Suction catheters for use in the respiratory tract

Sondes d'aspiration pour les voies respiratoires

General Information

Status
Withdrawn
Publication Date
05-Nov-1997
Withdrawal Date
05-Nov-1997
Current Stage
9599 - Withdrawal of International Standard
Start Date
29-Aug-2007
Completion Date
29-Aug-2007
Ref Project

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ISO 8836:1997 - Suction catheters for use in the respiratory tract
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INTERNATIONAL ISO
STANDARD 8836
Second edition
1997-11-15
Suction catheters for use in the respiratory
tract
Sondes d'aspiration pour les voies respiratoires
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

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 • CH-1211 Genève 20 • Switzerland
Internet central@iso.ch
X.400 c=ch; a=400net; p=iso; o=isocs; s=central
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.
iii
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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

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.

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]
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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