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EN 13976-2:2018 Standard

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  Keywords:

#transport #equipment #transportation #european #specifies

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Rescue systems - Transportation of incubators - Part 2: System requirements

  Purpose

This European Standard specifies the requirements for a transport incubator system needed for care and treatment of infants, used in emergency or planned transport. It specifies the particular requirements needed to ensure the proper function of equipment during transportation (e.g. monitors, respirators, infusion pumps, extra corporeal lung support- (ECLS-) systems, gas supply) and to provide safe transportation for infants and operators. This European Standard also specifies that the equipment or systems shall not interfere with the functions of the road and air ambulance providing transportation. This European Standard does not give requirements for the vehicles, crafts, devices or incubators as such, these requirements are found in other standards. However, transport incubators are normally combined with other equipment to form a transport incubator system.

  Publication

Wednesday 25th of March 2020

  Related Standards

EN 60601-1:2006/AC:2010

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Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

EN ISO 8835-4:2009

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

EN ISO 10651-2:2009

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Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilat...

EN ISO 10555-1:2009

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Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)

EN ISO 10535:2006

Medical devices Directive (93/42/EEC)

Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)

EN ISO 10524-4:2008

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Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

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