Liquid Leakage Under Pressure – Catheter Hub Assembly

Catheter hubs are checked for leaks by applying constant pressure.

Test Procedure

Catheters are connected to a filled syringe with a known amount of water to the nominal capacity of the syringe. A minimum pressure is applied and maintained for 30 seconds. The catheter hubs are inspected for any liquid leakage forming.

Equipment

Syringe
Calibrated Manometer
Calibrated Timing device
Fixture support for syringe

Service Levels

Applicable Standards

ISO 10555-1:2013
Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements

OLE/QV

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