Teresa et al,
I have emailed the MHRA with this question and have had no reply and wondered if anyone else could answer it.
Who decides on the catagorisation of pumps?
Do the manufacturers declare it or do the testers such as BIME define it?
There is a pump from a well known manufacturer that has just high, medium and low pressure alarms but is declared as a pump suitable for neonates/high risk, I would query this with such coarse alarms.
Obviously the manufacturers want to have pumps rated at the highest safety category so might stretch the boundries.
Only trying to help and spread the word