Information on the most widely used ASTM standards within the materials testing industry
ISO 7198 Cardiovascular implants and extracorporeal systems – Vascular prostheses – tubular vascular grafts and vascular patches
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.
Mainly test stipulated in the ISO 7198:
Mechanical test (Dynamic radial compliance, burst strength, Longitudinal and Circumferential Tensile Strength, suture retention)
Preclinical testing (fatigue, degradation, and in vitro evaluations)
Details Test Information:
| Test | Test Methods | Test Equipment |
| A: Strength Tests | ||
| Pressurized Burst Strength | Seal the graft, pressurize internally with fluid/gas at 10–70 kPa/s until rupture; record burst pressure. Use elastic non-permeable liner if needed. | Hydrostatic or pneumatic pressure Tester: Pressure chamber with a pressure transducer and a controlled fluid/gas infusion pump. |
| Longitudinal Tensile Strength | Clamp the sample (gauge length 50–150 mm), stretch at 50–200 mm/min until break; record max load. For factory anastomosis, test the seam region. | Universal tensile tester. |
| Circumferential Tensile Strength | Cut a ring segment, mount on two rounded pins, stretch at 50–200 mm/min; calculate strength as max load / (2×sample length). | Universal tensile tester.
|
Diaphragm Pressurized Burst Strength (Patch/flat sample) | Flatten the sample, clamp over elastic diaphragm, pressurize at 10–70 kPa/s until burst; record pressure. | Burst Tester with diaphragm (test area ~100 mm²), pressure sensor. |
| Probe Burst Strength | Clamp sample over 11.3 mm orifice, push hemispherical probe (9.5 mm dia) at 50–200 mm/min until rupture; record max load. | Tensile Tester with probe burst fixture.
|
| Strength after Repeated Puncture | Puncture 24 times/cm² (16G dialysis needle) on 1/3 graft circumference; test burst/circumferential strength post-puncture. | 16G needle, burst/tensile tester. |
| B: Suture Retention Strength | Place suture 2 mm from edge (straight/oblique/longitudinal mode), pull at 50–200 mm/min; record force for suture pull-through or material failure. | Tensile tester |
| C: Kink Diameter/Radius | Bend graft around graded mandrels/templates; record the smallest radius/diameter causing lumen collapse (≥50% narrowing). | Graded mandrels (1.5 mm increments) or radius templates. |
D: Dynamic Radial Compliance (Tubular elastomeric graft only) | Cyclic pressurization (60 bpm, 37±2°C, 80–120 mmHg); measure diameter/volume change, calculate % compliance per 100 mmHg. | Dynamic pulsatile tester, diameter/volume sensor, pressure transducer. |
| E: Other kinds test | ||
Permeability; Porosity (planimetric, gravimetric, microscopic); Water permeability; Integral water permeability/ leakage; Water entry pressure; Residual chemicals; Biostability; Preclinical in vivo; Clinical investigation; Clinical investigation. | ||
Related products and device
Related Standard
ISO 12417-1 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).
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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