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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)

  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 supersedes the "EN 13544-3:2001"

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

  Related Standards

EN ISO 15001:2011

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)

EN ISO 9170-1:2008

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Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 917...

EN 556-1:2001/AC:2006

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Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN 556-2:2015

Medical devices Directive (93/42/EEC)

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

EN 1789:2020

Medical devices Directive (93/42/EEC)

Medical vehicles and their equipment - Road ambulances

EN ISO 5361:2016

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)

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