Balloon Cyclic Fatigue

Balloons must withstand multiple inflations during clinical use to avoid inducing device failure or vessel damage.

Test Procedure

Tested balloons that are not constrained by any test fixture or device are inflated in incremental steps to defined target pressure. Pressure is held for a specific interval of time. Balloons are repeatedly deflated and inflated to the target pressure for a total of multiple cycles. Any loss of pressure, due to failure of the balloon, shaft, or proximal or distal seals is reported as a test failure.

Equipment

The test is performed with an automatic inflation/deflation system.

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 10555-1:2013
    Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements

  • 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

Related Tests

OLE1203


ViVitro Labs Advantages

Many companies look to academia to handle their testing needs due to the reduced cost. With ViVitro Laboratory Services you gain the following advantages:

Time to Market
We understand how critical your timelines are. Our expertise and experience ensure your schedule is met and our commitments are delivered on time.

ISO 17025 Accredited
For studies used for regulatory approval this is a must. Accredited by A2LA and Cofrac.

Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.

Guaranteed Confidentiality
We happily provide Non-Disclosure Agreements for all services, including initial consultation.

Join over 5000 cardiovascular device professionals who receive our testing and engineering insights and tips every month.