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ASTM International - ASTM F3067-14

Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents

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Organization: ASTM International
Publication Date: 15 October 2014
Status: active
Page Count: 19
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
significance And Use:

4.1 Upon deployment, at the site of the vascular stenosis, the stent establishes the patency of the lumen until vascular remodeling occurs. The radial load acting upon the stent is imparted by... View More

scope:

1.1 This document provides guidance for developing in vitro test methods for measuring the radial strength or collapse pressure of balloon-expandable vascular stents and chronic outward force of self-expanding vascular stents.

1.2 This guide is applicable to balloon-expandable and self-expanding stents of tubular geometry. It covers both stent and stent grafts. It does not cover bifurcated stents. It does not cover stents with non-circular cross-sections or tapered stents.

1.3 Units-The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.4 This guide does not recommend any specific test method or apparatus for measuring the radial strength, collapse pressure, or chronic outward force. Instead, this guide provides examples of test methodologies and equipment that could be used and recommends the format for presenting test results.

1.5 This guide covers only in vitro bench testing methods. In vivo behavior might be different.

1.6 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 and health practices and determine the applicability of regulatory limitations prior to use.

Document History

ASTM F3067-14
October 15, 2014
Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents
1.1 This document provides guidance for developing in vitro test methods for measuring the radial strength or collapse pressure of balloon-expandable vascular stents and chronic outward force of...
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