SIST EN ISO 80369-20:2025

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
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
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 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

v
ISO 80369-20:2024(en)
Introduction
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
the conditions is true.
In this document, the following verbal forms are used.
— “Shall” indicates requirements.
— “Should” indicates recommendations.
— “May” indicates permissions.
— “Can” indicates possibility or capability.
This document uses italic type to distinguish defined terms from the rest of the text. It is important for the
correct understanding of this document that those defined terms are identifiable throughout the text of this
document. A list of the defined terms used in this document (in italics) is given in Annex M.
Requirements in this document have been broken down so that each requirement is clearly delineated and
listed individually. This has been done to support the common practice of automatic tracking of requirements
and automatic verification of the requirements of this document.
Annex A contains guidance and rationale on specific subclauses in this document.

vi
International Standard ISO 80369-20:2024(en)
Small-bore connectors for liquids and gases in healthcare
applications —
Part 20:
Common test methods
1 Scope
NOTE Clause A.2 contains guidance or rationale for this clause.
This document specifies the common test methods to evaluate the performance requirements for small-bore
connectors specified in the ISO and IEC 80369 series as well as the ISO 18250 series.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 14971:2019, Medical devices — Application of risk management to medical devices
1)
ISO 80369-1:— , Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
requirements
3 Terms and definitions
1)
For the purposes of this document, the terms and definitions given in ISO 80369-1:—, ISO 14971:2019, and
the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
NOTE For convenience, the sources of all defined terms that appear in italics in this document are given in
Annex M.
3.1
type test
test on a representative sample of the equipment with the objective of determining if the equipment, as
designed and manufactured, can meet the requirements of this document
[SOURCE: IEC 60601-1:2005, 3.135, modified — replaced “standard” with “document.”]
4 Test methods for small-bore connectors
Table 1 contains the list of test methods and their corresponding Annex included in this document. For
statistical analysis, test methods may be modified according to Annex J. The tests to evaluate the performance
1) Third edition under preparation. Stage at the time of publication: ISO/FDIS 80369-1:2024. The previous edition is
ISO 80369-1:2018.
ISO 80369-20:2024(en)
requirements for small-bore connectors specified in the ISO and IEC 80369 series and the connectors specified
in the ISO 18250 series described in this document are intended be performed as type tests.
NOTE 1 The application parts of the ISO and IEC 80369 series and the ISO 18250 series specify which tests given in
Table 1 are required as well as their acceptance criterion.
[8]
NOTE 2 This document has been prepared to address the relevant essential principles guidance of the
International Medical Devices Regulators Forum (IMDRF) as indicated in Annex L.
Table 1 — Test methods and corresponding Annex in this document
Test method Annex in this document
Leakage by pressure decay Annex B
Falling drop positive-pressure liquid leakage Annex C
Subatmospheric-pressure air leakage Annex D
Stress cracking Annex E
Resistance to separation from axial load Annex F
Resistance to separation from unscrewing Annex G
Resistance to overriding Annex H
Disconnection by unscrewing Annex I
Air leakage during aspiration Annex K

ISO 80369-20:2024(en)
Annex A
(informative)
Rationale and guidance
A.1 General guidance
This annex provides a rationale for some requirements of this document and is intended for those who
are familiar with the subject of this document, but who have not participated in its development. An
understanding of the rationales underlying these requirements is considered essential for their proper
application. Furthermore, as clinical practice and technology change, it is believed that a rationale for the
present requirements will facilitate any revision of this document necessitated by those developments.
An attempt was made to harmonize the functional test methods for the connectors of each application in
this document. The test method annexes in this document describe a specific test procedure but allow for
modification to specific test conditions or acceptance criterion as necessary for each application.
2)
Many of the test methods in this document were extracted from the withdrawn ISO 594 series of documents .
An attempt was made to minimize changes to these test methods. However, changes were made to test
methods which contained subjective acceptance criteria.
The assembly procedure in each annex mimics the assembly procedure that was extracted from the withdrawn
ISO 594. An additional clarification was made for connectors with a floating or rotatable locking collar. Test
sample preconditioning and environmental test condition requirements were added to each annex.
A.2 Rationale for particular clauses and subclauses
A.2.1 General
The numbering of the following rationales corresponds to the numbering of the clauses and subclauses of
this document. The numbering is, therefore, not consecutive.
A.2.2 Clause 1: Scope
The ease of assembly test method that was part of the withdrawn ISO 594 series has been removed as a
requirement from the application parts of the ISO and IEC 80369 series and is not present in this document.
The acceptance criterion of the withdrawn ISO 594 series for ease of assembly was subjective. It was
underdefined for a standardized test method, i.e. “a satisfactory fit” is not repeatable. Furthermore, the
intent of the ease of assembly test was to ensure that the user can complete the connection using the mating
halves of the connector. This requirement is satisfied by the requirement for usability validation for all new
connectors being added to the ISO and IEC 80369 series. Therefore, the ease of assembly test method has
been omitted from the ISO and IEC 80369 series.
A.2.3 Clauses B.2, C.2, D.2, E.2, F.2, G.2, H.2, I.2, K.2: Test conditions
Clause 2 in each test method includes preconditioning and environmental test requirements.
Temperature and humidity preconditioning requirements from the withdrawn ISO 594-1 and ISO 594-2 have
been added in the test methods for hygroscopic materials, as these materials are known to absorb moisture
from surrounding gases and liquids, which can alter physical characteristics, dimensions, and performance
of connectors. The impact of humidity and temperature for materials can be evaluated using manufacturing
data, material technical data or comparative study.
2) Withdrawn and replaced by ISO 80369-7.

ISO 80369-20:2024(en)
The temperature range specified for testing is identical to that specified in the withdrawn ISO 594-1 and
ISO 594-2. However, it is permitted to utilize different ranges if specified in the relevant application part of
the ISO and IEC 80369 series and the ISO 18250 series, to evaluate the performance of connectors exposed to
heated solutions and outdoor conditions.
A.2.4 Annex B: Leakage by pressure decay test method
This pressure decay test method is based upon the informative liquid leakage test method of the withdrawn
3)
ISO 594-1:1986, Annex A . The test method of the withdrawn ISO 594-1:1986, Annex A used an applied
pressure on the inside of the connection and the change of this pressure over time to describe a leak. To
describe the size of a leak, the leakage rate was calculated by the leakage rate formula. In the development of
this document, it was seen that the leakage rate formula is only applicable under very specific test conditions.
Some of the factors are the geometrical shape of the leak which is unknown and the type of gas flow which
can change during the test. In order to overcome the difficulty related to the test conditions, the evaluation
within the test method was modified. The leakage rate and the calculation of the leakage rate were taken
out of the test method and the pressure change itself is used as the acceptance criterion. This modification
allows to use the test method in a wider range of test conditions.
The test conditions specified include:
— start pressure;
— test period;
— test volume.
Values for these test conditions are not specified in Annex B. These values are individual for each connector
depending on their use case and the pressure change threshold. The documents referencing the test method
of Annex B state the values for these test conditions for each specified pressure change threshold.
A.2.5 Annex C: Falling drop positive-pressure liquid leakage test method
This liquid leakage test method is performed in the same manner as in the now withdrawn ISO 594-1:1986
and ISO 594-2:1998.
A.2.6 Annex D: Subatmospheric-pressure air leakage test method
This subatmospheric-pressure air leakage test method is a new test method that was not part of the
withdrawn ISO 594 series.
This test method is similar to the test method of Annex B. The difference is that the test method of Annex D
applies a subatmospheric pressure inside the connector while the test method of Annex B pressurizes the
inside of the connector. Allowing for this difference, the rationale for Annex B is also applicable for Annex D.
A.2.7 Annex E: Stress cracking test method
This stress cracking test method is performed in the same manner as in the withdrawn ISO 594 series. The
acceptance criteria have been changed to require passing a functional leak test after the stress cracking test
has been performed.
A.2.8 Annex F: Resistance to separation from axial load test method
This resistance to separation from axial load test method is performed in the same manner as in the
withdrawn ISO 594 series. The title and principle have been elaborated to describe the intent of the test.
A.2.9 Annex G: Resistance to separation from unscrewing test method
This resistance to separation from unscrewing test method is performed in the same manner as in the
withdrawn ISO 594 series. The title and principle have been elaborated to describe the intent of the test.
3) Withdrawn and replaced by ISO 80369-7.

ISO 80369-20:2024(en)
A.2.10 Annex H: Resistance to overriding test method
This resistance to overriding test method is performed in the same manner as in the withdrawn ISO 594 series.
A.2.11 Annex I: Disconnection by unscrewing test method
This test method is intended to ensure that connectors, which can be connected and disconnected multiple
times per day, can be successfully disconnected by the user.
A.2.12 Annex J: Alternate test methods to generate variable data for statistical analysis
Multiple test methods in this document are written as attribute data test methods that can be modified to
become variable data test methods.
Attribute data tests are more commonly known as pass/fail tests. Attribute data tests can only determine if
the specification is met. They provide no indication of how the connector fails and typically require a large
sample size to have the same statistical power as an equivalent variable data test.
Variable data tests are those tests that produce a quantifiable result such as the force required to separate
the connectors or the actual change in pressure. Variable data test results determine the value at which the
connector fails, provide a numerical result that can be statistically analysed, and typically require a smaller
sample size to have the same statistical power as equivalent attribute data test results.
A.2.13 Annex K: Air leakage during aspiration test method
This air leakage during aspiration test method is based on a test method in the withdrawn ISO 594 series. It
is based on visually detecting bubbles of leaking air passing through water. This test method was refined to
overcome some shortcomings of the test method in the withdrawn ISO 594 series.
The test method of Annex D is not suitable to cover the requirements for all connector use cases. When the
intent of the connection is to convey liquids, whatever is the nature of the liquid, the test method of Annex K
can be a better and more suitable test method than the subatmospheric pressure air leakage test method.

ISO 80369-20:2024(en)
Annex B
(informative)
Leakage by pressure decay test method
NOTE Clause A.2 contains guidance and rationale for this Annex.
B.1 Principle
The connector under test is assembled to an appropriate reference connector. Air is introduced into the
connection and pressurized for the test period to demonstrate that the pressure loss is not exceeded.
B.2 Test conditions
B.2.1 Test sample preconditioning
Prior to testing, precondition the connector under test at (20 ± 5) °C and (50 ± 10) % relative humidity (RH)
for not less than 24 h. Preconditioning need not be performed for a connector made from non-hygroscopic
materials.
B.2.2 Environmental test conditions
Perform tests at a temperature within the range of 15 °C to 30 °C and at a RH between 10 % and 70 %,
unless other ranges are specified in the relevant application part of the ISO and IEC 80369 series and the
ISO 18250 series.
B.3 Apparatus
The following shall be used (see Figure B.1).
B.3.1 Connector, under test.
B.3.2 Appropriate reference connector, as specified in the relevant application part of the ISO 80369
series and the ISO 18250 series for the leakage test method, to be assembled to the connector under test.
B.3.3 A means to simultaneously apply an axial force of 27,5 N and torque of 0,12 N·m, or more if required
by the relevant application part of the ISO and IEC 80369 series and the ISO 18250 series.
B.3.4 A means to contain and pressurize air to the specified test pressure. Pressures specified in the
application parts of the ISO and IEC 80369 series and the ISO 18250 series are gauge pressures.
B.3.5 A means of measuring and displaying the elapsed time with an accuracy of ± 1 s.
B.3.6 A means of measuring the applied gauge pressure with an accuracy of ± 0,3 % of the applied
pressure.
B.3.7 A means to achieve the test volume specified in the relevant application part of the ISO 80369 series
and the ISO 18250 series.
ISO 80369-20:2024(en)
NOTE The test volume is the total volume of the connected system under pressure or vacuum, including small-
bore connector and measuring equipment. Potential methods to determine the test volume can be based on e.g. a
dimensional calculation or a measurement of the amount of water that the connected system can hold or a combination
of these.
B.3.8 A stop valve.
B.3.9 A means to seal the connector under test at its open end.
An automated pressure decay leak test system may be substituted for any or all items B.3.4, B.3.5, B.3.6,
B.3.7, B.3.8.
Key
1 means to seal the connector under test
2 connector under test
3 appropriate reference connector
4 stop-valve
5 pressure source
6 pressure-measuring device, e.g. a manometer
7 test volume
8 means to achieve the test volume
Apparatus shall be made of a material that is sufficiently rigid to provide accurate and repeatable test results.
Figure B.1 — Example test apparatus for leakage by pressure decay
B.4 Procedure
a) Seal the through bore of the connector under test prior to step c).
b) Assemble the connector under test to the appropriate reference connector, both connectors being dry, as
follows, unless otherwise specified in the relevant application part of the ISO and IEC 80369 series or
ISO 18250 series.
1) For a non-locking (slip) connector, assemble by applying an axial force of between 26,5 N and 27,5 N.
Then, while continuing to apply the axial force, rotate the connector under test with a torque not
exceeding 0,10 N·m to give a rotation not exceeding 90°. Hold the force and torque for 5 s to 6 s and
then release.
ISO 80369-20:2024(en)
2) For a locking connector, assemble by rotating the collar of the connector under test to a torque of
between 0,08 N·m and 0,12 N·m. Then, while continuing to apply the torque, apply an axial force of
between 26,5 N and 27,5 N. Hold the force and torque for 5 s to 6 s and then release.
c) Apply the pressure specified in the relevant application part of the ISO and IEC 80369 series and the
ISO 18250 series and close the valve.
d) Record the starting pressure and start the timing device.
e) After the test period specified in the relevant application part of the ISO and IEC 80369 series and the
ISO 18250 series, record the end pressure and the elapsed time.
f) Calculate the difference between end pressure and start pressure.
g) Determine whether the change in pressure as an absolute value exceeds the value specified in the
relevant application part of the ISO and IEC 80369 series and the ISO 18250 series.
B.5 Test report
Prepare a test report that:
a) specifies testing was performed according to this document (i.e. ISO 80369-20:2024, Annex B);
b) identifies the date of the testing;
c) identifies the connectors under test;
d) identifies the number of connectors tested;
e) identifies the preconditioning and environmental test conditions;
f) identifies the reference connector used;
g) identifies the applied pressure used;
h) identifies the acceptance criterion;
i) identifies any deviations from the procedure;
j) identifies any unusual features observed;
k) identifies the test volume used as defined in Figure B.1;
l) discloses the test period;
m) discloses the pressure change during the test period according to Clause B.4, f);
n) discloses whether the acceptance criterion is met.

ISO 80369-20:2024(en)
Annex C
(informative)
Falling drop positive-pressure liquid leakage test method
NOTE Clause A.2 contains guidance and rationale for this Annex.
C.1 Principle
A connector is assembled to a reference connector. Water is introduced into the connection and pressurized
for the test period to demonstrate that no water leaks from the connection.
C.2 Test conditions
C.2.1 Test sample preconditioning
Prior to testing, precondition the connectors under test at (20 ± 5) °C and (50 ± 10) % RH for not less than
24 h. Preconditioning need not be performed for a connector made from non-hygroscopic materials.
C.2.2 Environmental test conditions
Perform tests at a temperature within the range of 15 °C to 30 °C and at a RH between 10 % and 70 %,
unless other ranges are specified in the relevant application part of the ISO and IEC 80369 series and the
ISO 18250 series.
C.3 Apparatus
The following shall be used.
C.3.1 Connector, under test.
C.3.2 Appropriate reference connector, as specified in the relevant application part of the ISO 80369
series and the ISO 18250 series for the leakage test method, to be assembled to the connector under test.
C.3.3 A means to simultaneously apply an axial force of 27,5 N and torque of 0,12 N·m, or more if required
by the relevant application part of the ISO and IEC 80369 series and the ISO 18250 series.
C.3.4 A means to contain pressurized water and maintain the specified test pressure.
C.3.5 A means of measuring the applied pressure with a minimum accuracy of ± 0,3 % of the applied
pressure.
C.3.6 A means of measuring and displaying the elapsed time with an accuracy of ± 1 s.
C.3.7 Distilled or potable water. The water may be dyed with methylene blue.

ISO 80369-20:2024(en)
C.4 Procedure
a) Assemble the connector under test to the appropriate cone or socket reference connector, both connectors
being dry.
1) For a non-locking (slip) connector, assemble by applying an axial force of between 26,5 N and 27,5 N.
Then, while continuing to apply the axial force, rotate the connector under test with a torque not
exceeding 0,10 N·m to give a rotation not exceeding 90°. Hold the force and torque for 5 s to 6 s and
then release.
2) For a locking connector, assemble by rotating the collar of the connector under test to a torque of
between 0,08 N·m and 0,12 N·m. Then, while continuing to apply the torque, apply an axial force of
between 26,5 N and 27,5 N. Hold the force and torque for 5 s to 6 s and then release.
b) Introduce water into the assembly to expel the air.
c) Ensure that the outside of the connector assembly is dry.
d) With the axis of assembled connectors horizontal, seal the assembly outlet and increase the internal
water pressure to the applied pressure specified in the relevant application part of the ISO 80369 series
and the ISO 18250 series.
e) Maintain the pressure for the test period specified in the relevant application part of the ISO 80369 series
and the ISO 18250 series while maintaining the assembled connectors in the horizontal orientation.
f) Visually inspect for a falling drop of water from the connection during the specified test period.
C.5 Test report
Prepare a test report that:
a) specifies testing was performed according to this document (i.e. ISO 80369-20:2024, Annex C);
b) identifies the date of the testing;
c) identifies the connectors under test;
d) identifies the number of connectors tested;
e) identifies the preconditioning and environmental test conditions;
f) identifies the reference connector used;
g) identifies the acceptance criterion;
h) identifies any deviations from the procedure;
i) identifies any unusual features observed;
j) discloses the pressure range during the test period;
k) discloses the test period;
l) discloses the presence or absence of a falling drop of water within the specified test period according to
Clause C.4, f).
ISO 80369-20:2024(en)
Annex D
(informative)
Subatmospheric-pressure air leakage test method
NOTE Clause A.2 contains guidance and rationale for this Annex.
D.1 Principle
Air leakage during aspiration in a connector assembly is tested by measuring the change in subatmospheric
pressure over time after the vacuum pressure is applied to the bore of the connector. The relevant application
part of the ISO and IEC 80369 series and the ISO 18250 series specifies the test conditions (e.g. the test
volume, the test period, the start pressure and the acceptance criterion, i.e. the maximum pressure change).
D.2 Test conditions
D.2.1 Test sample preconditioning
Prior to testing, precondition the connector under test at (20 ± 5) °C and (50 ± 10) % RH for not less than
24 h. Preconditioning need not be performed for a connector made from non-hygroscopic materials.
D.2.2 Environmental test conditions
Perform tests at a temperature within the range of 15 °C to 30 °C and at a RH between 10 % and 70 %,
unless other ranges are specified in the relevant application part of the ISO and IEC 80369 series and the
ISO 18250 series.
D.3 Apparatus
The following shall be used (see Figure D.1).
D.3.1 Connector, under test.
D.3.2 Appropriate reference connector, as specified in the relevant application part of the ISO 80369
series and the ISO 18250 series for the leakage test method, to be assembled to the connector under test.
D.3.3 A means to simultaneously apply an axial force of 27,5 N and torque of 0,12 N·m, or more if required
by the relevant application part of the ISO and IEC 80369 series and the ISO 18250 series.
D.3.4 Vacuum source. Pressures specified in the application parts of the ISO and IEC 80369 series and the
ISO 18250 series are gauge pressures. Rigid fixtures and apparatus materials (e.g. metal) should be used to
achieve accurate and repeatable test results.
At high altitudes the specified subatmospheric pressure are not always achievable. In this case measures
shall be taken to increase the ambient pressure around the connector under test.
D.3.5 A means of measuring and displaying the elapsed time with an accuracy of ± 1 s.
D.3.6 A means of measuring the applied subatmospheric pressure with an accuracy of ± 0,3 % of the
applied pressure.
ISO 80369-20:2024(en)
D.3.7 A means to achieve the test volume specified in the relevant application part of the ISO and IEC 80369
series and the ISO 18250 series.
NOTE The test volume is the total volume of the connected system under pressure or vacuum, including small-
bore connector and measuring equipment. Potential methods to determine the test volume can be based on, e.g. a
dimensional calculation or a measurement of the amount of water that the connected system can hold or a combination
of these.
D.3.8 Stop valve.
D.3.9 A means to seal the connector under test at its open end.
An automated pressure decay leak test system may be substituted for any or all items D.3.4, D.3.5, D.3.6,
D.3.7, D.3.8.
Key
1 means to seal the connector under test
2 connector under test
3 appropriate reference connector
4 stop-valve
5 vacuum source
6 pressure-measuring device, e.g. a manometer
7 test volume
8 means to achieve the test volume
Apparatus shall be made of a material that is sufficiently rigid to provide accurate and repeatable test results.
Figure D.1 — Example of test apparatus for subatmospheric-pressure air leakage
D.4 Procedure
a) Seal the through bore of the connector under test prior to step c).
b) Assemble the connector under test to the appropriate cone or socket reference connector, both connectors
being dry.
1) For a non-locking (slip) connector, assemble by applying an axial force of between 26,5 N and 27,5 N.
Then, while continuing to apply the axial force, rotate the connector under test with a torque not

ISO 80369-20:2024(en)
exceeding 0,10 N·m to give a rotation not exceeding 90°. Hold the force and torque for 5 s to 6 s and
then release.
2) For a locking connector, assemble by rotating the collar of the connector under test to a torque of
between 0,08 N·m and 0,12 N·m. Then, while continuing to apply the torque, apply an axial force of
between 26,5 N and 27,5 N. Hold the force and torque for 5 s to 6 s and then release.
c) Apply the subatmospheric pressure specified in the relevant application part of the ISO and IEC 80369
series and the ISO 18250 series and close the valve.
d) Record the starting pressure and start the timing device.
e) After the test period specified in the relevant application part of the ISO and IEC 80369 series and the
ISO 18250 series, record the end pressure and the elapsed time.
f) Calculate the difference between end pressure and start pressure.
g) Determine whether the change in pressure as an absolute value exceeds the value specified in the
relevant application part of the ISO and IEC 80369 series and the ISO 18250 series.
D.5 Test report
Prepare a test report that:
a) specifies testing was performed according to this document (i.e. ISO 80369-20:2024 Annex D);
b) identifies the date of the testing;
c) identifies the connectors under test;
d) identifies the number of connectors tested;
e) identifies the preconditioning and environmental test conditions;
f) identifies the reference connector used;
g) identifies the acceptance criterion;
h) identifies any deviations from the procedure;
i) identifies any unusual features observed;
j) identifies the test volume as defined in Figure D.1;
k) discloses the test period;
l) discloses the pressure change during the test period according to Clause D.4, f);
m) discloses whether the acceptance criterion is met.

ISO 80369-20:2024(en)
Annex E
(informative)
Stress cracking test method
NOTE Clause A.2 contains guidance and rationale
...