Urinary Catheter Strength Tester

The Urinary Catheter Strength Tester is designed to evaluate the physical strength and mechanical properties of urinary catheters. It provides accurate, quantitative measurement of tensile strength, elongation, and other mechanical parameters, serving as a critical tool for catheter certification, quality control, and R&D.

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

Features

(1) High-precision testing: load measurement from 0.01 to 120 N with ±0.001 N accuracy

(2) Adjustable loading speed: 0–500 mm/min ±0.5 mm/min

(3) Multi-language interface: Simplified Chinese and English

(4) Integrated data management: stores up to 100 test records per cycle including deviation values

(5) Real-time monitoring: movement control (up/down), timing, and calibration system

(6) High-resolution touchscreen: 7-inch K600+ core, 800×480 resolution, 65k colors

(7) Built-in thermal printer for immediate test report generation

(8) Compact and lightweight: net weight 15 kg, easy to move and operate

Technical Parameters

Accessories

(1) Standard catheter clamps and fixtures

(2) Power cable

(3) Touchscreen interface manual

(4) Thermal printer paper rolls

(5) Calibration certificate

Test Procedures

(1) Mount the catheter sample in the provided clamps

(2) Set the nominal specification and span for the test

(3) Configure the load range and desired loading speed on the touchscreen

(4) Start the automated test, controlling movement up and down as needed

(5) Monitor load, deformation, and timing in real time

(6) Upon test completion, review results on the display

(7) Print test report using the onboard thermal printer

(8) Repeat for additional samples as required

Maintenance Information

(1) Keep the instrument clean and free from debris after each test

(2) Inspect clamps, sensors, and load cells regularly for wear or damage

(3) Calibrate the force transducer periodically to maintain measurement accuracy

(4) Avoid exposure to liquids and extreme temperatures

(5) Ensure proper grounding of the power supply to protect electronic components

(6) Maintain logs of calibration, testing, and maintenance for compliance purposes