Coating Integrity Optical Inspection

A Scanning Electron Microscope (SEM) and/or an optical microscope with proper magnification is used to inspect the surface defects and coating integrity of the device before and after testing. Coating anomalies, defects or artefacts are located and documented.

A Spectroscopic Analysis is used to identify the chemical composition of particulate material to differentiate coating and delivery system particulates from those from other sources.

Test Procedure

The examination is performed on at least six locations from each sample. If required, a section of the sample is prepared using scissor or scalpel.

Equipment

High resolution scanning electronic microscope

Scope

PTA, PTCA, coronary and peripheral stent delivery systems – functional performance during simulated use
TAVI and TMVR delivery systems – functional performance during simulated use
Thrombectomy devices — functional performance during simulated use
Guidewires testing – functional performance during simulated use
Endoscopic devices – functional performance during simulated use
RF ablation catheters testing – functional performance during simulated use
Any interventional delivery systems – functional performance during simulated use

Service Levels

Applicable Standards

ISO 25539-2:2020
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

Related Tests

OLE1412

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.