EN ISO 80369-20:2024

SLOVENSKI STANDARD
01-januar-2025
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 80369-20:2024)
Small-bore connectors for liquids and gases in healthcare applications - Part 20:
Common test methods (ISO 80369-20:2024)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 20: Allgemeine Prüfverfahren (ISO 80369-20:2024)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
20: Méthodes d'essai communes (ISO 80369-20:2024)
Ta slovenski standard je istoveten z: EN ISO 80369-20:2024
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.

EUROPEAN STANDARD EN ISO 80369-20

NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2024
ICS 11.040.10; 11.040.20; 11.040.25
Supersedes EN ISO 80369-20:2015
English version
Small-bore connectors for liquids and gases in healthcare
applications - Part 20: Common test methods (ISO 80369-
20:2024)
Raccords de petite taille pour liquides et gaz utilisés Verbindungsstücke mit kleinem Durchmesser für
dans le domaine de la santé - Partie 20: Méthodes Flüssigkeiten und Gase in medizinischen
d'essai communes (ISO 80369-20:2024) Anwendungen - Teil 20: Allgemeine Prüfverfahren (ISO
80369-20:2024)
This European Standard was approved by CEN on 9 September 2024.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2024 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO 80369-20:2024 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3

European foreword
This document (EN ISO 80369-20:2024) has been prepared by Technical Committee ISO/TC 210
"Quality management and corresponding general aspects for products with a health purpose including
medical devices" in collaboration with Technical Committee CEN-CENELEC/ JTC 3 “Quality
management and corresponding general aspects for medical devices” the secretariat of which is held by
NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2025, and conflicting national standards shall be
withdrawn at the latest by May 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 80369-20:2015.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN and CENELEC
websites.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 80369-20:2024 has been approved by CEN-CENELEC as EN ISO 80369-20:2024 without
any modification.
International
Standard
ISO 80369-20
Second edition
Small-bore connectors for
2024-11
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
Reference number
ISO 80369-20:2024(en) © ISO 2024

ISO 80369-20:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 80369-20:2024(en)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test methods for small-bore connectors . 1
Annex A (informative) Rationale and guidance . 3
Annex B (informative) Leakage by pressure decay test method . 6
Annex C (informative) Falling drop positive-pressure liquid leakage test method . 9
Annex D (informative) Subatmospheric-pressure air leakage test method .11
Annex E (informative) Stress cracking test method . 14
Annex F (informative) Resistance to separation from axial load test method .16
Annex G (informative) Resistance to separation from unscrewing test method .18
Annex H (informative) Resistance to overriding test method .20
Annex I (informative) Disconnection by unscrewing test method .22
Annex J (informative) Modification of the test methods to generate variable data for statistical
analysis .24
Annex K (informative) Air leakage during aspiration test method .27
Annex L (informative) Reference to the IMDRF essential principles .30
Annex M (informative) Alphabetized index of defined terms .31
Bibliography .32

iii
ISO 80369-20:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding
general aspects for products with a health purpose including medical devices, in collaboration with Technical
Committee IEC/SC 62D, Particular medical equipment, software, and systems, and with the European
Committee for Standardization (CEN) Technical Committee CEN/CLC/JTC 3, Quality management and
corresponding general aspects for medical devices, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 80369-20:2015), which has been technically
revised.
The main changes are as follows:
— clarification that these test methods are also used by the ISO 18250 series;
— major technical revision of the test methods described in Annex B “Leakage by pressure decay test
method” and Annex D “Subatmospheric-pressure air leakage test method” (replacement of leakage rate
by the pressure change as acceptance criterion; definition of three defined mandatory test conditions;
more information about this change is included in Annex A);
— introduction of a new attributive test method “Air leakage during aspiration” as Annex K;
— editorial revision of the assembling procedures of a connector under test, affecting all annexes with test
methods;
— editorial update according to ISO/IEC Directives, Part 2;
— replacement of the terms “male” by “cone” and “female” by “socket” in the description of a connector;
— update of dated normative references;
— definition for type test has been updated;
— expansion of the range of environmental test conditions for relative humidity;

iv
ISO 80369-20:2024(en)
— extension of requirements for test reports;
— clarification that all tests are intended to be type tests.
A list of all parts in the ISO and IEC 80369
...