ISO 28620:2020 pdf free downoad – Medical devices一Non-electrically driven portable infusion devices.
5 Operating requirements
5.1 Flow rate
Each nominal flow rate of the device shall be checked using control solutions at a given temperature. The nominal flow rate, the control solutions and the temperatures shall be specified in the instructions for use accompanying the device [see Clause 8 c) and g)].
The mean flow rate shall have a tolerance of ±15 % compared to the nominal flow rate. The adjustable flow rate shall have a tolerance of ±20 %. At least 80 % of the nominal volume shall be delivered at an instantaneous flow rate within ±50 % of the nominal flow rate. These requirements shall be verified using the test methods described in Clause 6.
NOTE The instantaneous flow rate can deviate by more than 50 % of the nominal flow rate if the device is exposed to external pressure.
5.2 Bolus, if applicable
The bolus volume shall be not more than 115 % of the nominal bolus volume (see ).
When the bolus device is activated after the nominal bolus refill time, the bolus volume shall be in the range of 50 % to 115 % of the nominal bolus volume.
When the bolus device is activated one or more times prior to the nominal refill time (see ), the accumulated bolus volume shall not be more than 150 % of the nominal bolus volume.
6 Test methods
6.1 Test conditions
6.1.1 General
Except for particular indications, the following provisions are common and applicable before each test.
6.1.2 Apparatus and reagents
6.1.2.1 Needles, with sizes recommended by the manufacturer or, in the absence thereof, needles with a minimum inner diameter of 1,2 mm.
6.1.2.2 Control solutions, as recommended by the manufacturer and listed in the accompanying documents (see Clause 8).
6.1.3 Operating conditions
Prepare the device according to the instructions for use and accompanying documents [see Clause 8 c)] so that the solution can be administered.
Fill the reservoir to the filling volume or as specified by the manufacturer.
Perform the tests at the conditions as specified by the manufacturer or, if not specified, at a temperature of (23 ± 2) °C at (50 ± 5) % relative humidity, with an ambient pressure between 86 kPa and 106 kPa, and with the reservoir and the distal outlet at the same head height.
NOTE Ambient pressure limits can be ignored in tests not affected by atmospheric pressure.
The temperature conditions for the test shall be controlled by placing the entire device or the flow restrictor within the controlled temperature environment in 6.1.3 or as specified by the manufacturer.
The distal end of the needle shall be at the same level of the centre of the outlet channel of the reservoir unless otherwise specified by the manufacturer.
6.2.3 Procedure
Perform the test with a zero counter-pressure or with the counter-pressure indicated by the
manufacturer.
NOTE Before starting the flow, stabilization can be required following a recommendation by the
manufacturer.
Take measurements in accordance with 6.2.4.2 until the solution initially present in the device is totally delivered.