EN ISO 8836:2020

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

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.

Contents Page
European foreword . 3

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.

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
ISO 8836:2019(E)
© 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
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below or ISO’s member body in the country of the requester.
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Published in Switzerland
ii © ISO 2019 – All rights reserved

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 8836:2019(E)
Foreword
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This document was prepared by Technical Committee ISO/T
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