ISO 5367:1991

INTERNATIONAL
STANDARD
5367
Third edition
1991-08-01
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Breathing tubes intended for use with
anaesthetic apparatus and ventilators
Tuyaux de veniilation destinh 3
W-e ufilis& avec des appareils
d ’anesth&ie et des ventilateurs
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Reference number
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ISO 5367:1991(E)

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ISO 5367:1991 (E)
Foreword
ISO (the international Organization for Standardization) is a worldwide
federation of national Standards bodies (ISO member bodies). The work
of preparing International Standards is normally carried out through ISO
technical committees. Esch member body interested in a subject for
which a technical committee has been established has the right to be
International organizations, govern-
represented on that committee.
mental and non-governmental, in liaison with ISO, also take part in the
work. ISO collaborates ‘closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an Inter-
national Standard requires approval by at least 75 % of the member
bodies casting a vote.
International Standard ISO 5367 was prepared by Technical Committee
ISO/TC 121, Anaesfhetic and respiratory equipment.
This third edition cancels and replaces the second edition
(ISO 5367:1985), of which it constitutes a minor revision.
Annex A forms an integral part of this International Standard. Annex B
is for information only.
0 ISO 1991
All rights reserved. No part of this publication may be reproduced or utilized in any form
or by any means, electronie or mechanical, including photocopying and microfilm, without
Permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 * CH-1211 Geneve 20 l Switzer land
Printed in Switzerland
ii

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Breathing tubes intended for use with anaesthetic apparatus
and Ventilators
3 Definitions
1 Scope
For the purposes of this International Standard, the
This International Standard specifies the basic re-
following definitions apply.
quirements for breathing tubes intended for use with
anaesthctic apparatus and most uentilators, humidi-
3.1 breathing tube: Non-rigid tube, usually corru-
fiers and nebulizers. lt also applies to breathing
tubes and Y-pieces supplied already assernbled and gated, used to convey qases and/or vapours be-
tween the anae&etic machine and/ot
to those supplied as components and assembled in
accordance with the manufacturer ’s instructions. humidifiers/nebulizers and/or some Ventilators.
Provision is made for breathing tubes having ends A breathing tube is usually described as having
NOTE 1
two en& and a body.
incorporating conical connectors or with plain ends
(either cylindrical or tapered).
3.2 Patient end: That end of the breathing tube
Breathing tubes for special purposes, such as those
which is intended to be connected to the Y-piece or
used with Ventilators having special compliance re-
other appropriate component near the Patient.
quirements, coaxial lumen tubes and paediatric
breathing tubes are outside the scope of this Inter-
3.3 machine end: That end of the breathing tube
national Standard.
which is intended to be connected to the anaesthetic
machine or Ventilator.
3.4 antistatic (conductive): Pertaining to breathing
2 Normative references
tubes and any integrally attached components with
electrical conductivity satisfying specified limits un-
The following Standards contain provisions which,
der the test conditions.
through reference in this text, constitute provisions
of this International Standard. At the time of publi-
3.5 non-conductive: Pertaining to breathing tubes
cation, the editions indicated were valid. All stan-
and any integrally attached components with insuf-
dards are subject to revision, and Parties to
ficient electrical conductivity to meet specified limits
agreements based on this International Standard
under the test conditions.
are encouraged to investigate the possibility of ap-
plying the most recent editions of the Standards in-
3.6 compiiance: Volurne added per unit pressure
dicated below. Members of IEC and ISO maintain
increase when gas is added to an enclosed space
registers of currently valid International Standards.
and that added volurne is expressed at the tern-
perature and humidity in that enclosed space and
ISO 468:1982, Surface roughness - Parameters, their
at an ambient atmospheric pressure.
and general rules for sp ecifying
values
requirem en ts .
3.7 Patient connection port: That opening at the
Patient end of a breathing System intended for con-
ISO 2882:1979, Rubber, vulcanized - Antistatic and
nection to a tracheal or tracheostomy tube connec-
conductive pr-oducts for hospital use -- Electrical re-
tor or adaptor, a face mask or a face mask
sistance limifs.
angle-piece.
ISO 53564 : 1987, Armsthefic and respirafory equip-
3.8 3-way breathing System connector (T- or Y-
ment - Conical connectors --- Part 1: Cones arid
piece): Tubular connector for use within a breathing
sockets.
1

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ISO 5367:1991 (E)
Patient connection port and two ports
System with a 7.1.2 The inside diameter of plain ends of breathing
for con nection to the breathing System. tubes that incorporate an internal ridqe, intended to
engage with the recess at the base oia 22 mm male
conical connector,
as shown in figure 3a) of
4 Design
ISO 5356~1:1987. shall he not less than’ 18 mm, ex-
cluding the ridge. Tbc, axial length shall be not less
Breathing tubes, whether of corrugated construction
than 26,5 mm, when measured in the unstretched
or otherwise, shall have either plain ends (cylindri-
condition.
cal or tapered) or assembled ends incorporating
conical connectors with
22 mm complying
7.1.3 When tested as described in A-3, plain ends
ISO 5356-1.
of breathing tubes shall not become detached from
the 22 mm male conicgl connector.
NOTES
2 A loop for suspending the tube may be provided near
7.2 Assembled ends
one of the ends.
When tested as described in A.4, the conical con-
3 The ends of breathing tubes may be constructed to
nector shali not become detached from the tube.
engage with the recess at the base of a 22 mm male
conical connector.
7.3 Breathing tubes permanently attached to
4 Recommendations for materials are given in
a Y-piece
annex 8.
lf breathing tubes intended for Single use are sup-
5 Dimensions plied in pah-s pertnanently attached to a Y-piece, the
Patient connectian port of that Y-piece shall be a
22 mm/15 mm maIe/femaIe coaxial conical connec-
5.1 Length
tor complying with ISO 5356-1.
The length of breathing tubes shall be designated
by their nominal overall length, expressed in me- 7.4 Freedom from leakage
tres, when measured in the unstretched condition.
The actual length shall be within 10 O/o of the desiq- For Single breathinq tubes and for breathinq tubes
\
nated length. supplied in pairs ~ermanqntly attached to ‘a non-
swivel Y-piece. when tested as descrihed in A.5,
there shall be no escape of air buhhles.
5.2 Inside diameter
NOTE 5 Requirements for leakage from breathing tubes
Except for smooth bore breathing tubes, the inside
attached to swivel Y-pieces are under consideration. lt is
diameter of the body of the tube shall be not less
intended to include thern in a future revision of this Inter-
than 18 mm. For smooth bore breathing tubes, the
national Standard.
inside of the tube body shall be not less than 15 mm.
There should be a smooth transition of the inside 8 Occlusion
surface between the body of the breathing tube and
the ends to minimize gas turbulente. When tested as described in A.6, the increase in
pressure at the point of application of the air flow
shall not exceed 1 kPa.
6 Resistance to flow
9 Information to be supplied by
When tested as described in A.2, the resistance to
the flow of air through a breathing tube shall not
manufactwer
exceed 100 Pa (1,0 cmH,O) per metre length of tube
at 60 Vmin.
9.1 The manufacturer shall, when requested, pr-o-
vide information to the user on the compliance of the
breathing tube.
7 Means of connection
NOTE 6 A suitable method for measuring compliance is
7.1 Plain ends
given in A.7.
7.1.1 The inside diarneter of plain ends of breathing The compli&ce of breatliing tubes varies according
tubes, excluding those specified in 7.1.2, shall be not to sterilkation processes, usage and storage con-
less than 18 mm and the axial length shall be not ditions. The cornpliance of a new tube at a pressure
less than 21 mm, when measured in the unstretched of 10 kPa (100 crnH,O) should not exceed 8 mI/kPa
condition. (0,8 ml/cmH,O) per metre le ’bgth of tube.
2

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ISO 5367:1991 (E)
9.2 For breathing tubes intended for re-use, the c) For bt-eathing tubes and integrally attached non-
manufact
...