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.
DIN EN 13544-3:2010 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
EN ISO 4135 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2022)*, 2022-02-09 Update
DIN EN 13544-3:2010 history
2010DIN EN 13544-3:2010 Respiratory therapy equipment - Part 3: Air entrainment devices; German version EN 13544-3:2001+A1:2009