Medical Intramedullary Nail Fatigue Testing Equipment ASTM Certified
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Whats/App: +86 156 1874 6768
Web: standard-groups.com
Standards
(1)YY/T 0591-2011: Chinese standard specifying bending fatigue test methods for intramedullary nails and locking screws, including load application, cycle counting, and failure criteria.
(2)ASTM F1264: International standard covering fatigue testing of intramedullary fixation devices, with protocols for sinusoidal loading at 5Hz–20Hz frequencies.
Product Advantages
(1)Precision Fatigue Testing:
Electromagnetic servo-controlled loading system ensures sinusoidal force application with ±0.5% accuracy, adhering to ASTM F1264’s frequency and load requirements.
Adjustable R-ratio (0.1–0.9) and load range (100 N–10.000 N) for versatile testing scenarios.
(2)Customized Fixturing:
Modular four-point bending clamps with interchangeable roller diameters (8–16mm) and contour-matching designs to accommodate diverse nail diameters and lengths.
Anti-slip mechanisms and specimen alignment guides for consistent results.
(3)Advanced Data Acquisition:
Real-time monitoring of cycles, load, and displacement with 5000Hz sampling rate.
Automatic calculation of key parameters: fatigue life (N cycles to failure), fatigue strength (S-N curve generation), and crack initiation points.
(4)User-Centric Design:
Intuitive software with preloaded SOPs for YY/T 0591 and ASTM F1264 compliance.
Multi-language interface (English/Chinese/Spanish) and exportable reports (PDF/Excel/CSV).
(5)Durability & Safety:
Corrosion-resistant steel frame and overload protection system for long-term reliability.
Low-noise operation (<65 dB) suitable for laboratory environments.
Product Features
(1)Load Capacity: 100 N–10.000 N (axial) / 50–500 Nm (torsional).
(2)Frequency Range: 0.01–20 Hz (adjustable for static/dynamic tests).
(3)Temperature Control: Optional environmental chamber (-20°C to +150°C) for simulating physiological conditions.
(4)Software Suite:
Customizable test profiles with automated pass/fail criteria.
21 CFR Part 11 compliance for audit trails and electronic signatures.
(5)Calibration: NIST-traceable certification included, with annual recalibration available.
Technical Parameters
| Parameter | Specification |
|---|---|
| Force Resolution | 0.1 N (axial) / 0.01 Nm (torsional) |
| Angular Accuracy | ±0.1° |
| Crosshead Speed | 0.001–500 mm/min |
| Power Supply | 220V/110V, 50/60Hz |
| Dimensions (W×D×H) | 800×600×1.800 mm |
| Weight | 400 kg |
| Compliance | CE, ISO 13485. YY/T 0591. ASTM F1264 |
Accessories (Included/Optional)
(1)Standard Kit:
Four-point bending clamps (8mm, 12mm, 16mm rollers).
Calibration weights and torque wrench.
Test control software with preloaded SOPs.
(2)Optional Upgrades:
Axial-torsional load frame (for combined loading tests).
High-temperature chamber (for thermal fatigue testing).
Custom fixturing for pediatric/specialized intramedullary nails.
Remote diagnostics and preventive maintenance package.
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