EVS-EN 13544-3:2002+A1:2009

Respiratory therapy equipment - Part 3: Air entrainment devices CONSOLIDATED TEXT

General information
Withdrawn from 01.06.2022
Base Documents
EN 13544-3:2001+A1:2009
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit:

Standard history

Main + amendment
EVS-EN 13544-3:2002
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.
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