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Radial Force & Tensile Testing Service | ASTM F2504, ISO 10555, 510(k)-Ready Test Reports
$1,250.00
Sale price
$1,250.00
Regular price
M4D LLC provides contract radial force and tensile testing for stents, catheters, and endovascular device components. ASTM F2504-compliant radial force curves, ISO 10555 tensile testing, and 510(k)-ready signed test reports. 10-business-day turnaround.
| Validation Parameters | |
|---|---|
| Radial Force Standard | ASTM F2504-05 |
| Fixture Type | Radially expanding/compressing (RX550 equiv.) |
| Test Temperature | 37°C ± 1°C (simulated body temp) |
| Output | Force-displacement curve, N/mm, mean ± SD (n≥5) |
| Tensile Standard | ISO 10555-1 methodology |
| Load Cell | 500 N, NIST-traceable calibration (annual) |
| Report Format | 510(k) design validation section-ready |
| Report Contents | Test method, cal cert #, environmental log, per-specimen data |
| Turnaround | 10 business days from sample receipt |
| Data Archive | QCBD QMS, indefinite retention |
| Regulatory | ISO 13485:2016, FDA Registered |