Home >> Products >> Test Fixtures >> Compression >> Segmented head stent radial loading compression test fixture
ASTM F3036, ISO 25539-2 Segmented head stent radial loading compression test fixture

Segmented head stent radial loading compression test fixture

ASTM F3067, ISO 25539-2

Segmented head stent radial loading compression test fixture is a specialized designed to evaluate the radial mechanical properties of vascular stents, including radial strength, chronic outward force (COF), collapse pressure, and radial stiffness. It simulates the physiological circumferential pressure exerted by blood vessel walls on implanted stents, providing critical data for stent design validation, regulatory compliance, and clinical safety assessment. This device is specifically referenced in ASTM F3067 (Standard Guide for Radial Loading of Balloon Expandable and Self-Expanding Vascular Stents) .

General introduction

Segmented head stent radial loading compression test fixture is a specialized designed to evaluate the radial mechanical properties of vascular stents, including radial strength, chronic outward force (COF), collapse pressure, and radial stiffness. It simulates the physiological circumferential pressure exerted by blood vessel walls on implanted stents, providing critical data for stent design validation, regulatory compliance, and clinical safety assessment. This device is specifically referenced in ASTM F3067 (Standard Guide for Radial Loading of Balloon Expandable and Self-Expanding Vascular Stents) .


Structure: The fixture consists of multiple rigid, segmental wedge blocks (usually 6 to 12) arranged in a circle. These wedges move synchronously along a predetermined arc, either closing inwards or opening outwards


Mechanism: As the wedges move, the effective diameter of the central aperture changes smoothly and concentrically. When a stent is placed inside this aperture, the moving wedges compress (crush) or allow the expansion of the stent in a highly controlled, uniform manner.

Key Features

  • Features
  • Standard

Uniform Loading: segmented mechanism applies circumferential pressure, eliminating two-point bending artifacts

Physiological Relevance: More accurately simulates vessel wall interaction than flat plate compression

Versatility: Compatible with both balloon-expandable and self-expanding stents of various diameters (2-14 mm)

Precision Control: Microprocessor-controlled movement ensures repeatable test conditions (CV ≤ 5%)

Comprehensive Data: Simultaneous measurement of force, displacement, and diameter changes


ASTM F3067 Standard Guide for Radial Loading of Balloon Expandable and Self-Expanding Vascular Stents.


ISO 25539-2:2020 Cardiovascular implants — Endovascular devices — Part 2: Vascular stents


FDA-1545

FDA Guidance: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff


FDA-1658

FDA Guidance: Coronary and Carotid Embolic Protection Devices – Premarket Notification [510(k)] Submissions





Specification

Stent Diameter Capacity2-14 mm (customizable up to 20 mm)
Force Measurement Range0-500 N (resolution 0.001 N)
Displacement Resolution0.001 mm
Compression Speed0.01-10 mm/min
Temperature Control37°C ± 0.5°C (range 5-60°C)
Segment Count6-12 (8 segments standard for optimal balance of uniformity and stiffness)
Data Sampling Rate100-1000 Hz
Test ModesStatic compression, cyclic loading, creep, stress relaxation


Standard

ASTM F3067 Radial Loading Test of Vascular Stents

ASTM F3067 establishes in vitro test frameworks to characterize the radial mechanical performance of balloon-expandable vascular stents and self-expanding vascular stents. It quantifies three key indicators: radial strength and collapse pressure for balloon-expandable stents, and chronic outward force (COF) for self-expanding stents.

ASTM F2606 Three-Point Bending Test for Balloon-Expandable Vascular Stents and Stent Systems

ASTM F2606 defines quantitative three-point bending procedures to characterize the bending flexibility and stiffness of balloon-expandable vascular stents and stent systems (pre-deployment and deployed states). It is a critical testing protocol in the biomedical engineering field. Since vascular anatomies are naturally curved and tortuous, a stent must be flexible enough to navigate through the delivery pathway (trackability) and conform to the vessel's curvature once deployed without causing vascular trauma . This standard provides the guidelines to measure these mechanical properties accurately.

ASTM F2942 Vascular Implants Axial, bending, torsional and compression durability testing

ASTM F2942 specifies in vitro test methodologies to evaluate the cyclic durability of vascular stents under non-radial mechanical deformations (axial, bending, and torsion) that occur in vivo due to musculoskeletal motion, breathing, or cardiac activity. 

ASTM F2477 Test for in-vitro Pulsatile Durability Testing of Vascular Stents

ASTM F2477 designed to evaluate the long-term fatigue durability and radial cyclic deformation resistance of vascular implants under simulated physiological pulsatile loading conditions. It is crucial for simulating the cyclical stresses these medical devices endure inside human blood vessels. 

ASTM F3036 Testing of Absorbable Stents

ASTM F2942 specifies in vitro test methodologies to evaluate the cyclic durability of vascular stents under non-radial mechanical deformations (axial, bending, and torsion) that occur in vivo due to musculoskeletal motion, breathing, or cardiac activity. include Axial, bending, torsional, Pulsatile Durability, Radial Loading etc., test. 

Step-by-Step Testing Procedure

1, Sample Preparation:

Balloon-expandable stents: Mount on delivery balloon, inflate to nominal pressure, deflate

Self-expanding stents: Load onto delivery system, deploy to nominal diameter

Sterilize and equilibrate in 37°C physiological saline for 10-30 minutes

2, Device Setup:

Install appropriate core shaft (matching stent inner diameter)

Set temperature chamber to 37°C ± 2°C

Calibrate force and displacement sensors

Configure test parameters (speed, compression ratio, cycles)

3, Stent Loading:

Position stent concentrically within the iris segments

Apply preload (0.05-0.1 N) to ensure uniform contact

Verify alignment with optical system

4, Testing Execution:

Start radial compression at specified speed (typically 0.5-2 mm/min)

Record force and displacement data continuously

For cyclic testing: Perform 3-5 preconditioning cycles before data collection

5, Data Analysis:

Generate force vs. diameter curve

Calculate radial strength, COF, stiffness, and hysteresis

Compare results with acceptance criteria from standards and product specifications

Require More Customized Solutions?

We offer customization to meet your specific needs. Our expert team will collaborate with you to develop the perfect product for you
Customize Now

Beijing United Test Co., Ltd.