Intramedullary Nails Internal-fixation Pull-out Force Tester

Standard

ASTM F543: Standard specification for metallic medical bone screws (dynamic loading protocols).

ISO 12172: Implants for surgery—Partial and total hip joint prostheses (fatigue testing methodologies).

YY/T 0342: Chinese standard for surgical implant testing (cutout resistance evaluation).

Adaptive Compliance: Customizable protocols for emerging regulatory frameworks.

Product Advantages

Dynamic Load Simulation: Replicates physiological gait-cycle forces (0–1.500 N at 5 Hz) for real-world failure prediction.

Dual-Axis Measurement: Simultaneous tracking of cutout force (N) and angular displacement (°) during cyclic testing.

Failure Prediction Algorithm: Proprietary software identifies pre-failure indicators using machine learning.

High-Speed Imaging Integration: Syncs with external cameras for real-time deformation visualization (optional upgrade).

Ergonomic Workflow: Touchscreen interface with pre-loaded ASTM/ISO templates and customizable test sequences.

Modular Design: Quick-swap fixtures for testing various nail designs (helical blades, lag screws, etc.).

Product Features

Electrodynamic Actuator: Delivers sinusoidal, triangular, or custom waveforms up to 10 Hz.

6-DoF Load Cell: Measures axial/torsional forces and moments with 0.1% FS accuracy.

High-Resolution Motion System: ±5° angular resolution for tracking nail migration paths.

Thermal Stability Chamber: Controls test environment (-20°C to +50°C) for material property analysis.

AI-Powered Analytics: Auto-generates failure mode maps comparing historical/current implant designs.

Remote Access: Cloud-connected system for real-time collaboration and audit trails.

Technical Parameters

Parameter	Specification
Max. Dynamic Load	±1.500 N (axial) / ±50 Nm (torsional)
Frequency Range	0.1–10 Hz (sinusoidal)
Angle Measurement	±5° (0.001° resolution)
Data Sampling Rate	10 kHz (synchronized across 8 channels)
Test Duration	1–10⁶ cycles (programmable)
Sample Compatibility	8–16 mm diameter nails, 100–500 mm length
Power Requirements	220V/110V ±10%, 50/60Hz, 1.200W
Dimensions (W×D×H)	1.200 × 800 × 1.800 mm
Weight	450 kg (including safety enclosure)

Accessories

Dynamic Test Fixture Kit:

Self-centering bone analog holder

Adjustable nail insertion guide (0–45° varus/valgus)

6-Channel Load Cell: Calibrated to ISO 376 standards.

TestMaster Pro Software:

Real-time hysteresis loop visualization

Fatigue life prediction (S-N curve generation)

21 CFR Part 11 compliance module

Safety Enclosure: Acrylic chamber with interlock system and LED lighting.

Calibration Bundle:

NIST-traceable weights (100g–1kg)

Angular verification jig

Operator Kit:

Torque wrench set (0.1–10 Nm)

Sterilizable bone cement spatulas

- ISO international standards: The design, manufacturing, and testing process of the equipment should meet the requirements of ISO international standards to ensure the international recognition of the test results. - National/regional standards: Different countries and regions may formulate specific standards for the mechanical property testing of orthopedic implants. When conducting tests, appropriate national/regional standards should be selected according to the actual situation. - Industry standards: The orthopedic implant industry may also have formulated relevant testing standards and specifications internally. These standards may include provisions on testing methods, testing conditions, testing equipment, etc.

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