ASTM F2514-08 (Reapproved 2014)

Standard Organization:

ASTM F2514-08 (Reapproved 2014)
Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial

Recognition Date2015-01-27
Recognition List038
Recognition Number3-88
Extent Complete standard
Standards Orgs ASTM ASTM International http://www.astm.org/
STG Cardiovascular
FDA Tech  Finn Donaldson   FDA/OMPT/CDRH/ODE/DCD/PIDB/   301-796-9579   Finn.Donaldson@fda.hhs.gov

Rationale:

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Scope:

This guide establishes general requirements and considerations for the development of finite element models used in the evaluation of the performance of a metallic vascular stent design under 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 and analysis results. Finally, the recommended content of an engineering report covering the mechanical simulations is presented.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
Unclassified Coronary Drug-Eluting Stent Class 3 NIQ
Unclassified Stent, Carotid Class 3 NIM
Unclassified Stent, Coronary Class 3 MAF
Unclassified Stent, Iliac Class 3 NIO
Unclassified Stent, Renal Class 3 NIN
Unclassified Stent, Superficial Femoral Artery Class 3 NIP

FDA Guidance:

Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Issued April 2010.

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