Metal Bone Screws Self Tapping Tester

Produced by: Standard International Group (HK) Limited

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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

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.

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).

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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