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ASTM F2394-04

Historical Revision

Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System

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1.1 This guide provides guidance for the design and development of pre-test treatments, tests, and test endpoints to measure stent securement of pre-mounted, unsheathed, balloon-expandable stent delivery systems. This guide is intended to aid investigators in the design, development, and in vitro characterization of pre-mounted, unsheathed, balloon-expandable stent delivery systems.

1.2 This guide covers the laboratory determination of the shear force required to displace or dislodge a balloon-expandable endovascular stent mounted on a delivery system. The guide proposes a set of options to consider when testing stent securement. The options cover pre-test treatments, possible stent securement tests, and relevant test endpoints. An example test apparatus is given in 7.1.

1.3 This guide covers in vitro bench testing characterization only. Measured levels of securement and product design/process differentiation may be particularly influenced by selections of pre-test treatments, securement test type (for example, stent gripping method), and test endpoint. In vivo characteristics may also differ from in vitro results.

1.4 This guide does not cover all possible pre-test treatments, stent securement tests, or test endpoints. It is intended to provide a starting point from which to select and investigate securement test options.

1.5 This guide does not specify a method for mounting the stent onto the delivery system.

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 requirements prior to use.


SDO ASTM: ASTM International
Document Number F2394
Publication Date May 1, 2004
Language en - English
Page Count 11
Revision Level 04
Supercedes
Committee F04.30
Publish Date Document Id Type View
July 15, 2007 F2394-07 Revision
May 1, 2004 F2394-04 Revision
Oct. 1, 2022 F2394-07R22 Reaffirmation
Sept. 1, 2017 F2394-07R17 Reaffirmation
March 1, 2013 F2394-07R13 Reaffirmation