【国外标准】 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
本网站 发布时间:
2024-02-28
开通会员免费在线看70000余条国内标准,赠送文本下载次数,单本最低仅合13.3元!还可享标准出版进度查询、定制跟踪推送、标准查新等超多特权!  
查看详情>>
标准简介
适用范围:
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.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.
标准号:
ASTM F2514-21
标准名称:
Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
英文名称:
Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading标准状态:
Active-
发布日期:
-
实施日期:
出版语种:
- 推荐标准
- 国家标准计划
- 24/30491443 DC standard
- 24/30489392 DC BS EN IEC 62358 Ferrite cores. Standard inductance factor for gapped cores and its tolerance
- BS ISO 19848:2024 - TC Tracked Changes. Ships and marine technology. Standard data for shipboard machinery and equipment
- BS ISO 19848:2024 Ships and marine technology. Standard data for shipboard machinery and equipment
- BS IEC 61360-7:2024 Standard data element types with associated classification scheme
- 24/30487130 DC BS EN 50566:2017/A2:2024 Product standard to demonstrate the compliance of wireless communication
- 24/30486472 DC - Product standard
- KS M ISO 4259-4 석유 및 관련 제품 — 측정 방법과 결과의 정밀도 — 제4부: 개별 실험실에서 표준 시험방법의 실행에 대한 ‘통계적 관리’ 상태를 확인하기 위한 통계적 관리도의 사용
- KS C IEC 61340-4-6 정전기학 — 제4-6부: 구체적 적용 분야에 대한 표준 시험방법 — 손목접지대
- KS C IEC 61340-4-7 정전기학 — 제4-7부: 구체적 적용 분야에 대한 표준 시험방법 — 이온화
- KS C IEC 61340-4-8 정전기학 — 제4-8부: 구체적 적용 분야에 대한 표준 시험방법 — ESD 차폐성 — 봉투
- 24/30485973 DC standard
- BS EN 14662-1:2023 - TC Tracked Changes. Ambient air quality. Standard method for measurement of benzene concentrations
- KS C IEC 61837-2 주파수 제어 및 선택을 위한 표면 실장형 압전 장치 — 표준 아웃라인 및 단자 리드 연결 — 제2부: 세라믹 함체
- BS EN IEC 61753-081-02:2023 Fibre optic interconnecting devices and passive components. Performance standard