ISO 10651-3:1997

Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators

Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators

General Information

• Status: Published
• Technical Committee: COVID 19 - COVID 19 - ISO
• Directive: standardi COVID-19 - UPDATE ON THE AVAILABILITY OF CEN, CENELEC, ISO, IEC STANDARDS AND THEIR NATIONAL ADOPTIONS IN RESPONSE TO THE COVID-19 OUTBREAK

Standards Content (Sample)

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IS0
INTERNATIONAL
10651-3
STANDARD
First edition
1997-01-15
Lung ventilators for medical use -
Part 3:
Particular requirements for emergency and
transport ventilators
Ven tila teurs pulmonaires 2 usage m6dical -
Partie 3: Exigences particuh&es pour ventilateurs de secours et de
transport
Reference number
IS0 10651-3:1997(E)

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ISOlO651-3:1997(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide fed-
eration of national standards bodies (IS0 member bodies). The work of
preparing International Standards is normally carried out through IS0
technical committees. Each member body interested in a subject for
which a technical committee has been established has the right to be
represented on that committee. International organizations, governmental
I and non-governmental, in liaison with ISO, also take part in the work. IS0
collaborates closely with the International Electrotechnical Commission
(IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are cir-
culated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting
a vote.
International Standard IS0 10651-3 was prepared by Technical Committee
lSO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3,
Lung ventilators and related equipment.
IS0 10651 consists of the following parts, under the general title Lung
ventilators for medical use:
Part ? : Particular requirements for critical care ventilators
Part 2: Particular requirements for home care ventilators
- Part 3: Particular requirements for emergent y and transport
ventilators
Annexes M and N of this part of IS0 10651 are for information only.
0 IS0 1997
All rights reserved. Unless otherwise specified, no part of this publication may be
reproduced or utilized in any form or by any means, electronic or mechanical, including
photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Geneve 20 l Switzerland
Printed in Switzerland
ii

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Introduction
This part of IS0 10651 specifies requirements for portable lung ventilators
designed for use in emergency situations and transport. These devices
must meet the definition of a lung ventilator (to automatically augment or
provide ventilation of the patient’s lungs), but will frequently be used
outside the hospital or home by persons with different levels of training.
A rationale for the most important requirements is given in annex M.
. . .
III

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INTERNATIONAL STANDARD @ IS0
Lung ventilators for medical use -
Part 3:
Particular requirements for emergency and transport ventilators
Section 1: General
1.1 Scope
NOTE - See the rationale in annex M.
This part of IS0 10651 is one of a series of International Standards based on IEC 601-l :I988 (the “General Standard”);
this type of International Standard is referred to as a “Particular Standard”. As stated in 1.3 of IEC 601-1:1988, the
requirements of this part of IS0 10651 take precedence over those of IEC 601-I :1988. Where this part of IS0 10651
specifies that a clause of IEC 601-I applies, it means that the clause applies only if the requirement is relevant to the
ventilator under consideration.
This part of IS0 10651 has common requirements with IEC 601-2-12. It also includes requirements from
IS0 10651-I :I 993.
The scope and object given in clause 1 of IEC 601-I :I 988 apply, except that 1 .I shall be replaced by the following:
This part of IS0 10651 specifies requirements for portable lung ventilators designed for use in emergency situations
and transport. Emergency and transport ventilators, called hereafter “ventilator”, are often installed in ambulances or
other types of rescue vehicles, but are often used outside this environment, where they have to be carried by the
operator or other persons. These devices will frequently be used outside the hospital or home by personnel with
different levels of training. This part of IS0 10651 is also applicable to devices permanently mounted in ambulances
or aircraft.
This part of IS0 10651 does not cover operator-powered ventilators (i.e. manual resuscitators).
1.2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this part
of IS0 10651. At the time of publication, the editions indicated were valid. All standards are subject to revision, and
parties to agreements based on this part of IS0 10651 are encouraged to investigate the possibility of applying the
most recent editions of the standards indicated below. Members of IEC and IS0 maintain registers of currently
valid International Standards.
- Marking for identification of con tent.
IS0 32: 1977, Gas cylinders for medical use

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IS0 1065%3:1997(E)
IS0 5356-l :I 996, Anaesthetic and respiratory equipment - Conical connectors - Part I: Cones and sockets.
IS0 5356-2:1987, Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-
bearing connectors.
IS0 5358:1992, Anaesthetic machines for use with humans.
IS0 5359: 1989, Low-pressure flexible connecting assemblies for use with medical gas systems.
I SO 5362: 1986, Anaes the tic reservoir bags.
IS0 5367: 1991, Breathing tubes intended for use with anaesthetic apparatus and ventilators.
IS0 7767:- 1), Oxygen monitors for monitoring patient breathing mixtures - Safety requirements.
IS0 9170: I 990, Terminal units for use in medical gas pipeline systems.
IS0 9703-I : 1992, Anaesthesia and respiratory care alarm signals - Part 1: Visual alarm signals.
IS0 9703-2: 1994, Anaesthesia and respiratory care alarm signals - Part 2: Auditory alarm signals.
10651-I :I 993, Lung ventilators for medical use - Part 1: Requirements.
IS0
IEC 68-2-6: 1982, Environmental testing - Part 2: Tests - Test Fc: Vibration (sinusoidal).
IEC 68-2-29:1987, Environmental testing - Part 2: Tests - Test Eb and Guidance: Bump.
IEC 68-2-32:1990, Environmental testing - Part 2: Tests - Test Ed: Free fall.
I EC 68-2-36: 1983, Environmental testing - Part 2: Tests - Test Fdb: Random vibration wide band -
Reproducibility medium.
IEC 79-4:1975, Electrical apparatus for explosive gas atmospheres - Part 4: Method of test for ignition
temperature.
I EC 601-I : 1988, Medica/ electrical equipment - Part 1: General requirements for safety.
I EC 601-I -2: 1993, Medical electrical equipment - Part I: General requirements for safety - Electromagnetic
compatibility - Requirements and tests.
I .3 Definitions
For the purposes of this part of IS0 10651, the definitions given in IS0 10651-I :I 993, I .3, and in clause 2 of
I EC 601-I : 1988 apply, with the following exceptions.
The definition given in IEC 601-I :I 988, 2.1.5, shall be replaced by the following:
2.1.5 applied part: All parts of the ventilator intended to be connected to the patient or to the breathing
system.
NOTE -
See also the rationale in annex M.
1) To be published.
2

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The definition given in IS0 10651-I :I 993, I .3.19, shall be replaced by the following:
1.3.19 high-pressure gas input part: Gas input port to which gas is supplied at a pressure greater than
500 kPa.
NOTE - Attention is drawn to the definitions given in IS0 4135.
The following definitions also apply:
1.3.1 emergency ventilator: Portable lung ventilator intended for emergency ventilation and resuscitation use
primarily outside hospital facilities.
1.3.2 microbial [bacterial] [particulate] filter: Device intended to reduce bacteria content and particulate matter
content of the gas stream.
1.3.3 neonatal: Pertaining to an individual weighing less than 5 kg.
1.3.4 operator-powered resuscitator: Portable non-active medical device used in emergency situation to
provide lung ventilation to individual whose breathing is inadequate.
1.3.5 paediatric: Pertaining to an individual weighing between 5 kg and 40 kg.
1.3.6 transport ventilator: Lung ventilator intended for use during transport to, between, or within hospital
facilities.
1.4 General requirements
The general requirements given in clause 3 of IEC 601-I :I 988 apply, with the following addition:
NOTE - All parts of the ventilator should be designed and manufactured to minimize health risks due to substances
leached or leaking from the device during use.
3.6 k) Applicable single-fault conditions are
short- and open-circuits of components or wiring which can increase temperature (see clause 7);
a)
b) incorrect output resulting from software error(s).
3.6 k 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.
NOTE - See also 54.1.
3.6 I) Illumination of 215 lux shall be provided. Measurement of ambient illumination shall be made from the
control panel toward the test subject. Test operator shall have vision of 1, corrected if necessary.
1.5 General requirements for tests
The requirements given in clause 4 of IEC 601-I :I 988 apply.
1.6 Classification
The classification given in clause 5 of IEC 601-I : 1988 applies.
NOTE - A ventilator may have applied parts of different types.
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1.7 Identification, marking and documents
The requirements given in clause 6 of IEC 601-I :I 988 apply with the following additions and modifications:
6.1 e) Amend existing IEC 601-I :I 988 text to read:
The address of the manufacturer and/or authorized representative, as applicable, shall also be marked.
After 6.1 z) add the following items:
unless non-interchangeable, shall be
6.1 aa) All operator-accessible flow-direction-sensitive components,
permanently marked with a clearly legible arrow indicating the direction of flow.
6.1 ab) Any high-pressure gas input port shall be marked with the name or symbol of the intended gas in
accordance with IS0 5359, the range of supply pressures and the maximum flow requirement.
6.1 ac) If operator-accessible ports are provided, they shall be marked. The following terms shall be used at
least in the national language or English. Alternatively, symbols may be used and explained in the instructions
for use.
Driving gas input port: the words “DRIVING GAS INPUT”;
fresh gas intake port: the words “FRESH GAS INTAKE”;
emergency air intake port: the words “WARNING: EMERGENCY AIR INTAKE - DO NOT OBSTRUCT”;
manual ventilation port: the word “BAG”;
5) gas output port: the words “GAS OUTPUT”;
6) gas return port: the words “GAS RETURN”;
7) gas exhaust port: the word “EXHAUST”;
8) pressure gauge port: the words “PRESSURE GAUGE” marked with a clearly legible arrow.
6.1 ad) Each ventilator assembly shall be provided with a permanently attached checklist which summarizes
the test procedures recommended by the manufacturer which have to be performed prior to use. The use of
electronic displays, e.g. a CRT, is permitted.
6.1 ae) The ventilator shall be durably and legibly marked with the following as far as applicable:
1) any particular storage and/or handling instructions;
2) any particular instructions for use;
any particular warnings and/or precautions relevant to the immediate operation of the ventilator;
3)
the range of body mass for which use of the ventilator is specified.
4)
6.1 af) Packages containing breathing attachments intended for single-patient use shall be clearly marked with
the following:
1) a description of the contents;
2) the words “SINGLE PATIENT USE”;
Symbol No. 1051 given in IS0 7000 may additionally be used.
NOTE -
3) the word “STERILE” or “NON-STERILE”, as applicable;
4) the name and/or trademark or the manufacturer and/or supplier;
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5) recommended methods of cleaning, disinfection and sterilization;
6) an identification reference to the type, batch or serial number;
7) the mass of the ventilator and any associated equipment (e.g. cylinder, batteries, regulators, carrying cases,
etc.);
NOTE - Some breathing attachments may contain these recommended methods in the instructions for use.
6.1 ag] Packages containing breathing attachments made of conductive materials shall be clearly r~ arked with
the word “CONDUCTIVE” or “ANTISTATIC”.
6.1 ah) Packages containing breathing attachments for single-patient use or which are disposab e shall be
clearly marked with the recommended duration of use.
6.1 ai) If gas-specific colour coding of flow controls and flexible hoses is provided, it shall be in a accordance
with IS0 32.
6.8.2 a) Add the following text:
The instructions for use shall additionally include the following:
I) Expected operating time and conditions therefor.
If the ventilator has an internal power source, a specification of the minimum operating time during
a)
which the ventilator meets the specifications under normal use as stated by the manufacturer shall be
given.
If the ventilator is pneumatically powered, the range of supply pressures shall be stated (see 10.2).
b)
If the ventilat or is provided with a reserve power supply, the functioning after a switchover to the
d
reserve powe shal be descr ibed.
r SUPPlY
2) Unless entrainment of air is prevented, recommendation for use in hazardous or explosive atmospheres,
including a warning that if the ventilator will entrain or permit the patient to inhale gas from the atmosphere,
its use in contaminated environments may be hazardous. If applicable, the manufacturer shall describe how
to prevent such entrainment or inhalation, for example, by the use of a filter.
A method of testing the following alarms prior to connection of the breathing system to the patient:
3)
high-pressure alarm;
a)
breathing circuit integrity alarm, if provided;
b)
power failure alarm;
d
d) high and low oxygen concentration alarms, if provided.
The intended use of the ventilator (e.g. adult, neonatal, range of body mass).
4)
5) If the ventilator is fitted with a gas mixing system, the manufacturer shall disclose the information
necessary for safe operation.
A recommendation that an alternative means of ventilation be available.
6)
6.8.2 d) Add the following text:
The instructions for use shall contain information about cleanliness and sterility upon delivery for parts in contact
with the patient or the respiratory gases.
6.8.3 a) Add the following text:
The requirement given applies with the following addition:
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Unless otherwise specified, parameters shall be assumed to be expressed under ATPD (atmospheric
temperature and pressure, dry) conditions. The technical description shall additionally include the following
information, as far as applicable.
1) The following pressure information:
maximum limited pressure (Prim max.);
minimum (subatmospheric) limited pressure (prim min.);
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);
a statement whether negative pressure (subatmospheric) is available in the expiratory phase. 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;
range of values to which the minimum (subatmospheric) working pressure can be set and the means
by which the minimum is assured.
2) Ranges of the following parameters, if preset or settabie to values above ambient:
- cycling pressure;
- end-expiratory pressure;
- delivered concentration of oxygen.
3) Description of the means of triggering.
type, range and sensing position of all measuring a nd display devices either incorporated into
4) The purpose,
for use wit h the ventilator.
the ventilator or recommended by the manufac turer
5) Conditions under which any measured or displayed flow, volume or ventilation (t) are to be 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 51.9.
For alarms used with the emergency ventilator, a statement of their type, capabilities, principle of the alarm
6)
detection and, if appropriate, suppression or delay of annunciation, estimated battery life and suitable
replacement batteries.
Size and type of battery, criteria for the need for replacement and any special precautions.
Internal volume of any breathing attachments or other components or subassemblies recommended by the
manufacturer to be placed between the patient connection port and the patient. The manufacturer of these
components shall disclose the test method on request.
The instructions for use shall include disclosure of the resistance, compliance, internal volume and other
functional characteristics of the complete ventilator breathing system, including any breathing attachment
or other components or subassemblies, e.g. humidifier or microbial filter, recommended by the
manufacturer, and identification of any operator-detachable breathing system components.
Inspiratory and expiratory resistances shall be disclosed for flowrates of 60 l/min for adult use, 30 I/min for
paediatric use and 5 I/min for neonatal use.
A statement that the operator will have to ensure (in accordance with 56.16) that these values are not
exceeded when adding attachments or other components or subassemblies to the breathing system.
IO) Disclosure of the characteristics or the microbial filter, if fitted.
11 ) Pneumatic diagram of the ventilato r and a diagram for each ventilator breathing sys tern either supplied or
recommended by th e man ufacturer
12 ) Details of any restrictions on the sequence of components within the ventilator breathing system, e.g.
where such components are flow-direction-sensitive.

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13) Interdependence of controls.
14) Disclosure of accuracies, in terms of precisions and bias and ranges of displayed values and calibrated
controls.
NOTE - Accuracies should be expressed in the form of maximum zero error, quoted directly in appropriate units,
plus a sensitivity error, quoted e.g. as a percentage of the reading.
Rationale: A zero error, together with a sensitivity error, is needed if a variable can pass through zero or can, in any
application, cover a range such that the minimum is a small fraction of the maximum.
15) Disclosure of how the delivered tidal or minute volumes and oxygen concentration 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, I,5 kPa, 3,0 kPa and 6,0 kPa.
16) Approximate duration of the gas supply, expressed as time per litre volume of the cylinder when charged at
a typical pressure and when the ventilator is set with typical ventilator settings. The chosen pressure and
the ventilator settings shall be disclosed.
After 6.8.3 d) add the following clause:
6.8.3 e) 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 IO, changing one parameter at a time, while the other parameters
are maintained within the limits given in clause IO, as well as combinations given by the manufacturer.
Outside the environmental and supply conditions specified in clause IO but within the limits declared, the
ventilator shall not cause a safety hazard to the patient or operator.
The ventilator might continue to function but outside the specified tolerances.
NOTE -
1.8 Power input
The requirements given in clause 7 of IEC 601-I :I 988 apply.
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Section 2: Environmental conditions
2.1 Basic safety categories
The requirements given in clause 8 of IEC 601-I :I 988 apply.
2.2 Removable protective means
The requirements given in 6.1 z) of IEC 601-I :I 988 apply.
2.3 Environmental conditions
The requirements given in clause IO of IEC 601-I :I 988 apply, with the following modifications and additions.
102.1 a) An ambient temperature range of - 18 OC to -+ 50 OC.
102.1 b) A relative humidity range of 15 % to 95 %.
10.21 c) An atmospheric pressure range of 70 kPa to l IO kPa.
10.2.2 c) The ventilator shall continue to function within the specified tolerances throughout the following
ranges of internal and external electrical power tolerances:
- a.c. voltage: - 25 % to + 15 % of nominal value;
- d.c. voltage: - 15 % to + 25 % of nominal value;
- a.c. frequency: - 5 % to + 5 % of nominal value.
NOTE - D.C. noise should be considered in the design of a ventilator intended to be powered by an external d.c. supply.
10.2.3 External pneumatic power
The ventilator shall continue to function within the specified tolerances throughout the range of pressure
variations specified by the manufacturer.
If the ventilator is intended to be connected to a medical gas supply (either a medical gas pipeline system
complying with prEN 737-3 or a pressure regulator complying with prEN 738-l), it shall operate and meet the
requirements of this part of IS0 10651 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 1 000 kPa
inlet pressure. The time-weighted average over IO s and the steady-state flowrate of each medical gas required
by the ventilator shall not exceed 60 I/min at a pressure of 280 kPa measured at the gas inlet port. The transient
flowrate of each medical gas required by the ventilator shall not exceed the equivalent of 200 I/min for 3 s.
10.3 The ventilator shall function under the extreme conditions and combinations of these as declared by the
manufacturer in 6.8.3 e).
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Section 3: Protection against electric shock hazards
3.1 General
The requirements given in clause 13 of IEC 601-l :I 988 apply.
3.2 Requirements related to classification
The requirements given in clause 14 of IEC 601-I :I 988 apply.
3.3 Limitation of voltage and/or energy
The requirements given in clause 15 of IEC 601-I :I 988 apply.
3.4 Enclosures and protective covers
The requirements given in clause 16 of IEC 601-I :I 988 apply.
3.5 Separation
The requirements given in clause 17 of IEC 601-I :I 988 apply.
Protective earthing, functional earthing and potential equalization
3.6
The requirements given in clause 18 of IEC 601-I :I 988 apply.
3.7 Continuous leakage currents and patient auxiliary currents
The requirements given in clause 19 of IEC 601-I :I 988 apply with the following amendment.
19.4 Add the following text to item h).
NOTE - See also annex M in this part of IS0 10651.
The patient leakage current shall be measured from the ventilator inlet(s) and outlet(s) and other parts which are
defined as applied parts for the purpose of this part of IS0 10651. All parts of the same type shall be connected
together electrically, with the exception of parts connected to the protective earth terminal which shall be
tested separately from parts not so connected.
3.8 Dielectric strength
The requirements given in clause 20 of IEC 601-I :I 988 apply.
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Section 4: Protection against mechanical hazards
4.1 Mechanical strength
Latlons:
The requirements given in clause 21 of IEC 601-I :I 988 apply with the following additions and modi*-’ ’
Replace the existing text with the following:
21.6
comply with the
The ventilator while functioning shall withstand the stresses caused by rough handling and shal
tests in 21.6 a) to d).
During and after the tests, the ventilator shall continue to function within the tolerances specified by the
manufacturer for normal use conditions.
21.6 a) Vibration (sinusoidal) in accordance with IEC 68-2-6 Test Fc
- Frequency range: 10 Hz-l 000 Hz
- Amplitude/acceleration: 0,35 mm/49 m-s-2
- Number of sweep cycles: four on each axis
- Sweep rate: 1 octave/min + 10 %
Reproducibility medium in accordance with IEC 68-2-36, Test Fdb
21.6 b) Random vibration (wide band) -
- ASD IO-200 Hz: O,Olg2/Hz
- ASD 200-500 Hz: 0,003g2/Hz
- Total r.m.s. acceleration: 1,7g (rms)
- Duration/axis/mounting: 30 min
21.6 c) Bump test in accordance with IEC 68-2-29, Test Eb
- Peak acceleration: 15g
- Pulse duration: 6 ms
- Number of bumps: 4 000
- Direction: vertical, with the ventilator in its normal operating positions
21.6 d) Free fall test in accordance with IEC 68-2-32, Procedure 1
- Height of fall: 0,75 m
- Number of falls: one on each of the six surfaces
4.2 Moving parts
The requirements given in clause 22 of IEC 601-I :I 988 apply.
4.3 Surfaces, corners and edges
The requirements given in clause 23 of IEC 601-I :I 988 apply.
IO

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Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
Q IS0 IS0 10651=3:1997(E)
4.4 Stability in normal use
The requirements given in clause 24 of IEC 601-I :I 988 apply.
4.5 Expelled parts
The requirements given in clause 25 of IEC 601-I :I 988 apply.
4.6 Vibration and noise
The requirements given in clause 26 of I EC 601-I :I 988 apply.
4.7 Pneumatic and hydraulic power
The requirements given in clause 27 of IEC 601-I :I 988 apply.
4.8 Suspended masses
The requirements given in clause 28 of IEC 601-I :I 988 apply.
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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dos
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