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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