Published
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.
Directives related to this standards.
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
Harmonized
Replaces
SSH EN 13544-3:2004
PUBLISHED
SSH EN 13544-3:2001+A1:2009
60.60
Standard published
Sep 30, 2011
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