1.1 This International Standard specifies requirements for pressure regulators and pressure regulators with flow-metering devices intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients. It applies to the types of pressure regulators given in a), b) and c) for use with the following medical gases:

air
carbon dioxide
helium
oxygen
nitrogen
nitrous oxide
xenon
mixtures of oxygen and carbon dioxide
mixtures of oxygen and helium
mixtures of oxygen and nitrogen
mixtures of oxygen and nitrous oxide

The types of pressure regulators are as follows:

a) high-pressure regulators (inlet pressure up to 20 000 kPa) intended to be connected by the user to high-pressure gas cylinders;
b) high-pressure regulators (inlet pressure up to 20 000 kPa) that are an integral part of medical equipment (e.g. anaesthetic machines, lung ventilators, resuscitators);
c) low-pressure regulators (inlet pressure up to 1 400 kPa) intended to be connected by the user to terminal units of medical gas pipeline systems.

This International Standard also applies to the following types of pressure regulators with flow-metering devices:

d) pressure regulators with integral flow-metering devices as described in a) and c);
e) pressure regulators with flow-metering devices that are not integral with the types of pressure regulators described in a) and c) but are not intended to be detached from the pressure regulator by the user. air

1.2This International Standard does not apply to

a)high-pressure and low-pressure regulators that are an integral part of medical gas pipeline systems;
b) low-pressure regulators, with or without flowmetering devices, that are an integral part of medical equipment;
c) pressure regulators integrated within cylinder valves;
d) vacuum regulators.