Information on the most widely used ASTM standards within the materials testing industry
ISO 12417-1:2024 specifies requirements for Vascular Device-Drug Combination Products (VDDCPs) (drug-eluting stents, drug-coated balloons, drug-bearing vascular grafts, etc.). It mandates mechanical tests for the device part (DP) (to verify structural/functional integrity) and a suite of drug-related, physicochemical, biological, and clinical tests.
Mechanical performance must comply with device-specific standards (ISO 25539-2, ISO 10555-4, ISO 7198) and remain unaffected by the drug-containing part (DCP).
ISO 12417-1 applies to vascular implants/devices with ancillary drug action (device = primary mode of action); excludes pure drug-delivery catheters. Covers permanent implants (drug-eluting stents) and temporary devices (drug-coated balloons)
Mechanical Tests
All mechanical tests use sterilized, clinically conditioned samples (per Clause 7.2.2): ≥3 samples from ≥3 batches, representative of all sizes/configurations.
| Mechanical Test | Test Method | Test Equipment |
|---|---|---|
| Radial Force/Support (Stent VDDCPs) | Test per ISO 25539-2: Expand the stent, apply radial compression at a constant rate; measure reaction force to verify coating does not reduce radial strength. | Radial force tester, load cell (±2% accuracy), displacement sensor, 37±2°C thermostatic bath. |
| Crush Resistance (Stent VDDCPs) | Static/dynamic crush loading per ISO 25539-2; inspect for deformation, coating delamination, or fracture. | Universal testing machine, crush fixture, optical microscope |
| Tensile Strength & Elongation (Graft/Stent VDDCPs) | Axial tension at 50–200 mm/min until failure (ISO 7198/ISO 25539-2); measure max load and elongation at break. | Universal tensile tester, length gauge (±0.5 mm) |
| Flexion / Bending Fatigue | Cyclic bending (simulating vascular motion) up to 10⁷ cycles; check for breakage, coating loss, or lumen occlusion. | Dynamic bending fatigue tester, 37°C fluid bath |
| Balloon Burst Pressure & Compliance (Drug-Coated Balloons) | Pressurize the balloon per ISO 10555-4; record burst pressure and pressure–diameter compliance; confirm coating does not weaken the balloon. | Balloon pressure tester, pressure transducer, diameter gauge |
| Delivery System Pushability/Trackability/Kink Resistance | Simulate vascular navigation; measure push force, trackability, and minimum kink radius (ISO 10555 series). | Vascular phantom, mechanical test bench, kink mandrels |
| Suture Retention Strength (Graft VDDCPs) | Insert suture 2 mm from the edge; pull at 50–200 mm/min (ISO 7198); record pull-through force. | Tensile tester, 3–0/4–0 non-absorbable suture |
| Procedural & Long-Term Durability | Simulate clinical use (delivery, expansion, retrieval) + cyclic pulsatile fatigue; verify structural/coating integrity. | Pulsatile fatigue system, simulated-use apparatus, imaging system |
Other test: Particulate Testing, Degradable Matrix Testing, Corrosion Testing, Biocompatibility, Preclinical In Vivo etc.,
Related products and device
Related Standard
ISO 7198 specifies test and performance requirements for tubular vascular grafts and vascular patches (surgical vascular prostheses). It defines mechanical tests (with full method/equipment/sample details) and other physicochemical, biological, dimensional, preclinical/clinical tests.
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 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 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 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 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.
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