Balloon Catheter Leak and Compliance Tester

Whats/App: +86 156 1874 6768

Web: standard-groups.com

Standards

ISO 13988-1:2017: Intravascular catheters - Part 1

ISO 8536-4:2016: Medical infusion equipment

YY/T 0285.4-2017: Intravascular catheters - Part 4

YY/T 1551.1-2017: Non-intravascular catheters

Features

Color LCD large screen display: Real-time display of test data and statistical values, intuitive and clear.

Intelligent touch control operation: Simple human-machine interface for quick experiment switching.

High-precision electronic flow meter: Achieves precise flow control, avoiding testing errors.

Top-tier sensor system: High-sensitivity data acquisition ensures stable and consistent test results.

Data security management: Four-level access control and encrypted storage prevent unauthorized operations and ensure the integrity and traceability of results.

Convenient result output: Equipped with a micro printer, supporting instant printing of single test results and statistical data.

Technical Parameters

Parameter	Specification
Pressure Range	Determined by test object & application scenarios:- e.g., 0 - 300kPa for medical breathing circuits- Narrower range (e.g., 0 - 50kPa) for routine compliance testing
Pressure Accuracy	Key for test accuracy; generally requires ±0.1% or higher (e.g., 0 - 50kPa pressure sensor can reach one-thousandth accuracy)
Flow Range	Covers various flow situations of tested catheters; common flowmeter range: 0 - 100L/min
Flow Accuracy	Important indicator; generally requires ±1% or higher (e.g., ±1%FS for 2L/min mass flow controller)
Volume Measurement Range and Accuracy	- Range: From a few milliliters to several liters (adapts to different catheter volumes)- Accuracy: Generally needs to reach ±0.1ml or higher (to accurately calculate catheter compliance)
Test Time Range	- Leakage tests: Flexible setting (a few seconds to several hours)- Compliance tests: Controls pressure change rate & time interval to capture catheter volume changes at different pressure stages

Accessoriess

Standard accessories include: specialized connectors for different sizes of medical tubing (such as ventilator/anesthesia machine breathing circuits), pressure/flow test tubing, tubing fixing clamps (to ensure sample stability during testing), standard test samples for equipment calibration (including standard leakage and compliance components), operating manual, and calibration certificate.

Test Procedures

Sample Pretreatment

Tubing Aging Treatment: Immerse in physiological saline at 37°C for 24 hours to relieve material stress;

Connection Sealing Inspection: Apply soapy water to the interfaces to confirm no initial leakage.

Typical Test Modes

Static Compliance Test:

Pressurize to 100kPa, maintain pressure for 30 seconds, and record the volume change ΔV1;

Release pressure to 0kPa, and record the volume recovery ΔV2;

Compliance calculation: C = (ΔV1 - ΔV2)/ΔP (unit: mL/kPa).

Dynamic Leakage Test:

Apply a sinusoidal pressure wave with a frequency of 1Hz and an amplitude of ±50kPa for 10 minutes;

Collect the leaked fluid and calculate the leakage rate using the weighing method (≤0.5mL/10min is considered acceptable).

Result Evaluation Standards (Refer to YY/T 0285.4-2017)

Compliance Deviation: ≤±15% compared to the nominal value;

Leakage: ≤1mL/minute under positive pressure of 100kPa, and no visible bubbles under negative pressure of -50kPa.

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