ISO 18242:2016/Amd 1:2023

INTERNATIONAL ISO
STANDARD 18242
First edition
2016-09-01
AMENDMENT 1
2023-08
Cardiovascular implants and
extracorporeal systems — Centrifugal
blood pumps
AMENDMENT 1: Worst-case conditions
for testing
Implants cardiovasculaires et systèmes extracorporels — Pompes
sanguines centrifuges
AMENDEMENT 1
Reference number
ISO 18242:2016/Amd.1:2023(E)
ISO 18242:2016/Amd.1:2023(E)
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ISO 18242:2016/Amd.1:2023(E)
Foreword
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SC 2, Cardiovascular implants and extracorporeal systems.
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ISO 18242:2016/Amd.1:2023(E)
Cardiovascular implants and extracorporeal systems —
Centrifugal blood pumps
AMENDMENT 1: Worst-case conditions for testing

Clause 3
Add the following term at the end of Clause 3:
3.10
worst-case condition
operating variable within those specified by the manufacturer for intended clinical use which represent
the appropriate worst-case device operation for the respective test such as blood cell damage, bearing
wear, backflow and cavitation
Clause 4
Replace the entire subclause of 4.3.3 with the following text:
4.3.3  Pump durability
When determined in accordance with 5.4.3, the components of the pump shall remain functional
over the duration of the testing specified by the manufacturer (e.g. bearing durability).
Add the following subclauses after 4.3.4:
4.3.5   Backflow under pulsatile mode
When tested in accordance with 5.4.5, test results shall demonstrate that no backflow can occur
under any conditions in pulsatile mode during the intended clinical use.
4.3.6  Cavitation
When tested in accordance with 5.4.6, test results shall demonstrate that no cavitation can occur
during intended clinical use.
5.4.1.2
Add the following text at the end of the subclause:
For rotational blood pumps with an intended use in pulsatile mode, measure the mean pressure
differential between the inlet and outlet and the corresponding mean flow rate. Construct a plot
showing the mean pressure differential versus mean flow rate for multiple mean r/min settings
over the entire rated operating range of the pump for at least three typical intended combinations
of frequency and flow amplitude of the pulsatile mode.
To characterize the dynamic pulsatile performance of the blood pump, measure the time-dependent
inlet and outlet pressures and the corresponding instantaneous flow rates for at least the minimum
and maximum operating condit
...