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Balloon Catheter Testing

Balloon Catheter Burst Testing

  • The purpose of balloon burst testing is to establish the maximum use pressure rating for the balloon.
  • This test utilises 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 utilises 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 utilises a Crescent Burst Tester and a ‘glass logic’ Laser Micrometer.
  • ISO 10555, FDA guidelines or customer requirements.

We offer a lot more Med Dev product and packaging test services.

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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 utilises manual inflation/deflation using indeflator (or a similar device) and stopwatch.
  • Testing performed to ISO 10555, FDA guidelines or customer requirements.

For more information on Anecto’s catheter testing services please…

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Case Study – Emerson Network Power

Case Study

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How Anecto developed a number of innovative solutions for the leading multinational Emerson Network Power.