Balloon Inflation Deflation Time

The time to inflate and deflate a balloon catheter to a predefined target pressure is measured.

Test Procedure

The pressure signal is recorded at a predefined high frequency and is used to estimate the inflation and deflation time at a predefined target pressure. Between the inflation and deflation phase, the target pressure is held constant for a specific interval of time.

Equipment

The test is performed with an automatic inflation/deflation system.

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-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

OLE1003

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