ASTM F2394-07(2022)
Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System

Standard No.

ASTM F2394-07(2022)

Release Date

2022

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F2394-07(2022)

Scope

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, balloonexpandable stent delivery systems. 1.2 This guide covers the laboratory determination of the shear force required to displace or dislodge a balloonexpandable 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 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. 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 F2394-07(2022) Referenced Document

• ASTM E1169 Standard Guide for Conducting Ruggedness Tests
• ASTM E1488 Standard Guide for Statistical Procedures to Use in Developing and Applying ASTM Test Methods
• ISO 10555-1 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements*， 2023-10-24 Update

ASTM F2394-07(2022) history

• 2022 ASTM F2394-07(2022) Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System
• 2017 ASTM F2394-07(2017) Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
• 2007 ASTM F2394-07(2013) Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
• 2007 ASTM F2394-07 Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
• 2004 ASTM F2394-04 Standard Guide for Measuring Securement of Balloon Expandable Stent Mounted on Delivery System