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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