EN 794-1:1997+A2:2009

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, 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 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
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).
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
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
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.
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.
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 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 single use;
NOTE Symbol ISO 7000-1051 can be used (see also EN 980).
 Any special storage and/or handling conditions;
th
 Any warning and/or precaution to take (see also 6.8.2 aa) 8 dash).
 Devices which are considered as active medical devices, year of manufacture, except for those covered
th
by 6.1 dd) 6 dash.
NOTE This indication can be included in the batch code or serial number.
 Where applicable, recommended methods of cleaning, disinfection and sterilization.
Packages containing breathing attachments made of conductive materials shall be clearly marked with the
word "CONDUCTIVE" or "ANTI-STATIC".
ee) Each ventilator shall be provided with a check list that summarises the test procedures recommended by
the manufacturer which have to be performed prior to use. The use of electronic displays e.g. a CRT (Cathode
Ray Tube) is permitted.
ff) If auxiliary mains socket-outlet(s) can accept a mains plug, the auxiliary mains socket-outlet(s) shall be
marked with symbol 14 given in table D.1 in appendix D of EN 60601-1:1990.
gg) If gas-specific colour-coding of flow controls and flexible hoses is provided, it shall be in accordance with
ISO 32. See annex FF for special national conditions.
In 6.8.2 add the following items:
aa) The instructions for use shall additionally include the following:
 R) A statement to the effect that antistatic or electrically conductive hoses or tubing should not be used.
 R) If the ventilator has an internal electrical power source, a specification of the operating time under
conditions stated by the manufacturer.
If the ventilator is pneumatically powered, the range of supply pressures shall be stated (see 10.2).
If the ventilator is provided with a reserve power supply, the functioning after a switchover to the reserve
power supply shall be described.
 A statement to the effect that the operator will have to ensure that the inspiratory and expiratory
resistances as measured in 56.104 are not exceeded when adding attachments or other components or
sub-assemblies to the breathing system.
 A method testing the following alarms prior to connection of the breathing system to the patient:
 High pressure alarm;
 Low volume alarm;
 Low oxygen concentration alarm (if oxygen is delivered see 51.110);
 Breathing system integrity alarm;
NOTE Examples are leaks or disconnections of breathing system components.
 Power failure alarm;
 Alarm for continuing pressure;
 Apnoea alarm.
 If auxiliary mains socket-outlet(s) accept a standard mains plug, a warning related to the symbol required
in item ff) of clause 6.1 to the effect that the connection of equipment to the auxiliary mains socket-
outlet(s) may increase the patient leakage currents to values exceeding the allowable limits in the event
of a defective earth conductor.
 The intended use of the ventilator (e.g. intensive therapy, adult, neonatal).
 A statement that an alternative means of ventilation shall be available whenever the ventilator is in use.
 If ports are non-conical, this information shall be given with the instructions for use or a marking shall be
applied.
In 6.8.2 add the following:
bb) The instructions for use shall contain, if applicable:
 information about cleaning and sterilization prior to first use;
 information about cleaning, disinfection and sterilization and any restriction concerning re-use.
cc) Manufacturers of software-controlled devices shall disclose by which means the possibility of hazards
arising from errors in the software program is minimised.
In 6.8.3 a) add the following items:
 R) 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 (sub-atmospheric) limited pressure (P );
lim, min
iii) Range of values to which the maximum working pressure can be set and the means by which
the maximum is assured (e.g. pressure cycling, pressure limiting, pressure generation);
iv) A statement whether negative pressure (sub-atmospheric) is available in the expiratory phase;
v) Range of values to which the minimum (sub-atmospheric) working pressure can be set and the
means by which the minimum is assured.
 A listing of the ranges of the following parameters, if applicable:
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 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 shall be provided, if applicable;
 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 clause 50, in 51.103
and in 51.106.
 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 battery life 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, e.g.

2) ATPD = Ambient temperature and pressure, dry
BTPS = Body temperature and pressure, saturated
humidifier or filter recommended by the manufacturer of the ventilator for inclusion in the ventilator
breathing system.
Resistance shall be disclosed for 60 l/min for adult use and 5 l/min for neonatal use.
 Disclosure of the characteristics of the microbial filter if fitted.
 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 restrictions on the sequence of components within the ventilator breathing system, e.g.
where such components are flow-direction sensitive.
 Interdependence of controls, if applicable.
 R) Disclosure of accuracies and ranges of displayed values and calibrated controls. Unless otherwise
specified, parameters shall be assumed to be expressed under ATPD conditions.
NOTE The accuracies should be expressed in the form of maximum zero error (bias) quoted in appropriate units plus
a sensitivity error e.g. quoted as a percentage of the reading.
7 Power input
Clause 7 of EN 60601-1:1990 applies.

Section 2. 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 additions:
In 10.2.2 add the following:
aa) The ventilator shall comply with this standard throughout the range of internal and/or external electrical
power variation stated by the manufacturer.
10.101 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 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.
Not used.
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 to item h):
101) R) The patient leakage current shall be measured from those applied parts classified as the same type
(see clause 14.6 of EN 60601-1:1990). 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.
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 ultrasonics)
Clause 35 of EN 60601-1:1990 applies.
36 Electromagnetic compatibility
Clause 36 of EN 60601-1:1990 applies with the following additions:
36.1 Electromagnetic compatibility
The ventilator shall continue to function and meet the requirements of this European Standard or shall fail
without causing a safety hazard when tested in accordance with EN 60601-1-2.
If an anomaly occurs, such as display interruption, alarm activation etc, it shall be possible to restore normal
operation within 30 s after the electromagnetic disturbances have been applied.
NOTE Silencing of an activated alarm should not be considered as a failure.
36.102 Electrostatic discharge
Discharges shall be applied only to accessible parts and coupling planes as defined in EN 60801-2.

Section six. Protection against hazards of ignition of flammable anaesthetic mixtures
37 Locations and basic requirements
Clause 37 of EN 60601-1:1990 applies.
38 Marking, accompanying documents
Clause 38 of EN 60601-1:1990 applies.
39 Common requirements for Category AP and Category APG equipment
Clause 39 of EN 60601-1:1990 applies.
40 Requirements and tests for Category AP equipment, parts and components
thereof
Clause 40 of EN 60601-1:1990 applies.
41 Requirements and tests for Category APG equipment, parts and components
thereof
Clause 41 of EN 60601-1:1990 applies.

Section seven. Protection against excessive temperatures and other safety hazards
42 Excessive temperatures
Clause 42 of EN 60601-1:1990 applies.
43 R) Fire prevention
Clause 43 of EN 60601-1:1990 applies together with the following additional requirements.
In order to reduce the risk to patients, other persons or the surroundings due to fire, ignitable material, under
normal and single fault conditions, shall not at the same time be subjected to conditions in which:
 The temperature of the material is raised to its minimum ignition temperature; and
 An oxidant is present.
Determine the minimum ignition temperature in accordance with IEC 79-4 using the oxidising conditions
present under the normal and single fault condition.
Compliance is checked by determining the temperature the material is raised to under the normal and single
fault condition.
If sparking can occur under a normal or a single fault condition, the materials subjected to the energy
dissipation of the spark shall not ignite under the oxidising conditions present.
Compliance is checked by observing if ignition occurs under the most unfavourable combination of normal
conditions with a single fault.
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization
and disinfection and compatibility
Clause 44 of EN 60601-1:1990 applies with the following modification:
Replace the first paragraph of 44.3 by the following:
During and after the test as described in 44.3 of EN 60601-1:1990.
 The ventilator shall b
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