Balloon Inflation Deflation Time

The time to inflate and deflate a balloon catheter to a predefined target pressure is measured.

Test Procedure

The pressure signal is recorded at a predefined high frequency and is used to estimate the inflation and deflation time at a predefined target pressure. Between the inflation and deflation phase, the target pressure is held constant for a specific interval of time.

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

OLE1003

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. Victoria and Marseille labs accredited by A2LA.

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.