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MEDICAL DEVICES AND PRECISION EQUIPMENT

Leak testing of medical devices and critical components

Technical Guide to Leak Testing for Medical Devices Such as Catheters, Cannulas, Endoscopes, Respiratory Valves, and Precision Components. Review leak rates, air testing methods, and recommended equipment to ensure safety, sterility, and regulatory compliance in medical applications.

SPECIALIZED TECHNICAL GUIDE

Selection of leak tests for medical devices

In the medical industry, leak testing is essential to ensuring patient safety and the integrity of medical devices. From low-pressure testing of components such as catheters to validation of flow control systems and respiratory equipment, this guide helps identify the appropriate method, acceptable leak rate, and ideal equipment for each clinical or manufacturing application.​

Component / Application Leak reference (Criteria) Recommended Method Recommended Equipment
Catheter leak test
Technical description
 A flexible medical device used to administer or drain fluids within the body requires a high level of integrity to prevent contamination.
0.1 mL/min Air LS-R740SS / LS-1881A
Leak test for cannula
Technical description
 A tube used to administer fluids or gases during medical procedures.
0.5 mL/min Air LS-R902 / LS-R700
Leak test for stainless steel piping
Technical description
 A metal tube used in medical equipment that requires pressure resistance and a proper seal.
1 mL/min Air LS-R700 / LS-1866
Leak Test for DigiChamber
Technical description
 A chamber used in medical devices to measure or control fluid flow.
0.5 mL/min Air LS-R700 / LS-1866
Leak Test for the Dent Ject Nozzle
Technical description
 A nozzle used in dental equipment for the precise application of fluids.
0.3 mL/min Air LS-R902 / LS-R700
Endoscope leak test
Technical description
 Medical device for internal visualization that must be sealed to prevent contamination and damage.
0.1 mL/min Air LS-R700 / LS-1866
Leak test for a lung force valve
Technical description
 A component in respiratory equipment that regulates the flow of air to the lungs.
0.5 mL/min Air LS-R700 / LS-1866
Panel leak test
Technical description
 Panel used in medical equipment that requires sealing to protect internal components.
0.09 mL/min Air LS-R740SS / LS-1881A
Leak test for ventilation filter
Technical description
 A filter that controls airflow in medical devices, preventing contaminants from entering.
0.1 mL/min Air LS-R700 / LS-1866
Leak test for microneedle port
Technical description
 High-precision port for microinjection in medical applications.
0.2 mL/min Air LS-R902 / LS-R700
Leak test for a magnetic gear pump
Technical description
 A pump used for transferring fluids in medical or pharmaceutical applications.
0.3 mL/min Air LS-R700 / LS-1866
Leak test for regulator
Technical description
 A device that monitors pressure or flow in medical systems.
3 mL/min Air LS-R700 / LS-1866

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