oSIST prEN ISO 8836:2026

SLOVENSKI STANDARD
01-maj-2026
Anestezijska in dihalna oprema - Aspiracijski katetri za čiščenje dihalnih poti
(ISO/DIS 8836:2026)
Anaesthetic and respiratory equipment - Suction catheters for use in the respiratory tract
(ISO/DIS 8836:2026)
Beatmungs- und Anästhesiegeräte - Absaugkatheter zur Verwendung im Atemtrakt
(ISO/DIS 8836:2026)
Matériel d’anesthésie et de réanimation respiratoire - Sondes d’aspiration pour les voies
respiratoires (ISO/DIS 8836:2026)
Ta slovenski standard je istoveten z: prEN ISO 8836
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 8836
ISO/TC 121/SC 2
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Suction catheters for
Voting begins on:
use in the respiratory tract
2026-03-03
ICS: 11.040.10; 11.040.25
Voting terminates on:
2026-05-26
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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BEING ACCEPTABLE FOR INDUSTRIAL,
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
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POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 8836:2026(en)
DRAFT
ISO/DIS 8836:2026(en)
International
Standard
ISO/DIS 8836
ISO/TC 121/SC 2
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Suction catheters for
Voting begins on:
use in the respiratory tract
ICS: 11.040.10; 11.040.25
Voting terminates on:
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
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POTENTIAL TO BECOME STANDARDS TO
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NATIONAL REGULATIONS.
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TO SUBMIT, WITH THEIR COMMENTS,
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 8836:2026(en)
ii
ISO/DIS 8836:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
5 Materials . 3
6 Design requirements . 3
6.1 General .3
6.2 *Size designations and dimensions .3
6.3 Suction catheter tip .4
6.4 *Suction catheter connector .5
6.5 Additional requirements for closed suction catheters .6
6.5.1 General design .6
6.5.2 Closed suction catheter manifold and connectors .7
6.5.3 Protective sleeve . .8
6.5.4 *Suction control device .8
6.5.5 Flushing system .9
6.5.6 T-piece port .9
6.6 Performance requirements .9
6.6.1 Security of construction .9
6.6.2 Shaft performance .10
6.6.3 Suction control device performance .10
6.6.4 *Leakage .10
6.6.5 *Resistance to flow .10
7 Requirements for suction catheters supplied sterile .10
8 Packaging.11
9 Information supplied by the manufacturer .11
9.1 General .11
9.2 Marking .11
9.3 Instructions for use . 12
Annex A (informative) Rationale .13
Annex B (normative) Test method for security of attachment .16
Annex C (normative) Measurement of residual vacuum . 17
Annex D (normative) *Method of testing leakage .20
Annex E (informative) Hazard identification for risk assessment .21
Bibliography .23

iii
ISO/DIS 8836:2026(en)
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.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 2, Airway devices and related equipment.
This sixth edition cancels and replaces the fifth edition (ISO 8836:2019), which has been technically revised.
The main changes compared to the previous edition are as follows:
— The second edition of ISO 18190 (ISO 18190:2025) is now referenced, with removal of requirements that
are now found in that document (evaluation of bicompatibility in accordance with ISO 18562-1).
— Terms defined in ISO 14971 have been removed from this document.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
ISO/DIS 8836:2026(en)
Introduction
This document is concerned with the basic requirements and method of size designation of both open and
closed suction catheters made of flexible materials.
The method of describing tube dimensions and configuration has been devised in order to assist clinicians in
the selection of the most suitable suction catheter for a particular patient. The size designation is important
when selecting a catheter because of its relationship to the ease with which the catheter can be passed
[1] [2]
through a tracheal EN ISO 5361 or tracheostomy tubeISO 5366 .
Throughout this document the following print types are used:
— Requirements and definitions: roman type;
— Conformance checks and test specifications: italic type;
— Informative material appearing outside of tables, such as notes, examples and references: smaller type.
The normative text of tables is also in smaller type;
— defined terms: italics.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex A.

v
DRAFT International Standard ISO/DIS 8836:2026(en)
Anaesthetic and respiratory equipment — Suction catheters
for use in the respiratory tract
1 Scope
This document specifies dimensions and requirements for both open and closed suction catheters made of
flexible materials and intended for use in suctioning of the respiratory tract through an airway device.
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical
equipment are not covered by this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 5361:2023, Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5367:2023, Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 18190:2025, Anaesthetic and respiratory equipment — General requirements for airways and related
equipment
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for
intravascular or hypodermic applications
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135, ISO 14971, ISO 18190 and
the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
*closed suction catheter
suction catheter (3.11) enclosed within a protective sleeve (3.8) that allows its use within the airway without
[3]
opening the ventilator breathing system (VBS) (3.17) directly to atmosphere ISO 4135:2022 3.10.3.2
3.2
*closed suction catheter manifold
[3]
part of the closed suction catheter (3.1) that provides a connection to an airway device ISO 4135:2022
3.10.3.3
3.3
connector
[3]
fitting to join together two or more componentsISO 4135:2022 3.1.4.5

ISO/DIS 8836:2026(en)
3.4
eye
side hole near the patient end (3.6) of the suction catheter (3.11)
3.5
machine end
that end of the catheter which is intended to be connected to suction tubing
3.6
patient end
[3]
the end of the suction catheter (3.11) which is intended to be inserted into a patientISO 4135:2022 3.1.4.42
3.7
patient connection port
[3]
opening intended for connection to an airway device ISO 4135:2022 3.1.4.41
3.8
protective sleeve
flexible barrier that encloses the suction catheter (3.11)shaft (3.10) to prevent contact with the user while
connected to the ventilator breathing system (VBS).
3.9
residual vacuum
negative pressure at the tip of the closed suction catheter (3.1) when the suction control device (3.13) is in the
relief (off) position
3.10
shaft
[3]
main part of the suction catheter (3.11) which is of uniform outside diameterISO 4135:2022 3.10.3.5
3.11
suction catheter
flexible tube designed for introduction into an airway device of the respiratory tract to remove material by
suction
3.12
*suction catheter connector
connector (3.3 at the machine end (3.5) of the suction catheter (3.11) that allows a connection to suction
[3]
tubing ISO 4135:2022 3.10.3.4
3.13
suction control device
means provided at or near the machine end (3.5) of a suction catheter (3.11) to control the level of suction in
[3]
the suction catheter ISO 4135:2022 3.10.3.7
Note 1 to entry: Suction control devices can be integrated into the suction catheter connector or be a stand-alone device
that attaches to the suction catheter connector.
3.14
terminal orifice
[3]
central aperture at thepatient end (3.6) of the suction catheter (3.11) ISO 4135:2022 3.10.3.8
3.15
tip
[3]
extremity of the patient end (3.6) of a suction catheter (3.11)ISO 4135:2022 3.10.3.6
3.16
vacuum
[3]
pressure less than atmospheric pressure ISO 4135:2022 3.1.1.27
Note 1 to entry: It is usually express as a difference from atmospheric pressure.

ISO/DIS 8836:2026(en)
3.17
ventilator breathing system (VBS)
inspiratory or expiratory pathways through which gas flows at respiratory pressures and bounded by the
[3]
port through which fresh gas enters, the patient connection port (3.7) and the exhaust port ISO 4135:2022
3.4.1.9
4 General requirements
The requirements of ISO 18190:2025, Clause 4 apply.
NOTE Annex E covers hazard identification for risk assessment of suction catheters.
5 Materials
5.1 The requirements of ISO 18190:2025, Clause 5 and the following apply.
5.2 The shaft of the suction catheter shall be constructed from materials which facilitate passage through
an airway device.
NOTE Examples of airway devices are tracheal tubes, tracheostomy tubes, tracheobronchial tubes and
supralaryngeal airways.
Check conformance by functional testing.
5.3 The shaft shall be sufficiently transparent to allow for visualization of liquids and secretions.
Check conformance by visual inspection.
6 Design requirements
6.1 General
The requirements of ISO 18190:2025, Clause 6 and the following apply:
6.2 *Size designations and dimensions
6.2.1 Designated sizes of suction catheters shall be within the tolerances of the nominal outside diameters
specified in Table 1 and expressed in millimetres. The designated size can additionally be expressed in
French (Charrière) gauge size.
NOTE 1 For the purposes of this document, the French gauge system of size (F) is based on the outside diameter of
the shaft gauged in steps of thirds of a millimetre (1 mm corresponds to 3F).
NOTE 2 The French gauge size is not an SI unit. Size designation in millimetres facilitates matching the outside
diameter of the suction catheter to the inside diameter of the tracheal or tracheostomy tube.
Check conformance by measurement and visual inspection.
6.2.2 Suction catheters shall have a colour identification at the machine end, to denote the designated size
in accordance with Table 1.
NOTE The use and choice of colour identification for designated sizes not listed in Table 1 are at the manufacturer's
discretion.
Check conformance by visual inspection.

ISO/DIS 8836:2026(en)
6.2.3 The minimum inside diameter of the shaft, shall be in accordance with Table 1 and shall not, at any
point between the suction catheter connector and the eye nearest to the machine end, be less than the inside
diameter of the shaft at that eye.
Check conformance by measurement.
6.2.4 The inside diameter of the terminal orifice shall be not less than 90 % of the minimum inside diameter
of the shaft.
Check conformance by measurement.
6.2.5 The shaft length shall be within ±5 % of the marked length.
Check conformance by measurement.
Table 1 — Designated size and colour identification
Designated size
Outside Minimum
French Nominal
diameter inside
Colour
(Charrière) outside
tolerance diameter
identification
equivalent diameter
(F) (mm) (mm) (mm)
4 1,33 ±0,10 0,55 Purple
4,5 1,5 ±0,10 0,70 Blue
5 1,67 ±0,10 0,80 Grey
6 2,0 ±0,10 1,0 Light green
6,5 2,1 ±0,10 1,1 Yellow green
7 2,33 ±0,10 1,25 Ivory
7,5 2,5 ±0,10 1,45 Pink
8 2,67 ±0,10 1,50 Light blue
9 3,0 ±0,15 1,75 Turquoise
10 3,33 ±0,15 2,00 Black
12 4,0 ±0,15 2,45 White
14 4,67 ±0,20 2,95 Green
15 5,0 ±0,20 3,20 Brown
16 5,33 ±0,20 3,40 Orange
18 6,0 ±0,20 3,90 Red
20 6,67 ±0,20 4,30 Yellow
6.3 Suction catheter tip
6.3.1 Suction catheters for use with suction systems operating at a vacuum >4,0 kPa, shall have a terminal
orifice and at least two eyes within 2 cm of the terminal orifice.
NOTE The availability of one or more eye(s) reduces the risk and likelihood of injury.
Check conformance by visual inspection.
6.3.2 Suction catheters for use with suction systems operated at vacuum ≤4,0 kPa shall have a terminal
orifice but need not have an eye.
Check conformance by visual inspection.
6.3.3 The edges of the tip, terminal orifice and eye(s) shall be smooth.

ISO/DIS 8836:2026(en)
NOTE This is to minimize injuries of the tracheal epithelium.
Check conformance by visual inspection.
6.3.4 The eye(s) shall not cause the suction catheter to kink or collapse during use.
Check conformance by inspection of the risk management file.
6.3.5 The axis of the tip can be at an angle to the long axis of the shaft (see Coudé suction catheter tip, key 7
in Figure 1).
NOTE This is to facilitate the introduction of the suction catheter into the left main bronchus.
6.4 *Suction catheter connector
6.4.1 Suction catheters shall be provided with a suction catheter connector, (see Figure 1 for examples),
intended for connection to the inlet port of suction tubing.
NOTE Requirements for suction tubing are specified in the ISO 10079 series of International Standards.
Check conformance by visual inspection.
6.4.2 Suction catheter connectors shall be securely attached to the shaft.
Check conformance by the test specified in 6.6.1.
6.4.3 Suction catheter connectors shall have an internal bore diameter equal to or greater than the internal
diameter of the shaft to which it is attached.
Check conformance by measurement.
6.4.4 Male suction catheter connectors shall be made from material with a modulus of elasticity either in
flexure or in tension >70 MPa and shall be compatible with suction tubing having an inside diameter of 6 mm
(see Figure 1).
Check conformance by inspection of the technical file.

ISO/DIS 8836:2026(en)
6.4.5 *Suction catheters should be provided with a suction control device.
Key
1 female conical suction catheter connector
2 female cylindrical suction catheter connector
3 female suction catheter connector with suction control device
4 male suction catheter connector
5 male suction catheter connector with suction control device
6 suction catheter tip with eyes
7 Coudé suction catheter tip with eyes
Figure 1 — Examples of designs for suction catheter connectors and suction catheter tips
6.5 Additional requirements for closed suction catheters
6.5.1 General design
In addition to the requirements for suction catheters, closed suction catheters shall be supplied with a closed
suction catheter manifold, a protective sleeve, and a suction control device. (See Figure 2).
Check conformance by inspection.

ISO/DIS 8836:2026(en)
Key
1 protective cap
2 suction catheter connector
34 suction control device
4 shaft of the suction catheter
5 protective sleeve
6 flushing line with non-return valve, female Luer connector, and cap
7 closed suction catheter manifold
8 machine end of the closed suction catheter manifold
9 ppatient connection port
10 suction catheter tip
11 closed suction catheter manifold as a T-piece
12 T-piece cap
NOTE The closed suction catheter shown is an example only. Actual systems can consist of other arrangements
and components not illustrated or listed.
Figure 2 — Example of closed suction catheter
6.5.2 Closed suction catheter manifold and connectors
6.5.2.1 The patient connection port shall be one of the following:
a) a female 15 mm conical connector complying with ISO 5356-1 and shall be in line with the suction catheter
and the airway. (See Figure 2) ; or
b) if intended to connect directly to the tracheal tube , the patient connection port shall be sized as per
6.3.2.1 of ISO 5361:2023.
Check conformance by inspection of the technical file.

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