IEC 60601-2-24 provides a standard method for measuring infusion pump flow accuracy by analyzing mass data collected over a defined period of time. Smithers evaluates delivered flow rate against programmed pump settings to determine delivery accuracy and identify deviations that could affect dosing performance.
Testing can be applied to both continuous infusion pumps and intermittent infusion systems to characterize device performance under defined operating conditions.
For pumps designed to deliver programmed doses, testing evaluates the accuracy and consistency of repeated dosing cycles. Smithers measures the mass of fluid delivered during each infusion event to determine the resulting flow rate and verify dose performance.
Bolus functionality allows infusion pumps to deliver an additional controlled volume of fluid when required by therapy protocols. Smithers measures the mass of fluid delivered during the bolus event to determine the resulting bolus volume and confirm delivery accuracy and repeatability.
IEC 60601-2-24 also defines procedures for determining occlusion alarm thresholds and unintended bolus volume. Testing is performed by creating a closed system and monitoring pressure until the occlusion alarm is triggered.
Smithers records the pressure at alarm activation and measures the mass of fluid released following the event to determine the unintended bolus volume.
Smithers evaluates the functionality of infusion pumps when used with specified syringes and primary containers. Compatibility testing assesses mechanical engagement and operational performance to confirm the device performs as intended with the defined delivery components.