Metal Bone Screws Self - tapping Tester

Criterios

• 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).

Parámetros técnicos

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