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SRPS EN 13544-3:2011

Respiratory therapy equipment - Part 3: Air entrainment devices

Jan 31, 2011

General information

90.92     Mar 20, 2019

ISS

Z076

European Norm

11.040.10  

English  

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Scope

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.

Related directives

Directives related to this standard.

93/42/EEC

Medical devices

Harmonized
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2007/47/EC

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

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Life cycle

NOW

PUBLISHED
SRPS EN 13544-3:2011
90.92 Standard to be revised
Mar 20, 2019

Related project

Adopted from EN 13544-3:2001+A1:2009