Standards:

Applications:

Product Information:

The Metal Bone Screws Self-tapping Tester is a specialized device designed to evaluate the self-tapping performance of orthopedic metal screws. It measures the torque, insertion force, and cutting efficiency as the screw taps into pre-drilled or synthetic bone materials, ensuring reliable screw design, optimal thread engagement, and consistent surgical performance. This tester is widely used in medical device R&D, quality control, and regulatory testing to verify that screws can be safely and effectively implanted without pre-tapping.

Standard

(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)

Test Procedures

(1)Prepare the screw and synthetic or real bone sample according to specifications.

(2)Mount the sample securely on the tester platform.

(3)Set the rotational speed and torque limits for the test.

(4)Insert the screw while recording torque, insertion force, and any anomalies.

Maintenance Information

(1)Clean the tester and accessories after each use to prevent residue buildup.

(2)Lubricate moving parts periodically according to manufacturer guidelines.

(3)Calibrate torque and force sensors regularly to ensure accuracy.

(4)Inspect mechanical and electrical components routinely for wear or damage.

FAQ

1.What is the purpose of the Metal Bone Screws Self-tapping Tester?

It measures the insertion torque, pull-out resistance, and performance of self-tapping metal bone screws in synthetic or real bone models.

2.What types of screws can be tested?

The tester supports various sizes and designs of metal self-tapping bone screws commonly used in orthopedic surgeries.

3.How is the test conducted?

Screws are inserted into a prepared bone sample while the machine records torque, insertion force, and any irregularities during the procedure.

4.How often should the tester be calibrated?

Torque and force sensors should be calibrated regularly, typically per manufacturer recommendations or before critical testing.

5.What maintenance is required?

The device should be cleaned after each use, lubricated periodically, and inspected for wear or damage to ensure accurate and safe operation.