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EN 794-3:1998+A2:2009 Standard

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  Keywords:

#powered #use #resuscitators #ventilators #devices

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators

  Purpose

This part of this European Standard specifies requirements for ventilators, driven by a power source and intended for emergency and transport use. This covers a range of devices, from relatively simple ventilators intended, primarily, for use with a face mask and for limited periods (e.g. gas powered ventilators) through to devices for pre-planned longer term use. This includes gas-powered resuscitators, which are generally used by first responders.This part does not cover operator-powered ventilators (i.e. manual resuscitators). Ventilators aboard aircraft are likely to be subject to additional requirements and national/international regulations. Additional parts, e.g. concerning lung ventilators for critical care (see EN 794-1), home care ventilators (see EN 794-2), operator powered resuscitators and recent developments such as jet and very high frequency ventilation and oscillation are published or under consideration.

  Publication

Wednesday 25th of March 2020

  Amendment

This standard is an amendment for "EN 794-3:1998"

  Related Standards

EN 60601-2-24:1998

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EN ISO 9360-2:2009

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EN ISO 10651-6:2009

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Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilat...

EN ISO 10651-4:2009

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Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)

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)

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