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

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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.
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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
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