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CEN

EN 794-1:1997+A2:2009

(Main + Amendment)

Lung ventilators - Part 1: Particular requirements for critical care ventilators

Lung ventilators - Part 1: Particular requirements for critical care ventilators

The scope given in clause 1 of the EN 60601-1:1989 applies except that 1.1 is replaced by the following.
1.1   This Part of this European Standard specifies requirements for lung ventilators intended for medical use. Additional Parts, e.g. concerning emergency and transport ventilators, home care ventilators, and recent developments such as jet and very high frequency ventilation and oscillation are under consideration. Requirements for ventilators intended for anaesthetic applications are given in prEN 740.

Lungenbeatmungsgeräte - Teil 1: Besondere Anforderungen an Beat-mungsgeräte für die Intensivpflege

Ventilateurs pulmonaires - Partie 1: Prescriptions particulières des ventilateurs pour soins critiques

Le domaine d'application indiqué à l'article 1 de l'EN 60601-1:1990 s'applique, à l'exception du paragraphe 1.1 qui
est remplacé par le suivant :
1.1 La présente partie de cette norme européenne spécifie les prescriptions concernant les ventilateurs
pulmonaires à usage médical. D'autres parties concernant, par exemple, les ventilateurs d'urgence et de transport,
les ventilateurs pour l'emploi à domicile et la mise au point de techniques récentes telles que la ventilation par
injection et à très haute fréquence sont à l'étude. Les prescriptions relatives aux ventilateurs destinés à des
applications d'anesthésie figurent dans l'EN 740.

Pljučni ventilatorji - 1. del: Posebne zahteve za ventilatorje za intenzivno nego

General Information

Status
Withdrawn
Publication Date
31-Mar-2009
Withdrawal Date
14-Apr-2011
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 2 - Lung ventilators
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
15-Apr-2011
Completion Date
15-Apr-2011
Directive
2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN 794-1:2000+A2:2009 - Lung ventilators - Part 1: Particular requirements for critical care ventilators

Relations

Merged From
EN 794-1:1997/A1:2000 - Lung ventilators - Part 1: Particular requirements for critical care ventilators
Effective Date
18-Jan-2023
Merged From
EN 794-1:1997 - Lung ventilators - Part 1: Particular requirements for critical care ventilators
Effective Date
18-Jan-2023
Replaced By
EN ISO 80601-2-12:2011 - Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2011)
Effective Date
23-Apr-2011

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 794-1:2000+A2:2009
01-julij-2009
3OMXþQLYHQWLODWRUMLGHO3RVHEQH]DKWHYH]DYHQWLODWRUMH]DLQWHQ]LYQRQHJR
Lung ventilators - Part 1: Particular requirements for critical care ventilators
Lungenbeatmungsgeräte - Teil 1: Besondere Anforderungen an Beat-mungsgeräte für
die Intensivpflege
Ventilateurs pulmonaires - Partie 1: Prescriptions particulières des ventilateurs pour
soins critiques
Ta slovenski standard je istoveten z: EN 794-1:1997+A2:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN 794-1:2000+A2:2009 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 794-1:2000+A2:2009

---------------------- Page: 2 ----------------------

SIST EN 794-1:2000+A2:2009


EUROPEAN STANDARD
EN 794-1:1997+A2

NORME EUROPÉENNE

EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN 794-1:1997
English Version
Lung ventilators - Part 1: Particular requirements for critical care
ventilators
Ventilateurs pulmonaires - Partie 1: Prescriptions Lungenbeatmungsgeräte - Teil 1: Besondere
particulières des ventilateurs pour soins critiques Anforderungen an Beatmungsgeräte für die Intensivpflege
This European Standard was approved by CEN on 5 March 1997 and includes Amendment 1 approved by CEN on 20 October 2000 and
Amendment 2 approved by CEN on 24 February 2009.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.

This European Standard exists 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.






EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 794-1:1997+A2:2009: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN 794-1:2000+A2:2009
EN 794-1:1997+A2:2009 (E)
Contents Page
Foreword .4
Introduction .5
1 Scope .5
2 Normative references .5
3 Terminology and definitions .6
4 General requirements and general requirements for test .9
5 Classification . 10
6 Identification, marking and documents . 10
7 Power input . 14
8 Basic safety categories . 14
9 Removable protective means . 14
10 Environmental conditions . 14
11 Not used. . 15
12 Not used. .
...

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NOTE 5     If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
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