EN 794-3:1998/prA2
(Amendment)Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
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.
Lungenbeatmungsgeräte - Teil 3: Besondere Anforderungen an Notfall- und Transportbeatmungsgeräte
Ventilateurs pulmonaires - Partie 3: Règles particulières pour les ventilateurs d'urgence et de transport
Pljučni ventilatorji - 3. del: Posebne zahteve za ventilatorje za nujno medicinsko pomoč in prevoz
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2009
3OMXþQLYHQWLODWRUMLGHO 3RVHEQH]DKWHYH]DYHQWLODWRUMH]DQXMQRPHGLFLQVNR
SRPRþLQSUHYR]
Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
Lungenbeatmungsgeräte - Teil 3: Besondere Anforderungen an Notfall- und
Transportbeatmungsgeräte
Ventilateurs pulmonaires - Partie 3: Règles particulières pour les ventilateurs d'urgence
et de transport
Ta slovenski standard je istoveten z: EN 794-3:1998/prA2
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.160 3UYDSRPRþ First aid
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
FINAL DRAFT
EN 794-3:1998
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA2
January 2009
ICS 11.040.10; 11.160
English Version
Lung ventilators - Part 3: Particular requirements for emergency
and transport ventilators
Ventilateurs pulmonaires - Partie 3: Règles particulières Lungenbeatmungsgeräte - Teil 3: Besondere
pour les ventilateurs d'urgence et de transport Anforderungen an Notfall- und Transportbeatmungsgeräte
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 215.
This draft amendment A2, if approved, will modify the European Standard EN 794-3:1998. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment was established by CEN in three official versions (English, French, German). A version in any other language made
by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 794-3:1998/prA2:2009: E
worldwide for CEN national Members.
Contents Page
Foreword . 3
1 Modification to Clause 2 . 4
2 Modification to 4.1 . 4
3 Modifications to Clause 6 . 4
4 Modification to Clause 48 . 5
5 Modification to Clause 54 . 5
6 Modifications to Annex ZA . 5
Foreword
This document (EN 794-3:1998/prA2:2009) has been prepared by Technical Committee
CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI.
This document is currently submitted to the Unique Acceptance Procedure.
This document has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements
of EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of
this document.
1 Modification to Clause 2
Add the following references:
"EN 60601-1-6, Medical electrical equipment - Part 1-6: General requirements for basic safety
and essential performance – Collateral Standard: Usability
EN 62304, Medical device software - Software life-cycle processes
EN 62366, Medical devices - Application of usability engineering to medical devices".
2 Modification to 4.1
Add the following to clause 4.1:
"3.10 Clinical evaluation
A clinical evaluation shall be performed and documented in the risk management file.
Check compliance by inspection of the risk management file."
3 Modifications to Clause
...
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