Air Leakage During Aspiration – Catheter Hub Assembly

Catheters are connected to a partially filled syringe, a negative pressure is applied by pulling on the syringe plunger, visual inspection is performed to detect any bubbles forming in the syringe.

Test Procedure

Catheter hubs assemblies are connected to the syringe to form a leak proof connection while sealing all valves that are intended to open during aspiration. A known volume of water is drawn into the syringe. While the syringe nozzle is pointing downward, the plunger is withdrawn to the maximum capacity, and held for a defined period of time. This is to verify that no bubbles are forming in the syringe, therefore testing the seals efficiencies.

Equipment

Syringe
Calibrated Manometer
Calibrated Timing device
Fixture support for syringe

Scope

Angioplasty balloon catheters
PTA, PTCA balloon catheters
Any interventional systems with balloon technology
Any delivery system with balloon technology

Service Levels

Applicable Standards

ISO 10555-1:2013
Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
ISO 25539-2:2020
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
FDA-1608
FDA Guidance: Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters – Class II Special Controls Guidance for Industry and FDA
FDA-1545
FDA Guidance: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff

Related Tests

OLE/QV

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