DS/EN 794-3 + A2:2009

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 85.95
Legislation:

Legislation

Harmonized under:
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

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.


Number of pages: 48

Published: 2009-10-30

Date of approval: 2009-09-28

International relationships : EN 794-3:1998+A2:2009 IDT

ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment 11.160 - First aid

Item number: M242772


Committees

Committee

  • CEN/TC 215/WG 2

Danish committee

DS/S-104