This part of this European Standard specifies minimum performance and safety requirements for air entrainment
devices used for delivery of a designated oxygen concentration to patients. It gives a test method to check the
oxygen concentration in the air/oxygen mixture generated by the air entrainment device.
It also specifies marking requirements and gives an optional system of colour coding to assist the user to identify
the designated oxygen concentration.
This standard does not cover air entrainment devices which are integral with medical devices specified in other
standards e.g. emergency lung ventilators, humidifiers, nebulizers, etc.
BS EN 13544-3:2001+A1:2009 Referenced Document
EN 1041 Information supplied by the manufacturer of medical devices*, 2013-09-01 Update
EN 738-1 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow metering devices (Incorporates Amendment A1: 2002)
EN 980 Graphical Symbols for Use in the Labelling of Medical Devices*, 2003-04-01 Update
EN ISO 4135 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2022)*, 2022-02-09 Update