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
- Unmatched Precision:
- High-resolution torque and angle sensors (±0.5% FS accuracy) ensure repeatable results for critical self-tapping performance evaluation.
- Versatile Testing Modes:
- Supports static/dynamic torque testing, insertion/removal cycle testing, and fatigue analysis to simulate real-world surgical scenarios.
- User-Centric Design:
- Intuitive touchscreen interface with multi-language support (English/Spanish/German/Chinese) and customizable test protocols.
- Durability & Safety:
- Corrosion-resistant stainless-steel frame and enclosed testing chamber with emergency stop functionality.
- 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
| Parameter | Specification |
|---|---|
| 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
- Test Kit:
- 3x Collet Chucks (M1.5, M3.5, M6.0)
- 5x ASTM F1839 Synthetic Bone Blocks (Density Grade 10/20/30)
- Software Suite:
- LabScrew Pro V3.0: Compliance-ready software with 21 CFR Part 11 audit trail support.
- Calibration Tools:
- NIST-traceable torque calibration adapter (certified)
- Angle verification jig
- Safety Kit:
- Emergency stop pendant
- Safety interlock sensors
- Documentation:
- Multilingual user manual (4 languages)
- CE Declaration of Conformity
- 12-month warranty certificate
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