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SSH EN 794-3:1998+A2:2009

Ventilatorët polmonarë - Pjesa 3 Kërkesa të veçanta për ventilatorët e urgjencës dhe të transportit

Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
26 mar 2012

General information

60.60     26 mar 2012

DPS

DPS/KT 316

European Norm

11.040.10     11.160  

anglisht  

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Scope

The scope given in clause 1 of EN 60601-1:1990 applies with the following addition:
1.101 R) 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.

Related directives

Directives related to this standards.

2007/47/EC

Direktiva 2007/47/EC e Parlamentit Europian dhe e Këshillit të 5 shtator 2007 amendon Direktivën e Këshillit 90/385/EEC mbi përafrimin e ligjeve të Shteteve Anëtare në lidhje me pajisje medicinale aktive transplatuese, Direktiva e Këshillit 93/42/EEC në lidhje me pajisjet mjekësore dhe Direktivën 98/8/EC në lidhje me vendosjen e produkteve biocide në treg

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN 794-3:2006

NOW

PUBLISHED
SSH EN 794-3:1998+A2:2009
60.60 Standard published
26 mar 2012

REVISED BY

PUBLISHED
SSH EN ISO 80601-2-84:2023

Related project

Adopted from EN 794-3:1998+A2:2009