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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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The IEC 60601-2-24 standard states the performance and usability requirements for infusion devices. 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 based on manufacturer recommendation in their performance procedure. This ensures that the equipment is working within its specification and is fit for purpose. The accuracy of the whole system, not just the device, must be included for infusion device testing. Possible inaccuracies can occur because of the syringe used and tubing.


Infusion device analysers offer an all in one solution for testing. They record real-time readings of the delivery rate and volume allowing for continuous infusion device testing without constant supervision. Some analysers have up to 4 channels, which can run simultaneously and even measure boluses. Furthermore, occlusions in the pressure circuit can be simulated by the analyser to test the infusion devices occlusion alarms.

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