BS ISO 28620:2020 Medical devices — Non-electrically driven portable infusion devices.
4.2 Materials
The materials used in the manufacture of the parts that come in contact with the drug solution shall
have undergone a biological evaluation in accordance with ISO 10993-1.
4.3 Design and characteristics
4.3.1 General
The device shall be designed to deliver according to its nominal flow rate (see 5Jj.
4.3.2 Fittings
If applicable, the fitting at the filling port shall be a female lock connector conforming to ISO 80369-6 or
ISO 80369-7.
If fittings at the distal end of the tubing are used, they shall be male lock connectors conforming to ISO 80369-6 or ISO 80369-7, as appropriate for the intended application.
All device fittings designed to be connected to other medical devices or accessories shall conform to ISO 80369-1, ISO 80369-6 or ISO 80369-7, as appropriate for the intended application.
4.3.3 Filter
The system shall include a particulate matter filter on the fluid path of the solution.
When tested in accordance with 9, the retention of latex particles on the filter shall be not less than 80 %.
4.3.4 Tubing
If the device is designed with tubing, it can be fixed or removable. If the tubing is removable, the connection system to the device shall use a lock connector when tested in accordance with .
The junction between the reservoir and the tubing shall resist a static traction of 15 N for 15 s.
4.3.5 Reservoir
All elements of the device designed to receive the drug shall constitute a closed, water-tight system. This requirement shall he verified by tests in accordance with 6.3. 6.4. 6.5 and 6.6.
If necessary, a redundant mechanism of the reservoir shall be available, minimizing the risk of leakage of the solution from the reservoir.
The reservoir of the device shall be designed so as to allow a visual inspection of the solution.
4.4 Sterility and non-pyrogenicity
All parts of the device in contact with the drug solution shall have been subjected to a validated sterilization process, shall be delivered sterile and non-pyrogenic, and shall he for single use only.BS ISO 28620 pdf download.