Burst Strength – Balloon Method

Pressure at which the prothesis bursts using a balloon to seal devices with high permeability which may not be able to hold pressure on their own.

 

Test Procedure

A balloon is inserted through the sample prosthesis or attach the sample prosthesis directly to the pressurization apparatus. The pressure-measuring device is attached so that it will record the pressure inside the sample prosthesis. Feed fluid or gas to produce a steady rise in pressure. Measure the pressure inside the sample prosthesis. Record the rate of pressure rise and the pressure at which either the sample prosthesis bursts or the test is discontinued.

A compliant balloon is placed inside the vascular implant sample. Sample with balloon is mounted on specific tubular adapters (internal sample diameter fitting with external adapter’s diameter and water-tight sealing systems between balloon and adapters). The adapters are connected to a flow loop with the upstream adapter. No pre-stretching is applied to sample, but axial displacement (axial elongation of the sample) is allowed.

A pump is providing a flow through the sample and pressure feeding the sample is measured. The flow is tuned to obtain a steady rise in pressure (between 10 kPa/s and 70 kPa/s or as defined in the test protocol). The rise in pressure and the pressure at which test sample bursts or test is discontinued are measured and recorded.
Test is discontinued if maximal pressure defined in the test protocol is reached.

Equipment

  • 1 pump with its hydrodynamic generator
  • Calibrated manometer
  • Pressure probe and transducer
  • 1 temperature regulation system
  • 1 calibrated thermometer
  • Data acquisition system with calibrated modules
  • 1 flow loop composed of temperature regulation system + pump + tank + specific tubular adapters + tubes

 

Measured Parameters

Burst pressure

Scope

  • Any device using vascular prostheses
  • Vascular prosthesis
  • Biological, synthetic textile/non-textile materials, non-textile material
  • Stent Grafts: SX or BX frame, NiTi, CrCo, SS, Biological tissues, synthetic textile materials/* non-textile material, non-textile material
  • Covered stent: SX or BX frame, NiTi, CrCo, SS, Biological tissue, synthetic textile/non-textile * material, non-textile material
  • Tubular, bifurcated, branched

Service Levels

Applicable Standards

  • ISO 7198:2016
    Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches

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OLE0616


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