EN ISO 8836:2014

SLOVENSKI STANDARD
01-januar-2015
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SIST EN ISO 8836:2009
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Suction catheters for use in the respiratory tract (ISO 8836:2014)
Absaugkatheter zur Verwendung im Atemtrakt (ISO 8836:2014)
Sondes d'aspiration pour les voies respiratoires (ISO 8836:2014)
Ta slovenski standard je istoveten z: EN ISO 8836:2014
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.

EUROPEAN STANDARD
EN ISO 8836
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 11.040.25; 11.040.10 Supersedes EN ISO 8836:2009
English Version
Suction catheters for use in the respiratory tract (ISO 8836:2014)
Sondes d'aspiration pour les voies respiratoires (ISO Absaugkatheter zur Verwendung im Atemtrakt (ISO
8836:2014) 8836:2014)
This European Standard was approved by CEN on 25 July 2014.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8836:2014 E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
Foreword
This document (EN ISO 8836:2014) 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 2015, and conflicting national standards shall be withdrawn at the
latest by April 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8836:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 8836:2014 has been approved by CEN as EN ISO 8836:2014 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the normative clauses of
this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
standard.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Essential Requirements
Clause(s)/subclause (ERs) of Directive
Qualifying remarks/notes
(s) of this EN 93/42/EEC amended by
2007/47/EC
4, 7.1 (second, and third In the EU, competent authorities always require
indents) applicable ERs
6.1, 7.2 6.1 mandates that these devices shall satisfy the
biological safety testing indicated in ISO 10993-1.
9.1,
9.1 and 9.2 covers the integrity of the packaging
9.2
only for devices supplied sterile
4.1.1, 7.3 first sentence 4.1.1, 4.1.2, and 6 mandates a risk assessment
be carried out which does not exclude risks
4.1.2,
associated with materials and the substances with
which they may come into contact.

6.8, 7.5 Partly addressed by 6.8 and 10.3.2 i) calls
specifically for a warning if phthalates are
10.3.2 i)
incorporated
9.1, 8.1 9.1 and 10.3.2 f) and 10.4.2 g) mandate that
sterile devices are clearly marked according to
9.2,
EN 556–1 mandates the requirements of
10.3.2 f)
ISO 11607-1 to ensure that the packaging is
10.4.2 g)
suitable to prevent contamination during
transportation and use.
9.2 8.3 Partly addressed by 9.2 which mandates the
requirements of ISO 11607-1 that the packaging
is suitable to prevent contamination during
transportation and use.
9.1 8.4 9.1 mandates that sterile devices satisfy 4.1 of
EN 556–1
9.1 8.5 9.1 mandates that sterile devices satisfy 4.1 of
EN 556–1
10.3.2 f) 8.7 Partly covered. Marked sterile if appropriate
10.4.2 g)
7.3 9.1 Generally covered by mandating construction and
testing of interface connectors, and leakage and
7.4.1
resistance when attached to breathing systems.
7.4.2
7.4.6
8.1
8.4
8.5
5.1 9.2 (first three requirements) Partly covered to address only the risk of injury in
connection with their physical features by
5.2
specifying sizing and marking conventions for the
7.1
ID/OD and length of the catheter, design and
7.2
construction of the tip, additional protections if
provided by components of a closed suction
7.4.1
catheter, security of construction, performance of
7.4.3
the catheter shaft and vacuum control device, and
7.4.4
radiopacity.
7.4.5
8.1
8.2
8.3
8.6
10.1.3 10.1 (first sentence) Partly covered to address indication of tip angle,
length measurement and marking in cm and
10.1.4
colour codes for length marks, if provided. Limits
10.1.5
of accuracy are specified in the standard and not
10.1.6
disclosed by the manufacturer.

10.1.3 10.2 Tip direction and length mark positions are
mandated to provide ergonomic visibility during
10.1.4
intubation.
10.1.5
10.1.6
10.1.4 10.3 Length marking is mandated using SI units (mm).
Additional use of (cm) is permitted.
10.1.5
7.4.2.1 12.7.4 Suction catheter gas connectors are mandated to
comply with ISO 5356-1 for 15 mm and 22 mm
7.4.2.2
connectors.
7.4.5
Suction catheter flushing system connectors are
mandated to comply with ISO 594-1 or ISO 594-2
for Luers.
10 13.1 Covered by mandating marking and labelling and
instructions on the suction catheter, connector,
Annex A, Clause 4
unit label, shelf/multi-unit label and instructions for

use.
Annex A, Clause 4 draws attention to
consideration of disclosure of specific labelling
and instructions for intended use that may deviate
from the currently accepted medical practice.
10.2 13.2 Symbols are mandated in 10.2 to conform to
EN 1041, ISO 7000 or ISO 15223-1 and
ISO 15223-2
10.3.2 c) 13.3 a) Manufacturer identification mandated on the
device and on individual pack or any insert.
10.4.2 c)
Authorized representative mandated on the

individual pack or any insert.
10.3.2 13.3 b)
10.4.2
10.3.2 f) 13.3 c)
10.4.2 g)
10.4.2 d) 13.3 d) Batch code preceded by the word “LOT”
mandated for EU countries.
10.4.2 e) 13.3 e) 'Use by date' is partly addressed 'where
appropriate' as 'an indication of the date by which
the catheter should be used'. The EU regulation
makes it mandatory.
10.4.2 g) 13.3 f)
10.4.2 i)
Annex A, Clause 4 13.3 j) Annex A, Clause 4 draws attention to
consideration of disclosure of specific labelling
and instructions for intended use that may deviate
from the currently accepted medical practice.
10.3.2 f) 13.3 m)
10.4.2 g)
10.3 13.6, a), b), c) Instructions are limited to the mandated
information on labelling of individual packs, and
10.4 f)
preparation for use instructions on the shelf/multi-
pack label only.
10.4.2 h) 13.6 h) Limited to mandated instructions for cleaning,
disinfection, and resterilization on the shelf/multi-
pack label only. Risks associated with the reuse of
devices marked for single use are covered partly
by the risk management file and use of the
informative Annex F Hazard identification for risk
assessment
10.4.2 f) 13.6 i) Limited to mandated instructions for preparation
for use on the shelf/multi-pack label only.

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard
INTERNATIONAL ISO
STANDARD 8836
Fourth edition
2014-10-15
Suction catheters for use in the
respiratory tract
Sondes d’aspiration pour les voies respiratoires
Reference number
ISO 8836:2014(E)
©
ISO 2014
ISO 8836:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, 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
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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
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Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 8836:2014(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 *General requirements for open and closed suction catheters . 5
4.1 Risk management . 5
4.2 Safety . 6
5 Specific requirements for open and closed suction catheters . 6
5.1 Size and length designations. 6
5.2 *Dimensions . 6
6 Materials . 7
7 *Design . 8
7.1 Lumen of the suction catheter . 8
7.2 Suction catheter tip . 8
7.3 *Suction catheter connector . 8
7.4 Additional requirements for closed suction catheters .10
8 Performance requirements .12
8.1 Security of construction .12
8.2 Shaft performance .12
8.3 *Vacuum control device performance .13
8.4 *Leakage .13
8.5 *Resistance to flow .13
8.6 *Radiopacity .13
9 Requirements for suction catheters supplied sterile.13
9.1 Sterility assurance .13
9.2 Packaging of suction catheters supplied sterile .14
10 Marking .14
10.1 Marking on suction catheters .14
10.2 Use of symbols .15
10.3 Labelling of individual packs .16
10.4 Labelling of shelf/multi-unit packs .16
Annex A (informative) Rationale .18
Annex B (normative) Test method for security of attachment .21
Annex C (normative) Measurement of residual vacuum .22
Annex D (normative) Method of testing leakage .24
Annex E (informative) Hazard identification for risk assessment .25
Bibliography .27
ISO 8836:2014(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. 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. 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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 2, Airways and related equipment.
This fourth edition of ISO 8836 cancels and replaces the third edition (ISO 8836:2007), of which it
constitutes a technical revision.
iv © ISO 2014 – All rights reserved

ISO 8836:2014(E)
Introduction
This International Standard specifies dimensions and requirements for suction catheters for use in the
respiratory tract. It 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. Size is designated by
outside diameter which is important when selecting a catheter because of its relationship to the ease
[2][3][4]
with which the catheter can be passed through a tracheal or tracheostomy tube.
Revisions in this fourth edition are intended to harmonize this International Standard with recent
amendments in the European Medical Device Directive.
Major technical revisions in this edition include requirements for closed suction catheters, new
requirements to harmonize this International Standard with requirements for critical care ventilators,
and risk management.
[1]
Terms defined in Clause 3 of this International Standard or in ISO 4135 appear in bold type.
Throughout this International Standard, text for which a rationale is provided in Annex A is indicated
by an asterisk (*).
INTERNATIONAL STANDARD ISO 8836:2014(E)
Suction catheters for use in the respiratory tract
1 Scope
This International Standard specifies requirements for suction catheters, including closed suction
catheters, made of flexible materials and intended for use in suctioning of the respiratory tract.
Angled-tip suction catheters (e.g. Coudé catheters) and suction catheters with aspirator collectors are
not considered to be specialized and are therefore included in the scope of this International Standard.
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical
equipment are not covered by this International Standard.
[6]
NOTE See ISO/TR 11991 for guidance on airway management during laser surgery of the upper airway.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable to its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
*ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment
— Part 1: General requirements
*ISO 594-2, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 2: Lock fittings
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
1)
ISO 5367:— , Anaesthetic and respiratory equipment — Breathing sets and connectors
2)
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 10079-1, Medical suction equipment — Part 1: Electrically powered suction equipment
ISO 10079-2, Medical suction equipment — Part 2: Manually powered suction equipment
ISO 10079-3, Medical suction equipment — Part 3: Suction equipment powered from a vacuum or positive
pressure gas source
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
1) To be published. (Revision of ISO 5367:2000)
2) The graphical symbols in ISO 7000 are also available on line in the ISO web store. For more information, consult
http://www.iso.org/iso/publications_and_e-products/databases.htm?=.
ISO 8836:2014(E)
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling, and information to
be supplied — Part 2: Symbol development, selection and validation
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
EN 556-1:2001, Sterilization of medical devices — Requirements for medical devices to be designated
“STERILE” — Part 1: Requirements for terminally sterilized medical devices
EN 1041, Information supplied by the manufacturer of medical devices
EN 15986, Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices
containing phthalates
ASTM D3002:2007, Standard Guide for Evaluation of Coatings Applied to Plastics
ASTM F640, Standard Test Methods for Determining Radiopacity for Medical Use
3 Terms and definitions
[1]
For the purposes of this document, the terms and definitions given in ISO 4135 and ISO 14971 and the
following apply.
3.1
adaptor
specialized connector to establish functional continuity between otherwise disparate or
incompatible components
[SOURCE: ISO 4135:2001, 4.2.3.1]
3.2
connector
fitting to join together two or more components
[SOURCE: ISO 4135:2001, 4.2.2.1]
3.3
*closed suction catheter
suction catheter enclosed within a protective sleeve and patient end adaptor that allows its use
within the airway without opening the breathing system directly to atmosphere
3.4
eye
side hole near the patient end of the suction catheter
[SOURCE: ISO 4135:2001, 8.3.6]
2 © ISO 2014 – All rights reserved

ISO 8836:2014(E)
3.5
machine end
that end of the catheter which is intended to be connected to a source of vacuum
[SOURCE: ISO 4135:2001, 8.3.2]
3.6
open suction catheter
suction catheter that is not enclosed within a protective sleeve and patient end adaptor or
attached to a VBS
3.7
patient connection port
opening at the patient end of a breathing system port of a ventilator
breathing system intended for connection to an airway device
[SOURCE: ISO 4135:2001, 4.2.1.2]
3.8
patient end
that end of the suction catheter which is intended to be inserted into a patient
[SOURCE: ISO 4135:2001, 8.3.3]
3.9
patient end
the patient connection port of the closed suction catheter patient end
adaptor intended to be connected to the conical connector of an artificial airway (e.g. tracheostomy or
tracheal tube)
3.10
*patient end adaptor
tubular connector with multiple ports, one of which is a patient connection port
3.11
protective sleeve
flexible barrier that encloses the suction catheter shaft to prevent contact with the user while
connected to the VBS
3.12
residual vacuum
negative pressure at the patient end of the suction catheter when the vacuum control device is in the
relief position
3.13
risk
combination of the probability of occurrence of harm and the severity of that harm
[SOURCE: ISO 14971:2007]
3.14
risk analysis
systematic use of available information to identify hazards and to estimate the risk
Note 1 to entry: Risk analysis includes examination of different sequences of events that can produce hazardous
situations and harm (see ISO 14971:2007, Annex F).
[SOURCE: ISO 14971:2007]
ISO 8836:2014(E)
3.15
risk assessment
overall process comprising a risk analysis and a risk evaluation
[SOURCE: SO 14971:2007]
3.16
risk evaluation
process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk
[SOURCE: ISO 14971:2007]
3.17
risk management
systematic application of management policies, procedures and practices to the tasks of analysing,
evaluating, controlling and monitoring risk
[SOURCE: ISO 14971:2007]
3.18
risk management file
set of records and other documents that are produced by risk management
[SOURCE: ISO 14971:2007, 2.23]
3.19
shaft
main part of the suction catheter which is of uniform outside diameter
3.20
single-fault condition
condition in which a single means for reducing a risk is defective or a single abnormal condition is present
3.21
suction
application of vacuum to remove gas, liquids or solid particles
[SOURCE: ISO 4135, 8.1.2]
3.22
suction catheter
flexible tube designed for introduction into the respiratory tract or an airway device to remove
material by suction
[SOURCE: ISO 4135]
3.23
*suction catheter connector
connector at the machine end of the suction catheter that allows a connection to a vacuum source
3.24
terminal orifice
central aperture at the tip of the suction catheter
[SOURCE: ISO 4135:2001, 8.3.5]
3.25
tip
extremity of the patient end of a suction catheter
[SOURCE: ISO 4135:2001, 8.3.4]
4 © ISO 2014 – All rights reserved

ISO 8836:2014(E)
3.26
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]
3.27
vacuum control device
means provided at or near the machine end of a suction catheter to control the flow of air and
entrained material
[SOURCE: ISO 4135:2001, 8.3.9]
3.28
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 and the exhaust port[ISO 80601-2-
[8]
12:2011, 201.3.221, and ISO 4135:2001, 4.1.1, modified]
3.29
wiper
means for removing secretion residues from the surface of the suction catheter
4 *General requirements for open and closed suction catheters
4.1 Risk management
4.1.1 An established risk management process in accordance with ISO 14971 shall be applied to the
design of the device.
Check compliance by inspection of the risk management file.
NOTE See Annex E.
4.1.2 The manufacturer shall apply a usability engineering process to assess and mitigate risks caused
by usability problems associated with correct use and use errors.
EXAMPLES IEC 60601–1 and IEC 62366–1.
Check compliance by inspection of the usability engineering file.
4.1.3 Clinical evaluation shall be performed. Clinical evaluation is the assessment and analysis of clinical
data pertaining to a medical device in order to verify the clinical safety and performance of the device.
Clinical data may be sourced from
— clinical investigation(s) of the device concerned, or
— clinical investigation(s) or other studies reported in the scientific literature, of a similar device for
which equivalence to the device in question can be demonstrated, or
— published and/or unpublished reports on other clinical experience with either the device in question
or a similar device for which equivalence to the device in question can be demonstrated.
If required, clinical investigations shall be performed under the conditions for which performance
is claimed and documented in the risk management file. The clinical studies shall comply with the
requirements of ISO 14155.
ISO 8836:2014(E)
Check compliance by inspection of the risk management file.
4.2 Safety
The manufacturer may use type tests different from those detailed within this International Standard,
if an equivalent degree of safety is obtained. Alternative test methods shall be validated against the test
methods specified in this International Standard.
5 Specific requirements for open and closed suction catheters
5.1 Size and length designations
5.1.1 The size of suction catheters shall be designated by the nominal outside diameter of the shaft,
expressed in millimetres; it may additionally be expressed in French (Charriere) gauge size (see Table 1).
NOTE 1 For the purposes of this International Standard, 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 suction
catheter outside diameter to the inside diameter of the tracheal or tracheostomy tube.
5.1.2 The size of the suction catheter shall also be designated by use of colour identification at the
machine end in accordance with Table 1, for the designated sizes listed.
5.1.3 The use and choice of colour identification for designated sizes not listed in Table 1 are at the
manufacturer’s discretion.
5.1.4 The length of the suction catheter shall be designated by the nominal shaft length, expressed
in millimetres.
5.2 *Dimensions
5.2.1 The outside diameter of the shaft shall be the designated nominal outside diameter, subject to a
tolerance in accordance with Table 1.
5.2.2 The minimum inside diameter of the shaft, excluding the tip, shall be in accordance with Table 1.
5.2.3 The minimum inside diameter of the terminal orifice at the tip shall be not less than 90 % of the
minimum inside diameter in accordance with Table 1.
5.2.4 The shaft length shall be the designated nominal shaft length subject to a tolerance of ±5 %.
6 © ISO 2014 – All rights reserved

ISO 8836:2014(E)
Table 1 — Colour identification for designated size of suction catheter
Designated size
Outside diameter Minimum inside
French (Charri- Nominal outside
tolerance diameter
Colour identification
ere) 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 Materials
6.1 Open and closed 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.
6.2 Open and closed suction catheters for use in the respiratory tract, in their ready-to-use state after
any preparation for use recommended by the manufacturer shall not contain natural rubber latex.
Check compliance by inspection of the technical documentation.
6.3 The outside surface of the shaft of the suction catheter shall be free from characteristics which
would hinder easy insertion through all types of plastic, rubber and metal oro- and naso-tracheal tubes,
tracheostomy tubes and appropriate connectors.
Check compliance by visual inspection.
6.4 Suction catheters and their markings should be resistant to deterioration by anaesthetic
vapours and gases.
6.5 The marking of suction catheters shall be durable and legible
Check compliance by inspection, as indicated in 6.4.1 of ASTM D3002:2007 or in simulated use.
ISO 8836:2014(E)
6.6 The mid-section of the shaft of suction catheters shall allow visualization of secretions removed
from the respiratory tract.
Check compliance by visual inspection.
6.7 If phthalates as categorized in EN 15986 are incorporated in parts of the medical devices coming
directly or indirectly into contact with the patient, the manufacturer shall identify the individual risks for
the affected patient populations [see 10.3.2 i)].
Check compliance by inspection of the risk management file.
7 *Design
7.1 Lumen of the suction catheter
The inside diameter of the shaft at any point between the suction catheter connector machine end and
the eye nearest to the machine end shall be not less than the inside diameter of the shaft at that eye.
7.2 Suction catheter tip
7.2.1 Suction catheters on which the patient end cannot be observed during use or which are for
use with suction systems operating at a vacuum pressure > 3,92 kPa, (40 cmH O), shall have a terminal
orifice and at least one eye within 2 cm of the terminal orifice.
NOTE The availability of one or more eyes reduces the risk and likelihood of injury.
7.2.2 Suction catheters that can be observed during use, or are for use with suction systems operated
at vacuum from 0 cm H O to 40 cmH O (3,92 kPa), need not have an eye.
2 2
7.2.3 The edges of the tip, terminal orifice and eye(s) shall be smooth.
NOTE This is to minimize injuries of the tracheal epithelium.
Check compliance by visual inspection.
7.2.4 The eye(s) should not cause the suction catheter to kink or collapse during use.
7.2.5 The axis of the patient end may be at an angle to the long axis of the shaft (see Coudé catheter
tip in Figure 1).
NOTE This is to facilitate the introduction of the suction catheter into the left or main bronchus.
7.3 *Suction catheter connector
7.3.1 A suction catheter shall be provided with a male suction catheter connector intended for
connection to the end-piece of suction tubing attached to a collection container that complies with
ISO 10079-1, ISO 10079-2, and ISO 10079-3.
A male suction catheter connector is required in order to comply with the ISO 10079-1, ISO 10079-2,
and ISO 10079-3 requirement that connections for the suction tubing be so designed as to minimize the
risk of wrong assembly when all parts are mated. The use of a male suction catheter connector also
distinguishes the use of the suction catheter from urethral catheters, umbilical catheters, thoracic
catheters, feeding tubes, and other catheters not designed for use in the respiratory tract.
8 © ISO 2014 – All rights reserved

ISO 8836:2014(E)
7.3.2 The suction catheter connector shall be securely attached to the shaft.
Check compliance by testing in accordance with 8.1.1.
7.3.3 The suction catheter connector shall have an internal diameter equal to or greater than the
internal diameter of the shaft to which it is attached.
7.3.4 The male end of the suction catheter connector shall be rigid or semi-rigid and shall fit inside
semi-rigid or elastomeric tubing having an inside diameter of 6 mm (see Figure 1).
NOTE It is advantageous if the male end of the suction catheter fits inside elastomeric tubing with a larger
inside diameter which can be used in an emergency to clear the airway.
7.3.6 *The suction catheter connector shall not be compatible with any of the conical connectors
specified in ISO 5356-1.
7.3.7 The suction catheter connector shall be designed to facilitate correct assembly to the suction
tubing or marked to indicate correct assembly when all parts are mated in accordance with ISO 10079-1,
ISO 10079-2, and ISO 10079-3.
NOTE Incorrect connections have frequently been a cause of misconnection to the vacuum source and/or a
loss of suction.
7.3.8 *The suction catheter shall be provided with a vacuum control device.
Check compliance by inspection.
Key
1 male suction catheter connector
2 male suction catheter connector with vacuum control device
3 suction catheter tip with eyes
4 Coudé suction catheter tip with eyes
Figure 1 — Examples of different designs for suction catheter connectors and suction catheter
tips for use in the respiratory tract
ISO 8836:2014(E)
Key
1 protective cap 7 patient end adaptor
2 suction catheter connector 8 machine end of the patient end adaptor,
with a male conical connector to connect
to the breathing system or ventilator
breathing system
3 vacuum control device 9 patient connection port of the patient
end adaptor, with a 15 mm female conical
connector (connects to airway device)
4 shaft of the suction catheter 10 suction catheter tip
5 protective sleeve 11 patient end adapter as a T-piece
6 flushing line with non return valve, female Luer 12 T-piece cap
connector, and cap
NOTE Closed suction catheter shown is an example only. Actual systems may consist of other arrangements
and components not illustrated or listed
Figure 2 — Example of a closed suction catheter
7.4 Additional requirements for closed suction catheters
7.4.1 General design
In addition to the requirements for suction catheters, closed suction catheters shall be supplied with
a patient end adaptor with a patient connection port, a protective sleeve, and vacuum control
device. See example in Figure 2.
Check compliance by inspection.
7.4.2 *Patient end adaptor and connectors for the closed suction catheter
7.4.2.1 The patient end of the patient end adaptor shall be a patient connection port comprised
of 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.
10 © ISO 2014 – All rights reserved

ISO 8836:2014(E)
7.4.2.2 The machine end of the patient end adaptor shall be a 22 mm female or 15 mm male conical
connector complying with ISO 5356-1.
7.4.2.3 The connectors should be free to rotate to minimize torsion on the airway device and breathing set.
NOTE See E.3 d).
7.4.2.4 The patient end adaptor shall contain a sealing mechanism to prevent leakage of gases from
the airway into the area between the sleeve and the catheter shaft.
Check compliance by testing in accordance wit
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