AS 60601.2.24:2018 pdf download.Medical electrical equipment Part 2.24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers (IEC 60601-2-24:2012 (ED.2.0), MOD).
Means shall be provided in the ME EQUIPMENT to protect the PATIENT from underinfusion resulting from occlusion.
NOTE An acceptable method of complying with this requirement is at OCCLUSION ALARM THRESHOLD to activate an ALARM SIGNAL of HIGH PRIORITY and terminate the infusion liquid flow. Means shall be provided in the ME EQUIPMENT to protect the PATIENT from UNINTENDED BOLUS
following activation of the ALARM SIGNAL for occlusion. Compliance is checked by the following test: This test applies only to INFUSION PUMPS, VOLUMETRIC INFUSION PUMPS, INFUSION PUMPS FOR AMBULATORY USE and SYRINGE OR CONTAINER PUMPS. The test apparatus shown in Figure 201.112 is used. Carry out the tests using a test solution of ISO 3696:1987 class 1II or using the existing drug in the INFUSION PUMP, if the drug is prefilled by the MANUFACTURER. Perform the test under normal conditions (20 °C土2 °C, 65 % 土5% RH). Operate the ME EQUIPMENT in NORMAL USE according to the MANUFACTURER’S instructions for use. Prime the ADMINISTRATION SET and the tubing connected to the pressure transducer. Select the INTERMEDIATE RATE and the minimum OCCLUSION ALARM THRESHOLD. Connect the PATIENT END of the PATIENT LINE to the stopcock. Open the stopcock to the collecting vessel. Start the ME EQUIPMENT and allow the flow to become constant. Switch the stopcock and measure the pressure at the OCCLUSION ALARM THRESHOLD. Measure the time taken from switching the stopcock to activation of the occlusion alarm.
If an automatic bolus reduction feature is available, allow this function to complete.
Inspect the ADMINISTRATION SET for ruptures or leaks. Empty the collecting vessel. Switch the stopcock and collect the UNINTENDED BOLUS volume generated as a result of the occlusion until the pressure is reduced to atmospheric. If the OCCLUSION ALARM THRESHOLD can be selected, repeat the test with it set to maximum. If an automatic bolus reduction feature can be disabled repeat the test with this feature disabled. If any OPERATOR action is given for the eleventh dashed item of 201.7.9.2.101 a test shall also be conducted of the means provided by the ME EQUIPMENT to release unreleased UNINTENDED BOLUS. This consists of performing the release as described before measuring the amount of the UNINTENDED BOLUS remaining.
Verify by volume or mass that the result of the test is in accordance with the requirements of 201.12.4.4.101 and 201.12.4.4. 102 and the disclosure statement in the ACCOMPANYING DOCUMENTS required by the eighth to eleventh dashed items of 201.7.9.2.101).
Replacement:
ME EQUIPMENT shall be so constructed that liquid which might leak from containers, tubing,couplings and the like does not impair the safe functioning of the ME EQUIPMENT nor wet uninsulated live parts or electrical insulation which is liable to be adversely affected by such a liquid.
Compliance is checked by the following test:
Set up the ME EQUIPMENT in the least favourable orientation of NORMAL USE and according to the MANUFACTURER’S instructions for use. By means of a pipette apply drops of the test solution specified by the MANUFACTURER to couplings, tubing connectors, seals and to parts of the ADMINISTRATION SET which might rupture. Moving parts are in operation or at rest whichever is the most unfavourable. Immediately after application of the test solution, carry out the test(s) from 201.12.1.102 to 201.12.1. 107 according to the classification of the ME EQUIPMENT, at the INTERMEDIATE RATE only. If the ME EQUIPMENT does not fall into one of the defined categories then use the appropriate test from 201.12. 1.102 to 201.12.1.107 ((see 201.12.1)). Carry out the tests of 201.12.4.4.106 and 201.12.4. 4.107. Switch off the ME EQUIPMENT and allow it to stand for a minimum of 12 h under normal conditions (20 °C士2 °C，65 %士5 % RH). By means of . functional tests determine that FREE FLOW does not occur. By inspection, check the function of controls and other parts which may have been adversely affected by the test solution. Carry out the test with a worst case test solution which consists of a 50 % dextrose solution or as indicated in the RISK MANAGEMENT FILE of the MANUFACTURER.AS 60601.2.24 pdf download.
AS 60601.2.24:2018 Particular requirements for the basic safety and essential performance of infusion pumps and controllers
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