ISO 5367:2000
(Main)Breathing tubes intended for use with anaesthetic apparatus and ventilators
Breathing tubes intended for use with anaesthetic apparatus and ventilators
Tuyaux de ventilation destinés à être utilisés avec des appareils d'anesthésie et des ventilateurs
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 5367
Fourth edition
2000-06-01
Breathing tubes intended for use with
anaesthetic apparatus and ventilators
Tuyaux de ventilation destinés à être utilisés avec des appareils
d'anesthésie et des ventilateurs
Reference number
ISO 5367:2000(E)
©
ISO 2000
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ISO 5367:2000(E)
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ii © ISO 2000 – All rights reserved
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ISO 5367:2000(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 General requirements.3
4.1 Re-usable breathing tubes.3
4.2 Materials .3
4.3 Design .3
4.4 Length.3
4.5 Resistance to flow .3
4.6 Means of connection .4
4.7 Leakage.5
4.8 Increase in flow resistance with bending.5
4.9 Compliance.5
5 Prevention of electrostatic charges.5
6 Requirements for breathing tubes supplied sterile .5
6.1 Sterility assurance.5
6.2 Packaging of breathing tubes supplied sterile.5
7 Marking .6
7.1 General.6
7.2 Marking of breathing tubes intended for re-use.6
7.3 Marking of packages .6
7.4 Expression of rated flow .7
8 Information to be supplied by the manufacturer.7
Annex A (normative) Measurement of resistance to air flow .8
Annex B (normative) Test for security of attachment of plain end to appropriately-sized male conical
connector.10
Annex C (normative) Test for security of attachment of adaptor to breathing tube.11
Annex D (normative) Test for leakage.12
Annex E (normative) Test for increase in flow resistance with bending.14
Annex F (normative) Test for compliance .15
Annex G (informative) Recommendations for materials and design.16
Bibliography.17
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ISO 5367:2000(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. 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 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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 5367 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 2, Tracheal tubes and other equipment.
This fourth edition cancels and replaces the third edition (ISO 5367:1991), which has been technically revised. This
edition differs from the previous edition primarily in that all sizes of breathing tubes are included and that each tube is
required to be marked with the rated flow that the manufacturer claims can be achieved without exceeding specified
limits for resistance.
Annexes A, B, C, D, E and F form a normative part of this International Standard. Annex G is for information only.
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ISO 5367:2000(E)
Introduction
This International Standard is one of a series dealing with anaesthetic and respiratory equipment. It is primarily
concerned with basic requirements for breathing tubes. Breathing tubes are characterized by the rated flow that a
manufacturer claims can be achieved without exceeding specified limits for resistance. The requirements also include
means of connection and several test methods, some of which have not been included in earlier editions of this
International Standard.
This International Standard includes requirements for both single-use and re-usable breathing tubes. Re-usable
breathing tubes are intended to comply with the requirements of this International Standard for the recommended
product life.
Certain tests are performed under constant pressure to simplify the test methodology. It is recognized that this does not
reflect clinical use, when pressure is (only) intermittent and peak pressures occur for short periods. The limits set in the
test methods take this into account. Whilst such test methods do not address product variability, the limits set also take
this into account.
Recommendations for materials and design are given in annex G.
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INTERNATIONAL STANDARD ISO 5367:2000(E)
Breathing tubes intended for use with anaesthetic apparatus and
ventilators
1 Scope
This International Standard specifies basic requirements for antistatic and non-antistatic breathing tubes and breathing
tubing supplied to be cut to length, intended for use with anaesthetic apparatus and ventilators, humidifiers and
nebulizers. It also applies to breathing tubes and Y-pieces supplied already assembled and to those supplied as
components and assembled in accordance with the manufacturers' instructions.
Provision is made for breathing tubes having ends incorporating adaptors with conical connectors (assembled ends) or
with plain ends (either cylindrical or tapered).
Breathing tubes for special purposes, such as those used with ventilators having special compliance requirements and
coaxial lumen tubes, are outside the scope of this International Standard.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 468, Surface roughness — Parameters, their values and general rules for specifying requirements.
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing.
ISO 11607, Packaging for terminally sterilized medical devices.
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety.
EN 556:1994, Sterilization of medical devices — Requirements for medical devices to be labelled “STERILE”.
3 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply.
3.1
APL valve
adjustable pressure-limiting valve
pop-off valve
pressure-limiting valve which releases gas over an adjustable range of pressures
[ISO 4135]
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ISO 5367:2000(E)
3.2
breathing tube
non-rigid tube used to convey gases and/or vapours between components of a breathing system
[ISO 4135]
3.3
adaptor
specialized connector to establish functional continuity between otherwise disparate or incompatible components, one
end of which is intended to be inserted into the end of a breathing tube, the other end having a conical connector
complying with ISO 5356-1
3.4
assembled end
end of a breathing tube incorporating an adaptor
3.5
plain end
end of a breathing tube designed to fit directly over a male conical connector complying with ISO 5356-1
3.6
patient end
that end of the breathing tube which is intended to be connected to the Y-piece or other appropriate component
near the patient
3.7
machine end
that end of the breathing tube which is intended to be connected to the anaesthetic workstation, ventilator or other
breathing attachment furthest from the patient
3.8
anti-static
property of breathing tubes and any integrally attached components with electrical conductivity satisfying specified
limits under the test conditions
3.9
compliance
volume added per unit pressure increase when gas is added to an enclosed space, expressed at the temperature and
humidity of that enclosed space and at an ambient atmospheric pressure
[ISO 4135]
3.10
patient connection port
that opening at the patient end of a breathing system intended for connection of a device such as a tracheal or
tracheostomy tube connector, a face mask, a laryngeal mask airway or a cuffed oropharyngeal airway
[ISO 4135]
3.11
3-way breathing system connector
Y-piece
tubular connector with three ports, one of which is a patient connection port
[ISO 4135]
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ISO 5367:2000(E)
3.12
swivel 3-way breathing connector
swivel Y-piece
specialized three-way connector which allows variation in the position of its three ports relative to each other
[ISO 4135]
3.13
rated flow
flow that the manufacturer claims results in an increase in pressure of not more than that specified in 4.5.1 or 4.5.2,
as appropriate
4 General requirements
4.1 Re-usable breathing tubes
Re-usable breathing tubes shall comply with the requirements of this International Standard throughout the
recommended product life as specified in 8.2.
4.2 Materials
Breathing tubes, in their ready-for-use state after any preparation recommended by the manufacturer, shall satisfy
appropriate biological safety testing, in accordance with ISO 10993-1.
NOTE Recommendations for materials are given in annex G.
4.3 Design
Breathing tubes, whether of corrugated construction or otherwise, shall have plain ends (cylindrical or tapered) and/or
assembled ends incorporating 22 mm or 15 mm conical connectors complying with ISO 5356-1.
NOTE 1 A loop for suspending the tube may be provided near one of the ends.
NOTE 2 The ends of breathing tubes may be constructed to engage with the recess at the base of a 22 mm male conical
connector.
NOTE 3 Recommendations for design are given in annex G.
4.4 Length
4.4.1 The length of breathing tubes shall be designated by their nominal overall length, expressed in metres,
when measured in the resting condition (without being held under tension), lying on a horizontal surface. Breathing
tubes intended to be extended when used shall be designated by both the unextended and extended lengths.
4.4.2 The designated length of breathing tubes provided integrally attached to a Y-piece shall include the length
of the Y-piece and any assembled ends.
4.4.3 The actual length shall be within 10 % of the designated length.
4.5 Resistance to flow
4.5.1 The manufacturer shall determine the rated flow to be marked.
4.5.2 When a breathing tube supplied ready for use (with assembled ends and Y-piece, if provided) is tested in
accordance with annex A using the rated flow marked by the manufacturer [see 7.2 d) and 7.3 d)], the increase in
pressure shall not exceed 0,2 kPa.
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ISO 5367:2000(E)
4.5.3 When breathing tubing supplied to be cut to length is tested in accordance with annex A using the rated
flow marked by the manufacturer [see 7.2 e) and 7.3 e)], the increase in pressure shall not exceed 0,1 kPa per
metre length of tubing.
4.6 Means of connection
4.6.1 Plain ends of tubes
4.6.1.1 The axial length (l ) of plain ends of breathing tubes [see Figure 1 a)], excluding those specified in
1
4.6.1.2, shall be not less than 21 mm for breathing tubes intended to engage with 22 mm male conical connectors
or not less than 14 mm for breathing tubes intended to engage with 15 mm male conical connectors.
4.6.1.2 The axial length (l ) of plain ends of breathing tubes that incorporate an internal ridge [see Figure 1 b)],
2
intended to engage with the recess at the base of a 22 mm male conical connector as specified in ISO 5356-1,
shall be not less than 26,5 mm.
4.6.1.3 When tested as described in annex B, plain ends of breathing tubes shall not become detached from
the appropriate male conical connector at a force of less than 40 N.
Figure 1 — Axial length of plain end of breathing tube
4.6.2 Adaptor
The end of the adaptor that is not intended for attachment to the breathing tube shall have a 22 mm or 15 mm conical
connector complying with ISO 5356-1.
4.6.3 Assembled end
When tested as described in annex C, the adaptor shall not become detached from the tube at a force of less than
45 N.
NOTE For the purpose of this requirement, a Y-piece provided integrally attached to a breathing tube is regarded as an
adaptor.
4.6.4 Breathing tubes integrally attached to a Y-piece
If breathing tubes are supplied in pairs integrally attached to a Y-piece, the patient connection port of that Y-piece shall
be a 22 mm male/15 mm female coaxial or 15 mm female conical connector complying with ISO 5356-1.
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ISO 5367:2000(E)
4.7 Leakage
4.7.1 When tested in accordance with annex D, breathing tubing supplied to be cut to length shall not leak at a
–1
rate of more than 10 ml·min per metre length of tubing.
Care should be taken when performing the test to exclude the possibility of leaking between the tubing and the
apparatus.
4.7.2 When tested in accordance with annex D, single breathing tubes shall not leak at a rate of more than
–1
25 ml·min .
4.7.3 When tested in accordance with annex D, breathing tubes supplied in pairs integrally attached to a
–1
non-swivel Y-piece, shall not leak at a rate of more than 50 ml·min .
4.7.4 Breathing tubes with integrally attached specialized adaptors, e.g. a swivel Y-piece, shall either:
–1
a) not leak at a rate of more than 50 ml·min when tested in accordance with annex D, or
b) be marked with the leakage rate determined in accordance with annex D [see 7.2 f) and 7.3 f)].
4.7.5 Breathing tubes marked in accordance with 4.7.4 b) shall have a marked leakage rate of not more than
–1
150 ml·min .
4.7.6 The actual leakage rate of br
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