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:

ISO 17025 Accredited
For studies used for regulatory approval this is a must. Victoria and Marseille labs accredited by A2LA.

Test Method Validation
The FDA and Notified Bodies around the world are requiring evidence of Test Method Validation. ViVitro Labs has invested significant resources to validate the most common test methods that are not ISO 17025 accredited. We continue to work closely with device manufacturers and share the burden with our clients to validate other specific test methods that are less in demand.

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

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.