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Medical Intramedullary Nail Fatigue Testing Equipment ASTM Certified

Get a quote:

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

ParameterSpecification
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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