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Home >> Application >> By Standard >> ASTM >> ASTM E-F >> ASTM F3067 Radial Loading Test of Vascular Stents

ASTM F3067 Radial Loading Test of Vascular Stents

ASTM F3067 Radial Loading Test for Balloon-Expandable and Self-Expanding 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.

Test Principle:

The test operates on the principle of uniform radial loading. Imagine squeezing a cylindrical object evenly from all sides. The load is directed perpendicular to the longitudinal axis of the stent and applied to its entire outer surface (or at least three equally distributed circumferential points) . By compressing the stent inward or allowing it to expand outward, the test measures the mechanical forces (radial strength, collapse pressure, or chronic outward force) the stent exerts or withstands .

Specific Test Methods:

The standard defines three test methods matched to stent type:

Segmented Head Apparatus Method

Wedge-shaped segments synchronously adjust to reduce the inner diameter, compressing the stent uniformly.

Measures radial strength (balloon-expandable stents) and chronic outward force (self-expanding stents).

ASTM F3067 Radial Loading Test of Vascular Stents

Sling Method

Employs a low-friction sling pulled through a restriction to tighten around the stent, radially compressing it .

Suitable for both balloon-expandable and self-expanding stents.

ASTM F3067 Radial Loading Test of Vascular Stents

Hydraulic/Pneumatic Chamber Method

The stent is placed inside a thin elastic tube within a pressurized chamber. External fluid or air pressure is applied to compress the stent.

Best suited for determining the collapse pressure of balloon-expandable stents.

ASTM F3067 Required Test Equipment & Apparatus

Recommend UnitedTest Universal testing machine + Segmented head stent radial loading compression test fixture.

Core fixtures: Segmented head fixture, low-friction sling fixture, hydraulic/pneumatic pressure chamber.

Loading system: Universal testing machine with force calibration (per ASTM E4) and displacement control.

Environmental control: Chamber to maintain 37±2 °C (body temperature) for temperature-sensitive stents (e.g., nitinol).

Measurement systems: Optical/laser diameter gauge (≥2 orthogonal directions), pressure sensor, data acquisition system.

Test Specimen Information

Geometry: The guide applies to stents with a tubular geometry. It covers both balloon-expandable and self-expanding stents, as well as stent-grafts .

Exclusions:It does not cover bifurcated stents, stents with non-circular cross-sections, or tapered stents .

Stent Length: Defined as the unstressed length after deployment. Measurements must be taken using non-contacting instruments (e.g., laser micrometer, profile projection) with a resolution of 0.1 mm or better.

Key Test Parameters

Parameter	Requirement
Loading rate	Slow enough to minimize inertial effects and static friction
Calibration	Force (ASTM E4), pressure, and diameter must be calibrated
Load normalization	Force normalized by stent length (N/mm) or area (kPa); pressure needs no extra normalization
Stent Length Change ( $L$ )	Used in area calculations. If the length change is less than 10%, the original expanded length (Lo) is used. If greater than 10%, the instantaneous length L(D)must be experimentally determined or computationally derived.
Tubing (hydraulic)	Thin, compliant, low-load-sharing elastic tubing

Test Application (Industry Field)

Core field: Cardiovascular & vascular medical device industry.

Uses: R&D characterization, design verification, quality control, and regulatory support for vascular stents and stent-grafts.

Purpose: Validate radial performance to ensure long-term vessel patency, fixation stability, and resistance to physiological/external loads.

Standard Test Procedures of ASTM F3067

The standard provides a general framework rather than a rigid step-by-step, as the exact procedure depends heavily on the chosen apparatus.

1, For Balloon-Expandable Stents (Segmented Head/Sling)

Deploy the stent to labeled diameter per IFU; measure outer diameter and length.

Preheat/hydrate if material-sensitive; place stent fully into the fixture.

Zero the load cell; compress the stent past clinically relevant deformation.

Record load–diameter data; determine radial strength via loading/unloading line offset method.

2, For Self-Expanding Stents (Segmented Head/Sling)

Deploy stent directly into the fixture or from free state; set aperture below min indicated use diameter.

Unload slowly to max indicated use diameter; record force at both diameters.

Normalize force by stent length to get max/min chronic outward force.

Related Standards:

ASTM F2477	Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
ASTM F2516	Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
ASTM F2606	Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
ISO 25539-2	Cardiovascular implants - Endovascular devices - Part 2: Vascular stents

Related products and device

ASTM F3067 Single column universal testing machine

A single column tensile tester is a sophisticated material testing instrument designed for measuring mechanical properties of various materials under tension, compression, bending, shear, and other loading conditions. As the name suggests, it features a single vertical column supporting a moving crosshead that applies force to test specimens.

ASTM F3067 Static Electronic Universal Testing machine

WDW Series Computer Control Electronic Universal Testing Machine made by UNITEDTEST range from 100N to 600KN load capacity with various models like single columns, table type, door frame type etc., is used to perform tension, compression, flexure/bending, shearing, peeling etc., test for metal and nonmetal specimens. Matched with UNITEDTEST design and produced various test fixture, like peel, flexure, puncture, tear, pneumatic grip, belt tension etc., this UTM can be used to almost all materials include but not limited to steel rod, rubber, steel wire, plastic, seat belt, textile, wood, panel etc., mechanical performance inspection.

ASTM F3067 Segmented head stent radial loading compression test fixture

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. Conform with ASTM F3067, ISO 25539-2

ASTM F2606 Three-Point Bending Test fixture for Vascular Stent

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. Conform with ASTM F2606, ISO 25539-2.

Related Standard

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.

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 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 F1044 Shear Testing for Calcium Phosphate and Metallic Coatings –

ASTM F1044 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings.

ASTM F1044 is a standard test method developed to evaluate the shear strength of coatings on metallic substrates, specifically targeting continuous calcium phosphate coatings (like hydroxyapatite) and metallic coatings. Its primary purpose is to measure either the adhesive strength between the coating and substrate or the cohesive strength within the coating itself when subjected to a force parallel to the coating plane.

ISO 7206-4, ISO 7206-6: Fatigue testing of femoral stem and femoral neck of hip prostheses –

ISO 7206‑4 and ISO 7206‑6 are key international standards defining fatigue endurance tests for stemmed femoral components of partial and total hip joint prostheses. ISO 7206‑4 evaluates the femoral stem under simulated proximal loosening; ISO 7206‑6 evaluates the femoral neck under well‑fixed, normal in‑vivo loading.

FAQs About ASTM F3067 Radial Loading Test for Vascular Stents

Q1: What is the main purpose of the ASTM F3067 standard?

A: The primary purpose of ASTM F3067 is to provide a standardized guide for developing in vitro test methods to measure how vascular stents respond to uniform radial loading. It helps manufacturers and researchers quantify key mechanical properties like radial strength, collapse pressure, and chronic outward force, ensuring stents can withstand the physical stresses of the human vascular system .

Q2: Why is measuring radial force or collapse pressure so important for vascular stents?

A: After a stent is deployed, it must maintain the openness (patency) of the blood vessel. It constantly faces radial loads from vessel stretch, pulsation (blood pressure changes), and even external physical impacts (like a patient being in a car accident). If a stent is too weak, it could deform, collapse, or migrate, leading to severe clinical complications. This test proves the stent has the necessary mechanical resilience to stay open and secure .

Q3: How does the testing approach differ between Balloon-Expandable and Self-Expanding stents?

A: The fundamental mechanics are completely different. Balloon-expandable stents are plastically deformed (permanently reshaped) by a balloon and then resist inward crushing forces. Self-expanding stents are made of materials like Nitinol; they spring open on their own and constantly push outward against the vessel wall. Because of this, the standard uses different terminologies and testing focuses: "Radial Strength" or "Collapse Pressure" for balloon-expandable stents, and "Chronic Outward Force" for self-expanding stents .

Q4: What is the difference between radial strength, collapse pressure, and chronic outward force?

A:Radial strength: Max radial load causing clinically relevant plastic deformation (balloon-expandable stents, segmented/sling).

Collapse pressure: Pressure causing catastrophic buckling of balloon-expandable stents (hydraulic/pneumatic).

Chronic outward force: Sustained opening force of self-expanding stents on vessel walls (length-normalized).

Q5: What is "Chronic Outward Force" (COF) and why is it critical for Self-Expanding stents?

A: Chronic Outward Force is the continuous, minimum opening force that a self-expanding stent applies to the vessel wall at a specific diameter. It is literally the "springiness" of the stent. Adequate COF is vital because it ensures the stent remains firmly pressed against the vessel wall, preventing it from migrating (moving out of place) over time .

Q6: Why does the standard emphasize normalizing the load by length or area?

A: Stents come in various sizes. If you simply measure the total force, a longer stent will naturally show a higher number than a shorter one, making comparisons impossible. By normalizing the load (dividing the force by the stent's length or cylindrical surface area), you create a standardized metric (like N/mm or Pa) that allows engineers to objectively compare the radial performance of different stent designs, lengths, and diameters .

Q7: Does the test environment (like temperature) affect the results?

A: Absolutely. Many stent materials, especially shape-memory alloys like Nitinol used in self-expanding stents, are highly sensitive to temperature. Therefore, the standard stipulates that if the stent material's properties change between room temperature and body temperature (37°C), the testing apparatus must be designed to maintain the specimen at 37 ± 2°C to yield physiologically accurate results .

Q8: Why can’t test results from different apparatuses be directly compared?

A: Each apparatus applies unique loading modes, which change the shape of radial loading curves. Direct comparison is only allowed after completing formal data correlation.

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