ISO 11195:2018 specifies requirements for the performance and safety of stand-alone gas mixers intended for mixing oxygen with another gas for medical use.
ISO 11195:2018 does not apply to:
a) blocks of flowmeters with separate controls for the flow of each gas,
b) stand-alone gas mixers which mix oxygen with ambient air,
c) stand-alone gas mixers with more than two different gas inlets,
d) stand-alone gas mixers connected to an oxygen concentrator.