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.
ASTM F2514-21 Referenced Document
ASTM E2655 Standard Guide for Reporting Uncertainty of Test Results and Use of the Term Measurement Uncertainty in ASTM Test Methods
ASTM E8/E8M Standard Test Methods for Tension Testing of Metallic Materials*, 2024-01-01 Update
ASTM F2477 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses*, 2023-02-01 Update
ASTM F2516 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials*, 2022-06-01 Update
ASTM F3067 Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
ISO 14971 Medical devices - Application of risk management to medical devices
ASTM F2514-21 history
2021ASTM F2514-21 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
2008ASTM F2514-08(2014) Standard Guide for Finite Element Analysis 40;FEA41; of Metallic Vascular Stents Subjected to Uniform Radial Loading
2008ASTM F2514-08 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading