What is balloon catheter testing?

Balloon catheter testing comprises a variety of tests to assess the structural strength, functionality, and operational safety of balloon catheters. These tests are vital to ensure that balloon catheters—devices which help save lives to facilitating the removal of blockages in blood vessels—comply with their listed requirements and intended usage.

Balloon Catheter Burst Testing

  • The purpose of balloon burst testing is to establish the maximum use pressure rating for the balloon
  • This test utilizes a Crescent Burst Tester
  • Balloon burst testing is performed to ISO 10555, FDA guidelines or Customer requirements

Balloon Catheter Fatigue Testing

  • The purpose of this test is to confirm that the balloon can be safely cycled through a defined number of inflations to rated pressure
  • This test utilizes a Crescent Burst Tester
  • Balloon catheter fatigue testing is performed to ISO 10555, FDA guidelines or Customer requirements

Balloon Catheter Compliance Testing

  • This test is performed to measure balloon diameter through the pressure range
  • Balloon catheter compliance testing utilizes a Crescent Burst Tester and a ‘glass logic’ Laser Micrometer
  • ISO 10555, FDA guidelines or Customer requirements

Balloon Catheter Inflation / Deflation Testing

  • The purpose of this test is to measure how long it takes the balloon to fully inflate to rated pressure and then to deflate
  • This test utilizes manual inflation/deflation using indeflator (or a similar device) and stopwatch.
  • Testing performed to ISO 10555, FDA guidelines or Customer requirements.

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