ASTM F2394-07 (2022) PDF

Full title and description

ASTM F2394-07 (Reapproved 2022) — Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System. This guide provides recommended approaches, test options, and endpoints for in vitro bench measurement of stent securement (displacement distances and dislodgement forces) for pre-mounted, unsheathed, balloon-expandable endovascular stent delivery systems.

Abstract

This guide describes laboratory methods and test considerations to determine the shear force or other metrics required to displace or dislodge a balloon-expandable vascular stent from its delivery balloon. It covers pre-test conditioning options, gripping and fixturing approaches, test endpoints, and suggested apparatus examples, and is intended to support manufacturers and researchers in developing reproducible securement testing protocols. The guide is intended for in vitro bench characterization and emphasizes that in vivo behaviour may differ.

General information

• Status: Active, reapproved edition (reapproval 2022).
• Publication date: October 1, 2022 (designated F2394-07(2022)).
• Publisher: ASTM International.
• ICS / categories: 11.040.20 (Transfusion, infusion and injection equipment / cardiovascular device testing).
• Edition / version: F2394-07 (original designation 2007; reapproved 2022).
• Number of pages: 13 pages (typical published PDF length).

Scope

The scope covers in vitro bench testing methods to characterize the securement of balloon-expandable vascular stents mounted on delivery balloons. It addresses selection of pre-test treatments, test types (including gripping methods), test endpoints (displacement distances, dislodgement force), and recommends example apparatus and conditioning procedures. The guide does not specify methods for mounting stents on delivery systems, and it does not claim to cover all possible clinical scenarios or safety concerns; users must interpret results in the context of device design and intended use.

Key topics and requirements

• Definitions: balloon-expandable stent, delivery system components, gripping/fixturing terminology.
• Pre-test conditioning options (environmental, mechanical cycling) and their influence on securement metrics.
• Suggested test apparatus and fixturing examples for applying shear/axial loads to stents without damaging the balloon.
• Measurement endpoints: displacement distance, peak dislodgement force, progressive slip behaviour.
• Guidance on selecting test parameters and interpreting in vitro results relative to potential clinical scenarios.
• Unit systems and reporting: SI and inch-pound values treated separately (do not combine).

Typical use and users

Primary users include medical device manufacturers, R&D engineers, bench testing laboratories, regulatory submission teams, and researchers developing or validating balloon-expandable stent delivery systems. The guide is used to design securement tests during device development, compare process or design variants, support verification activities, and inform regulatory test plans where bench characterization of stent retention is required.

Related standards

Related documents referenced for complementary test concepts include other ASTM cardiovascular device standards and international guidance on catheter and stent trackability and delivery system testing (for example, EN 14299 on trackability aspects). Users commonly consult device-specific ISO/ASTM test standards and regulatory guidance when integrating securement testing into broader verification programs.

Keywords

stent securement, balloon-expandable stent, dislodgement force, displacement, vascular stent, delivery system, bench testing, in vitro characterization, angioplasty, retention.

FAQ

Q: What is this standard?

A: It is an ASTM standard guide (F2394-07, reapproved 2022) that provides methods and options for measuring how securely a balloon-expandable vascular stent is retained on its delivery balloon prior to deployment.

Q: What does it cover?

A: The guide covers in vitro test selection, pre-test conditioning, gripping and fixturing strategies, measurement endpoints (e.g., displacement and dislodgement force), and example apparatus for bench testing stent securement. It does not prescribe mounting methods nor does it claim to represent all possible clinical conditions.

Q: Who typically uses it?

A: Medical device manufacturers, test labs, R&D and regulatory teams working on balloon-expandable stent products and delivery systems use this guide to design reproducible securement tests and to compare designs or processes.

Q: Is it current or superseded?

A: The edition is a reapproval of the F2394-07 designation and was reapproved/published in 2022; it is listed as an active ASTM guide. Users should verify the present status with ASTM for any amendments after 2022.

Q: Is it part of a series?

A: F2394 sits within ASTM Committee F04 (Medical and Surgical Materials and Devices) and Subcommittee F04.30 (Cardiovascular Standards); it is commonly used alongside related cardiovascular testing standards and device-specific guidance documents.

Q: What are the key keywords?

A: angioplasty, stent securement, balloon-expandable stent, dislodgement, displacement, retention, delivery system, bench testing.