Pump Performance Test

The pump performance will be evaluated against design specifications.

Test Procedure

The pump flow rate and inlet and outlet pressure will be measured across the range of conditions listed in the IFU. A temperature controlled flow loop with a blood analogue will be used as a test fluid.

Service Levels

Applicable Standards

  • ISO 14708-5:2020
    Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices

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