Product IntroductionThe Medical Needle Tubing Toughness Tester RX-01 is designed to evaluate the bending toughness of stainless-steel needle tubing used in disposable injection needles, prefilled syringe needles and infusion needles. The tester delivers repeatable bending cycles and precise measurement parameters for quality control in medical device manufacturing.
Product Features- Supports testing of various needle wall specifications: regular wall, thin wall and ultra-thin wall.
- 7-inch color touchscreen with intuitive graphical user interface (GUI) for easy operation.
- User-selectable bending angles and number of test cycles to match multiple test protocols.
- Automatic data storage with memory retention after power-off.
- Multiple safety features including emergency stop button and overload protection.
- Equipped with a micro-printer for automatic printing of test results on completion.
- Standard USB interface for convenient data export.
- Multi-level user permissions, compliant with GMP requirements for audit traceability.
- ISP online control and upgrade capability for remote adjustment and function updates.
Test PrincipleOne end of the stainless-steel needle tubing is clamped and a force is applied over a defined span. The tube is bent in one direction, then bent to a specified angle in the opposite direction; this bending cycle is repeated for the selected number of cycles to assess toughness and fatigue resistance.
Test Standards- ISO 9626:2016 - Stainless steel needle tubing for the manufacture of medical devices
- GB 15811-2025 - Sterile hypodermic needles for single use
- GB/T 18457-2024 - Stainless steel needle tubing for the manufacture of medical devices
Test ApplicationsBasic Applications: Disposable sterile injection needles, prefilled syringe needles, infusion needles
Extended Applications: Blood sampling needles, dental needles, biopsy needles and other stainless-steel medical tubing requiring stiffness and fatigue evaluation
ConfigurationsStandard Configurations: Instrument, Micro Printer, Positioning Ruler
Technical Specifications- Needle Tubing Size: 0.18 ~ 3.4 mm
- Tubing Wall Specifications: Regular, Thin, Extra-thin and Ultra-thin
- Test Frequency: 0.5 Hz ±0.025 Hz
- Bending Angles: 15°, 20°, 25° (adjustable from 0° to 50°)
- Number of Test Cycles: 20 (user-selectable)
- Bending Distance: 6 ~ 95 mm (equipped with positioning ruler)
- Bending Distance Accuracy: ±0.1 mm
- Power Supply: AC 100-240V 50/60Hz (can be changed to local requirement)
- Instrument Dimension: 400 mm (W) x 270 mm (D) x 330 mm (H)
- Net Weight: 14 kg