FprEN ISO 80369-6
(Main)Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neural applications (ISO/FDIS 80369-6:2025)
Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neural applications (ISO/FDIS 80369-6:2025)
NOTE Clause A.2 contains guidance or rationale for this clause.
This document specifies requirements for small-bore connectors intended to be used for connections in neural applications.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular standards for specific medical devices or accessories.
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 6: Verbindungsstücke für neurale Anwendungen (ISO/FDIS 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/FDIS 80369-6:2025)
NOTE L'Article A.2 contient des recommandations ou justifications concernant le présent article.
Le présent document spécifie des exigences pour les raccords de petite taille destinés à être utilisés pour les raccordements dans les applications neurales.
Le présent document ne spécifie pas d’exigences pour les dispositifs médicaux ou les accessoires utilisant ces raccords. Ces exigences sont données dans des documents propres aux dispositifs médicaux ou accessoires spécifiques.
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 6. del: Priključki za nevronsko uporabo (ISO/FDIS 80369-6:2025)
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 80369-6:2023
01-oktober-2023
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 6. del:
Priključki za nevronsko uporabo (ISO/DIS 80369-6:2023)
Small bore connectors for liquids and gases in healthcare applications - Part 6:
Connectors for neural applications (ISO/DIS 80369-6:2023)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 6: Verbindungsstücke für neurale Anwendungen
(ISO/DIS 80369-6:2023)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
6: Raccords pour applications neurales (ISO/DIS 80369-6:2023)
Ta slovenski standard je istoveten z: prEN ISO 80369-6
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 80369-6:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 80369-6:2023
oSIST prEN ISO 80369-6:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80369-6
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-08-11 2023-11-03
Small bore connectors for 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 destinés à des applications en contact avec le système nerveux (neuraxiales)
ICS: 11.040.25
This document is circulated as received from the committee secretariat.
This draft is submitted to a parallel vote in ISO and in IEC.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
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 80369-6:2023(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 2023
oSIST prEN ISO 80369-6:2023
ISO/DIS 80369-6:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80369-6
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
Small bore connectors for 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 destinés à des applications en contact avec le système nerveux (neuraxiales)
ICS: 11.040.25
This document is circulated as received from the committee secretariat.
This draft is submitted to a parallel vote in ISO and in IEC.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
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CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 80369-6:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
oSIST prEN ISO 80369-6:2023
ISO/DIS 80369-6:2023(E)
25 Contents
26 Foreword . 4
27 Introduction. 6
28 1 Scope . 7
29 2 Normative references . 7
30 3 Terms and definitions . 7
31 4 Non-interconnectability requirements . 8
32 5 Materials requirements . 8
33 6 Dimensions and tolerances . 8
34 7 Performance requirements . 9
35 7.1 Positive pressure leakage . 9
36 7.2 Sub-atmospheric pressure air leakage . 9
37 7.3 Stress cracking . 9
38 7.4 Resistance to separation from axial load . 9
39 7.5 Resistance to separation from unscrewing . 10
40 7.6 Resistance to overriding . 10
41 Annex A (informative) Rationale and guidance . 11
42 Annex B (normative) Dimensions and tolerances . 12
43 Annex C (normative) Reference connectors for testing small-bore connectors for neural
44 applications . 22
45 Annex D (informative) Assessment of medical devices and their attributes with connections
46 within this application . 28
47 Annex E (informative) Reference to the essential principles . 30
48 Bibliography . 33
49 Index of Terms and their Sources . 35
oSIST prEN ISO 80369-6:2023
ISO/DIS 80369-6:2023(E)
51 Foreword
52 ISO (the International Organization for Standardization) is a worldwide federation of national
53 standards bodies (ISO member bodies). The work of preparing International Standards is normally
54 carried out through ISO technical committees. Each member body interested in a subject for which a
55 technical committee has been established has the right to be represented on that committee.
56 International organizations, governmental and non-governmental, in liaison with ISO, also take part in
57 the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
58 matters of electrotechnical standardization.
59 The procedures used to develop this document and those intended for its further maintenance are
60 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
61 different types of ISO documents should be noted. This document was drafted in accordance with the
62 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
63 Attention is drawn to the possibility that some of the elements of this document may be the subject of
64 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
65 any patent rights identified during the development of the document will be in the Introduction and/or
66 on the ISO list of patent declarations received (see www.iso.org/patents).
67 Any trade name used in this document is information given for the convenience of users and does not
68 constitute an endorsement.
69 For an explanation on the meaning of ISO specific terms and expressions related to conformity
70 assessment, as well as information about ISO's adherence to the WTO principles in the Technical
71 Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
72 The committee responsible for this document is ISO/TC 210, Quality management and corresponding
73 general aspects for medical devices, and IEC/SC62D, Electromedical equipment. The draft was circulated
74 for voting to the national bodies of both ISO and IEC.
75 A list of all parts in the ISO 80369 series can be found on the ISO website.
76 This second edition cancels and replaces the first edition (ISO 80369-6:2016), which has been
77 technically revised after a systematic review. The main changes compared to the previous edition are as
78 follows:
79 — Tolerances of several connector dimensions in Annex B were modified. All changes are deemed
80 backwards compatible, except for pitch which is now a performance requirement and r2 of
81 Figure B.1 which is now normative. The figures were updated for clarity.
82 — Annex C reference connector figures and dimensions were reviewed and modified to increase
83 tolerances. All reference connectors manufactured to the requirements of ISO 80369-6:2016
84 also conform to the modified figures of this document. The figures were updated for clarity.
85 — Annex E and Annex F (of the first edition of this document) were removed as the small-bore
86 connectors defined in this document have been verified against usability and design
87 requirements.
88 — Annex G (of the first edition of this document) and all Clause 4 references to non-
89 interconnectability including all residual misconnections / misconnection analysis was moved
90 to Annex E of ISO 80369-1.
91 — Annex H (of the first edition of this document) was removed as this content is included in Annex
92 B of ISO 80369-1.
4 © ISO 2023 – All rights reserved
oSIST prEN ISO 80369-6:2023
ISO/DIS 80369-6:2023(E)
93 — Annex J (of the first edition of this document) was converted to an Index of Terms and their
94 Sources and placed after the Bibliography.
95 — Remaining Annexes were re-lettered and re-referenced accordingly.
96 — Editorial updates were made throughout the document. This allows harmonization with other
97 parts of the ISO 80369 series of standards.
98 — As per Clause 8.6 of ISO/IEC Directives Part 2, to ensure inclusive wording the word male was
99 replaced by cone and female replaced by socket throughout the document.
100 — ISO 80369-6 Edition 1 was created and published as neuraxial applications. However, many of
101 the applications listed in the scope and Annex D are neural applications therefore the word
102 neuraxial has been replaced with neural throughout the document.
103 Any feedback or questions on this document should be directed to the user’s national standards body. A
104 complete listing of these bodies can be found at www.iso.org/members.html.
oSIST prEN ISO 80369-6:2023
ISO/DIS 80369-6:2023(E)
105 Introduction
106 The small-bore connectors specified in this document conform with the non-interconnectability
107 requirements of ISO 80369-1.
108 This document includes design and performance requirements for small-bore connectors for the neural
109 application.
110 It is recognised that the small-bore connectors specified in this document might not be suitable for some
111 medical devices within this application.
112 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
113 combination of the conditions is true.
114 In this document, the following verbal forms are used:
115 — “shall” indicates a requirement;
116 — “should” means that conformance with a requirement or a test is recommended but is not
117 mandatory for conformance with this document;
118 — “may” indicates a permission;
119 — “can” indicates a possibility or a capability.
6 © ISO 2023 – All rights reserved
oSIST prEN ISO 80369-6:2023
ISO/DIS 80369-6:2023(E)
121 Small-bore connectors for liquids and gases in healthcare
122 applications — Part 6: Connectors for neural applications
123 1 Scope
124 NOTE 1 There is rationale for this requirement in Annex A, A.1.
125 This document specifies requirements for small-bore connectors intended to be used for connections in
126 neural applications. Neural applications involve the use of medical devices intended to administer
127 medications to neural sites, wound infiltration anaesthesia delivery, and other regional anaesthesia
128 procedures or to m
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