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ASTM F2394

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

Standard by ASTM, 2022-10-12

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About This Item

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ASTM F2394 is the ASTM standard guide for measuring securement of a balloon-expandable vascular stent mounted on a delivery system. It is intended to help define a consistent approach for evaluating how securely the stent remains attached during handling, preparation, and delivery-related conditions. For manufacturers, test labs, and quality teams, this guide supports clearer product assessment and more comparable results when examining stent securement performance.

Purpose of ASTM F2394

The purpose of ASTM F2394 is to provide a technical guide for measuring the securement of a balloon-expandable vascular stent mounted on its delivery system. As a guide, it helps establish a structured way to assess attachment behavior rather than prescribing a final product design. This is useful when comparing delivery configurations, supporting development testing, or documenting performance-related measurements. ASTM F2394 can help align testing practices so securement evaluations are more repeatable and easier to interpret.

Common use cases of ASTM F2394

This standard is commonly used in cardiovascular device development and testing environments where balloon-expandable vascular stents are evaluated on their delivery systems. It may support bench testing, engineering verification, and quality control activities tied to stent mounting and retention behavior. ASTM F2394 is also relevant during product comparison or procurement review when securement performance needs to be measured in a consistent, standards-based way. Its focus is practical measurement of the mounted stent condition.

Why ASTM F2394 matters

ASTM F2394 matters because securement is a critical part of the overall performance of a mounted vascular stent delivery system. Consistent measurement helps reduce variability, support compliance efforts, and improve confidence in test results used for product evaluation. For organizations developing or assessing these devices, the standard can aid risk reduction by making securement-related testing more transparent and comparable. ASTM F2394 also helps teams communicate expectations clearly across engineering, testing, and quality functions.

  • Balloon-expandable vascular stent securement
  • Mounted delivery system evaluation
  • Bench and verification testing support
  • Repeatable measurement practices
  • Quality and compliance documentation
SKU: b06a83199855

  • Publication Date: 2022-10-12
  • Publisher: ASTM

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