ASTM WK34602

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

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    Developed by Subcommittee: F04.30 | Committee F04 | Contact Staff Manager



    WK34602

    1. Scope

    1. Scope 1.1 This document provides guidance for the 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. 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 testing 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.

    No current guide standard or test method(s) exist within the ASTM in order to evaluate stent resistance to radial loads. The guide is used by medical device manufacturers for the development and regulatory filing with government agencies. It is used to justify release for clinical and market approvals.


    Keywords

    vascular stents

    The title and scope are in draft form and are under development within this ASTM Committee.

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    Work Item Status

    Date Initiated:
    09-02-2011

    Technical Contact:
    Erik Eli

    Item:
    014

    Ballot:
    F04 (14-01)

    Status:
    Negative Votes Need Resolution