ASTM F2514-21

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

SIGNIFICANCE AND USE
4.1 Finite element analysis is a valuable tool for evaluating the performance of metallic stents and in estimating quantities such as stress, strain, and displacement due to applied external loads and boundary conditions. FEA of stents is frequently performed to determine the worst-case size for experimental fatigue (or durability) testing and differentiation of performance between designs. A finite element analysis is especially valuable in determining quantities that cannot be readily measured.
SCOPE
1.1 Purpose—This guide establishes recommendations and considerations for the development, verification, validation, and reporting of structural finite element models used in the evaluation of the performance of a metallic vascular stent design undergoing uniform radial loading. This standard guide does not directly apply to non-metallic or absorbable stents, though many aspects of it may be applicable. The purpose of a structural analysis of a stent is to determine quantities such as the displacements, stresses, and strains within a device resulting from external loading, such as crimping or during the catheter loading process, and in-vivo processes, such as expansion and pulsatile loading.  
1.2 Limitations—The analysis technique discussed in this guide is restricted to structural analysis using the finite element method. This document provides specific guidance for verification and validation (V&V) of finite element (FE) models of vascular stents subjected to uniform radial loading using ASME V&V40 as the basis for developing and executing risk-informed V&V plans.  
1.2.1 Users of this document are encouraged to read ASME V&V40 for an introduction to risk-informed V&V, and to read ASME V&V10 for further guidance on performing V&V of computational solid mechanics models. This document is not intended to cover all aspects of developing a finite element model of radial deformation of a stent. It is intended for a FE analyst with structural modeling experience.  
1.2.2 While risk-informed V&V is encouraged, it is not required. Analysts may utilize alternate V&V methods. The methodology employed should be developed by knowledgeable stakeholders with consideration as to the expectations and requirements of internal teams and external bodies that will assess the performance of the stent and the credibility of the model used to make performance predictions.  
1.2.3 If an alternative V&V method is employed, then Sections 5, 6, 7, and 10 that follow ASME V&V40 guidelines may be viewed as suggestions only. Other portions of the document that refer to question of interest, risk, and context of use may be viewed in the same manner.  
1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for informational purposes only.  
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.

General Information

• Status: Published
• Publication Date: 31-Jul-2021
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.30 - Cardiovascular Standards

Standards Content (Sample)

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.
Designation: F2514 − 21
Standard Guide for
Finite Element Analysis (FEA) of Metallic Vascular Stents
1
Subjected to Uniform Radial Loading
This standard is issued under the fixed designation F2514; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Thisguideestablishesgeneralrecommendationsandconsiderationsforusingfiniteelementanalysis
techniques for the numerical simulation of metallic stents subjected to uniform radial loading. These
stents are intended for use within the human vascular system.
1. Scope able stakeholders with consideration as to the expectations and
requirements of internal teams and external bodies that will
1.1 Purpose—This guide establishes recommendations and
assess the performance of the stent and the credibility of the
considerations for the development, verification, validation,
model used to make performance predictions.
and reporting of structural finite element models used in the
1.2.3 If an alternative V&V method is employed, then
evaluation of the performance of a metallic vascular stent
Sections 5, 6, 7, and 10 that followASME V&V40 guidelines
design undergoing uniform radial loading. This standard guide
may be viewed as suggestions only. Other portions of the
does not directly apply to non-metallic or absorbable stents,
document that refer to question of interest, risk, and context of
though many aspects of it may be applicable. The purpose of a
use may be viewed in the same manner.
structural analysis of a stent is to determine quantities such as
the displacements, stresses, and strains within a device result- 1.3 The values stated in SI units are to be regarded as the
ing from external loading, such as crimping or during the standard.The values given in parentheses are for informational
catheter loading process, and in-vivo processes, such as expan- purposes only.
sion and pulsatile loading.
1.4 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.2 Limitations—The analysis technique discussed in this
ization established in the Decision on Principles for the
guide is restricted to structural analysis using the finite element
Development of International Standards, Guides and Recom-
method. This document provides specific guidance for verifi-
mendations issued by the World Trade Organization Technical
cation and validation (V&V) of finite element (FE) models of
Barriers to Trade (TBT) Committee.
vascular stents subjected to uniform radial loading using
ASME V&V40 as the basis for developing and executing
2. Referenced Documents
risk-informed V&V plans.
2
1.2.1 Users of this document are encouraged to readASME
2.1 ASTM Standards:
V&V40 for an introduction to risk-informed V&V, and to read
E8/E8M Test Methods for Tension Testing of Metallic Ma-
ASME V&V10 for further guidance on performing V&V of
terials
computational solid mechanics models. This document is not
E2655 Guide for Reporting Uncertainty of Test Results and
intended to cover all aspects of developing a finite element
Use of the Term Measurement Uncertainty inASTM Test
model of radial deformation of a stent. It is intended for a FE
Methods
analyst with structural modeling experience.
F2477 Test Methods for in vitro Pulsatile Durability Testing
1.2.2 While risk-informed V&V is encouraged, it is not
of Vascular Stents
required. Analysts may utilize alternate V&V methods. The
F2516 Test Method for Tension Testing of Nickel-Titanium
methodology employed should be developed by knowledge-
Superelastic Materials
F3067 GuideforRadialLoadingofBalloon-Expandableand
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.30 on Cardiovascular Standards. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Aug. 1, 2021. Published August 2021. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 2008. Last previous edition approved in 2014 as F2514 – 08 (2014). Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F2514-21. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2514 − 21
Self-Expanding Vascular Stents 3.1.9 pulsatile, a
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2514 − 08 (Reapproved 2014) F2514 − 21
Standard Guide for
Finite Element Analysis (FEA) of Metallic Vascular Stents
1
Subjected to Uniform Radial Loading
This standard is issued under the fixed designation F2514; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
This guide establishes general requirementsrecommendations and considerations for using finite
element analysis techniques for the numerical simulation of metallic stents subjected to uniform radial
loading. These stents are intended for use within the human vascular system.
1. Scope
1.1 Purpose—This guide establishes general requirements recommendations and considerations for the development of
development, verification, validation, and reporting of structural finite element models used in the evaluation of the performance
of a metallic vascular stent design underundergoing 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 This standard guide does not directly apply to
non-metallic or absorbable stents, though many aspects of it may be applicable. The purpose of a structural analysis of a stent is
to determine quantities such as the displacements, stresses, and strains within a device resulting from external loading, such as
crimping or during the catheter loading process, and analysisin-vivo results. Finally, the recommended content of an engineering
report covering the mechanical simulations is presented.processes, such as expansion and pulsatile loading.
1.2 Limits: Limitations—
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. The analysis technique discussed in this guide is restricted to
structural analysis using the finite element method. This document provides specific guidance for verification and validation
(V&V) of finite element (FE) models of vascular stents subjected to uniform radial loading using ASME V&V40 as the basis for
developing and executing risk-informed V&V plans.
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.30
on Cardiovascular Standards.
Current edition approved March 1, 2014Aug. 1, 2021. Published April 2014August 2021. Originally approved in 2008. Last previous edition approved in 20082014 as
F2514 – 08. 08 (2014). DOI: 10.1520/F2514-08R14.10.1520/F2514-21.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2514 − 21
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.
1.2.1 This guideUsers of this document are encouraged to read ASME V&V40 for an introduction to risk-informed V&V, and to
read ASME V&V10 for further guidance on performing V&V of computational solid mechanics models. This document is not
intended to include complete descriptions of the finite element method, nor its theoretical basis and formulation. cover all aspects
of developing a finite element model of radial deformation of a stent. It is intended for a FE analyst with structural modeling
experience.
1.2.2 While risk-informed V&V is encouraged, it is not required. Analysts may utilize alternate V&V methods. The methodology
em
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