ASTM F3067 is a standard guide focused on radial loading characterization for balloon-expandable and self-expanding vascular stents (including stent grafts with tubular geometry). It supports bench testing used to quantify outputs such as radial strength, collapse pressure, and chronic outward force.
This guide does not prescribe one mandatory test method or fixture. Instead, it provides example approaches, equipment concepts, and result-presentation formats so labs and device teams can develop a repeatable in vitro radial-loading test that fits their device design and risk focus. If you need help aligning your internal method to the edition cited in a requirement, you can talk with our team.
ASTM F3067 – Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
ASTM F3067 is written for developers and test labs performing in vitro radial loading evaluation of vascular stents. It is commonly used to support design verification, test method development, and documentation packages where radial mechanical performance needs to be demonstrated in a consistent way.
Because it is a guide (not a single prescriptive test method), equipment selection and the exact fixture style typically depend on the stent type (balloon-expandable vs self-expanding) and the specific output being reported.
Quick Definition
Document type: Standard guide.
In plain terms: A framework for developing bench tests that apply circumferential radial loading to vascular stents and reporting radial loading performance metrics in a consistent format.
What This Standard Covers
ASTM F3067 provides guidance for developing in vitro test methods that measure:
- Balloon-expandable stents: radial strength or collapse pressure.
- Self-expanding stents: chronic outward force.
It applies to balloon-expandable and self-expanding stents of tubular geometry and also includes stent grafts in that geometry range. The scope specifically excludes bifurcated stents, non-circular cross-sections, and tapered stents.
Units: SI units only are used in this standard.
Why This Standard Matters in Testing
Radial loading performance is directly tied to whether a deployed stent can resist external vessel/lesion forces without excessive deformation or sustained collapse. ASTM F3067 is often used when teams need a structured way to document how radial loading was applied, how curves were generated, and how outputs were calculated and presented.
The guide also emphasizes an important practical limitation: bench tests can be designed to simulate aspects of clinical loading, but in vitro results are not automatically predictive of in vivo performance.
Common Materials, Product Types, or Applications Covered
Common product types: balloon-expandable vascular stents, self-expanding vascular stents, and tubular-geometry stent grafts.
Common application context: intravascular implant development and verification where radial force / crush resistance metrics are part of the mechanical performance story (for example, product comparison, design changes, or verification evidence supporting a submission or customer requirement).
Common Test or Verification Workflow
Workflows built around ASTM F3067 commonly follow a pattern like:
- Define the performance output (radial strength, collapse pressure, or chronic outward force) and select a radial-loading approach suitable for the stent type.
- Select a fixture concept that applies circumferentially uniform radial loading (many labs use segmented-jaw or iris-style radial compression approaches for radial force characterization).
- Run compression/expansion sequences while capturing force and displacement/diameter-related signals to generate radial loading curves.
- Calculate and report outputs using a consistent format, including the curve presentation and any key derived values required by an internal spec, customer requirement, or regulatory plan.
Practical note: Because ASTM F3067 is a guide, the final method details (conditioning, endpoints, sequence design, and calculation conventions) should be matched to the exact device design and the edition cited by the requirement.
Equipment Commonly Used for This Standard
ASTM F3067 discusses example apparatus and methodologies rather than mandating one machine type. In practice, equipment selection is typically driven by the force range, resolution, and how the lab applies a controlled, circumferential radial load to the stent.
Common equipment building blocks:
- Electromechanical test frame or other controlled-motion test system capable of low-force, high-resolution compression/expansion measurement.
- Radial loading fixture/tooling designed to apply a circumferential radial load (for example, segmented compression/“iris” style fixtures used to generate radial force curves).
- Data acquisition and analysis software for force–displacement capture, curve generation, and repeatable calculations/reporting.
- Environmental control (when required by the test plan): temperature conditioning (often around physiological temperature) and/or fluid exposure setups, if the test program calls for it.
If you are selecting a radial compression fixture diameter/length range, force capacity, or environmental configuration for stent testing, you can request a detailed quote for an equipment setup aligned to your workflow.
How to Read This Designation or Revision
ASTM standards are commonly cited with a base designation and a year identifier. ASTM F3067 is frequently seen as F3067-14 and also as F3067-14 (Reapproved 2021) / F3067-14R21.
What that typically means in purchasing and documentation: “14” indicates the version originally issued in 2014, and “Reapproved 2021” / “R21” indicates a 2021 reapproval status for that edition. When a requirement cites ASTM F3067, confirm whether it requires a specific edition or accepts the active/reapproved version, since reporting format and expectations can be edition-sensitive.
Related Standards, Methods, or Frameworks when useful
ASTM F3067 is often used alongside broader endovascular device frameworks that also address mechanical performance and verification planning for vascular implants. In many test programs, radial loading characterization is one element within a larger matrix that may include dimensional verification, corrosion evaluation, durability/fatigue, and delivery-system performance testing.
When you are mapping a full verification plan, it is common to cross-reference vascular implant standards from ISO and ASTM that cover complementary attributes (for example, endovascular device requirements and durability-related methods) and then use ASTM F3067 specifically for the radial loading portion of the program.
Get help selecting a test setup for ASTM F3067
If you are building or upgrading stent radial-loading capability, the fastest path is usually to align the fixture concept (segmented/iris-style vs other approaches), force range, and environmental needs to the exact output you must report (radial strength, collapse pressure, or chronic outward force). For configuration help or pricing, request a quote.