Suction catheters for use in the respiratory tract (ISO 8836:2019)

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.
NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].

Absaugkatheter zur Verwendung im Atemtrakt (ISO 8836:2019)

Dieses Dokument legt Maße und Anforderungen an sowohl offene als auch geschlossene Absaugkatheter aus flexiblen Materialien zur Verwendung bei der Absaugung im Atemtrakt fest.
Absaugkatheter zur Verwendung mit brennbaren Anästhesiegasen oder Anästhesiemitteln, mit Lasern oder elektrochirurgischen Geräten sind nicht Gegenstand dieses Dokuments.
ANMERKUNG   ISO/TR 11991 enthält einen Leitfaden zur Sicherung der Luftwege bei Laserchirurgie in den oberen Atemwegen [4].

Sondes d'aspiration pour les voies respiratoires (ISO 8836:2019)

Le présent document spécifie les dimensions et les exigences applicables aux sondes d'aspiration fermées, mais aussi ouvertes constituées de matériaux souples et destinées à une utilisation dans l'aspiration des voies respiratoires.
Les sondes d'aspiration destinées à une utilisation avec des gaz ou agents anesthésiques inflammables, des lasers ou des appareils électrochirurgicaux ne sont pas couvertes par le présent document.
NOTE Pour obtenir des recommandations relatives à la façon d'assurer la ventilation au cours d'opérations par laser des voies respiratoires supérieures, se reporter à l'ISO/TR 11991[4].

Aspiracijski katetri za čiščenje dihalnih poti (ISO 8836:2019)

General Information

Status
Published
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
07-Oct-2020
Completion Date
07-Oct-2020

RELATIONS

Buy Standard

Standard
EN ISO 8836:2020
English language
32 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day
Draft
prEN ISO 8836:2018
English language
34 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

Standards Content (sample)

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.

---------------------- Page: 1 ----------------------
SIST EN ISO 8836:2020
---------------------- Page: 2 ----------------------
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 8836:2020
EN ISO 8836:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
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.

---------------------- Page: 5 ----------------------
SIST EN ISO 8836:2020
---------------------- Page: 6 ----------------------
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
---------------------- Page: 7 ----------------------
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
---------------------- Page: 8 ----------------------
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
---------------------- Page: 9 ----------------------
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
---------------------- Page: 10 ----------------------
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.
© ISO 2019 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 8836:2020
---------------------- Page: 12 ----------------------
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]
© ISO 2019 – All rights reserved 1
---------------------- Page: 13 ----------------------
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]
2 © ISO 2019 – All rights reserved
---------------------- Page: 14 ----------------------
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.

© ISO 2019 – All rights reserved 3
---------------------- Page: 15 ----------------------
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.
4 © ISO 2019 – All rights reserved
---------------------- Page: 16 ----------------------
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.
© ISO 2019 – All rights reserved 5
---------------------- Page: 17 ----------------------
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.
6 © ISO 2019 – All rights reserved
---------------------- Page: 18 ----------------------
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.
© ISO 2019 – All rights reserved 7
---------------------- Page: 19 ----------------------
SIST EN ISO 8836:2020
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 —
...

SLOVENSKI STANDARD
oSIST prEN ISO 8836:2018
01-november-2018
$VSLUDFLMVNLNDWHWUL]DþLãþHQMHGLKDOQLKSRWL ,62',6
Suction catheters for use in the respiratory tract (ISO/DIS 8836:2018)
Absaugkatheter zur Verwendung im Atemtrakt (ISO/DIS 8836:2018)
Sondes d'aspiration pour les voies respiratoires (ISO/DIS 8836:2018)
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
oSIST prEN ISO 8836:2018 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 8836:2018
---------------------- Page: 2 ----------------------
oSIST prEN ISO 8836:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8836
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2018-08-21 2018-11-13
Suction catheters for use in the respiratory tract
Sondes d'aspiration pour les voies respiratoires
ICS: 11.040.25; 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 8836:2018(E)
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. ISO 2018
---------------------- Page: 3 ----------------------
oSIST prEN ISO 8836:2018
ISO/DIS 8836:2018(E)

49 A.3.2 CLOSED SUCTION CATHETER MANIFOLD ................................................................................... 23

50 A.3.18 SUCTION CATHETER CONNECTOR ............................................................................................ 23

51 A.4 General requirements for open and CLOSED SUCTION CATHETERS ......................................... 24

52 A.6.3.5 SUCTION CATHETER CONNECTORS ........................................................................................ 24

53 A.6.4.2.3 CLOSED SUCTION CATHETER MANIFOLD rotation .............................................................. 24

54 A.6.4.2.7 Internal volume ................................................................................................................... 25

55 A.6.4.4 SUCTION CONTROL DEVICE .................................................................................................... 25

56 A.6.5.4 Leakage .................................................................................................................................. 25

57 A.6.5.5 Resistance to flow .................................................................................................................. 25

58 A.Annex D ........................................................................................................................................... 26

59 A.Annex D.2.2 ..................................................................................................................................... 26

60 Annex B (normative) *Test method for security of attachment ..................................................... 27

61 B.1 Principle ........................................................................................................................................ 27

62 B.2 Apparatus ..................................................................................................................................... 27

63 B.3 Procedure...................................................................................................................................... 27

64 B.4 Expression of results .................................................................................................................... 27

65 Annex C (normative) Measurement of residual vacuum ................................................................ 28

66 C.1 Principle........................................................................................................................................ 28

67 C.2 Apparatus ..................................................................................................................................... 28

68 C.3 Procedure ..................................................................................................................................... 28

69 C.4 28

70 Expression of results .......................................................................................................................... 28

71 Annex D (normative) *Method of testing leakage ........................................................................... 30

72 D.1 Principle........................................................................................................................................ 30

73 D.2 Apparatus ..................................................................................................................................... 30

74 D.3 Procedure ..................................................................................................................................... 30

75 D.4 Expression of results.................................................................................................................... 30

76 Annex E (informative) Hazard identification for risk assessment ................................................. 31

77 General ................................................................................................................................................ 31

78 E.1 Patient harm associated with the use of SUCTION CATHETERS ................................................. 31

COPYRIGHT PROTECTED DOCUMENT
79 E.1.1 Patient harm associated with the placement, removal and use of SUCTION
© ISO 2018

80 CATHETERS .............................................................................................................................. 31

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

81 E.1.2 Patient harm associated with routine use of normal saline instillation and SUCTION

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

82 CATHETERS .............................................................................................................................. 31

below or ISO’s member body in the country of the requester.
ISO copyright office

83 E.1.3 Patient or user harm associated with toxicity ...................................................................... 32

CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva

84 E.2 Hazardous situations and hazards associated with the use of SUCTION CATHETERS ............. 32

Phone: +41 22 749 01 11
Fax: +41 22 749 09 47

85 Bibliography........................................................................................................................................ 34

Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 20148 – All rights reserved
iii
ii © ISO 2018 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 8836:2018

49 A.3.2 CLOSED SUCTION CATHETER MANIFOLD ................................................................................... 23

50 A.3.18 SUCTION CATHETER CONNECTOR ............................................................................................ 23

51 A.4 General requirements for open and CLOSED SUCTION CATHETERS ......................................... 24

52 A.6.3.5 SUCTION CATHETER CONNECTORS ........................................................................................ 24

53 A.6.4.2.3 CLOSED SUCTION CATHETER MANIFOLD rotation .............................................................. 24

54 A.6.4.2.7 Internal volume ................................................................................................................... 25

55 A.6.4.4 SUCTION CONTROL DEVICE .................................................................................................... 25

56 A.6.5.4 Leakage .................................................................................................................................. 25

57 A.6.5.5 Resistance to flow .................................................................................................................. 25

58 A.Annex D ........................................................................................................................................... 26

59 A.Annex D.2.2 ..................................................................................................................................... 26

60 Annex B (normative) *Test method for security of attachment ..................................................... 27

61 B.1 Principle ........................................................................................................................................ 27

62 B.2 Apparatus ..................................................................................................................................... 27

63 B.3 Procedure...................................................................................................................................... 27

64 B.4 Expression of results .................................................................................................................... 27

65 Annex C (normative) Measurement of residual vacuum ................................................................ 28

66 C.1 Principle........................................................................................................................................ 28

67 C.2 Apparatus ..................................................................................................................................... 28

68 C.3 Procedure ..................................................................................................................................... 28

69 C.4 28

70 Expression of results .......................................................................................................................... 28

71 Annex D (normative) *Method of testing leakage ........................................................................... 30

72 D.1 Principle........................................................................................................................................ 30

73 D.2 Apparatus ..................................................................................................................................... 30

74 D.3 Procedure ..................................................................................................................................... 30

75 D.4 Expression of results.................................................................................................................... 30

76 Annex E (informative) Hazard identification for risk assessment ................................................. 31

77 General ................................................................................................................................................ 31

78 E.1 Patient harm associated with the use of SUCTION CATHETERS ................................................. 31

79 E.1.1 Patient harm associated with the placement, removal and use of SUCTION

80 CATHETERS .............................................................................................................................. 31

81 E.1.2 Patient harm associated with routine use of normal saline instillation and SUCTION

82 CATHETERS .............................................................................................................................. 31

83 E.1.3 Patient or user harm associated with toxicity ...................................................................... 32

84 E.2 Hazardous situations and hazards associated with the use of SUCTION CATHETERS ............. 32

85 Bibliography........................................................................................................................................ 34

© ISO 20148 – All rights reserved
iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 8836:2018
© ISO 20148 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 8836:2018
87 Foreword

88 ISO (the International Organization for Standardization) is a worldwide federation of national

89 standards bodies (ISO member bodies). The work of preparing International Standards is normally

90 carried out through ISO technical committees. Each member body interested in a subject for which a

91 technical committee has been established has the right to be represented on that committee.

92 International organizations, governmental and non-governmental, in liaison with ISO, also take part in

93 the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all

94 matters of electrotechnical standardization.

95 The procedures used to develop this document and those intended for its further maintenance are

96 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

97 different types of ISO documents should be noted. This document was drafted in accordance with the

98 editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives

99 Attention is drawn to the possibility that some of the elements of this document may be the subject of

100 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

101 any patent rights identified during the development of the document will be in the Introduction and/or

102 on the ISO list of patent declarations received. www.iso.org/patents

103 Any trade name used in this document is information given for the convenience of users and does not

104 constitute an endorsement.

105 For an explanation on the meaning of ISO specific terms and expressions related to conformity

106 assessment, as well as information about ISO's adherence to the WTO principles in the Technical

107 Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

108 The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,

109 Subcommittee SC 2, Airways and related equipment.

110 This fifth edition of ISO 8836 cancels and replaces the fourth edition (ISO 8836:2014), of which it

111 constitutes a technical revision.

112 The main changes are: The Standard has been formatted to align with ISO 18190, Anaesthetic and

113 respiratory equipment -- General requirements for airways and related equipment. It is no longer a

114 requirement to have only male type SUCTION CATHETER CONNECTOR on the SUCTION CATHETER, female type

115 SUCTION CATHETER CONNECTOR has been reinstated following removal in the 2014 version of this

116 Standard. The Terms and definitions in the standard have been revised. The conditions for the

117 measurement of residual vacuum in CLOSED SUCTION CATHETERS has been revised.
118
© ISO 20148 – All rights reserved
---------------------- Page: 7 ----------------------
oSIST prEN ISO 8836:2018
119 Introduction

120 This International Standard specifies dimensions and requirements for SUCTION CATHETERS for use in the

121 respiratory tract. It is concerned with the basic requirements and method of size designation of both

122 OPEN and CLOSED SUCTION CATHETERS made of flexible materials.

123 The method of describing tube dimensions and configuration has been devised in order to assist

124 clinicians in the selection of the most suitable SUCTION CATHETER for a particular patient. Size is

125 designated by outside diameter which is important when selecting a catheter because of its relationship

[2][3]

126 to the ease with which the catheter can be passed through a TRACHEAL OR TRACHEOSTOMY TUBE.

127 Throughout this International Standard the following print types are used:
128 ⎯ Requirements and definitions: roman type;
129 ⎯ Compliance checks and test specifications: italic type;

130 ⎯ Informative material appearing outside of tables, such as notes, examples and references:

131 smaller type. The normative text of tables is also in smaller type;
132 ⎯ DEFINED TERMS APPEAR IN SMALL CAPS

133 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates

134 that there is guidance or rationale related to that item in Annex A.

135 The attention of Member Bodies and National Committees is drawn to the fact that equipment

136 manufacturers and testing organizations may need a transitional period following publication of a

137 new, amended or revised ISO or IEC publication in which to make products in accordance with the

138 new requirements and to equip themselves for conducting new or revised tests. It is the

139 recommendation of the committee that the content of this publication be adopted for implementation

140 nationally not earlier than 3 years from the date of publication for equipment newly designed and not

141 earlier than 5 years from the date of publication for equipment already in production.

142
© ISO 20148 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 8836:2018
143 Suction catheters for use in the respiratory tract
144 1 Scope

145 This International Standard specifies requirements for SUCTION CATHETERS, made of flexible

146 materials and intended for use in suctioning of the respiratory tract.

147 SUCTION CATHETERS intended for use with flammable anaesthetic gases or agents, lasers or

148 electrosurgical equipment are not covered by this International Standard.

149 NOTE See ISO/TR 11991 for guidance on airway management during laser surgery of the

[5]
150 upper airway.
151 2 Normative references

152 The following documents are referred to in the text in such a way that some or all of their

153 content constitutes requirements of this document. For dated references, only the edition

154 cited applies. For undated references, the latest edition of the referenced document

155 (including any amendments) applies.

156 ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones

157 and sockets

158 ISO 5367:2016 Anaesthetic and respiratory equipment — Breathing sets and connectors

159 ISO 10079-1, Medical suction equipment — Part 1: Electrically powered suction equipment

160 ISO 10079-2, Medical suction equipment — Part 2: Manually powered suction equipment

161 ISO 10079-3, Medical suction equipment — Part 3: Suction equipment powered from a

162 vacuum or positive pressure gas source

163 ISO 14971:2007, Medical devices — Application of risk management to medical devices

164 ISO 15223, Medical devices – Symbols to be used with medical device labels, labelling, and

165 information to be supplied – Part 1: General requirements

166 ISO 18190, Anaesthetic and respiratory equipment -- General requirements for airways and

167 related equipment

168 ISO 18562-1, Biocompatibility evaluation of breathing gas pathways in healthcare

169 applications -- Part 1: Evaluation and testing within a risk management process

170 ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications -- Part

171 7: Connectors for intravascular or hypodermic applications

172 EN 15986, Symbol for use in the labelling of medical devices — Requirements for labelling of

173 medical devices containing phthalates
174 ASTM F640, Standard Test Methods for Determining Radiopacity for Medical Use
© ISO 20148 – All rights reserved
---------------------- Page: 9 ----------------------
oSIST prEN ISO 8836:2018
175 3 Terms and definitions
[1]

176 For the purposes of this document, the terms and definitions given in ISO 4135 and

177 ISO 14971 and the following apply.
178 3.1
179 *CLOSED SUCTION CATHETER

180 SUCTION CATHETER enclosed within a PROTECTIVE SLEEVE that allows its use within the

181 airway without opening the BREATHING SYSTEM directly to atmosphere
182 3.2
183 *CLOSED SUCTION CATHETER MANIFOLD

184 part of the CLOSED SUCTION CATHETER that provides a connection to an airway device

185 3.3
186 CONNECTOR
187 fitting to join together two or more components
188 [SOURCE: ISO 4135:2001, 4.2.2.1]
189 3.4
190 EYE
191 side hole near the patient end of the SUCTION CATHETER
192 [SOURCE: ISO 4135:2001, 8.3.6]
193 3.5
194 MACHINE END
195 that end of the catheter which is intended to be connected to suction tubing
196 [SOURCE: ISO 4135:2001, 8.3.2]
197 3.6
198 PATIENT END

199 The end of the SUCTION CATHETER which is intended to be inserted into a patient

200
201 [Source: ISO 4135:2001, 8.3.3]
202
203 3.7
204 PATIENT CONNECTION PORT
205 opening intended for connection to an airway device
206 [SOURCE: ISO 4135:2001, 4.2.1.2]
207 3.8
208 PROTECTIVE SLEEVE

209 flexible barrier that encloses the SUCTION CATHETER shaft to prevent contact with the user

210 while connected to the VBS
211 3.9
212 RESIDUAL VACUUM

213 negative pressure at the TIP of the CLOSED SUCTION CATHETER when the SUCTION CONTROL

214 DEVICE is in the relief position
215 3.10
© ISO 20148 – All rights reserved
---------------------- Page: 10 ----------------------
oSIST prEN ISO 8836:2018
216 RISK

217 combination of the probability of occurrence of harm and the severity of that harm

218 [SOURCE: ISO 14971:2007]
219 3.11
220 RISK ANALYSIS

221 systematic use of available information to identify hazards and to estimate the RISK

222 Note to entry RISK ANALYSIS includes examination of different sequences of events that can produce

223 hazardous situations and harm (see ISO 14971:2007, Annex F).
224 [SOURCE: ISO 14971:2007]
225 3.12
226 RISK ASSESSMENT
227 overall process comprising a RISK ANALYSIS and a RISK EVALUATION
228 [SOURCE: ISO 14971:2007]
229 3.13
230 RISK EVALUATION

231 process of comparing the estimated RISK against given RISK criteria to determine the

232 acceptability of the RISK
233 [SOURCE: ISO 14971:2007]
234 3.14
235 RISK MANAGEMENT

236 systematic application of management policies, procedures and practices to the tasks of

237 analysing, evaluating, controlling and monitoring RISK
238 [SOURCE: ISO 14971:2007]
239 3.15
240 RISK MANAGEMENT FILE
241 set of records and other documents that are produced by RISK MANAGEMENT
242 [SOURCE: ISO 14971:2007, 2.23]
243 3.16
244 SHAFT
245 main part of the SUCTION CATHETER which is of uniform outside diameter
246 3.17
247 SINGLE-FAULT CONDITION

248 condition in which a single means for reducing a RISK is defective or a single abnormal

249 condition is present
250 3.18
251 SUCTION CATHETER

252 flexible tube designed for introduction into the respiratory tract or an airway device to

253 remove material by suction
254 [SOURCE: ISO 4135]
© ISO 20148 – All rights reserved
---------------------- Page: 11 ----------------------
oSIST prEN ISO 8836:2018
255 3.19
256 *SUCTION CATHETER CONNECTOR

257 CONNECTOR at the MACHINE END of the SUCTION CATHETER that allows a connection to suction

258 tubing
259 3.20
260 SUCTION CONTROL DEVICE

261 means provided at or near the MACHINE END of a SUCTION CATHETER to control the level of

262 suction in the SUCTION CATHETER

263 Note to entry SUCTION CONTROL DEVICES can be integrated into the SUCTION CATHETER

264 CONNECTOR or be a stand-alone device that attaches to the SUCTION CATHETER CONNECTOR.

265 [SOURCE: ISO 4135:2001, 8.3.9]
266 3.21
267 TERMINAL ORIFICE
268 central aperture at the TIP of the SUCTION CATHETER
269 [SOURCE: ISO 4135:2001, 8.3.5]
270 3.22
271 TIP
272 extremity of the patient end of a SUCTION CATHETER
273 [SOURCE: ISO 4135:2001, 8.3.4]
274 3.23
275 VACUUM
276 pressure less than atmospheric pressure

277 Note to entry It is usually expressed as a difference from atmospheric pressure.

278 [SOURCE: ISO 4135:2001, 8.1.1]
279 3.24
280 VENTILATOR BREATHING SYSTEM
281 VBS

282 inspiratory or expiratory pathways through which gas flows at respiratory pressures and

283 bounded by the port through which fresh gas enters the PATIENT CONNECTION PORT and the

284 exhaust port
[7]
285 [SOURCE: ISO 80601-2-12:2011, 201.3.221]
286 4 *General requirements
287 The requirements of ISO 18190:2016 clause 4 apply.
288 5
289 5 *Materials
290 The requirements of ISO 18190:2016 clause 5 apply.
291 In addition:
© ISO 20148 – All rights reserved
---------------------- Page: 12 ----------------------
oSIST prEN ISO 8836:2018

292 5.1 The shaft of the SUCTION CATHETER shall be constructed from materials which

293 facilitate passage through an airway device.
294 Check compliance by inspection of the technical file.
295 5.2 The SHAFT shall be transparent.
296 Check compliance by visual inspection.

297 5.3 SUCTION CATHETERS shall also be evaluated for biocompatibility in accordance with ISO

298 18562-1.
299 Check compliance by inspection of the technical file.
300 6 Design Requirements
301 The requirements of ISO 18190:2016 Clause 6 apply.
302 In addition.
303 6.1 Size designations and dimensions

304 6.1.1 Designated sizes of SUCTION CATHETERS shall be within the tolerances of the

305 nominal outside diameters specified in Table 1 and expressed in millimetres. The

306 designated size may additionally be expressed in French (Charrière) gauge size.

307 NOTE 1 For the purposes of this International Standard, the French gauge system of size (F) is

308 based on the outside diameter of the SHAFT gauged in steps of thirds of a millimetre (1 mm

309 corresponds to 3F).

310 NOTE 2 The French gauge size is not an SI unit. Size designation in millimetres facilitates

311 matching the outside diameter of the SUCTION CATHETER to the inside diameter of the tracheal or

312 tracheostomy tube.
313 Check compliance by measurement

314 6.1.2 SUCTION CATHETERS shall have a colour identification at the MACHINE END, to denote

315 the designated size in accordance with Table 1.

316 Note: The use and choice of colour identification for designated sizes not listed in Table 1 are at the

317 manufacturer's discretion.
318 Check compliance by visual inspection

319 6.1.3 The minimum inside diameter of the SHAFT, shall be in accordance with Table 1

320 and shall not, at any point between the SUCTION CATHETER CONNECTOR and the EYE nearest to

321 the MACHINE END, be less than the inside diameter of the SHAFT at that EYE.
322 Check compliance by measurement

323 6.1.4 The inside diameter of the TERMINAL ORIFICE shall be not less than 90 % of the

324 minimum inside diameter of the SHAFT.
325 Check compliance by measurement
326 6.1.5 The SHAFT length shall be within ± 5 % of the marked length .
© ISO 20148 – All rights reserved
---------------------- Page: 13 ----------------------
oSIST prEN ISO 8836:2018
327 Check compliance by measurement
328
© ISO 20148 – All rights reserved
---------------------- Page: 14 ----------------------
oSIST prEN ISO 8836:2018
329 Table 1 —Designated size and colour identification
Designated size
Outside diameter Minimum inside
French Nominal
Colour
tolerance diameter
(Charriere) outside
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
330 6.2 SUCTION CATHETER TIP

331 6.2.1 SUCTION CATHETERS for use with suction systems operating at a VACUUM > 4,0 kPa,

332 shall have a TERMINAL ORIFICE and at least two EYES within 2 cm of the TERMINAL ORIFICE.

333 NOTE The availability of one or more EYE(S) reduces the RISK and likelihood of injury.

334 Check compliance by visual inspection.

335 6.2.2 SUCTION CATHETERS for use with suction systems operated at VACUUM from ≤ 4,0 kPa

336 shall have a TERMINAL ORIFICE but need not have an EYE.
337 Check compliance by visual inspection.
338 6.2.3 The edges of the TIP, TERMINAL ORIFICE and EYE(S) shall be smooth.
339 NOTE This is to minimize injuries of the tracheal epithelium.
340 Check compliance by functional testing.

341 6.2.4 The EYE(S) shall not cause the SUCTION CATHETER to kink or collapse during use

342 restricting the terminal orifice
© ISO 20148 – All rights reserved
---------------------- Page: 15 ----------------------
oSIST prEN ISO 8836:2018
343 Check compliance by functional testing

344 6.2.5 The axis of the TIP may be at an angle to the long axis of the SHAFT (see item 7

345 Coudé SUCTION CATHETER TIP in Figure 1).

346 NOTE This is to facilitate the introduction of the SUCTION CATHETER into the left main

347
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.