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EN 13544-3:2001 +A1:2009 Standard

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  Keywords:

#oxygen #air #concentration #gives #designated

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 25th of March 2020

  Description:

Respiratory therapy equipment - Part 3: Air entrainment devices

  Purpose

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.

  Publication

Friday 17th of November 2017

  Amendment

This standard is an amendment for "EN 13544-3:2001"

  Reference

This standard superseed the "EN 13544-3:2001"

Anyway is still possible use the "EN 13544-3:2001" until March 21st, 2010

  Related Standards

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