ASTM F2477-23
Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses

Standard No.

ASTM F2477-23

Release Date

2023

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F2477-23

Scope

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.

ASTM F2477-23 Referenced Document

• ASTM D1193 Standard Specification for Reagent Water
• ASTM F2514 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
• ASTM F3067 Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
• ASTM F3172 Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
• ASTM F3211 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
• ISO 14971 Medical devices - Application of risk management to medical devices

ASTM F2477-23 history

• 2023 ASTM F2477-23 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
• 2019 ASTM F2477-19 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
• 2007 ASTM F2477-07(2013) Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
• 2007 ASTM F2477-07 Standard Test Methods forin vitro Pulsatile Durability Testing of Vascular Stents
• 2006 ASTM F2477-06 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents