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.