SIST EN ISO 80369-6:2025

SLOVENSKI STANDARD
01-julij-2025
Nadomešča:
SIST EN ISO 80369-6:2016
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 6. del:
Priključki za nevronsko uporabo (ISO 80369-6:2025)
Small bore connectors for liquids and gases in healthcare applications - Part 6:
Connectors for neural applications (ISO 80369-6:2025)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 6: Verbindungsstücke für neurale Anwendungen
(ISO 80369-6:2025)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
6: Raccords pour applications neurales (ISO 80369-6:2025)
Ta slovenski standard je istoveten z: EN ISO 80369-6:2025
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 80369-6

NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2025
ICS 11.040.25
Supersedes EN ISO 80369-6:2016
English version
Small bore connectors for liquids and gases in healthcare
applications - Part 6: Connectors for neural applications
(ISO 80369-6:2025)
Raccords de petite taille pour liquides et gaz utilisés Verbindungsstücke mit kleinem Durchmesser für
dans le domaine de la santé - Partie 6: Raccords pour Flüssigkeiten und Gase in medizinischen
applications neurales (ISO 80369-6:2025) Anwendungen - Teil 6: Verbindungsstücke für neurale
Anwendungen (ISO 80369-6:2025)
This European Standard was approved by CEN on 26 May 2025.

CEN and CENELEC 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 and CENELEC 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 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
© 2025 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO 80369-6:2025 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3

European foreword
This document (EN ISO 80369-6:2025) has been prepared by Technical Committee ISO/TC 210 "Quality
management and corresponding general aspects for products with a health purpose including medical
devices" in collaboration with Technical Committee CEN-CENELEC/ JTC 3 “Quality management and
corresponding general aspects for medical devices” the secretariat of which is held by NEN.
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 December 2025, and conflicting national standards
shall be withdrawn at the latest by December 2025.
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.
This document supersedes EN ISO 80369-6:2016.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. 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 80369-6:2025 has been approved by CEN-CENELEC as EN ISO 80369-6:2025 without
any modification.
International
Standard
ISO 80369-6
Second edition
Small bore connectors for
2025-05
liquids and gases in healthcare
applications —
Part 6:
Connectors for neural applications
Raccords de petite taille pour liquides et gaz utilisés dans le
domaine de la santé —
Partie 6: Raccords pour applications neurales
Reference number
ISO 80369-6:2025(en) © ISO 2025

ISO 80369-6:2025(en)
© ISO 2025
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 80369-6:2025(en)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Non-interconnectability requirements . 2
5 Materials requirements . 2
6 Dimensions and tolerances . 2
7 Performance requirements . . 3
7.1 Positive pressure leakage .3
7.1.1 General .3
7.1.2 Leakage by pressure decay .3
7.1.3 Falling drop positive pressure liquid leakage .3
7.2 Sub-atmospheric pressure air leakage.3
7.3 Stress cracking .3
7.4 Resistance to separation from axial load .4
7.5 Resistance to separation from unscrewing .4
7.6 Resistance to overriding .4
Annex A (informative) Rationale and guidance . 5
Annex B (normative) Dimensions and tolerances . . 7
Annex C (normative) Reference connectors for testing small-bore connectors for neural
applications .16
Annex D (informative) Assessment of medical devices and their attributes with connections
within this application .22
Annex E (informative) Reference to the IMDRF essential principles .23
Annex F (normative) Leakage by pressure decay test method .24
Annex G (normative) Subatmospheric-pressure air leakage test method .27
Annex H (informative) Alphabetized index of defined terms .30
Bibliography .31

iii
ISO 80369-6:2025(en)
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,
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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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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constitute an endorsement.
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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 210, Quality management and corresponding
general aspects for products with a health purpose including medical devices, in collaboration with Technical
Com
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