ISO 8836:1997
(Main)Suction catheters for use in the respiratory tract
Suction catheters for use in the respiratory tract
Sondes d'aspiration pour les voies respiratoires
General Information
Relations
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 8836
Second edition
1997-11-15
Suction catheters for use in the respiratory
tract
Sondes d'aspiration pour les voies respiratoires
A
Reference number
ISO 8836:1997(E)
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ISO 8836:1997(E)
Contents
Page
1 Scope .1
2 Normative references .1
3 Definitions.1
4 Size designation and dimensions.2
5 Materials .3
6 Design .3
7 Performance requirements .4
8 Requirements for suction catheters supplied sterile.5
9 Marking.5
Annexes
A (normative) Test for security of construction .8
B (normative) Measurement of residual vacuum .9
C (informative) Guidance on design and materials .11
D (informative) Bibliography .12
© ISO 1997
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
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microfilm, without permission in writing from the publisher.
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Printed in Switzerland
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ISO ISO 8836:1997(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 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.
International Standard ISO 8836 was prepared by Technical Committee ISO/TC 121, Anaesthetic and
respiratory equipment, Subcommittee SC 2, Tracheal tubes and other equipment.
This second edition cancels and replaces the first edition (ISO 8836:1988), of which it constitutes a technical
revision.
It differs from ISO 8836:1988 in that it introduces a table of colour identification for use with suction
catheters and it no longer includes requirements for suction catheters made of rubber.
Annexes A and B form an integral part of this International Standard. Annexes C and D are for information
only.
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ISO 8836:1997(E) ISO
Introduction
This International Standard specifies dimensions and requirements for suction catheters for use in the
respiratory tract.
Size is designated by outside diameter which is important when selecting catheters, because of its
relationship to the ease with which the catheter can be passed through a tracheal or tracheostomy tube (see
ISO 5361 for details of requirements for tracheal tubes and tracheostomy tubes). Requirements for suction
catheters made of rubber have been deleted because they are no longer in general use.
Table 1 has been introduced in order to standardize the (optional) use of colour identification for
designating size of suction catheters. The sizes and colours listed in table 1 have been included as a result
of a survey of current practice by manufacturers of suction catheters. No attempt has been made to
standardize the colour identification of size designations not listed in table 1. Such tubes are permitted at
the manufacturer’s discretion.
Flammability of suction catheters, for example if flammable anaesthetics, electrosurgical units or lasers are
1)
used, is a well-recognized hazard that is addressed by appropriate clinical management, and is outside the
scope of this International Standard.
___________
1) See ISO/TR 11991
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INTERNATIONAL STANDARD ISO ISO 8836:1997(E)
Suction catheters for use in the respiratory tract
1 Scope
This International Standard specifies requirements for suction catheters made of plastic
materials and intended for use in suction of the respiratory tract.
Specialized suction catheters, e.g. those with more than one lumen, are excluded from the
scope of this International Standard. Angled-tip suction catheters (e.g. Coudé catheters) are not
considered to be specialized and are therefore included in the scope.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute
provisions of this International Standard. At the time of publication, the editions indicated were
valid. All standards are subject to revision, and parties to agreements based on this
International Standard are encouraged to investigate the possibility of applying the most recent
editions of the standards indicated below. Members of IEC and ISO maintain registers of
currently valid International Standards.
1
ISO 10993-1: — , Biological evaluation of medical devices - Part 1 : Guidance on selection of
tests
ISO 11607:1997, Packaging for terminally sterilized medical devices
EN 556 : 1994, Sterilization of medical devices - Requirements for medical devices to be labelled
‘STERILE’
3 Definitions
For the purposes of this International Standard, the following definitions apply.
3.1 adaptor: Specialized connector to establish functional continuity between otherwise
disparate or incompatible components.
3.2 connector: Fitting to join together two or more components. [ISO 4135]
3.3 eye: Lateral aperture near the patient end of the catheter. [ISO 4135]
3.4 machine end: That end of the catheter which is intended to be connected to a source of
vacuum. [ISO 4135]
1
To be published. (Revision of ISO 10993-1:1992)
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ISO 8836:1997(E) ISO
3.5 patient end: That end of the catheter which is intended to be inserted into the patient.
[ISO 4135]
3.6 residual vacuum: Negative pressure at the patient end of the suction catheter when the
vacuum control device is in the relief position.
3.7 shaft: Main part of the catheter which is of uniform outside diameter.
3.8 suction catheter: Flexible tube designed for introduction into a respiratory tract to
remove material by suction. [ISO 4135]
3.9 terminal orifice: Central opening of the patient end of the suction catheter.
3.10 tip: Extremity of the patient end of a catheter. [ISO 4135]
3.11 vacuum control device: Means provided at or near the machine end of a catheter to
control the flow of air and entrained material.
4 Size designation and dimensions
4.1 Size designation
4.1.1 The size of suction catheters shall be designated by the following:
a) the nominal outside diameter of the shaft, expressed in millimetres. It may
additionally be expressed in French (Charrière) gauge size;
b) the nominal shaft length, expressed in millimetres.
4.1.2 The size of the device may additionally be designated by use of colour identification at
the machine end. If a colour code is used it shall be in accordance with table 1 for the
designated sizes listed.
NOTE - Use and choice of colour identification for designated sizes not listed in table 1 are at the
manufacturer’s discretion.
Table 1 - Colour identification for designated size of suction catheter
Designated size
Colour identification
Nominal outside diameter French (Charrière)
mm size equivalent
1,67 5 grey
2,0 6 light green
2,5 7,5 pink
2,67 8 light blue
3,0 9 turquoise
3,33 10 black
4,0 12 white
4,67 14 green
5,0 15 brown
5,33 16 orange
6,0 18 red
6,67 20 yellow
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ISO ISO 8836:1997(E)
4.2 Dimensions
4.2.1 The outside diameter and the minimum inside diameter of suction catheters, excluding the
tip, shall be in accordance with table 2.
NOTE - For the purposes of this International Standard, the French (Charrière) gauge system of size (F) is
based on the outside diameter of the shaft gauged in steps of thirds of a millimetre (1 millimetre corresponds
to 3F); the French (Charrière) gauge size is not an SI unit. Size designation in millimetres facilitates matching
suction catheter outside diameter to the inside diameter of the tracheal or tracheostomy tube.
4.2.2 The minimum inside diameter at the tip shall be not less than 90 % of the inside diameter
specified in table 2.
4.2.3 The actual shaft length shall be the marked shaft length subject to a tolerance of ± 5 %.
Table 2 - Basic dimensions of suction catheters - Metric sizes
Designated size
Nominal outside French (Charrière) Outside diameter Minimum inside
diameter size equivalent tolerance diameter
mm mm
mm F or Ch
1,33 4 ±0,1 0,55
1,5 4,5 ±0,1 0,7
1,67 5 ±0,1 0,8
2 6 ±0,1 1,05
2,5 7,5 ±0,1 1,45
2,67 8 ±0,1 1,5
3 9 ±0,15 1,75
3,33 10 ±0,15 2
4 12 ±0,15 2,45
4,67 14 ±0,2 2,95
5 15 ±0,2 3,2
5,33 16 ±0,2 3,4
6 18 ±0,2 3,9
6,67 20 ±0,2 4,3
5 Materials
Suction catheters for use in the respiratory tract, in their ready-to-use state after any preparation
for use recommended by the manufacturer, shall satisfy appropriate biological safety testing, as
indicated in ISO 10993-1.
NOTE - It is recommended that the shaft be colourless and either transparent or translucent.
6 Design
6.1 Lumen
The inside diameter of the shaft at any point between the machine end and the eye nearest to the
machine end shall be not less than the inside diameter of the shaft at that eye.
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ISO 8836:1997(E) ISO
6.2 Patient end
6.2.1 The suction cathete
...
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