SIST EN ISO 8836:2020

SLOVENSKI STANDARD
SIST EN ISO 8836:2020
01-december-2020
Nadomešča:
SIST EN ISO 8836:2015
Aspiracijski katetri za čiščenje dihalnih poti (ISO 8836:2019)
Suction catheters for use in the respiratory tract (ISO 8836:2019)
Absaugkatheter zur Verwendung im Atemtrakt (ISO 8836:2019)
Sondes d'aspiration pour les voies respiratoires (ISO 8836:2019)
Ta slovenski standard je istoveten z: EN ISO 8836:2020
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
SIST EN ISO 8836:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8836:2020

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SIST EN ISO 8836:2020


EN ISO 8836
EUROPEAN STANDARD

NORME EUROPÉENNE

October 2020
EUROPÄISCHE NORM
ICS 11.040.10; 11.040.25 Supersedes EN ISO 8836:2014
English Version

Suction catheters for use in the respiratory tract (ISO
8836:2019)
Sondes d'aspiration pour les voies respiratoires (ISO Absaugkatheter zur Verwendung im Atemtrakt (ISO
8836:2019) 8836:2019)
This European Standard was approved by CEN on 24 June 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8836:2020 E
worldwide for CEN national Members.

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SIST EN ISO 8836:2020
EN ISO 8836:2020 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 8836:2020
EN ISO 8836:2020 (E)
European foreword
This document (EN ISO 8836:2020) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2021, and conflicting national standards shall be
withdrawn at the latest by October 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8836:2014.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 8836:2019 has been approved by CEN as EN ISO 8836:2020 without any modification.


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SIST EN ISO 8836:2020

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SIST EN ISO 8836:2020
INTERNATIONAL ISO
STANDARD 8836
Fifth edition
2019-12
Suction catheters for use in the
respiratory tract
Sondes d'aspiration pour les voies respiratoires
Reference number
ISO 8836:2019(E)
©
ISO 2019

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SIST EN ISO 8836:2020
ISO 8836:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

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SIST EN ISO 8836:2020
ISO 8836:2019(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 *General requirements . 3
5 Materials . 4
6 Design requirements . 4
6.1 General . 4
6.2 Size designations and dimensions . 4
6.3 Suction catheter tip . 5
6.4 *Suction catheter connector . . 6
6.5 Additional requirements for closed suction catheters . 7
6.5.1 General design. 7
6.5.2 Closed suction catheter manifold and connectors . 8
6.5.3 Protective sleeve . 9
6.5.4 *Suction control device . 9
6.5.5 Flushing system .10
6.5.6 T-piece port .10
6.6 Performance requirements .10
6.6.1 Security of construction .10
6.6.2 Shaft performance .10
6.6.3 Suction control device performance .11
6.6.4 *Leakage .11
6.6.5 *Resistance to flow .11
7 Requirements for suction catheters supplied sterile .11
8 Packaging .11
9 Information supplied by the manufacturer .11
9.1 General .11
9.2 Marking .12
9.3 Instructions for use .13
Annex A (informative) Rationale .14
Annex B (normative) Test method for security of attachment .17
Annex C (normative) Measurement of residual vacuum .18
Annex D (normative) *Method of testing leakage .20
Annex E (informative) Hazard identification for risk assessment .21
Bibliography .24
© ISO 2019 – All rights reserved iii

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SIST EN ISO 8836:2020
ISO 8836:2019(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.
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, Airways and related equipment.
This fifth edition cancels and replaces the fourth edition (ISO 8836:2014), which has been technically
revised. The main changes compared to the previous edition are as follows:
— it is no longer a requirement to have only male-type suction catheter connector on the suction
catheter;
— the female-type suction catheter connector has been reinstated following removal in the fourth
edition of this document;
— the terms and definitions have been revised;
— the conditions for the measurement of residual vacuum in closed suction catheters have been revised.
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 2019 – All rights reserved

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SIST EN ISO 8836:2020
ISO 8836:2019(E)

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
[2][3]
the catheter can be passed through a tracheal or tracheostomy tube .
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.
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SIST EN ISO 8836:2020

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SIST EN ISO 8836:2020
INTERNATIONAL STANDARD ISO 8836:2019(E)
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.
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical
equipment are not covered by this document.
[4]
NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991 .
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 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5367:2014, Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 18190:2016, Anaesthetic and respiratory equipment — General requirements for airways and related
equipment
ISO 18562-1, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1:
Evaluation and testing within a risk management process
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 following terms and definitions 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 (3.17) enclosed within a protective sleeve (3.8) that allows its use within the airway
without opening the breathing system directly to atmosphere
3.2
*closed suction catheter manifold
part of the closed suction catheter (3.1) that provides a connection to an airway device
3.3
connector
fitting to join together two or more components
[SOURCE: ISO 4135:2001, 4.2.2.1]
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SIST EN ISO 8836:2020
ISO 8836:2019(E)

3.4
eye
side hole near the patient end (3.6) of the suction catheter (3.17)
3.5
machine end
that end of the catheter which is intended to be connected to suction tubing
3.6
patient end
that end of the suction catheter (3.17) which is intended to be inserted into a patient
[SOURCE: ISO 4135:2001, 8.3.3]
3.7
patient connection port
opening intended for connection to an airway device
3.8
protective sleeve
flexible barrier that encloses the suction catheter (3.17) shaft (3.15) to prevent contact with the user
while connected to the VBS (3.23)
3.9
residual vacuum
negative pressure at the tip (3.21) of the closed suction catheter (3.1) when the suction control device
(3.19) is in the relief position
3.10
risk
combination of the probability of occurrence of harm and the severity of that harm
[SOURCE: ISO 14971:2019, 3.18]
3.11
risk analysis
systematic use of available information to identify hazards and to estimate the risk (3.10)
[SOURCE: ISO 14971:2019, 3.19]
Note 1 to entry: Risk analysis includes examination of different sequences of events that can produce hazardous
situations and harm (see ISO 14971:2019, 5.4).
3.12
risk assessment
overall process comprising a risk analysis (3.11) and a risk evaluation
[SOURCE: ISO 14971:2019, 3.20]
3.13
risk management
systematic application of management policies, procedures and practices to the tasks of analysing,
evaluating, controlling and monitoring risk (3.10)
[SOURCE: ISO 14971:2019, 3.24]
3.14
risk management file
set of records and other documents that are produced by risk management (3.13)
[SOURCE: ISO 14971:2019, 3.25]
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SIST EN ISO 8836:2020
ISO 8836:2019(E)

3.15
shaft
main part of the suction catheter (3.17) which is of uniform outside diameter
3.16
single-fault condition
condition in which a single means for reducing a risk (3.10) is defective or a single abnormal condition
is present
3.17
suction catheter
flexible tube designed for introduction into the respiratory tract or an airway device to remove material
by suction
3.18
*suction catheter connector
connector (3.3) at the machine end (3.5) of the suction catheter (3.17) that allows a connection to
suction tubing
3.19
suction control device
means provided at or near the machine end (3.5) of a suction catheter (3.17) to control the level of
suction in the suction catheter
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.
3.20
terminal orifice
central aperture at the tip (3.21) of the suction catheter (3.17)
3.21
tip
extremity of the patient end (3.6) of a suction catheter (3.17)
[SOURCE: ISO 4135:2001, 8.3.4]
3.22
vacuum
pressure less than atmospheric pressure
Note 1 to entry: It is usually expressed as a difference from atmospheric pressure.
[SOURCE: ISO 4135:2001, 8.1.1]
3.23
ventilator breathing system
VBS
inspiratory or expiratory pathways through which gas flows at respiratory pressures and bounded by
the port through which fresh gas enters, the patient connection port (3.7) and the exhaust port
[SOURCE: ISO 80601-2-12:2011, 201.3.221]
4 *General requirements
The requirements of ISO 18190:2016, Clause 4 apply.
NOTE Annex E covers hazard identification for risk assessment of suction catheters.
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SIST EN ISO 8836:2020
ISO 8836:2019(E)

5 Materials
5.1 The requirements of ISO 18190:2016, 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 inspection of the technical file.
5.3 The shaft shall be transparent.
Check conformance by visual inspection.
5.4 Suction catheters shall also be evaluated for biocompatibility in accordance with ISO 18562-1.
Check conformance by inspection of the technical file.
6 Design requirements
6.1 General
The requirements of ISO 18190:2016, 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.
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.
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.
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SIST EN ISO 8836:2020
ISO 8836:2019(E)

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.
NOTE This is to minimize injuries of the tracheal epithelium.
Check conformance by inspection.
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SIST EN ISO 8836:2020
ISO 8836:2019(E)

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 performance requirements and 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.
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SIST EN ISO 8836:2020
ISO 8836:2019(E)

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.
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ISO 8836:2019(E)

Key
1 protective cap 7 closed suction catheter manifold
2 suction catheter connector 8 machine end of the closed suction catheter manifold
3 suction control device 9 patient connection port
4 shaft of the suction catheter 10 suction catheter tip
5 protective sleeve 11 closed suction catheter manifold as a T-piece
6 flushing line with non-return valve, 12 T-piece cap
female Luer connector, and 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 —
...