EN 794-3:1998+A2:2009

SLOVENSKI STANDARD
01-oktober-2009
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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.
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.
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 subclauses 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 subclauses
which have corresponding rationale statements are marked with R) after their number.

Section one. General
1 Scope
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.
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.
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"
EN 737-1, Medical gas pipeline systems – Part 1: Terminal units for compressed medical gases and vacuum
prEN 737-3:1994, Medical gas pipeline systems – Part 3: Pipelines for compressed medical gases and
vacuum
prEN 737-6:1996, 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
EN 739, Low pressure hose assemblies for use with medical gases
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)
EN 1820, Anaesthetic reservoir bags
EN ISO 4135:1996, Anaesthesiology – Vocabulary (ISO 4135:1995)
EN ISO 8185, Humidifiers for medical use – General requirements for humidification systems (ISO 8185:1997)
EN 12342, Breathing tubes intended for use with anaesthetic apparatus and ventilators
prEN 12598:1996, Oxygen monitors for patient breathing mixtures – Particular requirements
EN 60601-1:1998, Medical electrical equipment – Part 1: General requirements for safety
EN 60601-1-2, Medical electrical equipment – Part 1: General requirements for safety – Collateral standard:
Electromagnetic compatibility – Requirements and tests
#EN 62304, Medical device software - Software life-cycle processes$
IEC 60068-2-6, Environmental testing – Tests method – Test F – Vibration (sinusoidal)
c
IEC 60068-2-29, Environmental testing procedures – Test – Test E and guidance – Bump
b
IEC 60068-2-32:1975, Basic environmental testing procedures – Tests methods – Part 2: Tests – Test E :
d
Free fall
IEC 60068-2-36, Basic environmental testing procedures – Tests methods – Part 2: Tests – Test F : Random
db
vibration wide band – Reproducibility medium
IEC 60079-4, Electrical apparatus for explosive gas atmospheres – Pat 4: Method of test for ignition
temperature
IEC 61000-4-2, Electrostatic discharge immunity test – Basic EMC publication
ISO 32:1977, Gas cylinders for medical use – Marking for identification of content
ISO 9360:1992, Anaesthetic and respiratory equipment – Heat and moisture exchangers for use in
humidifying respired gases in humans
3 Terminology and definitions
Clause 2 of EN 60601-1:1990 applies with the following additions, and the definitions given in
EN ISO 4135:1996 apply:
2.1.5 applied part R): Add the following item:
All parts of the ventilator intended to be connected to the patient or to the breathing system.
3.1
clearly legible
visual attribute of information displayed by the equipment that allows the operator to discern (or identify)
qualitative or quantitative values or functions under a specific set of environmental conditions
3.2
cyling pressure
pressure in the ventilator breathing system which initiates an inspiratory or expiratory phase
3.3
emergency and transport ventilator
portable active medical device for lung ventilation intended for emergency use and/or transportation
NOTE Hereinafter called 'ventilator'.
3.4
label
printed or graphic information applied to a medical device or any of its containers or wrappers
3.5
marking
inscription in writing or as a symbol applied on a medical device from which the inscription is not dissociable
3.6
maximum limited pressure (P )
lim max
highest pressure, measured at the patient connection port, which can be attained in the ventilator breathing
system with a single fault condition of the ventilator
3.7
operator powered resuscitator
resuscitation device in which ventilation of the lungs is produced by the operator compressing the
compressible unit of the device
3.8
operator's position
intended orientation of the operator with respect to the equipment for normal use according to the instructions
for use
3.9
permanent connection
connection which can be separated only by the use of a tool
3.10
•
ventilation (V )
volume of gas per minute entering or leaving the patient's lungs
3.11
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 intake and exhaust port(s), if these are provided
4 General requirements and general requirements for tests
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.
NOTE See also 54.1.
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.
#
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.$
4.2 Clause 4 of EN 60601-1:1990
Clause 4 of EN 60601-1:1990 applies.
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 60601-1:1990 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 authorized
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 j):
The marking(s) for the rated input requirements of the ventilator required in 6.1 j) of EN 60601-1:1990 shall be
given in amperes.
In 6.1 add the following 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 EN 739, with the range of supply pressures in kPa and with the maximum flow requirement in l/min
nd th
(see 6.8.3a), 2 dash, 6 bullet).
6.1cc) If operator-accessible ports are provided, they shall be marked. The following terms may be used:
 Driving gas input port: "DRIVING GAS INPUT PORT"
 Inflating gas input port: "INFLATING GAS INPUT"
 Fresh gas intake port: "FRESH GAS INTAKE"
 Fresh gas input port: "FRESH GAS"
 Emergency air intake port: "WARNING: EMERGENCY AIR INTAKE – DO NOT OBSTRUCT"
 Manual ventilation port: "BAG"
 Gas return port: "GAS RETURN"
 Gas exhaust port: "EXHAUST"
Alternatively, other terms, pictograms or symbols may be used, in which case they shall be explained and
referred to in the above terms.
dd) Labelling and packaging of the ventilator and accessories (e.g. breathing system attachments)
The labeling 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 and the name and address of
authorized representative. For attachments imported into the community, 6.1e) of this European
Standard applies where the manufacturer does not have a registered place of business in the
Community;$
 Device identification and content information;
 Where appropriate, the symbol STERILE in accordance with EN 980 and the method of sterilization;
 Where appropriate, the batch code preceded by the symbol LOT in accordance with EN 980 or serial
number;
 Where appropriate, an indication of the date by which the device can be used, expressed as the year
and month;
 Where appropriate, an indication that the device is for singe use #. For single use devices the
manufacturer shall disclose the risks associated with reusing in the instructions for use or upon
request$;
#NOTE 1$ Symbol ISO 7000 – 1051 can be used (see EN 980).
#NOTE 2 Manufacturer's attention is drawn to the regulatory provision for a consistent use of indication for single use
devices.$
 Any special storage and/or handling conditions;
 Any warning and/or precaution to take;
 For devices which are considered as active medical devices, year of manufacture, except for those
covered by 6.1 dd) 6th dash;
#NOTE 3$ This indication can be included in the batch code or serial number.
 Where applicable, recommended methods of cleaning, disinfection and sterilization.
#
 If phthalates are incorporated in parts of the medical devices coming directly or indirectly into contact
with the patient the medical device shall be labelled accordingly. If such devices are used for the
treatment of children or treatment of pregnant or nursing women, the residual risk has to be identified
and stated in the instructions for use.$
Packages containing breathing attachments made of conductive materials shall be clearly marked with the
word "CONDUCTIVE" or "ANTI-STATIC".
ee) If gas-specific colour coding of flow controls and flexible hoses is provided, it shall be in accordance with
ISO 32. See annex DD for special national conditions.
ff) If the ventilator is designed to be fixed only, a warning that the ventilators shall be maintained fixed.
gg) A statement that volume-limited ventilators are not to be used on unattended patients (see also 51.102).
hh) For volume-limited ventilators, with no VBS pressure measuring device, marking of the maximum
limitation pressure under normal use as specified in 51.102.
In 6.8.2 add the following items:
aa) The instructions for use shall additionally include the following:
 R) If the ventilator has an internal power source, a specification of the minimum operating time
during which the ventilator meets the specifications under normal use as stated by the manufacturer.
If the ventilator is pneumatically powered, the range of supply pressures and flow requirements (see
10.101).
If the ventilator is provided with a reserve power supply, a description of the functioning after a
switchover to the reserve power supply.
 A method of testing the following alarms prior to connection of the breathing system to the patient:
 High pressure alarm;
 Breathing system integrity alarm, if provided;
 Power failure alarm;
 Low oxygen concentration alarm, if provided.
 The intended use of the ventilator (e.g. for adult, paediatric, neonatal, range of body mass).
NOTE Other intended uses can include:
 Emergency:
 In resuscitation at the scene of an accident, drowning, etc.:
 Longer-term use in continuing emergency (e.g. fire, mining accident).
 Transport:
 Between hospital rooms and departments;
 Between hospitals and/or other sites;
 Emergency situation;
 Long-distance planned transport.
 If the ventilator incorporates a gas mixing system the manufacturer shall disclose the information
nd th
necessary for safe operation of the mixing system. See 6.8.3 a), 2 dash, 15 bullet;
 Each ventilator shall be provided with a check list that summarises the test procedure recommended
by the manufacturer which has to be preformed prior to use. The use of electronic displays, e.g. a
cathode ray tube (CRT), is permitted;
 A recommendation that an alternative means of ventilation should be available;
 A statement that volume-limited ventilators are not to be used on unattended patients;
 The mass of the ventilator and any associated equipment e.g. cylinders, batteries, regulators,
carrying cases, etc, and the external dimensions of the ventilator;
 Unless entrainment of air is prevented, recommendations for use in hazardous or explosive
atmospheres shall be given, including a warning that if the ventilator will entrain or permit the patient
to inhale gas from the atmosphere, its use in contaminated environments can be hazardous. If
applicable, the manufacturer shall describe how to prevent or minimize such entrainment or
inhalation, for example, by the use of a non-return valve or a filter.
bb) Manufacturers of software controlled devices shall disclose by what means the possibility of hazards
arising from errors in the software program is minimized. #For medical devices which incorporate software
or which are medical software in themselves, the software development process shall comply with EN
62304.$
#
cc) The instructions for use shall contain the date of issue or the latest revision.$
In 6.8.2 d) add the following:
R) The instructions for use shall contain:
 Instructions for the dismantling and reassembly of components for cleaning and sterilization (if
applicable). This shall include an illustration of the parts in their correct relationship. The
manufacturer shall recommend a functional test of operation to be carried out after reassembly;
 Recommendations for the preferred methods of cleaning and disinfection or sterilization of the
ventilator and its components;
 A recommended functional test for operation to be carried out immediately prior to use.
In 6.8.3 a) add the following items:
R) The requirement given applies with the following addition:
1)
 Unless otherwise specified, parameters shall be assumed to be expressed under ATPD conditions;
 The technical description shall additionally include disclosure of the following information, as far as
applicable:
 A listing of the following pressures:
i) Maximum limited pressure (P );
lim max
ii) Minimum (subatmospheric) limited pressure (P );
lim min
iii) Range of values to which the maximum working pressure (P ) can be set and the
w max
means by which the maximum is assured (e.g. pressure cycling, pressure-limiting, pressure
generation);
iv) A statement whether negative pressure (subatmospheric) is available in the expiratory
phase;
v) Range of values to which the minimum (subatmospheric) working pressure (P ) can be
w min
set and the means by which the minimum is assured.
 A listing of the ranges of the following parameters:
i) Delivered ventilation (i.e. minute volume);
ii) Delivered volume (i.e. tidal volume);
iii) Ventilatory frequency;
iv) I:E ratio or % inspiratory time;
v) Cycling pressure;
vi) End-expiratory pressure;
vii) Delivered concentration of oxygen, if preset or adjustable by controls on the ventilator.
 If there is a facility for negative pressure in the expiratory phase, the limiting pressure and
generated pressure, if applicable, shall be listed for the expiratory phase and the inspiratory
phase;
 A technical description of the means of triggering;
 The purpose, type, range and sensing position of all measuring and display devices either
incorporated into the ventilator or recommended by the manufacturer for use with the ventilator;
 R) The conditions under which any measured or displayed flow, volume or ventilation is to be
2)
expressed (e.g. ATPD, BTPS ) and the condition and composition of gas in the corresponding
sensor so that the display complies with the accuracy requirements specified in 50, 51.102 and
51.106.
1) ATPD: Ambient temperature and pressure, dry.
2) BTPS: Body temperature and pressure, saturated.
 For alarms used with the ventilator, a statement of their type, capabilities, principle of the alarm
detection, and, if appropriate, disabling or delay of annunciation. A statement of the estimated
life of the battery and suitable replacement batteries.
 The internal volume of any breathing attachments or other components or sub-assemblies,
supplied or recommended by the manufacturer of the ventilator, to be placed between the
patient connection port and the patient;
The manufacturer shall disclose the test method on request.
 The inspiratory and expiratory resistance, compliance and internal volume of the complete
ventilator breathing system and/or any breathing attachment or other components or sub-
assemblies recommended by the manufacturer of the ventilator for inclusion in the ventilator
breathing system;
Resistance shall be disclosed for flows of 60 l/min for adult use, 30 l/min for paediatric use and
5 l/min for neonatal use, whichever is applicable.
 Disclosure of the functional characteristics or manufacturer's identification of operator
detachable breathing system components including the microbial filter fitted or recommended by
the manufacturer;
 A diagram of the pneumatic system of the ventilator and a diagram for each ventilator breathing
system either supplied or recommended by the manufacturer;
 Details of any restriction on the sequence of components within the ventilator breathing system,
e.g. where such components are flow-direction sensitive;
 Interdependence of controls, if applicable;
 Disclosure of accuracies and ranges of displayed values and calibrated controls.
NOTE The accuracies should be expressed in the form of maximum zero error (bias) quoted in appropriate units plus
a sensitivity error quoted e.g. as a percentage of the reading.
 Disclosure of how the delivered tidal or minute volumes and oxygen concentrations are affected
by pressure at the patient connection port, in particular the maximum deviations from the
calibrated or stated settings of these parameters at mean pressures of 0,5 kPa, 1,5 kPa, 3 kPa
and 6 kPa (5 cmH O, 15 cmH O, 30 cmH O and 60 cmH O).
2 2 2 2
 The approximate duration of the gas supply, expressed as time per litre of the volume of the
cylinder when charged at a typical nominal pressure and when the ventilator is set with typical
ventilator settings. The chosen pressure and the ventilator settings shall be declared.
In 6.8.3 add the following:
aa) Extreme conditions
The manufacturer shall declare how the ventilator will respond as the environmental and supply conditions are
extended outside the limits given in clause 10, changing one parameter at a time, whilst the other parameters
are maintained within the limits given in clause 10, as well as combinations given by the manufacturer.
Outside the environmental and supply conditions specified in clause 10 but within the limits declared, the
ventilator shall not cause a safety hazard to the patient or operator.
NOTE The ventilator might continue to function, but outside the specified tolerances.
7 Power input
Clause 7 of EN 60601-1:1990 applies.
Section two: Environmental conditions
8 Basic safety categories
Clause 8 of EN 60601-1:1990 applies.
9 Removable protective means
Not used.
10 Environmental conditions
Clause 10 of EN 60601-1:1990 applies with the following modifications and additions:
10.2.1 R) Environment
Replace items a), b), and c) with the following:
a) An ambient temperature range of - 10 ˚C to + 40 ˚C;
b) A relative humidity of 15 % RH to 95 RH %;
c) An atmospheric pressure range of 70 kPa to 110 kPa.
In 10.2.2 add the following:
aa) R) The ventilator shall operate and meet the requirements of this European Standard throughout the
following internal and/or external electrical power tolerances:
 AC voltage:  - 25 % + 15 % of nominal value;
 DC voltage  - 15 % + 25 % of nominal value;
 AC frequency - 5 % + 5 % of nominal value.
NOTE DC noise should be considered in the design of a ventilator intended to be powered by an external DC supply.
In clause 10 add the following:
10.101 External pneumatic power
If the ventilator is intended to be connected to a medical gas supply system (either a medical gas pipeline
system complying with prEN 737-3:1994 or a pressure regulator complying with EN 738-1), it shall operate
and meet the requirements of this European Standard for a pneumatic power supply throughout a range of
280 kPa to 600 kPa and shall cause no safety hazard under the single fault condition of the medical gas
supply of up to 1000 kPa inlet pressure. The time-weighted average over 10 s and the steady state flow of
each medical gas required by the ventilator shall not exceed 60 l/min at a pressure of 280 kPa measured at
the gas input port. The transient flow of each medical gas required by the ventilator shall not exceed the
equivalent of 200 l/min for 3 s.
10.102 Extreme conditions
The ventilator shall function under the extreme conditions and combinations of these as declared by the
manufacturer in 6.8.3 aa).
11 Not used.
12 Not used.
Section three: Protection against electric shock hazards
13 General
Clause 13 of EN 60601-1:1990 applies.
14 Requirements related to classification
Clause 14 of EN 60601-1:1990 applies.
15 Limitation of voltage and/or energy
Clause 15 of EN 60601-1:1990 applies.
16 Enclosures and protective covers
Clause 16 of EN 60601-1:1990 applies.
17 Separation
Clause 17 of EN 60601-1:1990 applies.
18 Protective earthing, functional earthing and potential equalization
Clause 18 of EN 60601-1:1990 applies.
19 Continuous leakage currents and patient auxiliary currents
Clause 19 of EN 60601-1:1990 applies with the following addition:
In 19.4 add the following item to h):
101 R) The patient leakage current shall be measured from those applied parts classified as the same type
(see 14.6 of EN 60601:1990). The parts shall be connected together electrically. Parts connected to the
protective earth terminal shall be tested separately.
20 Dielectric strength
Clause 20 of EN 60601-1:1990 applies.

Section four: Protection against mechanical hazards
21 Mechanical strength
Clause 21 of EN 60601-1:1990 applies with the following additions:
21.101 The ventilator shall be submitted to the following tests:
 Vibration (sinusoidal) according to IEC 60068-2-6, Test Fc, using the following parameters:
Frequency range: 10 Hz-1000Hz
-2
Amplitude/acceleration: 0,35 mm/49 ms
Sweep rate: 1 octave/min
Number of sweep cycles: 4 in each axis
 Random vibration wide band – Reproducibility Medium according to IEC 60068-2-36, Test Fdb, using
the following parameters:
3)
ASD 10Hz-200Hz: 0,01 g /Hz
ASD 200Hz-500Hz: 0,003 g /Hz
Total rms acceleration: 1,7 g
ms
Duration/axis/mounting: 30 min
 Bump according to IEC 60068-2-29, Test Eb, using the following parameters:
Peak acceleration: 15 g
Pulse duration: 6 ms
Number of bumps: 4000
Direction: Vertical, with the ventilator in its normal operating position(s)
During and after the tests, the ventilator shall continue to function within the tolerances specified by the
manufacturer.
21.102 The ventilator shall, while functioning, be submitted to the following test:
 Free fall according to IEC 60068-2-32:1975, Procedure 1, using the following parameters:
Height of fall: 0,75 m
Number of falls: 1 on each of the 6 faces
If the ventilator is fixed, as defined in 2.2.12 of EN 60601-1:1990, it is exempted from this test.
After the test, the ventilator shall function within the tolerances specified by the manufacturer.

3) Acceleration Spectral Density.
22 Moving parts
Clause 22 of EN 60601-1:1990 applies.
23 Surfaces, corners and edges
Clause 23 of EN 60601-1:1990 applies.
24 Stability in normal use
Clause 24 of EN 60601-1:1990 applies.
25 Expelled parts
Clause 25 of EN 60601-1:1990 applies.
26 Vibration and noise
Clause 26 of EN 60601-1:1990 applies.
27 Pneumatic and hydraulic power
Clause 27 of EN 60601-1:1990 applies.
28 Suspended masses
Clause 28 of EN 60601-1:1990 applies.

Section five: Protection against hazards from unwanted or excessive radiation
29 X-radiation
Clause 29 of EN 60601-1:1990 applies.
30 Alpha, beta, gamma, neutron radiation and other particle radiation
Clause 30 of EN 60601-1:1990 applies.
31 Microwave radiation
Clause 31 of EN 60601-1:1990 applies.
32 Light radiation (including lasers)
Clause 32 of EN 60601-1:1990 applies.
33 Infra-red radiation
Clause 33 of EN 60601-1:1990 applies.
34 Ultra-violet radiation
Clause 34 of EN 60601-1:1990 applies.
35 Acoustical energy (including ultra-sonics)
Clause 35 of EN 60601-1:1990 applies.
36 Electromagnetic compatibility
Clause 36 of EN 60601-1:1990 applies with the following additions:
36.101 General
The ventilator shall continue to function and meet the requirements of this European standard or shall fail
without caus
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