Automatic catheter leakage and compliance apparatus

Whats/App: +86 156 1874 6768

Web: standard-groups.com

Applications

The catheter leakage and compliance tester is mainly used to detect the leakage and compliance of medical catheters (such as the breathing circuits of ventilators and anesthesia machines). Specifically, it can: Leakage Test: By applying a certain pressure inside the catheter and monitoring the rate or extent of pressure drop, it determines whether there is leakage in the catheter. This is crucial for ensuring the sealing and safety of the catheter during medical procedures. Compliance Test: Compliance refers to the ability of the catheter to deform when subjected to external forces. The tester applies a certain pressure inside the catheter and measures the volume change of the catheter to evaluate its compliance. This is of great significance for understanding the flexibility and elasticity of the catheter, as well as its applicability in medical applications.

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

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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