension, crushing, or abrasion. Test apparatus include a pressure measurement system, dimensional measurement devices, a cycle counting system, and a temperature control system.1.1 These test methods cover the determination of the durability of a vascular stent or endoprosthesis by exposing it to diametric deformation by means of hydrodynamic pulsatile loading. This testing occurs on a test sample that has been deployed into a mock (elastically simulated) vessel. The test is conducted for a number of cycles to adequately establish the intended fatigue resistance of the sample.1.2 These test methods are applicable to balloon-expandable and self-expanding stents fabricated from metals and metal alloys and endovascular prostheses with metal stents. This standard does not specifically address any attributes unique to coated stents, polymeric stents, or biodegradable stents, although the application of this test method to those products is not precluded.1.3 These test methods may be used for assessing stent and endovascular prosthesis durability when exposed to blood vessel cyclic diametric change. These test methods do not address other cyclic loading modes such as bending, torsion, extension, or compression.1.4 These test methods are primarily intended for use with physiologically relevant diametric change, however guidance is provided for hyper-physiologic diametric deformation (that is, fatigue to fracture).1.5 These test methods do address test conditions for curved mock vessels, however might not address all concerns.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, 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.

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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.

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