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Metal Bone Screws Self - tapping Tester

Standard

  • ISO 6475: Implants for surgery – Wear of total hip-joint prostheses
  • ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws
  • YY/T 1505-2016: Chinese Standard for Orthopedic Implant Testing
  • EN ISO 14708: Implants for surgery – Active implantable medical devices

Product Advantages

  1. Unmatched Precision:
    • High-resolution torque and angle sensors (±0.5% FS accuracy) ensure repeatable results for critical self-tapping performance evaluation.
  2. Versatile Testing Modes:
    • Supports static/dynamic torque testing, insertion/removal cycle testing, and fatigue analysis to simulate real-world surgical scenarios.
  3. User-Centric Design:
    • Intuitive touchscreen interface with multi-language support (English/Spanish/German/Chinese) and customizable test protocols.
  4. Durability & Safety:
    • Corrosion-resistant stainless-steel frame and enclosed testing chamber with emergency stop functionality.
  5. Global Compliance:
    • Pre-certified for CE (EU), FDA (US), and TGA (Australia) regulatory requirements, simplifying export procedures.

Product Features

  • Dual-Mode Drive System:
    • Servo motor with 0.1° rotation resolution for precise screw insertion control.
    • Manual override mode for delicate sample positioning.
  • Advanced Data Acquisition:
    • Real-time torque-angle curve display with automatic peak detection and statistical analysis (max/min/mean values).
  • Modular Fixture System:
    • Quick-change chucks accommodate screw diameters from 1.5mm to 8.0mm (M1.5 to M8).
    • Adjustable bone substitute holders for ASTM F1839 synthetic bone blocks.
  • Environmental Simulation:
    • Optional temperature-controlled chamber (-20°C to +150°C) for extreme condition testing.
  • Connectivity:
    • USB/Ethernet ports for data export (CSV/Excel) and integration with laboratory information systems (LIMS).

Technical Parameters

ParameterSpecification
Torque Range 0–10 N·m (0–88.5 lbf·in)
Angular Resolution 0.1°
Speed Control 1–300 RPM (adjustable)
Axial Load Capacity 0–500 N (0–112.4 lbf)
Power Supply 100–240V AC, 50/60Hz
Dimensions (W×D×H) 500 × 450 × 1,200 mm
Weight 85 kg (187 lbs)

Accessories Included

  1. Test Kit:
    • 3x Collet Chucks (M1.5, M3.5, M6.0)
    • 5x ASTM F1839 Synthetic Bone Blocks (Density Grade 10/20/30)
  2. Software Suite:
    • LabScrew Pro V3.0: Compliance-ready software with 21 CFR Part 11 audit trail support.
  3. Calibration Tools:
    • NIST-traceable torque calibration adapter (certified)
    • Angle verification jig
  4. Safety Kit:
    • Emergency stop pendant
    • Safety interlock sensors
  5. Documentation:
    • Multilingual user manual (4 languages)
    • CE Declaration of Conformity
    • 12-month warranty certificate

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