prEN ISO 80369-2

SLOVENSKI STANDARD
01-oktober-2015
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Small bore connectors for liquids and gases in healthcare applications - Part 2 -
Connectors for respiratory applications
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 2: Verbindungsstücke für respiratorische
Anwendungen
Joints de petite dimension pour liquides et gaz pour des applications en santé - Partie 2 :
Joints pour systèmes respiratoires et applications au gaz propulseur
Ta slovenski standard je istoveten z: prEN ISO 80369-2
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT INTERNATIONAL STANDARD ISO/DIS 80369-2
ISO/TC 210 Secretariat: ANSI
Voting begins on Voting terminates on
2015-07-30 2015-10-30
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  ORGANISATION INTERNATIONALE DE NORMALISATION
INTERNATIONAL ELECTROTECHNICAL COMMISSION   МЕЖДУНАРОДНАЯ ЭЛЕКТРОТЕХНИЧЕСКАЯ КОММИСИЯ   COMMISSION ÉLECTROTECHNIQUE
INTERNATIONALE
Small bore connectors for liquids and gases in healthcare
applications —
Part 2:
Connectors for breathing systems and driving gases applications
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé —
Partie 2: Raccords destinés à des systèmes respiratoires et applications au gaz propulseur

ICS 11.040.10; 11.040.20
This draft is submitted to a parallel enquiry in ISO and a CDV vote in the IEC.

ISO/CEN PARALLEL PROCESSING
This final draft has been developed within the European Committee for Standardization (CEN), and
processed under the CEN-lead mode of collaboration as defined in the Vienna Agreement. The final draft
was established on the basis of comments received during a parallel enquiry on the draft.
This final draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
two-month approval vote in ISO and two-month formal vote in CEN.
Positive votes shall not be accompanied by comments.
Negative votes shall be accompanied by the relevant technical reasons.

To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.

THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS 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 NATIONAL REGULATIONS.
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.
©  International Organization for Standardization, 2015

ISO/DIS 80369-2
©  ISO 2015
All rights reserved. Unless otherwise specified, 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.
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Published in Switzerland
ii © ISO 2015 – All rights reserved

1 Contents
2 1 Scope . 9
3 2 Normative references . 9
4 3 Terms and definitions. 10
5 4 General requirements . 11
6 4.1 General requirements for the respiratory APPLICATION . 11
7 4.2 Material used for SMALL-BORE CONNECTORS . 12
8 5 Dimensional requirements for SMALL-BORE CONNECTORS for the respiratory APPLICATION . 12
9 5.1 RESP-125 (R1) SMALL-BORE CONNECTORS . 12
10 5.2 RESP-6000 (R2) SMALL-BORE CONNECTORS . 13
11 6 Performance requirements . 13
12 6.1 General performance requirements . 13
13 6.2 Leakage by pressure decay . 13
14 6.3 Subatmospheric-pressure air leakage . 13
15 6.4 Stress cracking . 13
16 6.5 Resistance to separation from axial load . 14
17 6.6 Resistance to separation from unscrewing . 14
18 6.7 Resistance to overriding . 14
19 6.8 Disconnection by unscrewing . 14
20 Annex A (informative) Rationale and guidance . 15
21 Annex B (normative) SMALL-BORE CONNECTORS for BREATHING SYSTEMS and driving gases for
22 respiratory use . 16
23 ANNEX C (normative) Reference CONNECTORS for testing SMALL-BORE CONNECTORS for neuraxial
24 APPLICATIONS . 24
25 Annex D (informative) Assessment of MEDICAL DEVICES and their attributes with CONNECTIONS within
26 this APPLICATION . 38
27 ANNEX E (informative) Summary of the usability requirements for SMALL-BORE CONNECTORS for
28 BREATHING SYSTEMS and driving gases for respiratory use . 42
29 Annex F (informative) Summary of SMALL-BORE CONNECTOR criteria and requirements for
30 BREATHING SYSTEMS and driving gases for respiratory use APPLICATIONS . 44
31 Annex G (informative) Summary of assessment of the design of the SMALL-BORE CONNECTORS for
32 BREATHING SYSTEMS and driving gases for respiratory use . 49
33 Annex H (informative) Reference to the Essential Principles . 52
34 Table H.1 — Correspondence between this document and the essential principles (1 of 2) . 52
35 Annex I (informative) Terminology — alphabetized index of defined terms . 54
36 Annex ZA (informative) Relationship between this document and the Essential Requirements of
37 EU Directive 93/42/EEC . 56

ISO 80369-2:2015(E)
4 © ISO 2015 – All rights reserved

ISO 80369-2:2015(E)
39 Foreword
40 ISO (the International Organization for Standardization) is a worldwide federation of national standards
41 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
42 through ISO technical committees. Each member body interested in a subject for which a technical
43 committee has been established has the right to be represented on that committee. International
44 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
45 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
46 electrotechnical standardization.
47 The procedures used to develop this document and those intended for its further maintenance are
48 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
49 different types of ISO documents should be noted. This document was drafted in accordance with the
50 editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
51 Attention is drawn to the possibility that some of the elements of this document may be the subject of
52 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
53 patent rights identified during the development of the document will be in the Introduction and/or on
54 the ISO list of patent declarations received. www.iso.org/patents
55 Any trade name used in this document is information given for the convenience of users and does not
56 constitute an endorsement.
57 For an explanation on the meaning of ISO specific terms and expressions related to conformity
58 assessment, as well as information about ISO's adherence to the WTO principles in the Technical Barriers
59 to Trade (TBT) see the following URL: Foreword - Supplementary information
60 ISO 80369-2 was prepared by a Joint Working Group of Technical Committee ISO/TC 210, Quality
61 management and corresponding general aspects for medical devices, IEC/TC 62, Electrical equipment,
62 Subcommittee SC 62D, Electrical equipment in medical practice and CEN/CENELEC TC3/WG 2, Small-bore
63 connectors.
64 This is the first edition of ISO 80369-2.
65 ISO 80369 consists of the following parts, under the general title Small-bore connectors for liquids and
66 gases in healthcare applications:
67  Part 1: General requirements
68  Part 2: Connectors for breathing systems and driving gases applications (this standard)
69  Part 3: Connectors for enteral applications
70  Part 4: Connectors for urethral and urinary applications
71  Part 5: Connectors for limb cuff inflation applications

Planned but not yet begun as of the date of publication.
ISO 80369-2:2015(E)
72  Part 6: Connectors for neuraxial applications
73  Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
74  Part 20: Common test methods
75 In this standard, the following print types are used:
76  Requirements and definitions: roman type.
77  Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
78 Normative text of tables is also in a smaller type.
79  TERMS DEFINED IN CLAUSE 3 OF THIS STANDARD OR AS NOTED: SMALL CAPITALS.
80 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
81 of the conditions is true.
82 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
83 Part 2. For the purposes of this standard, the auxiliary verb:
84  “shall” means that compliance with a requirement or a test is mandatory for compliance with this
85 standard;
86  “should” means that compliance with a requirement or a test is recommended but is not mandatory
87 for compliance with this standard;
88  “may” is used to describe a permissible way to achieve compliance with a requirement or test.
89 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
90 that there is guidance or rationale related to that item in Annex A.
91 The attention of Member Bodies and National Committees is drawn to the fact that equipment
92 manufacturers and testing organizations may need a transitional period following publication of a new,
93 amended or revised ISO or IEC publication in which to make products in accordance with the new
94 requirements and to equip themselves for conducting new or revised tests. It is the recommendation of
95 the committees that the content of this publication be adopted for implementation nationally not earlier
96 than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from
97 the date of publication for equipment already in production.
6 © ISO 2015 – All rights reserved

ISO 80369-2:201
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