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SIST EN 794-3:2000/kprA2:2009

(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

Status
Not Published
Public Enquiry End Date
19-May-2009
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
11.160 - First aid
Technical Committee
VAZ - Healthcare
Current Stage
98 - Abandoned project (Adopted Project)
Start Date
27-Mar-2013
Due Date
01-Apr-2013
Completion Date
27-Mar-2013
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
EN 794-3:1998/prA2 - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators

Relations

Consolidated By
SIST EN 794-3:2000+A2:2009 - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
Effective Date
18-Jan-2023
Consolidated By
SIST EN 794-3:2000+A2:2009 - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
Effective Date
19-Jan-2023
Amends
SIST EN 794-3:2000 - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
Effective Date
01-Apr-2009
Consolidated By
SIST EN 794-3:2000+A2:2009 - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
Effective Date
01-Oct-2009

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EN 794-3:2000/kprA2:2009EN 794-3:2000/kprA2:2009
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EN 794-3:2000/kprA2:2009
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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 794-3:2000/kprA2:2009
01-april-2009
3OMXþQLYHQWLODWRUMLGHO3RVHEQH]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
SIST EN 794-3:2000/kprA2:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN 794-3:2000/kprA2:2009

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

SIST EN 794-3:2000/kprA2:2009
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.

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

SIST EN 794-3:2000/kprA2:2009
EN 794-3:1998/prA2:2009 (E)
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

2

---------------------- Page: 4 ----------------------

SIST EN 794-3:2000/kprA2:2009
EN 794-3:1998/prA2:2009 (E)
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.
3

---------------------- Page: 5 ----------------------

SIST EN 794-3:2000/kprA2:2009
EN 794-3:1998/prA2:2009 (E)
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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The scope given in clause 1 of EN 60601-1:1990 applies with the following addition:
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