Standards · Standard or regulation
IEC 60601-2-24
Medical electrical equipment, Part 2-24: Particular requirements for infusion pumps and controllers
In plain words
What it covers.
The particular standard for volumetric infusion pumps, syringe pumps and controllers. It adds rules on top of IEC 60601-1 for flow accuracy, occlusion detection, free-flow protection, air-in-line detection, bolus after occlusion release and alarm behaviour. Its trumpet curve test shows how flow varies over short and long periods.
Who uses it: Infusion device manufacturers and test houses; clinical engineers writing PM procedures, comparing tenders and investigating infusion incidents.
A summary written by BMEssentia for learning, not the text of the standard. Always work from the current official edition and the manufacturer's instructions.
It covers
- Flow rate accuracy and trumpet curves
- Occlusion alarm pressure and time to alarm
- Bolus volume on occlusion release
- Free-flow prevention
- Air-in-line detection
- End of infusion and battery alarms
Key points
What engineers need to know.
- Accuracy is shown with start-up graphs and trumpet curves over set observation windows.
- Time to occlusion alarm is longer at low flow rates, a key risk for neonates.
- When an occlusion is released, the stored pressure can push an unintended bolus to the patient.
- Free flow must be prevented when the set is removed or the door is opened.
- Air-in-line detectors must alarm before a dangerous volume of air passes.
- Syringe pumps need syringe-size detection and plunger-disengagement alarms.
- Hospital checks use an infusion device analyser to verify rate and occlusion pressure.
Devices
Devices it applies to.
Each device in the Medical City Device Lab, with its Device Library course on the Platform.
Medical City
Where you practise it.
- S1-M001 The First Call
- Preventive Maintenance pump rounds
- Patient Safety cases such as bolus on release and air in the line
- Procurement infusion fleet tender