EN 794-3:1998+A2:2009
(Main)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
EN 60601 1:1990, Abschnitt 1 gilt in Verbindung mit folgender Ergänzung:
1.101 R) Dieser Teil dieser Europäischen Norm legt Anforderungen an Beatmungsgeräte fest, die energetisch betrieben werden und für Notfälle und Transport vorgesehen sind.
Dieser Teil umfasst eine Reihe von Geräten, angefangen von relativ einfachen Beatmungsgeräten, die in erster Linie mit einer Gesichtsmaske benutzt werden und für einen begrenzten Zeitraum vorgesehen sind (z. B. gasbetriebene Beatmungsgeräte), bis hin zu Geräten für den längerfristigen Gebrauch. !Dies schließt gasdruckbetriebene Wiederbelebungsgeräte ein, die in der Regel von Ersthelfern verwendet werden."
Dieser Teil umfasst keine Beatmungsgeräte, die vom Anwender betrieben werden (d. h. keine manuellen Wiederbelebungsgeräte).
Beatmungsgeräte in Flugzeugen sind wahrscheinlich zusätzlichen Anforderungen und nationalen/internatio¬nalen Vorschriften unterworfen.
Weitere Teile, z. B. für Beatmungsgeräte für die Intensivpflege (siehe EN 794-1), Beatmungsgeräte für die häusliche Pflege (siehe EN 794-2), anwenderbetriebene Wiederbelebungsgeräte und neuere Entwicklungen wie Jet- und Hochfrequenzbeatmung und Oszillation, wurden veröffentlicht oder befinden sich zurzeit in Beratung.
Ventilateurs pulmonaires - Partie 3 : Règles particulières pour les ventilateurs d'urgence et de transport
Le domaine d'application indiqué à l'article 1 de l'EN 60601-1:1996 s'applique avec l'ajout suivant :
1.101 R) La présente partie de cette norme européenne spécifie les exigences relatives aux ventilateurs pulmonaires d'urgence et de transport, reliés à une source d'énergie.
Elle couvre une gamme d'appareils allant des ventilateurs relativement simples, destinés essentiellement à être utilisés avec un masque facial et pour des périodes limitées (par exemple avec des ventilateurs à énergie pneumatique) aux appareils prévus pour être utilisés à plus long terme. !Cela inclut les ressuscitateurs à puissance motrice pneumatique, qui sont en général utilisés par les premiers intervenants."
Cette partie ne traite pas des ventilateurs actionnés par l'opérateur (ressuscitateurs manuels).
Les ventilateurs embarqués à bord d'avions sont susceptibles d'être soumis à des exigences et des réglementations nationales/internationales supplémentaires.
D'autres parties sont publiées ou à l'étude, concernant par exemple les ventilateurs pulmonaires pour soins critiques (voir EN 794-1), les ventilateurs pour l'emploi à domicile (voir EN 794-2), les ressuscitateurs actionnés par l'opérateur, et la mise au point de techniques récentes telles que la ventilation par injection et à très haute fréquence et à oscillation.
Pljučni ventilatorji - 3. del: Posebne zahteve za ventilatorje za nujno medicinsko pomoč in prevoz
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-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+A2:2009
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
EN 794-3:1998+A2
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2009
ICS 11.040.10; 11.160 Supersedes EN 794-3:1998
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 European Standard was approved by CEN on 1 July 1998 and includes Amendment 1 approved by CEN on 25 May 2005 and
Amendment 2 approved by CEN on 23 July 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 794-3:1998+A2:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .4
Introduction .5
Section one. General .6
1 Scope .6
2 Normative references .6
3 Terminology and definitions .7
4 General requirements and general requirements for tests .8
5 Classification .9
6 Identification, marking and documents .9
7 Power input . 15
8 Basic safety categories . 16
9 Removable protective means . 16
10 Environmental conditions . 16
11 Not used. . 17
12 Not used. . 17
13 General . 18
14 Requirements related to classification . 18
15 Limitation of voltage and/or energy . 18
16 Enclosures and protective covers . 18
17 Separation . 18
18 Protective earthing, functional earthing and potential equalization . 18
19 Continuous leakage currents and patient auxiliary currents . 18
20 Dielectric strength . 18
21 Mechanical strength . 19
22 Moving parts . 20
23 Surfaces, corners and edges . 20
24 Stability in normal use . 20
25 Expelled parts . 20
26 Vibration and noise. 20
27 Pneumatic and hydraulic power . 20
28 Suspended masses . 20
29 X-radiation . 21
30 Alpha, beta, gamma, neutron radiation and other particle radiation . 21
31 Microwave radiation . 21
32 Light radiation (including lasers) . 21
33 Infra-red radiation . 21
34 Ultra-violet radiation . 21
35 Acoustical energy (including ultra-sonics) . 21
36 Electromagnetic compatibility . 21
37 Locations and basic requirements . 23
38 Marking, accompanying documents . 23
39 Common requirements for Category AP and Category APG equipment . 23
40 Requirements and test for Category AP equipment, parts and components thereof . 23
41 Requirements and test for Category APG equipment, parts and components thereof . 23
42 Excessive temperatures . 24
43 R) Fire prevention . 24
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and
disinfection . 24
45 Pressure vessels and parts subject to pressure . 24
46 Not used . 25
47 Not used . 25
48 Biocompatibility . 25
49 Interruption of the power supply . 25
50 Accuracy of operating data . 26
51 Protection against hazardous output . 26
52 Abnormal operation and fault conditions . 30
53 Environmental tests . 30
54 General . 31
55 Enclosures and covers . 31
56 Components and general assembly . 31
57 Mains parts, components and layout . 34
58 Protective earthing – Terminals and connections . 34
59 Construction and layout . 34
Annex AA (informative) Rationale . 35
Annex BB (normative) Legibility and visibility . 40
Annex CC (informative) Bibliography . 41
Annex DD (normative) Special national conditions . 42
Annex ZA (informative) ####Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC$$$$ . 43
Foreword
This document (EN 794-3:1998+A2:2009) has been prepared by Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by February 2010, and conflicting national standards shall be withdrawn
at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document includes Amendment 1, approved by CEN on 2005-05-25 and Amendment 2, approved by
CEN on 2009-07-23.
This document supersedes EN 794-3:1998.
The start and finish of text introduced or altered by amendment is indicated in the text by tags
!" and # $.
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard.
See annex DD for Special National Conditions.
This European Standard applies to lung ventilators and has been prepared in three parts. This Part addresses
lung ventilators for emergency and transport use. Parts 1 and 2 address lung ventilators for critical care and
lung ventilators for home care respectively.
Annexes BB and DD are normative and form part of this Part of this European Standard.
Annexes AA, CC and ZA are for information only.
...
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