Medical Device Balloon Catheter Testing

Balloons and catheters need rigorous testing to ensure that they perform according to their intended use and labeling. The balloon catheter tests are designed to measure the parameters which are used for the balloon fatigue assessment, inflation and deflation time, burst pressure, and balloon compliance measurement. STEMart offers state-of-the-art technology and facilities to provide multiple balloon catheter testing according to FDA guidance document recommendations and ISO standards.

Our Balloon Catheter Testing:

• Balloon Catheter Burst Testing

  The balloon catheter burst testing is designed to ascertain the maximum use pressure rating for the balloon. In another word, the typical balloon catheter burst testing process starts at an initial pressure and is then stepped periodically over time. This test ends when the sample bursts and the data is recorded, then analyzed.

• Balloon Catheter Fatigue Testing

  The Balloon Catheter Fatigue Testing is used to confirm that the balloon can be safely cycled through a defined number of inflations to rated pressure. In another word, this test utilizes a Crescent Burst Tester to meet the testing requirements of ISO 10555 or FDA guidelines.

• Balloon Catheter Compliance Testing

  The Balloon Catheter Compliance testing is used to measure the balloon diameter through the pressure range. In another word, it’s a comparative test using a Crescent Burst Tester and a laser micrometer machine to meet the ISO 10555 standard or FDA guidelines.

• Balloon Catheter Inflation / Deflation Testing

  The Balloon Catheter Inflation/ Deflation Testing is used to measure how long it will take the balloon to fully inflate to rated pressure and then to deflate. In another word, this test is performed with an automatic inflation/deflation system to measure the balloon catheter inflation/deflation ability.

With extensive expertise in medical device balloon catheter testing, STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks.

If you have any additional questions about Medical Device Balloon Catheter Testing or would like to consult with the experts at STEMart, please feel free to contact us.