prEN ISO 80369-1
(Main)Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO/DIS 80369-1:2023)
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO/DIS 80369-1:2023)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO/DIS 80369-1:2023)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 1: Exigences générales (ISO/DIS 80369-1:2023)
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 1. del: Splošne zahteve (ISO/DIS 80369-1:2023)
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SLOVENSKI STANDARD
01-september-2023
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 1. del:
Splošne zahteve (ISO/DIS 80369-1:2023)
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General
requirements (ISO/DIS 80369-1:2023)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO/DIS 80369-
1:2023)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
1: Exigences générales (ISO/DIS 80369-1:2023)
Ta slovenski standard je istoveten z: prEN ISO 80369-1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80369-1
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-06-21 2023-09-13
Small-bore connectors for liquids and gases in healthcare
applications —
Part 1:
General requirements
ICS: 11.040.20; 11.040.10
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ISO/DIS 80369-1:2023(E)
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80369-1
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
Small-bore connectors for liquids and gases in healthcare
applications —
Part 1:
General requirements
ICS: 11.040.20; 11.040.10
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 80369-1:2023(E)
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ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
ISO 80369-1:2023(E)
1 Contents
2 Foreword . 5
3 Introduction. 6
4 1 Scope . 8
5 2 Normative references . 8
6 3 Terms and definitions. 9
7 4 Small-bore connector non-interconnectable requirement . 12
8 5 Small-bore connectors for clinical applications . 12
9 5.1 Small-bore connectors for new clinical applications . 12
10 5.2 Small-bore connectors for respiratory applications. 12
11 5.3 Small-bore connectors for enteral applications . 13
12 5.4 Small-bore connectors for limb cuff inflation applications . 13
13 5.5 Small-bore connectors for neural applications . 13
14 5.6 Small-bore connectors for intravascular and hypodermic applications . 13
15 5.7 Other use cases utilizing an ISO 80369-7 small-bore connector . 13
16 6 Alternative small-bore connectors . 15
17 Annex A (informative) Rationale . 16
18 Annex B (normative) Process for demonstrating non-interconnectable characteristics . 21
19 Figure B.1 — Illustration of the process to evaluate the non-interconnectable characteristics . 22
20 Figure B.2 — Example of typical fixed collar cone connector diameters to be evaluated . 23
21 Figure B.3 — Example of typical full threaded socket connector diameters to be evaluated . 24
22 Figure B.4 — Example of a typical rib diameter to be evaluated . 24
23 Figure B.5 — Example of a typical connector with a lug to be evaluated . 25
24 Figure B.6 — Example of a typical cylinder-to-cylinder interface to be evaluated . 25
25 Figure B.7 — Example of a typical cylinder to full thread interface to be evaluated . 26
26 Figure B.8 — Example of a typical cylinder to full thread interface to be evaluated (cross-section
27 view) 26
28 Figure B.9 — Example of a typical cylinder to external lug interface to be evaluated . 26
29 Figure B.10 — Example of a typical cylinder to external lug interface to be evaluated (cross-
30 section view) . 27
31 Annex C (normative) Assessment procedures for small-bore connectors . 35
32 Annex D (informative) Applications of small-bore connectors and the relevant standard . 38
3 © ISO 2023 – All rights reserved
ISO 80369-1:2023(E)
33 Annex E (informative) Design assessment summary . 40
34 Annex F (informative) Reference to the Essential Principles . 43
35 Bibliography . 50
36 Alphabetical index of defined terms . 51
4 © ISO 2023 – All rights reserved
ISO 80369-1:2023(E)
38 Foreword
39 ISO (the International Organization for Standardization) is a worldwide federation of national standards
40 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
41 through ISO technical committees. Each member body interested in a subject for which a technical
42 committee has been established has the right to be represented on that committee. International
43 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
44 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
45 electrotechnical standardization.
46 The procedures used to develop this document and those intended for its further maintenance are
47 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
48 different types of ISO documents should be noted. This document was drafted in accordance with the
49 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
50 Attention is drawn to the possibility that some of the elements of this document may be the subject of
51 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
52 patent rights identified during the development of the document will be in the Introduction and/or on
53 the ISO list of patent declarations received (see www.iso.org/patents).
54 Any trade name used in this document is information given for the convenience of users and does not
55 constitute an endorsement.
56 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
57 expressions related to conformity assessment, as well as information about ISO's adherence to the World
58 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
59 www.iso.org/iso/foreword.html.
60 This document was prepared by Technical Committee ISO/TC 210, Quality management and
61 corresponding general aspects for medical devices, in collaboration with IEC/TC 62, Electrical equipment
62 in medical practice, Subcommittee SC D, Electromedical equipment and CEN/CENELEC TC 3/WG 2, Small-
63 bore connectors.
64 This third edition cancels and replaces the second edition (ISO 80369-1:2018), which has been
65 technically revised.
66 The main changes compared to the previous edition are as follows:
67 — the normative references have been updated;
68 — reformatted according to most recent Central Secretariat editing rules;
69 — added respiratory applications; and
70 — extended the use of the ISO 80369-7 connector to medical devices and accessories beyond
71 intravascular and hypodermic applications where the risk is acceptable.
72 A list of all parts in the ISO and IEC 80369 series can be found on the ISO and IEC websites.
73 Any feedback or questions on this document should be directed to the user’s national standards body. A
74 complete listing of these bodies can be found at www.iso.org/members.html.
5 © ISO 2023 – All rights reserved
ISO 80369-1:2023(E)
75 Introduction
76 In the 1990s, concern grew regarding the proliferation of medical devices fitted with Luer connectors as
77 specified in ISO 594 series and the reports of patient death or injury arising from unintended connections
78 that resulted in the inappropriate delivery of fluids and gases via incorrect routes. In addition to clinical
79 and workplace protocols and warnings, attention was turned to engineering solutions to reduce the
80 probability of wrong route administration of liquids and gases.
81 Concerns regarding the use of Luer connectors with enteral feeding tubes and gas sampling and gas
82 delivery systems were raised with CEN/BT and the European Commission. In November 1997, the newly
83 created CHeF steering group set up a Forum Task Group (FTG) to consider the problem.
[7]
84 The FTG produced CEN Report, CR 13825 , in which they concluded that there is a problem arising from
85 the use of a single connector design to several different applications. In a coronary care unit, there were
86 as many as 40 Luer connectors on the medical devices used with a single patient until the use of connectors
87 defined in the ISO and IEC 80369 documents started to be established. Therefore, it is not surprising that
88 unintended connections were made.
89 Medical devices have, for many years, followed the established principle of “safety under single fault
90 conditions.” Simply stated, this means that a single fault should not result in an unacceptable risk. This
[5]
91 principle is embodied in the requirements of numerous medical device standards . Extending this
92 principle to the use of Luer connectors (i.e., that an unintended connection should not result i
...
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