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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 13408-2:2018

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

EN ISO 25539-1:2009

Medical devices Directive (93/42/EEC)

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

EN 60601-2-46:1998

Medical devices Directive (93/42/EEC)

Medical electrical equipment -- Part 2-46: Particular requirements for the safety of operating tablesIEC 60601-2-46:1998

EN 60601-2-41:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaire...

EN 60601-2-12:2006

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilatorsIE...

EN 60601-2-3:1993

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipmentIEC 60601-2-3:1991

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