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Intramedullary Nails Internal - fixation Pull - out Force Tester

Intramedullary Nails Internal - fixation Pull - out Force Tester
  • Intramedullary Nails Internal - fixation Pull - out Force Tester
供应商: 标准集团

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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

  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.).

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

ParameterSpecification
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

  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.


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