SIST EN 794-1:2000+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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 794-1:2000+A2:2009
01-julij-2009
3OMXþQLYHQWLODWRUMLGHO 3RVHEQH]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.
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SIST EN 794-1:2000+A2:2009
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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.
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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. . 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
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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$$ . 42
$$
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SIST EN 794-1:2000+A2:2009
EN 794-1:1997+A2:2009 (E)
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, 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.
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Introduction
This European Standard is one of a series based on European Standard EN 60601-1:1990.
In EN 60601-1:1990 this type of European Standard is referred to as a "Particular Standard". As stated in 1.3
of EN 60601-1:1990, the requirements of this European Standard take precedence over those of
EN 60601-1:1990.
Clauses and sub-clauses additional to those in EN 60601-1:1990 are numbered beginning '101'. Additional
annexes are lettered beginning 'AA'. Additional items in lettered lists are lettered beginning 'aa)'. Additional
tables and figures are numbered beginning '101'.
Annex AA contains rationale statements for this Part of this European Standard. The clauses and sub-clauses
which have corresponding rationale statements are marked with R) after their number.
Section one. General
1 Scope
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.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications.
These normative references are cited at the appropriate places in the text and the publications are listed
hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to
this European Standard only when incorporated in it by amendment or revision. For undated references the
latest edition of the publication referred to applies.
Appendix L of EN 60601-1:1990 applies with the following additions:
EN 475, Medical devices – Electrically-generated alarm signals
EN 550, Sterilization of medical devices – Validation and routine control of ethylene oxide sterilization
EN 552, Sterilization of medical devices – Validation and routine control of sterilization by irradiation
EN 554, Sterilization of medical devices – Validation and routine control of sterilization by moist heat
EN 556, Sterilization of medical devices – Requirements for medical devices to be labelled "STERILE"
prEN 737-1, Medical gas pipeline systems – Part 1: Terminal units for compressed medical gases and
vacuum
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prEN 737-2, Medical gas pipeline systems – Part 2: Anaesthetic gas scavenging disposal systems – Basic
requirements
prEN 737-3, Medical gas pipeline systems – Part 3: Pipelines for compressed medical gases and vacuum –
Basic requirements
prEN 737-6, Medical gas pipeline systems – Part 6: Dimensions of probes for terminal units for compressed
medical gases and vacuum
EN 738-1, Pressure regulators for use with medical gases – Part 1: Pressure regulators and pressure
regulators with flow-metering devices
prEN 739, Low pressure flexible connecting assemblies (hose assemblies) for use with medical gas supply
1)
systems
EN 980, Graphical symbols for use in the labelling of medical devices
EN 1281-1, Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets
EN 1281-2, Anaesthetic and respiratory equipment – Conical connectors – Part 2: Screw-threaded weight-
bearing connectors (ISO 5356-2:1987 modified)
prEN 1820, Anaesthetic reservoir bags
prEN 12342, Breathing tubes intended for use with anaesthetic apparatus and ventilators
EN 60601-1:1990, Medical electrical equipment – Part 1: General requirements for safety (IEC 601-1:1988)
EN 60601-1-2, Medical electrical equipment – Part 1: General requirements for safety – Collateral standard:
Electromagnetic compatibility – Requirements and tests (IEC 601-1-2:1993)
prEN ISO 8185-1, Humidifiers for medical use – Part 1: General requirements for humidification systems
(ISO/DIS 8185-1:1995)
ISO 32, Gas cylinders for medical use – Marking for identification of content
ISO/DIS 7767, Oxygen monitors for monitoring patient breathing mixtures – Safety requirements
ISO 9360, Anaesthetic and respiratory equipment – Heat and moisture exchangers for use in humidifying
1)
respired gases in humans
IEC 79-4, Electrical apparatus for explosive gas atmospheres – Part 4: Method of test for ignition temperature
EN 60801-2, Electromagnetic compatibility for industrial-process measurement and control equipment – Part
2: Electrostatic discharge requirements (IEC 801-2:1991)
3 Terminology and definitions
Clause 2 of EN 60601-1:1990 applies with the following additions:
2.1.5 R) applied part. Add the following item:
all parts of the ventilator intended to be connected to the breathing system.
1) See also Annex AA (in this European Standard).
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3.1
cycling pressure
pressure in the ventilator breathing system which initiates an inspiratory or expiratory phase
3.2
driving gas
gas which powers the ventilator but is not delivered to the patient
3.3
driving gas input port
gas input port to which driving gas is supplied
NOTE An input port is a port to which gas is supplied under positive pressure and through which the gas is driven by
this pressure. The gas may be supplied either at a controlled pressure or at a controlled flow.
3.4
emergency air intake port
dedicated gas intake port through which ambient air may be drawn by the patient when the supply of fresh
and/or inflating gas is insufficient.
NOTE A gas intake port is a port through which gas is drawn into the ventilator breathing system by the ventilator or
the patient. Gas may be supplied to the port at or about ambient atmospheric or end-expiratory pressure, or the port may
simply be left open to the atmosphere. In a ventilator breathing system, energy is required to reduce the pressure below
that of the atmosphere.
Therefore, when gas is supplied at or about atmospheric pressure to a gas intake port, work is done, either by the
ventilator (using energy from, for example, an electrical supply and/or a driving gas supply) or by the patient in order to
lower the breathing system pressure sufficiently for gas to flow in through the gas intake port. In this sense, gas is "drawn"
into the breathing system. A similar argument applies, even if gas is supplied to the gas intake port at a small positive
pressure to compensate for the use of positive end-expiratory pressure.
3.5
fresh gas
gas supplied to the ventilator breathing system
It excludes the following:
a) Air drawn through the emergency air intake port;
b) Air drawn through leaks in the ventilator breathing system;
c) Expired gas from the patient.
3.6
fresh gas intake port
gas intake port, other than the emergency air intake port, through which fresh gas may be drawn into the
ventilator breathing system by the ventilator or the patient (see note to 3.4)
3.7
fresh gas input port
gas input port to which fresh gas is supplied (see note to 3.3)
NOTE There can be more than one fresh gas input port.
3.8
gas exhaust port
the port of the ventilator from which gas is discharged to the atmosphere under normal operating conditions
either directly or via an anaesthetic gas scavenging system
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3.9
gas output port
the port of the ventilator through which gas is delivered at respiratory pressures through an operator-
detachable part of the breathing system to the patient connection port
3.10
gas return port
the port of the ventilator through which gas is returned at respiratory pressures through an operator-
detachable part of the breathing system from the patient connection port
3.11
high pressure gas input port
gas input port to which gas is supplied at a pressure greater than 100 kPa (see note to 3.3)
3.12
inflating gas
fresh gas which powers the ventilator and is supplied to the patient
3.13
inflating gas input port
gas input port to which inflating gas is supplied (see note to 3.3)
3.14
label
all printed information applied to a medical device or any of its containers or wrappers
3.15
low pressure gas input port
gas input port to which gas is supplied at a pressure not exceeding 100 kPa
3.16
lung ventilator
automatic device which is intended to augment or provide ventilation of the patient's lungs when connected to
the patient's airway
3.17
manual ventilation port
the port of the ventilator to which a device may be connected for manual inflation of the lungs
3.18
marking
an inscription in writing or as a symbol applied on a medical device from which the inscription is not
dissociable
3.19
maximum limited pressure (P )
lim, max
highest pressure measured at the patient connection port which can be attained in the ventilator breathing
system during malfunction of the ventilator but which functioning safety mechanism
NOTE Components of a ventilator are operating normally when individually they operate as the manufacturer
intended, even though particular combinations or settings of controls and of the compliance and resistance of the patient's
respiratory tract may lead to an inappropriate pattern of ventilation.
3.20
maximum working pressure (P )
w, max
highest pressure which can be attained at the patient connection port during the inspiratory phase,
irrespective of the setting of controls other than any control intended to adjust this pressure, with the ventilator
working normally
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NOTE Even if not adjustable, this maximum may be less than the maximum limited pressure.
3.21
microbial filter
device intended to reduce bacteria content and particulate matter content of the gas stream
3.22
minimum limited pressure (P )
lim, min
lowest (most negative) pressure measured at the patient connection port, which can be attained in the
ventilator breathing system during malfunction of the lung ventilator but with functioning safety mechanism
NOTE See the note to 3.19
3.23
patient connection port (of the ventilator breathing system)
the port of the ventilator breathing system to which the patient can be connected
3.24
ventilation (V)
volume of gas per minute entering or leaving the patient's lungs
3.25
ventilator breathing system (VBS)
breathing system bounded by the low pressure gas input port(s), the gas intake port(s) and the patient
connection port together with the fresh gas inlet and exhaust port(s), if these are provided. (See annex CC).
NOTE Valves can be placed anywhere in relation to ports and, indeed, anywhere in the ventilator breathing system,
provided the requirements of this standard are met.
4 General requirements and general requirements for test
4.1 Modifications to clause 3 of EN 60601-1:1990
Clause 3 of EN 60601-1:1990 applies with the following additions:
In 3.6 add the following:
aa) Applicable single fault conditions are:
short and open-circuits of components or wiring which can:
cause sparks to occur; or
increase the energy of sparks; or
increase temperature (see section seven);
incorrect output resulting from software error.
bb) R An oxidant leak which is not detected by e.g. an alarm or periodic inspection shall be considered a
normal condition and not a single fault condition.
4.2 Clause 4 of EN 60601-1:1990
Clause 4 of EN 60601-1:1990 applies.
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5 Classification
Clause 5 of EN 60601-1:1990 applies.
NOTE A ventilator can have applied parts of different types.
6 Identification, marking and documents
Clause 6 of EN 6060-1:1990 applies with the following additions and modifications:
In 6.1 add the following to item e):
If imported from outside the EU, the name and address of the person responsible or of the authorised
representative of the manufacturer or the importer established within the EU shall be provided with the label or
the accompanying documents.
In 6.1 add the following to item k):
The requirement for marking of auxiliary mains socket-outlets shall apply to each auxiliary mains socket-outlet
and the maximum allowed output shall be marked in amperes.
In 6.1 add the following additional items.
aa) All operator-interchangeable flow-direction sensitive components shall be permanently marked with a
clearly legible arrow indicating the direction of flow.
bb) Any high pressure gas input port shall be marked on or in the vicinity with the name or symbol of the gas
as given in prEN 739, with the range of supply pressures in kPa and with the maximum flow requirement in
l/min.
cc) If operator-accessible ports are provided, they shall be marked. The following terms may be used:
Driving gas input port: "DRIVING GAS INPUT"
Inflating gas input port: "INFLATING GAS INPUT"
Fresh gas input port: "FRESH GAS"
Fresh gas intake port: "FRESH GAS INTAKE"
Emergency air intake port: "WARNING: EMERGENCY AIR INTAKE – DO NOT OBSTRUCT"
Manual ventilation port: "BAG"
Gas output port: "GAS OUTPUT"
Gas return port: "GAS RETURN"
Gas exhaust port: "EXHAUST"
If the volume of gas discharged from the exhaust port is either more or less than the expired volume,
additionally: "NOT FOR SPIROMETER".
Alternatively, other terms, pictograms or symbols may be used, in which case they shall be explained and
referred to in the above terms.
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dd) Label and packaging of the ventilator and accessories (e.g. breathing system attachments)
The labelling and marking of the packages of the devices shall contain the following:
If the intended purpose of the device is not obvious to the operator, the attachment or its package shall be
provided with an instruction leaflet or operating instructions.
The name or trade name and address of the manufacturer. For attachments imported into the EU, 6.1 e)
of this European Standard applies.
Device identification and content information
Where appropriate, the symbol STERILE in accordance
...
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