Intramedullary Nails Internal - fixation Pull - out Force Tester

Стандарты

• 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.

Преимущества продукции

1. Dynamic Load Simulation: Replicates physiological gait-cycle forces (0–1,500 N at 5 Hz) for real-world failure prediction.
2. Dual-Axis Measurement: Simultaneous tracking of cutout force (N) and angular displacement (°) during cyclic testing.
3. Failure Prediction Algorithm: Proprietary software identifies pre-failure indicators using machine learning.
4. High-Speed Imaging Integration: Syncs with external cameras for real-time deformation visualization (optional upgrade).
5. Ergonomic Workflow: Touchscreen interface with pre-loaded ASTM/ISO templates and customizable test sequences.
6. Modular Design: Quick-swap fixtures for testing various nail designs (helical blades, lag screws, etc.).

Особенности продукции

• 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.

Технические параметры

Приложение

1. Dynamic Test Fixture Kit:
   • Self-centering bone analog holder
   • Adjustable nail insertion guide (0–45° varus/valgus)
2. 6-Channel Load Cell: Calibrated to ISO 376 standards.
3. TestMaster Pro Software:
   • Real-time hysteresis loop visualization
   • Fatigue life prediction (S-N curve generation)
   • 21 CFR Part 11 compliance module
4. Safety Enclosure: Acrylic chamber with interlock system and LED lighting.
5. Calibration Bundle:
   • NIST-traceable weights (100g–1kg)
   • Angular verification jig
6. 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.