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Rigel Medical's free guide to IEC 60601

We've updated our practical guide to the IEC 60601 Standard

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An infusion pump is an electronic device used to control the administration of intravenous fluids to deliver measured amounts at careful and regulated rates. They can produce high and low but controlled pressures to inject controlled amount of fluids.
The reliability of infusion devices is important as these devices are very common, as well as being used on patients who are likely to be in a critical condition. There is a wide range of methods used to test the performance and accuracy of infusion devices which vary in procedure and equipment. The primary aim is to accurately measure the delivery volume and flow rate of the infusion device, check occlusion alarms and determine that it is safe for use.


Testing is provided in the manufacturer’s preventative maintenance procedure and ensures that the equipment is working within its specification and is fit for purpose. The primary test is to measure the accuracy of the delivery volume and flow rate over a range of time periods, typically between 10 minutes and 1 hour.


Occlusion tests check the capability of an infusion device to detect an obstruction. With a blockage, pressure will build up and it’s important that an infusion device will activate an alarm when specific pressure thresholds have been exceeded.
Bolus delivery must also be tested to maintain the performance of the infusion device especially with patient controlled devices where the bolus is self-medicated.

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