Corrosion – Immersion Test

The catheter is immersed in a physiological saline solution for 5 hours then in boiling distilled or dionized water for 30 min. Samples are kept at 37°C for 48 hours before cooling down to room temperature. Test samples are visually inspected for traces of corrosion with an optical microscope in comparison to reference samples.

Test Procedure

Test specimens should be electrically joined before exposure. External electrical connection should be employed such as to allow current measurement.

The coupled assembly is next immersed in the test electrolyte for the period of exposure. Exposure duration should be sufficient to allow prediction of the behavior for the entire service duration. Since service duration is long, corrosion data can be taken as a function of time until a curve can be developed that can be extrapolated to the service duration, provided that steady-state conditions have been reached and that no transient environmental conditions are expected in service to affect this steady state.

Data recorded during exposures may include galvanic current measurements and couple and control specimen potentials measured relative to a suitable reference.

Scope

  • PTA, PTCA, coronary and peripheral stent delivery systems
  • TAVI and TMVR delivery systems
  • Thrombectomy devices
  • Guidewires testing
  • Endoscopic devices
  • RF ablation catheters testing
  • Any interventional delivery systems

Service Levels

Applicable Standards

  • ISO 10555-1:2013
    Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements

Related Tests

OLE1008


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