Balloon Compliance

Balloon pressure and corresponding balloon diameter is verified for the full range of recommended inflation diameters.

Test Procedure

A compliance chart that correlate balloon diameter to balloon pressure is verified for the full range of recommended inflation diameters. The compliance chart may include pressures up to (but not exceeding) 25% above the Rated Burst Pressure (RBP).

Equipment

The test is performed with an automatic inflation/deflation system and precision optical microscope.

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 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
ISO 10555-4:2013
Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters

Related Tests

OLE1202

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.