Bone Fixation Screw Self-Tapping Test Machine ISO/ASTM Standards

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Whats/App: +86 156 1874 6768

Web: standard-groups.com

Standards

(1)ISO 6475: Implants for surgery – Wear of total hip-joint prostheses

(2)ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws

(3)YY/T 1505-2016: Chinese Standard for Orthopedic Implant Testing

(4)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

(1)Dual-Mode Drive System:

Servo motor with 0.1° rotation resolution for precise screw insertion control.

Manual override mode for delicate sample positioning.

(2)Advanced Data Acquisition:

Real-time torque-angle curve display with automatic peak detection and statistical analysis (max/min/mean values).

(3)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.

(4)Environmental Simulation:

Optional temperature-controlled chamber (-20°C to +150°C) for extreme condition testing.

(5)Connectivity:

USB/Ethernet ports for data export (CSV/Excel) and integration with laboratory information systems (LIMS).

Accessories

(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

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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