1.1   This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:

a) a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;

 

1.2   This document applies to the following types of flow control devices (FCDs):

a) flowmeters;

NOTE Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.

 

1.3   This document applies to flow control devices for the following gases:

— oxygen;

NOTE Flow control devices can be available for other gases.

 

1.4   This document does not apply to flow control devices that are:

a) for use with gases for driving surgical tools;

This document specifies the design, construction, type testing, and marking requirements for pressure regulators (as defined in 3.18) intended for the administration of medical gases and their mixtures in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving surgical tools.

Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.

This document applies to pressure regulators:
a) intended to be connected to cylinders by the operator;
b) with integral flow-metering devices intended to be connected to cylinders by the operator;
 

A pressure regulator can be provided with pressure outlet or flow outlet, and can be adjustable or pre-set.
 

Pressure Regulators are intended to be fitted to refillable cylinders with a working pressure up to 30 000 kPa ( 300 bar) and can be provided with devices which control and measure the flow of the medical gas delivered.