Suction catheters for use in respiratory tract

Sondes d'aspiration pour les voies respiratoires

General Information

Status
Withdrawn
Publication Date
14-Dec-1988
Withdrawal Date
14-Dec-1988
Current Stage
9599 - Withdrawal of International Standard
Start Date
05-Nov-1997
Completion Date
05-Nov-1997
Ref Project

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ISO 8836:1988 - Suction catheters for use in respiratory tract
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Standards Content (sample)

IS0
INTERNATIONAL STANDARD
8836
First edition
1988-12-01
Corrected and
reprinted
1989-02-15
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
ORGANISATION INTERNATIONALE DE NORMALISATION
MEXAYHAPOAHAR OPTAHM3AuMR no CTAHAAPTM3AL&iM
Suction catheters for use in the respiratory tract
Sondes d'aspiration pour les voies respiratoires
Reference number
IS0 8836 : 1988 (E)
---------------------- Page: 1 ----------------------
IS0 8836 : 1988 (E)
Contents Page

Foreword.. . .. . . . . . . .. . . . . . . . . . . . . . . . . . . . . . ... . .. . . . . . . . . . . . . . . . . . . .. . . iii

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv

1 Scope.. . ... . . . . ... . . . . .. . . . . . . . . .. . . . . . . . . . . . . . .. . . . . . . . . . . . . . . .. . . 1

2 Normative reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

3 Definitions . . .. . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

4 Dimensions and size designation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

5 Design . .... . . . . . .. . . . . . . . .................................. 2

6 Performance requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

7 Testmethods. ... . .. . . . . . . .. . . . . . . . . . . . . . .. . . .. . . . . . . . . . ... . . . . . . . . . . 4

8 Packaging . . . .. . . .. . . . . . . .. . . . . . . . . . . . . . .. . . . . . . . . . . . . . . .. . . . . . . . . . . 6

9 Marking ............................................................ 7
An nexes

A Recommendationsfor materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

B Recommendations for finish and design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

C Bibliography ........................................................ 9
@ International Organization for Standardization, 1988 0
Printed in Switzerland
---------------------- Page: 2 ----------------------
IS0 8836 : 1988 (El
Foreword

IS0 (the International Organization for Standardization) is a worldwide federation 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, govern-

mental 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 circulated to

the member bodies for approval before their acceptance as International Standards by

the IS0 Council. They are approved in accordance with IS0 procedures requiring at

least 75 % approval by the member bodies voting.
International Standard IS0 8836 was prepared by Technical Committee ISO/TC 121,
Anaesthetic and respiratory equipment.
Annexes A, B and C of this International Standard are for information only.
---------------------- Page: 3 ----------------------
IS0 IS0 8836 8836 : : 1988 1988 (E) (E)
Introduction Introduction

Suction Suction catheters catheters are are commonly commonly inserted inserted through through tracheal tracheal and and tracheostomy tracheostomy tubes tubes

(see (see IS0 IS0 5361-1, 5361-1, IS0 IS0 5361-2, 5361-2, IS0 IS0 5361-3, 5361-3, IS0 IS0 5361-4, 5361-4, IS0 IS0 5366-2 5366-2 and and IS0 IS0 7228). 7228).

The The need need for for this this International International Standard Standard arises arises from from the the considerable considerable international international

trade trade in in suction suction catheters; catheters; at at the the same same time time there there is is a a need need to to provide provide a a range range of of sizes sizes

which which will will prove prove acceptable acceptable for for clinical clinical purposes. purposes.

a a

Annex Annex A A gives gives recommendations recommendations for for materials materials and and annex annex B B gives gives recommendations recommendations

for for the the finish finish and and design design of of catheters. catheters. A A bibliography bibliography listing listing those those International International Stan- Stan-

dards dards referred referred to to for for information information is is given given in in annex annex C. C.

a a
iv iv
---------------------- Page: 4 ----------------------
INTERNATIONAL STANDARD IS0 8836 : I988 (E)
Suction catheters for use in the respiratory tract
1 Scope machine end : That end of the catheter which is in-
3.5
tended to be connected to a source of vacuum.
This International Standard specifies requirements for suction

catheters intended for use in suction of the respiratory tract. It NOTE - It may either incorporate a connector or have a conical

covers suction catheters that are supplied either sterile or non- expansion to facilitate the insertion of a connector.

sterile and those that are intended either for single use or to be
reused.
patient end : That end of the catheter which is intended
3.6
to be inserted into the patient.
2 Normative reference
3.7 shaft : That part of a suction catheter between the con-
nector or conical expansion at the machine end and the tip.
The following standard contains provisions which, through
reference in this text, constitute provisions of this International
Standard. At the time of publication, the edition indicated was
3.8 suction catheter : Flexible tube designed for intro-
valid. All standards are subject to revision, and parties to
duction into the respiratory tract to remove material by suction.
agreements based on this International Standard are encour-
aged to investigate the possibility of applying the most recent
tip : Extremity of the patient end.
3.9
editions of the standard indicated below. Members of IEC and
IS0 maintain registers of currently valid International Stan-
dards. 3.10 vacuum control device : Means provided at the
machine end of the catheter to control the flow of air and en-
IS0 468 : 1982, Surface roughness - Parameters, their values trained material.
and general rules for specifying requirements.
3 Definitions
4 Dimensions and size designation
For the purposes of this International Standard, the following
definitions apply.
4.1 Dimensions
The outside diameter and the minimum inside diameter of
3.1 adaptorl) : Specialized connector to establish functional
suction catheters shall be as given in table 1 or table 2, as
continuity between otherwise disparate or incompatible com-
appropriate.
ponents.
NOTE - For the purposes of this International Standard, the Charrière
3.2 connectorl) : Fitting to join together two or more com-
gauge system of size is based on the outside diameter of the shaft
ponents.
gauged in steps of thirds of a millimetre; the Charrière gauge size is not
an SI unit. It is anticipated that the use of suction catheters manufac-
tured in Charrière sizes will decline in the future and the use of metric
3.3 effective length : Length of the shaft.
size catheters will become prevalent. It is therefore intended to revise
this International Standard five years after its publication to delete
reference to the Charrière gauge sizes.
3.4 eye : Aperture in the patient end of the catheter.
1) Definitions taken from IS0 4135.
---------------------- Page: 5 ----------------------
IS0 8836 : 1988 (E)
Table 1 - Basic dimensions of suction catheters - Metric sizes
Dimensions in millimetres
Outside diameter
Minimum inside diameter
I tol. Charrière
size
Plastics Plastics
equivaientl)
Rubber Rubber
materials
materials
I 0,l f 0,15 4,5 F 03 0,4
2 f 0,l f 0,15 6F 1 ,O5 03
f 0,l I 0,25 7.5 F 1,45 1,l
3 I 0,15 f 0,25 91; 1,75 1,4
4 I 0.15 f 0,25 12F 2,45 281
5 I 0,2 f 0,25 15F 32 2,7
6 f 0,2 f 0.25 18F 3,9 3,4
Table 2 - Basic dimensions of suction catheters - Charrière sizes
Dimensions in millimetres
Outside diameter
I Minimum inside diameter
tol.
Charrière
sizel) Plastics
Plastics
I Rubber 1 I Rubber
materials materials
I 0.1
4F 1,32 - 0,55 -
5F 1,67
* 0,l I 0,15 03 0.4
6F 2 f 0,l f 0,15 1 ,O5 03
8F 2,67 f 0.1 f 0,25 1,s 1.2
10 F 3,33 f 0,15 f 0,25 2 1,7
12F 4 f 0,15 f 0,25 2,45 281
14 F 4,7 f 0,2 I 0,25 2,95 23
16 F 5,33 f 0,2 I 0,25 3,4 3
18F 6 f 0,2 f 0,25 3,9 3.4
4.2 Size designation 5 Design
The size of suction catheters shall be designated by the follow-
5.1 Lumen
ing characteristics :
The inside diameter of the shaft at any point between the
a) the outside diameter of the shaft, expressed in
machine end and the eye nearest to the machine end shall be
millimetres;
not less than the inside diameter of the shaft at that eye.
b) the nominal effective length, expressed in millimetres,
5.2 Patient end
with a tolerance of f 5 %.
The catheter shall have a terminal orifice and one or more eyes.
The size shall be expressed according to the following desig-
nation example :
NOTE - The dimensions of an eye or eyes should be such that they do
not cause the suction catheter to kink or collapse in use.
6 mm (18 F) x 500 mm
5.3 Machine end
6 mm (18 Ch) x 500 mm
5.3.1 The machine end of the suction catheter shall be either
NOTE - For recommendations regarding the appropriate size of suc-
a) female (see 5.3.2) - designed to receive a male-to-male
tion catheter, attention is drawn to the following article : ROSEN, M.
adaptor suitable for connection to a vacuum source that ter-
and "LARD, E.K., The use of suction in clinical medicine, Br. J.
Anaesth., 32, 1960 : pp. 486-504. minates in a female end; or
---------------------- Page: 6 ----------------------
IS0 8836 : 1988 (E)

b) male (see 5.3.3) - designed for connection to a NOTE - A means may be provided near the machine end to facilitate

control of the vacuum by the operator.
vacuum source that terminates in a female end.
5.3.4 The machine end of a suction catheter having an
5.3.2 Female ends shall be semi-rigid or elastomeric and shall
angulated patient end shall, by a mark or other means, indicate
be either conical or cylindrical over a length of not less than
the direction in which the tip points.
25 mm (see figure 1). When tested in accordance with 7.1, the
female end shall not part from the test connector.
NOTE - In the event of a female end to the suction catheter and a
5.4 Shaft
female end to the vacuum source, a male-to-male adaptor is needed
(see figure 1). The minimum inside diameter should be not less than
When the machine end of the suction catheter is connected to
the minimum inside diameter of the suction catheter.
a vacuum source at 40 kPa (300 mmHg) below ambient
pressure for 15 s at a temperature of 23 OC f 2 OC with the
5.3.3 Male ends shall be rigid or semi-rigid and shall fit inside
patient end occluded and, if present, the vacuum control

elastomeric tubing having an inside diameter of 6 mm (see device occluded, the shaft shall not collapse.

1).
figure
Example of female connectors
to fit a male test connector
complying with figure 2
,25 mm min.
Alternatives
Example of male connector
with vacuum control device
to fit inside elastomeric
tubing having an inside
diameter of 6 mm
Example of a male-to-male adaptor to fit inside
elastomeric tubing having an inside diameter of 6 mm

NOTE - The figure is intended to illustrate essential features of a suction catheter but does not otherwise form part of the requirements specified in

this international Standard.
Figure 1 - Example of a suction catheter for use in the respiratory tract
---------------------- Page: 7 ----------------------
IS0 8836 : 1988 (E)
7.1.3.2 Ensure that the female end of the catheter and the test
6 Performance requirements
connector are clean and dry.
6.1 Security of construction
7.1.4 Test procedure
When tested in accordance with 7.2, the force required to

detach any component bonded to the shaft shall be not less 7.1.4.1 Fit the appropriate test connector (7.1.2.1) into the

female end to a depth of engagement of, or exceeding, 10 mm
than that specified in table 3.
(i.e. up to, or beyond, the mark circumscribed on the
connector).
Table 3 - Minimum force needed to detach any
component bonded to
...

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