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SLOVENSKI STANDARD
01-februar-2023
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 3. del:
Priključki za enteralno uporabo - Dopolnilo A1 (ISO 80369-3:2016/Amd 1:2019)
Small-bore connectors for liquids and gases in healthcare applications - Part 3:
Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 3: Verbindungsstücke für enterale Anwendungen -
Änderung 1 (ISO 80369-3:2016/Amd 1:2019)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
3: Raccords destinés à des applications entérales - Amendement 1 (ISO 80369-
3:2016/Amd 1:2019)
Ta slovenski standard je istoveten z: EN ISO 80369-3:2016/A1:2022
ICS:
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 80369-3:2016/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2022
ICS 11.040.25
English version
Small-bore connectors for liquids and gases in healthcare
applications - Part 3: Connectors for enteral applications -
Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
Raccords de petite taille pour liquides et gaz utilisés Verbindungsstücke mit kleinem Durchmesser für
dans le domaine de la santé - Partie 3: Raccords Flüssigkeiten und Gase in medizinischen
destinés à des applications entérales - Amendement 1 Anwendungen - Teil 3: Verbindungsstücke für enterale
(ISO 80369-3:2016/Amd 1:2019) Anwendungen - Änderung 1 (ISO 80369-3:2016/Amd
1:2019)
This amendment A1 modifies the European Standard EN ISO 80369-3:2016; it was approved by CEN on 21 November 2022.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant 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 and CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees 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, Türkiye and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2022 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO 80369-3:2016/A1:2022 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
European foreword
The text of ISO 80369-3:2016/Amd 1:2019 has been prepared by Technical Committee ISO/TC 210
"Quality management and corresponding general aspects for medical devices” of the International
Organization for Standardization (ISO) and has been taken over as EN ISO 80369-3:2016/A1:2022 by
Technical Committee CEN-CENELEC/ JTC 3 “Quality management and corresponding general aspects
for medical devices” the secretariat of which is held by NEN.
This Amendment to the European Standard EN ISO 80369-3:2016 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by May 2023, and
conflicting national standards shall be withdrawn at the latest by May 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN and CENELEC websites.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 80369-3:2016/Amd 1:2019 has been approved by CEN-CENELEC as EN ISO 80369-
3:2016/A1:2022 without any modification.
INTERNATIONAL ISO
STANDARD 80369-3
First edition
2016-07-01
AMENDMENT 1
2019-02
Small-bore connectors for liquids and
gases in healthcare applications —
Part 3:
Connectors for enteral applications
AMENDMENT 1
Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 3: Raccords destinés à des applications entérales
AMENDEMENT 1
Reference number
ISO 80369-3:2016/Amd.1:2019(E)
©
ISO 2019
ISO 80369-3:2016/Amd.1:2019(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 80369-3:2016/Amd.1:2019(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 i
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