prEN ISO 80369-6
(Main)Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neural applications (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)
ISO 80369-6:2016 specifies requirements for small-bore connectors intended to be used for connections in neuraxial applications. Neuraxial applications involve the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes.
NOTE 1 Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain, and the epi-, extra-, or peri-dural space. Neuraxial application anaesthetics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents.
NOTE 2 For the purposes of this part of ISO 80369, local anaesthesia injected hypodermically is not considered a neuraxial application.
EXAMPLES Intended administration includes intrathecal chemotherapy, local anaesthetics, radiological contrast agents, antibiotics, analgesics.
This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of these small-bore connectors intended to be used with medical devices.
This part of ISO 80369 does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.
NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into medical devices, medical systems, or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for small-bore connectors, as specified in this part of ISO 80369, will be included. Furthermore, it is recognized that standards need to be developed for many medical devices used for neuraxial applications.
NOTE 4 ISO 80369-1:2010, 5.8, specifies alternative methods of compliance with ISO 80369-1:2010, for small-bore connectors intended for use with neuraxial application medical devices or accessories, which do not comply with this part of ISO 80369.
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)
L'ISO 80369-6:2016 spécifie les exigences relatives aux raccords de petite taille destinés à être utilisés pour effectuer des raccordements dans des applications neuraxiales. Les applications neuraxiales impliquent l'utilisation de dispositifs médicaux destinés à l'administration de médicaments au niveau de sites neuraxiaux, à l'administration d'anesthésiques pour l'infiltration des plaies, à d'autres procédures d'anesthésie locorégionale ou à la surveillance ou au retrait de liquide céphalo-rachidien à des fins thérapeutiques ou de diagnostic.
NOTE 1 Les sites des applications neuraxiales comprennent la colonne vertébrale, l'espace intrathécal ou sous-arachnoïdien, les ventricules cérébraux et l'espace épidural, extradural ou péridural. Les anesthésiques pour applications neuraxiales peuvent être administrés localement et agissent sur une grande partie du corps, par exemple un membre. Ce type d'anesthésie inclut les blocs plexiques, tels que les blocs du plexus brachial ou les blocs nerveux. Les procédures relatives aux applications neuraxiales comprennent l'infiltration continue des plaies avec des agents anesthésiques locaux.
NOTE 2 Pour les besoins de la présente partie de l'ISO 80369-6:2016, les anesthésiques locaux injectés par voie sous-cutanée ne sont pas considérés comme une application neuraxiale.
EXEMPLES Les substances qu'il est prévu d'administrer sont les chimiothérapies par voie intrathécale, les anesthésiques locaux, les agents de contraste radiographiques, les antibiotiques, les analgésiques.
L'ISO 80369-6:2016 spécifie les dimensions et les exigences relatives à la conception et aux performances fonctionnelles de ces raccords de petite taille destinés à être utilisés avec des dispositifs médicaux.
L'ISO 80369-6:2016 ne spécifie pas les exigences relatives aux dispositifs médicaux ou aux accessoires sur lesquels ces raccords sont utilisés. Ces exigences figurent dans des Normes internationales spécifiques traitant de dispositifs médicaux ou d'accessoires particuliers.
NOTE 3 Les fabricants sont incités à intégrer les raccords de petite taille spécifiés dans la présente partie de l'ISO 80369-6:2016 dans les dispositifs médicaux, les systèmes médicaux ou les accessoires, même si cela n'est pas actuellement requis par les normes appropriées, spécifiques de ces dispositifs médicaux. Il est prévu d'inclure des exigences relatives aux raccords de petite taille, tels que spécifiés dans la présente partie de l'ISO 80369, lors de la révision des normes appropriées spécifiques de ces dispositifs médicaux. En outre, il est communément admis que des normes doivent être élaborées pour de nombreux dispositifs médicaux utilisés dans les applications neuraxiales.
NOTE 4 L'ISO 80369-1:2010, 5.8, spécifie d'autres méthodes de vérification de la conformité à l'ISO 80369‑1:2010 pour les raccords de petite taille destinés à être utilisés avec des dispositifs médicaux ou des accessoires à application neuraxiale, mais qui ne sont pas conformes à la présente partie de l'ISO 80369.
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 6. del: Priključki za nevronsko uporabo (ISO/DIS 80369-6:2023)
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Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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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
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 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.
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 80369-6:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 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
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
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.
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
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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