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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

ParameterSpecification
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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