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CEN

EN 794-1:1997+A2:2009

(Main)

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Withdrawn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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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. . 15
13 General . 15
14 Requirements related to classification . 15
15 Limitation of voltage and/or energy . 15
16 Enclosures and protective covers . 15
17 Separation . 15
18 Protective earthing, functional earthing and potential equalization . 15
19 Continuous leakage currents and patient auxiliary currents . 15
20 Dielectric strength . 16
21 Mechanical strength . 16
22 Moving parts . 16
23 Surfaces, corners and edges . 16
24 Stability in normal use . 16
25 Expelled parts . 16
26 Vibration and noise. 16
27 Pneumatic and hydraulic power . 16
28 Suspended masses . 16
29 X-radiation . 17
30 Alpha, beta, gamma, neutron radiation and other particle radiation . 17
31 Microwave radiation . 17
32 Light radiation (including lasers) . 17
33 Infra-red radiation . 17
34 Ultra-violet radiation . 17
35 Acoustical energy (including ultrasonics) . 17
36 Electromagnetic compatibility . 17
37 Locations and basic requirements . 18
38 Marking, accompanying documents . 18
39 Common requirements for Category AP and Category APG equipment . 18
40 Requirements and tests for Category AP equipment, parts and components thereof . 18
41 Requirements and tests for Category APG equipment, parts and components thereof . 18
42 Excessive temperatures . 18
43 R) Fire prevention . 18
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and
disinfection and compatibility . 19
45 Pressure vessels and parts subject to pressure . 19
46 . 19
47 Electrostatic charges . 19
48 Biocompatibility . 19
49 Interruption of the power supply . 19
50 Accuracy of operating data . 20
51 Protection against hazardous output . 20
52 Abnormal operation and fault conditions . 26
53 Environmental tests . 26
54 General . 26
55 Enclosures and covers . 26
56 Components and general assembly . 26
57 Mains parts, components and layout . 30
58 Protective earthing – Terminals and connections . 31
59 Construction and layout . 31
Annex A A (informative) Rationale . 32
Annex B B (normative) Legibility and visibility of visual indications. 36
Annex C C (informative) Typical ventilator arrangements . 37
Annex D D (informative) Bibliography . 39
Annex E E (informative) Auditory components of alarms . 40
Annex F F (normative) Special national conditions . 41
Annex ZA (informative) ####Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC$$ . 42
$$
Foreword
This document (EN 794-1:1997+A2:2009) has been prepared by Technical Committee 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 October 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
This document includes Amendment 1, approved by CEN on 2000-10-20 and Amendment 2, approved by
CEN on 2009-02-24.
This document supersedes EN 794-1:1997.
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 Directives, see informative annex ZA, which is an integral part of this standard.
See Annex FF for Special National Conditions.
This European Standard applies to lung ventilators and has been prepared in three parts. This Part addresses
lung ventilators for critical care; Parts 2 and 3 address respectively lung ventilators for home care and lung
ventilators for emergency and transport use.
Annexes BB and FF are normative and form part of this Part of this European Standard.
Annexes AA, CC, DD, EE and ZA are for information only.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Cze
...

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c)        heating, ventilation, and air-conditioning (HVAC) systems;
d)       aspects of laser safety other than airborne contamination; and
e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

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CEN
EN ISO 15002:2024(Main)
Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
SIST EN ISO 15002:2024

This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)    flowmeters;
b)    flowgauge FCDs; and
c)    fixed orifice FCDs.
NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

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CEN
EN ISO 80601-2-55:2018/A1:2023(Amendment)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
SIST EN ISO 80601-2-55:2018/A1:2024
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