Balloon Compliance

Balloon pressure and corresponding balloon diameter is verified for the full range of recommended inflation diameters.

Test Procedure

A compliance chart that correlate balloon diameter to balloon pressure is verified for the full range of recommended inflation diameters. The compliance chart may include pressures up to (but not exceeding) 25% above the Rated Burst Pressure (RBP).

Equipment

The test is performed with an automatic inflation/deflation system and precision optical microscope.

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 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

  • ISO 10555-4:2013
    Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters

Related Tests

OLE1202


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