ISO 10651-2:1996

IS0
INTERNATIONAL
10651-2
STANDARD
First edition
1996-08-01
Lung ventilators for medical use -
Part 2:
Particular requirements for home care
ventilators
Ventiiateurs pulmonaires a usage medical -
Partie 2: Prescriptions particuli&es pour ven tila teurs pour soins
domes tiques
Reference number
IS0 10651-2:1996(E)
IS0 10651-2:1996(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 rep-
resented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. IS0 col-
laborates 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 10651-2 was prepared by Technical Committee
ISO/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 I: Particular requirements for critical care ventilators
- Part 2: Particular requirements for home care ventiia tors
Part 3: Particular requirements for emergency and transport ven ti-
la tors
Annexes M, N and P of this part of IS0 10651 are for information only.
0 IS0 1996
All rights reserved. Unless otherwise specified, no part of this publication may be repro-
duced or utilized in any form or by any means, electronic or mechanical, including photo-
copying 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
(Q IS0 IS0 10651-2:1996(E)
Introduction
This part of IS0 10651 specifies requirements for lung ventilators intended
mainly for home care use but which could be used elsewhere (in hospitals)
for appropriate patients in locations where the use of a ventilator comply-
ing with IS0 10651-l is not required. These devices must meet the defi-
nition of a lung ventilator (to automatically augment or provide ventilation
of the patient’s lungs), but will frequently be used in the home or else-
where by persons with different levels of training. Devices intended solely
to augment the ventilation of spontaneously breathing patients are ex-
cluded from the scope of this part of IS0 10651.
A rationale for the most important requirements is given in annex M.
. . .
III
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INTERNATIONAL STANDARD o Iso IS0 10651=2:1996(E)
Lung ventilators for medical use -
Part 2:
Particular requirements for home care ventilators
Section 1: General
This part of IS0 10651 does not cover operator-
1.1 Scope
powered ventilators (i.e. manual resuscitators).
NOTE - See the rationale in annex M.
This part of IS0 10651 is one of a series of Inter-
1.2 Normative references
national Standards based on IEC 601-I :1988 (the
“General Standard”); this type of International Stan-
The following standards contain provisions which,
dard is referred to as a “Particular Standard”. As
through reference in this text, constitute provisions of
stated in 1.3 of IEC 601-I :I 988, the requirements of
this part of IS0 10651. At the time of publication, the
this part of IS0 10651 take precedence over those of
editions indicated were valid. All standards are subject
IEC 601-l :1988. Where this part of IS0 10651 speci-
to revision, and parties to agreements based on this
fies that a clause of IEC 601-I applies, it means that
part of IS0 10651 are encouraged to investigate the
the clause applies only if the requirements are rel-
possibility of applying the most recent editions of the
evant to the ventilator under consideration.
standards listed below. Members of IEC and IS0
maintain registers of currently valid International Stan-
This part of IS0 10651 has common requirements
dards.
with IEC 601-2-12 (see annex P). It also includes re-
quirements from IS0 10651-I.
IS0 32:1977, Gas cylinders for medical use - Mark-
The scope and object given in clause 1 of ing for identification of con tent.
IEC 601-l :I 988 apply with the following addition:
IS0 5356-l : -I), Anaes the tic and respiratory equip-
This part of IS0 10651 specifies requirements for
ment - Conical connectors - Part 7: Cones and
lung ventilators intended mainly for home care
sockets.
use but which could be used elsewhere (in hospi-
tals) for appropriate patients in locations where
IS0 5356-2: 1987, Anaesthetic and respiratory equip-
the use of a ventilator complying with
ment - Conical connectors - Part 2: Screw-threaded
IS0 10651-I is not required.
weigh t-bearing connectors.
Devices intended solely to augment the venti-
IS0 5359: 1989, Low-pressure flexible connecting as-
lation of spontaneously breathing patients are
semblies (hose assemblies) for use with medical gas
excluded from this part of IS0 10651, as are cuir-
systems.
ass ventilators which apply negative pressure to
the chest wall.
IS0 5362: 1986, Anaesthetic reservoir bags.
NOTE - Requirements for ventilators intended for
anaesthetic application are given in IS0 8835-l.
1) To be published. (Revision of IS0 5356-1:1987)

0 IS0
IS0 10651=2:1996(E)
NOTE - Attention is drawn to the rationale in annex M
IS0 5367: 1991, Breathing tubes intended for use with
and to the definitions given in IS0 4135.
anaes the tic apparatus and ventilators.
The following definitions also apply.
IS0 7000: 1989, Graphical symbols for use on equip-
Index and synopsis.
ment -
1.3.1 adult: Pertaining to an individual weighing
40 kg or more.
ISO7767:- *), Oxygen monitors for monitoring pa-
tien t breathing mixtures - Safety requirements.
1.3.2 calibrated control: Control with numbered
IS0 8185:1988, Humidifiers for medical use - Safety
marks on which the numbers purport to indicate the
requirements. value of the parameter being controlled, whether or
not the control has been individually calibrated.
I SO 9360: 1992, Anaes the tic and respiratory equip-
ment - Heat and moisture exchangers for use in
1.3.3 clearly legible: Visual attribute of information
humidifying respired gases in humans.
displayed by equipment that allows the operator to
discern (or identify) qualitative or quantitative values or
IS0 9703-I : 1992, Anaesthesia and respiratory care
functions under a specific set of environmental con-
alarm signals - Part I: Visual alarm signals.
ditions.
EN 550:1994, Sterilization of medical devices - Vali-
dation and routine control of ethylene oxide steriliz-
1.3.4 cycling pressure: Pressure in the ventilator
a tion.
breathing system which initiates an inspiratory or ex-
piratory phase.
EN 552:1994, Sterilization of medical devices - Vali-
dation and routine control of sterilization by irradiation.
ung ven ti-
1.3.5 driving gas: Gas which powe rs the I
EN 554:1994, Sterilization of medical devices - Vali-
lator and which also may be del ivered to the patient.
dation and routine control of steam sterilization.
1.3.6 driving gas port: Driving gas entrance or exit
EN 556:1994, Sterilization of medical devices - Re-
of no particular configuration unless specified.
quirements for medical devices to be labelled
“Sterile “.
NOTE - Examples of arrangements of ports are given in
IEC 79-4: 1975, Electrical apparatus for explosive gas annex N.
Part 4: Method of test for ignition
atmospheres -
temperature.
1.3.7 driving gas input port: Input port to which
driving gas is su pplied.
I EC 601-I : 1988, Medical electrical equipment -
Part 7: General requirements for safety.
NOTE - SeeannexN.
I EC 601-I -2: 1993, Medical electrical equipment -
Part 7: General requirements for safety. 2. Collateral
1.3.8 emergency air intake port: Dedicated gas
standard: Electromagnetic compatibility - Require-
intake port through which ambient air may be drawn
ments and tests.
when the supply of fresh and/or inflating gas is insuf-
ficient.
I EC 801-2: 1991, Electromagnetic compatibility for
industrial-process measurement and control equip-
NOTE - See annex N.
Part 2: Electrostatic discharge requirement.
ment -
1.3.9 enabling condition: Necessary, but not
necessarily sufficient, condition to cause an action.
1.3 Definitions
For the purposes of this part of IS0 10651, the defi-
1.3.10 expired tidal volume: Volume of gas leaving
nitions given in clause 2 of IEC 601-I :I 988 apply, ex-
the patient’s lungs during an expiratory phase.
cept that the definition given in 2.1.5 shall be replaced
by the following:
1.3.11 flow-direction-sensitive component: Com-
ponent through which gas flow must be in one direc-
2.1.5 applied part: Any part of the ventilator in-
tion only for its proper functioning and/or for patient
tended to be connected to the patient or to the
safety.
breathing system.
2) To be published. (Revision of IS0 7767:1988)
@ IS0 IS0 10651=2:1996(E)
1.3.22 operator’s position: Intended orientation of
1.3.12 fresh gas: Gas supplied to the ventilator
the operator with respect to the equipment for normal
breathing system, excluding:
use according to the instructions for use.
a) air drawn through the emergency air intake port;
1.3.23 paediatric: Pertaining to an individual weigh-
b) air drawn through leaks in the ventilator breathing
ing between 5 kg and 40 kg.
system;
c) gas expired from the patient.
1.3.24 particulate filter: Device intended to reduce
bacteria content and particulate matter content of the
gas exhaust port: Port of the lung ventilator
1.3.13
gas stream.
from which gas is discharged to the atmosphere.
1.3.25 respiratory irregularity alarm: Alarm which
NOTE - See annex N, figure N.l b).
is activated when a cyclic change in a variable related
to the ventilation of the patient does not occur within
1.3.14 gas intake port: Port through which gas is a specified period of time.
drawn into the ventilator breathing system by the lung
ventilator or the patient.
1.3.26 ventilation (f) : Volume of gas per minute
entering or leaving the patient’s lungs.
NOTES
1 Gas may be supplied to the port at or near ambient
1.3.27 ventilator breathing system (VBS): Breath-
atmosphere or end-expiratory pressure, or the port may
ing system bounded by the connector to the inspira-
simply be left open to the atmosphere.
tory port, the patient connection port and, if provided,
2 See annex N.
the connector to the expiratory port.
1.3.15 high-pressure gas input port: Input port to NOTE - Attention is drawn to the definition of a breathing
which gas is supplied at a pressure greater than system in IS0 4135.
100 kPa.
1.3.28 maximum working pressure (pw max.):
Highest pressure that can be attained at the patient
1.3.16 home care ventilator: Ventilator suitable for
connection port during the inspiratory phase, irrespec-
domiciliary ventilation of a patient without continuous
tive of the setting of controls other than any control
professional supervision.
intended to adjust this pressure with the ventilator
working normally.
1.3.17 inflating gas: Fresh gas which powers the
ventilator.
NOTE - Even if not adjustable, this maximum may be
less than the maximum limited pressure
1.3.18 manual ventilation port: Port of the venti-
lator to which a device may be connected for manual
1.4 General requirements
inflation of the lungs.
The general requirements given in clause 3 of
NOTE - See annex N.
IEC 601-I :I 988 apply, with the following addition.
NOTE - All parts of the ventilator should be designed
1.3.19 maximum limited pressure Iplim max.):
and manufactured to minimize health risks due to sub-
Highest pressure measured at the patient connection
stances leached or leaking from the device during use.
port which can be attained in the ventilation breathing
system during normal use and under single-fault con-
3.6 j) Applicable single-fault conditions are
dition.
short- and open-circuits of components or
a)
wiring which can
1.3.20 minimum
limited pressure (Pjim min.):
Lowest (most negative) pressure measured at the
- cause sparks to occur, or
patient connection port which can be attained in the
- increase the energy of sparks, or
ventilation breathing system during normal use and
under single-fault condition.
- increase the temperature (see section 7);
b) incorrect output resulting from software error.
X3.21 neonatal: Pertaining to an individual weigh-
ing less than 5 kg.
NOTE -
See also 54.1.
0 IS0
IS0 10651=2:1996(E)
be marked in ki lopascals (kPa) and the maximum
3.6 k) An oxidant leak which remains undetected
by e.g. an alarm or periodic inspection shall be flowrate in litres per menu te (l/min).
considered a normal condition and not a single-fault
condition.
6.1 ac) If operator-accessible ports are provided,
they shall be marked. The following marking terms
3.6 I) Illumination of 215 lux shall be provided.
shall be used at least in the national language or
Measurement of ambient illumination shall be
English. Alternatively, symbols may be used and
made from the control panel toward the test sub-
explained in the instructions for use.
ject. Test operator shall have vision of 1, corrected
if necessary.
1) Driving gas input port: the words “DRIVING
GAS INPUT”;
2) emergency air intake port: the words
1.5 General requirements for tests
“WARNING: EMERGENCY AIR INTAKE - DO
The requirements given in clause 4 of IEC 601-I :I 988 NOT OBSTRUCT”;
apply*
3) gas output port: the words “GAS OUTPUT”;
4) gas return port: the words “GAS RETURN”;
1.6 Classification
5) gas exhaust port: the words “EXHAUST”
The requirements given in clause 5 of IEC 601-I :I 988
apply 9
If the volume of gas discharged from the ex-
haust port is either more or less than the
NOTE - A ventilator may have applied parts of different
expired volume, mark additionally the words
types.
“NOT FOR SPIROMETER”.
6.1 ad) The ventilator shall be durably and legibly
1.7 Identification, marking and
marked with the following, as far as applicable:
documents
1) any particular storage and/or handling instruc-
The requirements given in clause 6 of IEC 601-I :I 988 tions;
apply, with the following additions and modifications.
2) any particular instructions for use;
6.1 e) Amend existing IEC 601-I :I 988 text to
3) any particular warnings and/or precautions
read:
relevant to the immediate operation of the
ventilator;
The name and address of the manufacturer and/or
authorized representative, as applicable, shall also
4) warning statements to the effect that the
be marked.
ventilator shall:
- not be covered or locate d so that t he ve nti-
6.1 j) Amend existing IEC 601-I :I 988 text to read:
lation of the ventilator is impeded and
The power input marking required in 6.1 j) of
- not be operated immediately following
IEC 601-I :I988 shall be given, as well as the sum
storage or transport outside the recom-
of the current ratings for the ventilator and the
mended operating conditions.
specific auxiliary mains socket outlets.
NOTE - If the size of the home care ventilator does
not permit the complete marking as specified through-
After 6.1 z) add the following:
out subclause 6.1, at least the following should be
marked on the home care ventilator:
6.1 aa) All operator-accessible flow-direction-
sensitive components of the home care ventilator - the name of the manufacturer;
shall be permanently marked with a clearly legible
- a serial or lot or batch identifying number;
arrow indicating the direction of flow.
- symbol 14 in table DI of IEC 601-I :I 988.
6.1 ab) Any high-pressure gas input port shall be
marked with the name or symbol of the intended
6.1 ae) Packages containing breathing attach-
gas in accordance with IS0 5359, the range of
ments or other ventilator components intended for
supply pressures and the maximum flow require-
single use shall be clearly marked with the follow-
ment (see 6.8.3 a) 5). The maximum pressure shall
ing, as far as applicable:
0 IS0 IS0 10651=2:1996(E)
time shall also be specified under the con-
a description of the contents;
ditions stated by the manufacturer. The man-
2) the words “SINGLE USE”, or the symbol
ner of connection to the ventilator shall be
No. 1051 given in IS0 7000;
described and also how automatic switchover
can be achieved when the primary power
3) the word “STERILE” or “NON-STERILE”;
supply falls below the required level.
4) the name and/or trademark of the manufac-
Any electrically powered ventilator, whether or
turer and/or supplier;
not it has an internal reserve battery, should
have the capability of operating from an exter-
5) an identification reference to the type, batch
nal reserve battery. The expected operating
and serial number;
time should be specified under the conditions
stated by the manufacturer, the means of
6) if applicable, packages containing ventilator
connection to the ventilator should be de-
components made of conductive materials
scribed, as should the manner in which auto-
shall be clearly marked with the word
matic switchover to an internal source can be
“CONDUCTIVE” or “ANTISTATIC”.
achieved when the external battery power
supply falls below the required level.
6.1 af) Packages containing breathing attach-
ments or other ventilator components intended for
2) A method of testing the following prior to con-
reuse shall be clearly marked with the following: nection of the breathing system to the patient.
a description of the contents;
a) High-pressure alarm/pressure-relief sys-
tem;
2) the name and/or trademark of the manufac-
turer and/or supplier;
b) respiratory irregularity alarm;
3) recommended methods of cleaning, disinfec-
NOTE - Examples of respiratory irregularity
tion and sterilization;
which may be detected are leaks or discon-
nections of breathing system attachments.
NOTE - Some breathing attachments may con-
tain these recommended methods in the instruc-
c) high and low oxygen concentration alarm
tions for use.
(if an oxygen monitor is supplied);
4) if applicable, packages containing ventilator
power failure alarm;
d)
components made of conductive materials
e) alternative or reserve power supply, if
shall be clearly marked with the word
applicable.
“CONDUCTIVE” or “ANTISTATIC”.
Packaging containing breathing attachments for
3) A check list for each ventilator which sum-
single-patient use or which are disposable shall be marizes the test procedures recommended by
clearly marked with the recommended duration of
the manufacturer which have to be performed
use. prior to use. The use of an electronic display
such as a CRT meets these requirements.
6.1 ag) If gas-specific colour coding of flow con-
4) The intended use of the ventilator (e.g. adult,
trols and flexible hoses is provided, it shall be in
neonatal, range of body weights).
accordance with IS0 32.
A
5) recommendation that an alternative means
of ventilation be available
6.8.2 a) Add the following text:
6) A list provided by the manufacturer of the
The instru ctions for use shall additionally include
ventilator of the applicable monitoring, alarm
followi ng:
the
and protection devices against hazards from
Expected operating time and conditions there- delivery of energy or substances to the patient
1)
by the ventilator; e.g. oxygen monitor when
for .
the home care ventilator is designed to deliver
If the ventilator has an internal power source,
oxygen concentration(s) above ambient.
a specification of the expected operating time
under conditions as stated by the manufac-
7) The statement that the operator will have to
turer. If the ventilator has no internal electrical
ensure that the inspiratory and expiratory re-
power source, the manufacturer shall specify
sistances, as measured in 56.16, are not
a suitable reserve power source which can be
exceeded when adding attachments or other
connected to the ventilator to provide at least
components or subassemblies to the breath-
1 h operating time. The expected operating
ing system.
0 IS0
IS0 10651=2:1996(E)
The purpose, type, range and sensing position
The manufacturer shall disclose the maximum 41
8)
achievable pressure at the patient connection of all measuring and display devices either in-
port under a single-fault condition. corporated into the ventilator or recommended
by the manufacturer for use with the venti-
A warning statement to the effect that, if
9)
lator.
class I equipment is used, the protective earth
of the domiciliary electrical installation shall be
Conditions under which any measured or dis-
5)
checked for safe and effective operation.
played flow, volume or ventilation is to be ex-
pressed (e.g. ATPD, BTPS) and the condition
Unless the home care ventilator is designed to
10)
and composition of gas in the corresponding
withstand radiated fields in excess of IO V/m,
sensor so that the display complies with the
the instructions for use shall additionally con-
accuracy requirements specified in 51.9. Un-
tain a warning statement to the effect that
less otherwise specified, parameters shall be
levels exceeding IO V/m may compromise
assumed to be expressed under ATPD con-
equipment safety.
ditions.
6.8.2 d) Add the following text:
For alarms used with the ventilator, a state-
6)
ment of their type, capabilities, principle of
The instructions for use shall contain requirements
alarm detection, and, if appropriate, suppres-
for cleaning of components, if applicable.
sion or delay of annunciation.
6.8.3 Add the following text to item a):
Internal volume of any breathing attachments
7)
or other components or subassemblies rec-
The technical description shall additionally include
ommended by the manufacturer to be placed
disclosure of all information necessary to check
between the patient connection port and the
that the ventilator is installed correctly and is in
patient. The manufacturer of these com-
safe and correct working order. It shall also specify
ponents shall disclose the test method on re-
the nature and frequency of maintenance oper-
quest.
ations necessary to ensure continuing safety and
correct operation. This information should be con-
Resistance, compliance and volume of the
8)
tained in the instructions for the use of the venti-
complete ventilator breathing system and/or
lator and of the accessory components. It shall
any breathing attachment or other com-
include the following information, as far as appli-
ponents or subassemblies, e.g. humidifier or
cable.
filter recommended by the manufacturer for
inclusion in the ventilator breathing system.
The following pressure information:
1)
maximum limited pressure (pjim max.); The inspiratory and expiratory resistances, as
-
measured in 56.16, shall be disclosed,
- range of values to which the maximum
working pressure can be set and the
Disclosure of the functional characteristics or
9)
means by which the maximum is assured
identification of operator-
manufacturer’s
(e.g. pressure cycling, pressure-limiting
detachable breathing system components,
pressure generation) and a statement
including particulate filter fitted or recom-
whether negative pressure is available in
mended.
the expiratory phase;
- minimum (subatmospheric) limited press-
Pneumatic diagram of the ventilator and a dia-
10)
ure (J9jir-n min.);
gram for each ventilator breathing system
either supplied or recommended by the manu-
- range of values to which the minimum
facturer.
(subatmospheric) working pressure can
be set and the means by which the mini-
Details of any restrictions on the sequence of
mum is assured. 11)
components within the ventilator breathing
Ranges of the following parameters:
a where such components are
system, e.g.
flow-direction-sensitive.
- cycling pressure;
- end expiratory pressure; Interdependence of controls, if applicable.
1 a
- delivere dc oncentration of oxygen, if ad-
Disclosure of accuracies and ranges of dis-
13)
justable controls on the ventilator.
bY
played values and calibrated controls.
Description of the means of triggering.
3)
IS0 10651=2:1996(E)
@ IS0
NOTE - Accuracies should be expressed in the 1.8 Power input
form of maximum zero error (bias), quoted in ap-
propriate units, plus a sensitivity error, quoted e.g.
The requirements given in clause 7 of IEC 601-I :I 988
as a percentage of the reading.
apply.
@ IS0
IS0 10651=2:1996(E)
Section 2: Environmental conditions
10.3 Operation under extreme conditions
2.1 Basic safety categories
The manufacturer shall declare how the ventilator
The requirements given in clause 8 of IEC 601-I :I 988
will respond as the environmental and supply con-
apply=
ditions are extended to the following limits,
changing one parameter at a time while other par-
ameters are maintained within normal limits:
2.2 Removable protective means
- ambient temperature range of + 5 “C to
+ 50°C;
The requirements given in 6.1 z) of IEC 601-l :I 988
- ambient relative humidity range of 10 % to
apply*
95 %;
- atmospheric pressure range of 60 kPa to
110 kPa (600 mbar to 1 100 mbar);
2.3 Environmental conditions
- supply voltage range of - 20 % to + 10 % of
declared nominal value;
The requirements given in clause 10 of IEC 601-I :I 988
- ambient temperature of + 45 “C combined
apply, with the following additions.
with 75 % relative humidity.
Outside the environmental and supply conditions
10.2.3 Electrical and pneumatic driving power
specified in clause 10.2 of IEC 601-l :1988, but
supplies
within the limits stated above, the ventilator shall
not cause a safety hazard to the patient or oper-
The ventilator shall continue to function within the
ator.
specified tolerances throughout the range of sup-
ply variation specified by the manufacturer (see
NOTE - The ventilator might continue to function
51.5).
outside the specified tolerances.
@ IS0 IS0 10651=2:1996(E)
Protection against electric shock hazards
Section 3:
3.6 Protective earthing, functional
3.1 General
earthing and potential equalization
The requirements given in clause 13 of IEC 601-I :1988
The requirements given in clause 18 of IEC 601-I :I 988
apply l
apply l
3.2 Requirements related to
3.7 Continuous leakage currents
classification
and patient auxiliary currents
The requirements given in clause 14 of IEC 601-I :I 988
The requirements given in clause 19 of IEC 601-I :I 988
apply* apply, with the following amendment.
19.4 Add the following text to item h).
3.3 Limitation of voltage and/or energy
See also annex M in this part of IS0 10651.
NOTE -
The requirements given in clause 15 of IEC 601-I :I 988
The patient leakage current shall be measured
apply l
from the machine outlet(s) and other parts which
are defined as applied parts for the purposes of
this part of IS0 10651. All parts of the same type
3.4 Enclosures and protective covers
shall be connected together electrically, with the
exception of parts connected to the protective
The requirements given in clause 16 of IEC 601-l :I 988
earth terminal which shall be tested separately
apply.
from parts not so connected.
3.8 Dielectric strength
3.5 Separation
The requirements given in clause 20 of IEC 601-I :I 988
The requirements given in clause 17 of IEC 601-I :I 988
apply l
apply*
@ IS0
IS0 10651=2:1996(E)
Section 4: Protection against mechanical hazards
4.1 Mechanical strength 4.5 Expelled parts
The requirements given in clause 21 of IEC 601-I :1988 The requirements given in clause 25 of IEC 601-l :I 988
apply*
apply l
4.2 Moving parts 4.6 Vibration and noise
The requirements given in clause 22 of IEC 601-I :1988 The requirements given in clause 26 of IEC 601-I :I 988
apply.
apply*
4.3 Surfaces, corners and edges 4.7 Pneumatic and hydraulic power
The requirements given in clause 23 of IEC 601-I :I 988 The requirements given in clause 27 of IEC 601-l :1988
apply. apply.
4.4 Stability in normal use 4.8 Suspended masses
The requirements given in clause 24 of IEC 601-I :I 988 The requirements given in clause 28 of IEC 601-I :I 988
apply* apply l
IS0 10651=2:1996(E)
@ IS0
Section 5: Protection against hazards from unwanted or excessive
radiation
5.5 Infrared radiation
5.1 X-radiation
The requirements given in clause 33 of IEC 601-l :I 988
The requirements given in clause 29 of IEC 601-l :I 988
apply*
apply.
5.6 Ultraviolet radiation
The requirements given in clause 34 of IEC 601-l :1988
5.2 Alpha, beta, gamma, neutron
apply l
radiation and other particle radiation
The requirements given in clause 30 of IEC 601-I :1988
5.7 Acoustical energy (including
apply*
ultrasonics)
The requirements given in clause 35 of IEC 601-l :1988
apply*
5.3 Microwave radiation
5.8 Electromagnetic compatibility
The requirements given in clause 31 of IEC 601-I :1988
apply* The requirements given in IEC 601-l-2:1 993 apply, with
the following modifications.
36.202.1) Replace the test voltages for ESD-test
by the test voltages specified by severity level 4 in
5.4 Light radiation (including lasers)
IEC 801-2:1991.
36.202.2.1 a) and b) Replace the level of 3 V/m
The requirements given in clause 32 of IEC 601-l :I 988
with 10 V/m.
apply*
@ IS0
IS0 10651=2:1996(E)
Protection against hazards of ignition of flammable
Section 6:
anaesthetic mixtures
6.1 Locations and basic requirements 6.4 Requirements and tests for category
AP equipment, parts and components
The requirements given in clause 37 of IEC 601-I :I 988
thereof
apply*
The requirements given in clause 40 of IEC 601-I :I 988
do not apply.
6.2 Marking, accompanying documents
The requirements given in clause 38 of IEC 601-I :I 988
do not apply.
6.5 Requirements and tests for category
APG equipment, parts and components
6.3 Common requirements for category
thereof
AP and category APG equipment
The requirements given in clause 41 of IEC 601-I :I 988
The requirements given in clause 39 of IEC 601-I :1988
do not apply.
do not apply.
@ IS0 IS0 10651-2:1996(E)
Section 7: Protection against excessive temperatures
and other safety hazards
continue to function within the tolerances specified
7.1 Excessive temperatures
by the manufacturer for normal-use conditions.
The requirements given in clause 42 of IEC 601-I :1988
44.7 Add the following text.
apply.
Ventilator breathing system attachments and sub-
assemblies intended for reuse shall be constructed
7.2 Fire prevention
so that they can be dismantled for cleaning, dis-
infection or sterilization.
The requirements given in clause 43 of IEC 601-l :I 988
apply, together with the following additions.
7.4 Pressure vessels and parts subject to
43.1 In order to reduce the risk to patients, other
pressure
persons or the surroundings due to fire, ignitable
material, under normal and single-fault conditions,
The requirements given in clause 45 of IEC 601-I :1988
shall not at the same time be subjected to con-
apply, with the following addition.
ditions in which
45 Add the following text to the first paragraph.
- the temperature of the material is raised to its
minimum ignition temperature, and
The requirements given in clause 45 of IEC 601-I :I 988
do not apply to the ventilator breathing system.
- an oxidant is present.
The minimum ignition temperature shall be deter-
mined in accordance with IEC 794 using the oxi-
7.5 Human errors
dizi’rrg conditions present under the normal and
single-fault conditions.
Not used.
Compliance is checked by determining the tem-
perature to which the material is raised under nor-
7.6 Electrostatic charges
mal and single-fault conditions.
Not used.
43.2 If sparking can occur under normal or single-
fault conditions, the material subjected to the en-
ergy dissipation of the spark shall not ignite under
7.7 Materials in applied parts in contact
the oxidizing conditions present.
with the body of the patient
Compliance is checked by observing if ignition oc-
Not used.
curs under the most unfavourable combination of
normal conditions with a single fault.
Interruption of the power supply
7.8
7.3 Overflow, spillage, leakage,
The requirements given in clause 49 of IEC 601-I :I 988
humidity, ingress of liquids, cleaning,
apply (see also 51.5), with the following additions.
sterilization and disinfection
Means shall be provided to prevent inadvertent op-
The requirements given in clause 44 of IEC 601-I :I 988
eration of the off-switch.
apply, with the following modifications.
49.5 Spontaneous breathing during power failure
44.3 Modify as follows.
The ventilator shall be designed so that under con-
During and after the test as specified in
ditions of power failure, either electrical or pneu-
clause 44.3 of IEC 601-I :I 988, the ventilator shall
matic, the patient can breathe spontaneously.
@ IS0
IS0 10651=2:1996(E)
During power failure, the resistance of the venti-
The ventilators shall be provided with means for a
reserve power supply (see also 6.8.2 a) 1). lator breathing system to inspiratory and expiratory
56.16
flows shall not exceed the value specified in
NOTE 1 The means could be, for example, an inte-
(see 10.3 of this part of IS0 10651).
grated reserve supply or connectors for an external
power supply.
NOTE 2 The design of the ventilator breathing system
should be such that, during failure, rebreathing is mini-
mized (i.e. one-way valves may be needed to prevent
inhalation of expired gas).
@ IS0
IS0 10651=2:1996(E)
Section 8: Accuracy of operating data and protection against
hazardous output
shall be accurate within fI (2 % of the full-scale
8.1 Accuracy of operating data
reading + 8 % of the actual reading).
The requirements given in clause 50 of IEC 601-I :I 988
Test for compliance by visual inspection and verifi-
apply, with the following addition.
cation of accuracy.
While the ventilator is in normal use, all displays of
measured values shall be within the manufac- 51.8 High-pressure alarm
turer’s disclosed range of accuracies when tested
A high-pressure alarm shall be provided. It shall
under the operating conditions given in subclauses
activate an audible signal when the inspiratory-
10.2.2 of IEC 601-l :1988 and 10.2.3 of this part of
pressure alarm level is reached after not more than
IS0 10651.
three consecutive breaths.
Subclauses 3.6 I) and 51.12 c) of this part of
It shall not be possible to set the alarm levels
IS0 10651 give requirements and test methods
relating to legibility of markings, controls and indi- above the maximum pressure achieved by the
pressure limitation as described in 51.6.
cators.
The alarm is tested during controlled ventilation of
the test lung (see figure 1 and table 1) and while
simulating relevant single-fault conditions. The
8.2 Protection against hazardous output
pressure at the patient connection port is meas-
ured.
The requirements given in clause 51 of IEC 601-l :1988
apply, with the following additions.
51.5 Power-failure alarm
I’/:
51.5.1 Electrical or pneumatic driving power
The ventilator shall have a power-failure alarm
which activates an audible alarm signal of at least
120 s duration if the electrical or pneumatic power
supply falls below the values specified by the
manufacturer.
Compliance shall be checked by simulating a drop
below the values specified by the manufacturer
(pneumatic and/or electrical) required for the
Key
specified purpose of use.
Ventilator
2 Volume measurement device to be tested
51.5.2 Alternative and reserve power supplies
3 Resistance to flow
If a switchover (automatic or manual) to an alterna-
4 Test lung
tive or reserve power supply has occurred, this
shall be indicated by an audible alarm.
5 Pressure sensor
6 Recorder (pressure as a function of time) with an
51.6 Pressure limitation
accuracy + 2 % of actual reading for verification of
accuracy of volume measurement device
The maximum pressure at the patient connection
7 Breathing system
port under normal use and single-fault condition
shall not exceed 8 kPa (80 cmH20) or 120 % of the
Location of the volume measurement device
NOTE -
maximum working pressure, whichever is greater.
(2) is arbitrary; it may be located elsewhere in the
breathing system (7).
51.7 Device for measuring respiratory pressure
Figure I - Typical configuration of test
A device shall be provided for measuring the res-
apparatus for measurement of expiratory
piratory pressure. The value read by the operator
volume
0 IS0
IS0 10651-2:1996(E)
51.10 Respiratory irregu larity a larm
Table 1 - Conditions for expiratory volume
measurements
A respiratory irregularity alarm shall be provided.
Test conditions shall be activated
An audible and visual signal
r
Adjustable parameter
when the measured variable deviates from the set
Adult use Paediatric use
I
breathing pattern
Tidal volume, VT (ml) as
measured by a pressure
- during controlled ventilation for more than 15 s,
sensor on the test lung
or
(VT = c x pw max.)
- during IMV (intermittent mandatory ventilation)
Respiratory cycle fre- 10
for more than 1 IMV cycle but not longer than
quency, f(min-1)
45 s, or
I/E ratio 112
- during spontaneous modes of ventilation for
or nearest or nearest
more than the period specified by the manu-
facturer.
Resistance to flow, R 0,5f 10 % 1+10%
(kPa+1 s-1)
A means for muting the auditory alarm signal shall
Isothermal compliance, C 30+5 Yo be provided.
(mI/kPa)
NOTE - Examples of a respiratory irregularity alarm
NOTE - The accuracies for C and R apply over the
are
entire range of measurements.
- breathing system integrity alarm, which provides
means to generate an alarm in the case of discon-
nection of the patient from the ventilator or other
loss of detivered volume;
51.9 Device for measuring expiratory voIhlsme
- apn,ea alarm, for intermittently controlled, assisted
or spontaneous modes of ventil&on, which pro-
A device for measuring either the expiratory or de-
vides means to generate an al!arm when: th.e
livered tidal volume shall be provided. The accuracy
p&ent’s breathing effort fails to appear within the
requirement is + 20 % of actual reading for the
de&red period of time.
range specified by the manufacturer.
51.11 Oxygen monitor and afarm
Test by visual inspection and verification of the ac-
curacy using the apparatus as outlined in figure 1
If the ventilator is provided with an oxygen mot+
and described below.
tor, it shall be in compliance with IS0 7767 and
shall have an oxygen concentration alarm with ad-
Adjustable parameters:
justable high and low alarm limits. An audible and
a) Tidal volume, VT, expressed in millilitres, on visual signal shall be generated when the alarm
the ventilator (1) by means of a pressure sen-
limits are exceeded.
sor (5) on the test lung (4)
NOTE - If the ventilator permits an inspiratory oxygen
VT = c x pw max. concentration above ambient level, an oxygen monitor
may be needed for measurement of the inspiratory oxy-
where
gen concentration.
C is the isothermal compliance, in
Compliance shall be tested by visual inspection and
milli I’itres per kilopascal;
functional testing via simulating oxygen concentra-
tions above and below the set alarm limits.
pw max. is the maximum working press-
ure, expressed in kilopascals.
51.12 Alarms
b) Z/E ratio adjusted to l/2 or nearest possible
value. The characteristics of any auditory alarm shall
a)
be disclosed by the manufacturer.
c) Respiratory cycle frequency, f(min-1).
b) Visual alarm indication shall comply with
d) Resistanceto flow, R (kPa+1-s1).
IS0 9703-I. Auditory alarms for use in the
home environment should be such that they
The accuracies for C and R apply over the entire
will allow nonprofessional home care providers
range of measurements.
to detect a home care ventilator limit violation.
A home care ventilator auditory alarm should
IS0 10651-2:1996(E)
not be masked by or confused with sounds 51.12.4 When an alarm is activated and when
the home. the condition causing the alarm has cleared,
tally found in
tYPi
the auditory signal shall be cancelled.
NOTE - Auditory alarms may comply with
IS0 9703-2. c) Visual indicators and their associated markings
and warnings integral to the ventilator that are
intended to be viewed from the operator’s
51.121 Means shall be provided to indicate
position.shall be clearly legible when tested as
the set points of adjustable alarms.
follows:
Place the test operator in the operator’s po-
51.12.2 The maximum time an auditory alarm
sition at a distance of 500 mm from the venti-
can be silenced shall be 120 s.
lator. The test is passed if the test operator
can correctly identify all controls and indi-
cators, verify all qualitative and quantitative
51.12.3 If the auditory alarm signal(s) can be
information, and read all warning statements
disabled by the operator, there shall be a visual
from that position.
indication that it has been disabled.

@ IS0
IS0 10651=2:1996(E)
Abnormal operation and fault conditions; environmental tests
Section 9:
9.2 Environmental tests
9.1 Abnormal operation and fault
conditions
The requirements given in clause 53 of IEC 601-I :I 988
apply*
The requirements given in clause 52 of IEC 601-l :1988
apply 9
@ IS0
IS0 10651=2:1996(E)
Section 10: Constructional requirements
nal unit, it shall be in accordance with
10.1 General
IS0 5359.
The requirements given in clause 54 of IEC 601-I :I 988
b) Ventilator breathing system connector
apply, with the following additions.
A ventilator breathing system connector, if
To facilitate data transfer capability between differ-
conical, shall be either a 15 mm or a 22 mm
ent monitoring devices, a BUS system for data
connector in accordance with IS0 5356-l.
transfer may be used.
cl Gas intake port connector
54.1 Arrangements of functions
A gas intake port connector, if provided, shall
not be compatible with connectors complying
A single-fault condition shall not cause a monitoring
with IS0 5356-l.
and/or alarm device as per section 51 and the cor-
responding ventilation control function to fail in
Emergency air intake port
d)
such a way that the monitoring function becomes
simultaneously ineffective and thus fails to detect
An emergency air intake port shall be provided
the loss of the monitored ventilator function.
and any connector shall not be compatible
with connectors complying with IS0 5356-l.
Test for compliance by simulation of a single-fault
condition and/or visual inspection.
NOTE - An emergency air intake port should be
designed so that it cannot easily be obstructed
when the ventilator is in use.
54.3 Protection against inadvertent adjustments
Inspiratory port connector (gas output port
e)
Means of protection against inadvertent adjust-
connector) and expiratoty port connector (gas
ments of cont
...