Occluder testing - Cardiovascular Implants

Questmed GmbH is a Test Laboratory for Occluder and Closure Device Testing of Cardiovascular Implants. We testing Cardiovascular Implants like Occluder for fatigue and durability and other mechanical loads in accordance with ISO 25539-1, ISO 25539-2 und ISO 22679 (DIS).
For fatigue and durability testing with axial and hydrodynamic loads we use our accredited test procedure.

Differential hydrodynamic pressure test

Fatigue and durability tests runs with 1.2 Hz up to 90 Hz at 37°C tempered 0.9% saline ringer's solution.
hydrodynamic test principle
Our multidevice cardiac implant test systems for Occluder are available for 1 up to 30 Samples.

hydrodynamic test setup
High cycle fatigue and durability testing demonstrates the occluder’s ability to withstand physiological stresses during long term implantation.
We perform pulsatile fatigue and durability testing for 10 million up to 600 million cycles.
Our test systems provides highspeed pressure tests with differential hydrodynamic pressures to the occluder with highspeed data recording to test the performance of occluders using the Questmed OTV test system.
Pulsatile flows simulate the intended deployment location for occluder and closure devices.
Steady flow will also be performed to better understand the fundamental operation of devices.
Tests include:
  • Fatigue testing
  • Durability testing
  • Short-term and long-term pressurization
  • Interim visual inspections without removing the test samples
  • Metal ion release analysis

Differential pressure pulsation for fatigue and durability testing sorted by type of occluders

  • Type - Differential Pressure pulsation
  • PFO - diff 14 mmHg
  • ASD - diff 14 mmHg
  • PDA - diff 110 mmHg
  • VSD - diff 110 mmHg
  • PVL - diff 119 mmHg
  • LAA - diff 27 mmHg
  • AFR - diff 30 mmHg
  • AAA - diff 20 mmHg

Axial fatigue and durability testing

Axial tests runs with 10 Hz up to 90 Hz in 37°C tempered 0.9% saline ringer's solution.
Our multidevice cardiac implant test system for Occluders is available for 12 Samples.

axial test principle