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EN 13544-3:2001+A1:2009 Standard

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  Keywords:

#air #oxygen #concentration #gives #designated

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  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

Wednesday 25th of March 2020

  Amendment

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

  Related Standards

EN 1060-3:1997+A2:2009

Medical devices Directive (93/42/EEC)

Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

EN ISO 10993-17:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

EN ISO 7376:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)

EN ISO 8359:2009

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Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)

EN ISO 8359:2009/A1:2012

Medical devices Directive (93/42/EEC)

Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)

EN ISO 8835-4:2009

Medical devices Directive (93/42/EEC)

Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)

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