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Home >> Products >> Test Fixtures >> Flexural >> ASTM F2606 Three-Point Bending Test fixture for Vascular Stent

ASTM F2606 Three-Point Bending Test fixture for Vascular Stent

ASTM F2606, ISO 25539-2

Three-Point Bending Test fixture for Vascular Stent is a specialized mechanical testing instrument designed to evaluate the flexural properties of balloon-expandable vascular stents and stent system. It quantifies critical performance metrics including flexural stiffness, bending resistance, yield behavior, and structural integrity under controlled bending conditions, simulating the physiological stresses stents encounter during navigation through tortuous blood vessels and post-implantation vessel wall interactions. This device is explicitly referenced in ASTM F2606 (Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems) .

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General introduction

Core Working Principle

The device operates on the classic three-point bending mechanics principle, applying a concentrated load at the midpoint of a stent sample supported by two fixed parallel cylindrical supports. This creates a state of pure bending in the stent's central region, allowing precise measurement of the relationship between applied force and resulting deflection.

Key Features

Features
Key mechanical processes
Standard
Critical Considerations & Limitations

1, Low-Friction and Biocompatible Contact Surface:

Support columns and loading heads are usually made of polytetrafluoroethylene (PTFE) or other engineering materials with low friction coefficients, excellent rigidity, and that do not scratch the stent, ensuring that external forces are fully used for pure bending deformation of the stent, eliminating friction interference.

2, Physiological Environment Temperature Simulation (Key Features):

Considering that the mechanical properties of stent materials such as Nitinol are extremely sensitive to temperature, high-end testing devices integrate environmental test chambers (like BioBox) or constant temperature water baths (like BioBath). Testing can be conducted in a bionic liquid or air environment at 37 ± 2°C to obtain mechanical data closest to the actual in vivo conditions.

3, High-Precision Closed-Loop Control and Multi-Mode Testing:

The device can accurately control actuator movement (position control or force control) to achieve a constant deflection loading rate. It also supports real-time monitoring of force-displacement (P-δ) throughout the process and can perform multi-cycle loading-unloading tests to evaluate the stent's elastic recovery and hysteresis characteristics.

Loading phase: A moving upper cylindrical indenter applies displacement at a controlled rate (typically 1-10 mm/min) to the stent midpoint.

Force-deflection monitoring: High-precision load cells and displacement sensors record real-time data to generate bending force vs. deflection curves.

Unloading phase (optional): The indenter retracts to measure elastic recovery and hysteresis behavior.

Failure detection: The system identifies yield points and structural failure (fracture, permanent deformation) based on predefined criteria.

ASTM F2606 Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems.

Applicability: Balloon-expandable stents and stent systems (pre-deployment and post-deployment states)ASTM International

Span Length Requirement: Minimum 4:1 span-to-stent outer diameter ratio (as tested)

Loading Protocol:

Pre-deployment testing: Evaluate stent system flexibility in the stent-balloon region

Post-deployment testing: Characterize deployed stent flexibility after balloon expansion

Deflection Limit: Test typically stops at 0.2 × span length or until structural failure

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

Span-to-Diameter Ratio: Failure to maintain ≥ 4:1 ratio results in invalid stress distribution and non-compliant data.

Stent Alignment: Misalignment (>0.1 mm) causes asymmetric loading and inaccurate stiffness measurements.

Surface Finish: Rough support/indenter surfaces (Ra > 0.8 μm) can damage stent struts and affect test results.

Temperature Sensitivity: Nickel-titanium (NiTi) stents exhibit temperature-dependent mechanical properties; precise 37°C control is mandatory.

Preload Application: Insufficient preload leads to inconsistent initial contact; excessive preload causes plastic deformation.

Test Speed: Faster speeds (>10 mm/min) may induce dynamic effects that do not reflect physiological conditions.

Main Technical Specification

Stent Diameter Capacity	2-14 mm (customizable up to 20 mm)
Stent Length Capacity	8-40 mm
Span Length Range	20-100 mm
Force Measurement Range	0-50 N (resolution 0.001 N)
Displacement Resolution	0.001 mm
Test Speed	0.1-50 mm/min (standard: 2 mm/min)
Temperature Control	37°C ± 0.5°C (range 5-60°C)
Data Sampling Rate	100-1000 Hz
Test Modes	Static bending, cyclic loading, creep, stress relaxation

Standard

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 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 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 –

Step-by-Step Testing Procedure

1, Sample Preparation:

Pre-deployment: Mount stent on delivery balloon (no inflation); ensure proper crimpingASTM International

Post-deployment: Inflate balloon to nominal pressure (per manufacturer's specs), deflate, and remove balloonASTM International

Equilibrate in 37°C physiological saline for 10-30 minutes to simulate body temperatureASTM International

2, Device Setup:

Select appropriate span length (≥ 4× stent outer diameter)ASTM International

Calibrate force and displacement sensors according to manufacturer guidelines

Set temperature chamber to 37°C ± 0.5°C

Configure test parameters: speed (typically 2 mm/min), deflection limit (0.2× span), data sampling rate (100 Hz)

3, Testing Execution

3.1, Stent Loading:

Position stent perpendicular to supports, centered under the indenter

Apply preload (0.05-0.1 N) to ensure uniform contact with all three points

Verify alignment with optical system (coaxiality ≤ 0.1 mm)

3.2, Bending Test:

Start displacement-controlled loading at specified speed

Record force and displacement data continuously throughout the test

Stop test at deflection limit or when structural failure occurs (force drop ≥ 20%)

4, Post-Test Analysis:

Generate force vs. deflection curve

Calculate key parameters: flexural stiffness, yield force, maximum force, deflection at failure

Perform visual inspection for cracks, permanent deformation, or structural damage

Compare results with acceptance criteria from standards and product specifications