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


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