Automatic catheter mechanical strength testing equipment
Whats/App: +86 156 1874 6768
Web: standard-groups.com
Application
The tester is suitable for testing urinary catheters in the following industries and products:
(1) Medical Device Manufacturing: Quality control and validation of single-use sterile urinary catheters.
(2) Research & Development: Mechanical testing of new catheter designs, wall thickness, and material properties.
(3) Certification & Regulatory Testing: Compliance testing according to national and international standards.
(4) Third-Party Testing Laboratories: Independent verification of catheter strength and performance.
(5) Educational & Training Institutions: Demonstration and training for medical device testing protocols.
Standards
The instrument is compliant with the following standard:
(1) YY 0325-2016 – Single-use Sterile Urinary Catheters, specifying requirements for mechanical and physical strength testing
(2) ISO 10555-1:2013 – Intravascular catheters — Sterile single-use catheters — Part 1: General requirements
(3) ASTM F2081-15 – Standard Test Method for Tensile Strength of Catheter Tubing
(4) EN ISO 10555-2 – Sterile single-use urinary catheters — Part 2: Materials, tensile strength, and elongation testing
Technical Parameters
| Parameter | Specification |
|---|---|
| Interface Language | Simplified Chinese / English |
| Nominal Specifications | Supports all catheter sizes |
| Load Range | 0.01–120 N |
| Accuracy | ±0.001 N |
| Loading Speed | 0–500 mm/min ±0.5 mm/min |
| Printing System | Stores 100 test records per cycle (data + deviation) |
| Net Weight | 15 kg |
| Dimensions (L×W×H) | 430 × 290 × 250 mm |
| Power Supply | AC 110–220 V, 50 Hz (auto-adaptive) |
| Power Consumption | 70 W |
| Control System | PLC + ARM programmable controller |
| Touchscreen | 7-inch K600+ core, 800×480 resolution, 65k colors |
| Sensor | High-precision force transducer |
| Force Measurement | Built-in load cell system |
| Printing Device | Onboard thermal printer |
Accessories
(1) Standard catheter clamps and fixtures
(2) Power cable
(3) Touchscreen interface manual
(4) Thermal printer paper rolls
(5) Calibration certificate
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