FprEN ISO 80369-20

SLOVENSKI STANDARD
oSIST prEN ISO 80369-20:2023
01-junij-2023
Nadomešča:
SIST EN ISO/IEC 80369-20:2015
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 20.
del: Splošne preskusne metode (ISO/DIS 80369-20:2023)
Small-bore connectors for liquids and gases in healthcare applications - Part 20:
Common test methods (ISO/DIS 80369-20:2023)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 20: Allgemeine Prüfverfahren (ISO/DIS 80369-
20:2023)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
20: Méthodes d'essai communes (ISO/DIS 80369-20:2023)
Ta slovenski standard je istoveten z: prEN ISO 80369-20
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 80369-20:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 80369-20:2023
oSIST prEN ISO 80369-20:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80369-20
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-03-14 2023-06-06
Small-bore connectors for liquids and gases in healthcare
applications —
Part 20:
Common test methods
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé —
Partie 20: Méthodes d'essai communes
ICS: 11.040.20; 11.040.10; 11.040.25
This document is circulated as received from the committee secretariat.
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 80369-20:2023(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 80369-20:2023
ISO/DIS 80369-20:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80369-20
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
Small-bore connectors for liquids and gases in healthcare
applications —
Part 20:
Common test methods
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé —
Partie 20: Méthodes d'essai communes
ICS: 11.040.20; 11.040.10; 11.040.25
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
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
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 80369-20:2023(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 80369-20:2023
ISO/DIS 80369-20:2023(E)
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.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland.
iii
oSIST prEN ISO 80369-20:2023
ISO/DIS 80369-20:2023(E)
1 Contents Page
2 Foreword . 5
3 Introduction . 7
4 1 Scope . 1
5 2 Normative references . 1
6 3 Terms and definitions . 1
7 4 Test methods for small-bore connectors . 1
8 Annex A (informative) Rationale and guidance . 3
9 Annex B (normative) Leakage by pressure decay test method . 6
10 Annex C (normative) Falling drop positive-pressure liquid leakage test method . 9
11 Annex D (normative) Subatmospheric-pressure air leakage test method .11
12 Annex E (normative) Stress cracking test method.14
13 Annex F (normative) Resistance to separation from axial load test method .16
14 Annex G (normative) Resistance to separation from unscrewing test method .18
15 Annex H (normative) Resistance to overriding test method .20
16 Annex I (normative) Disconnection by unscrewing test method .22
17 Annex J (informative) Modification of the test methods to generate variable data
18 for statistical analysis .24
19 Annex K (normative) Air leakage during aspiration test method .27
20 Bibliography .30
21 Terminology — Alphabetized index of defined terms .31
iv
oSIST prEN ISO 80369-20:2023
ISO/DIS 80369-20:2023(E)
23 Foreword
24 ISO (the International Organization for Standardization) is a worldwide federation of national standards
25 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
26 through ISO technical committees. Each member body interested in a subject for which a technical
27 committee has been established has the right to be represented on that committee. International
28 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
29 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
30 electrotechnical standardization.
31 The procedures used to develop this document and those intended for its further maintenance are
32 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
33 different types of ISO documents should be noted. This document was drafted in accordance with the
34 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
35 Attention is drawn to the possibility that some of the elements of this document may be the subject of
36 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
37 patent rights identified during the development of the document will be in the Introduction and/or on
38 the ISO list of patent declarations received (see www.iso.org/patents).
39 Any trade name used in this document is information given for the convenience of users and does not
40 constitute an endorsement.
41 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
42 expressions related to conformity assessment, as well as information about ISO's adherence to the World
43 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
44 www.iso.org/iso/foreword.html.
45 This document was prepared by Technical Committee ISO/TC 210, Quality management and
46 corresponding general aspects for medical devices, and IEC/SC62D, Electromedical equipment in
47 collaboration with the European Committee for Standardization (CEN/CLC) Technical Committee CEN/
48 CLC JTC 3, Quality management and corresponding general aspects for medical devices, in accordance with
49 the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
50 This second edition cancels and replaces the first edition (ISO 80369-20:2015), which has been
51 technically revised. The main changes compared to the previous edition are as follows:
52 Major technical revision of the test methods described in annex B “Leakage by pressure decay test
53 method” and annex D “Subatmospheric-pressure air leakage test method.” As acceptance criterion the
54 leakage rate is replaced by the pressure change. Three defined mandatory test conditions were defined.
55 More information about this change is included in Annex A.
56 — Introduction of a new attributive test method “Air leakage during aspiration” as Annex K.
57 — Editorial revision of the assembling procedures of a connector under test. All annexes with test
58 methods are affected.
59 — Editorial update due to the latest ISO formatting standards.
60 — Replacing the terms “male” by “cone” and “female” by “socket” in the description of a connector half.
61 — Update of dated normative references.
62 — Technical revision of the test methods described in Annex B and Annex D. All test conditions have
63 been specified thereby the leakage rate calculation has become superfluous.
64 — Definition for type test is updated.
65 — The range of environmental test conditions for relative humidity has been expanded.
66 — The requirements for test reports have been extended.
v
oSIST prEN ISO 80369-20:2023
ISO/DIS 80369-20:2023(E)
67 — Clarified that all tests are intended be type tests.
68 A list of all parts in the ISO and IEC 80369 series can be found on the ISO and IEC websites.
69 Any feedback or questions on this document should be directed to the user’s national standards
70 body. A complete listing of these bodies can be found at www.iso.org/members.html and
71 www.iec.ch/national-committees.
vi
oSIST prEN ISO 80369-20:2023
ISO/DIS 80369-20:2023(E)
72 Introduction
73 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
74 of the conditions is true.
75 In this document, the following verbal forms are used:
76 — “shall” indicates a requirement;
77 — “should” indicates a recommendation;
78 — “may” indicates a permission;
79 — "can" is used to describe a possibility or capability.
80 This document describes the common test methods for evaluating the performance requirements of the
81 small-bore connectors specified in this series.
82 It is recognized that not all connectors can be evaluated using each test method in this document. The test
83 methods applicable to each connector are specified in the respective part of the ISO and IEC 80369 series.
oSIST prEN ISO 80369-20:2023
oSIST prEN ISO 80369-20:2023
ISO/DIS 80369-20:2023(E)
84 Small-bore connectors for liquids and gases in healthcare
85 applications — Part 20: Common test methods
86 1 Scope
87 NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2.
88 This document specifies the common test methods to evaluate the performance requirements for small-
89 bore connectors specified in the ISO and IEC 80369 series.
90 NOTE 2 The application parts of the ISO and IEC 80369 series specify which tests are required as well as their
91 acceptance criterion.
92 2 Normative references
93 The following documents are referred to in the text in such a way that some or all of their content
94 constitutes requirements of this document. For dated references, only the edition cited applies. For
95 undated references, the latest edition of the referenced document (including any amendments) applies.
96 NOTE Informative references are listed in the bibliography.
97 ISO 14971:2019, Medical devices — Application of risk management to medical devices
98 ISO 80369-1:2018, Small-bore connectors for liquids and gases in healthcare applications — Part 1:
99 General requirements
100 3 Terms and definitions
101 For the purposes of this document, the terms and definitions given in ISO 80369-1:2018, ISO 14971:2019,
102 and the following apply.
103 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
104 — ISO Online browsing
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