Self-tapping Performance Tester for Metal Bone Screws
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).
Accessories
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
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) |
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