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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 60601-2-3:1993

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

EN ISO 16061:2009

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Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version...

EN ISO 18777:2009

Medical devices Directive (93/42/EEC)

Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)

EN ISO 17665-1:2006

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a...

EN ISO 17664:2004

Medical devices Directive (93/42/EEC)

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical dev...

EN ISO 17510-2:2009

Medical devices Directive (93/42/EEC)

Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)

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