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 While the syringe nozzle is pointing downward, the plunger is withdrawn to the maximum capacity, and held for a defined period of time.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

• Fast Track
• Standard Service
• Full Service

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

• Balloon Compliance
• Balloon Cyclic Fatigue
• Balloon Inflation Deflation Time
• Balloon Rated Burst Pressure (RBP)
• Corrosion – Immersion Test
• Torsional Bond Strength
• Burst Pressure Under Static Conditions

OLE/QV