SIST EN ISO 80369-20:2015

SLOVENSKI STANDARD
SIST EN ISO 80369-20:2015
01-september-2015
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GHO6SORãQHSUHVNXVQHPHWRGH,62
Small-bore connectors for liquids and gases in healthcare applications - Part 20:
Common test methods (ISO 80369-20:2015)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 20: Allgemeine Prüfverfahren (ISO 80369-20:2015)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
20: Méthodes d'essai courantes (ISO 80369-20:2015)
Ta slovenski standard je istoveten z: EN ISO 80369-20:2015
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 80369-20:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 80369-20:2015

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SIST EN ISO 80369-20:2015

EUROPEAN STANDARD
EN ISO 80369-20

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040.25
English Version
Small-bore connectors for liquids and gases in healthcare
applications - Part 20: Common test methods (ISO 80369-
20:2015)
Raccords de petite taille pour liquides et gaz utilisés dans le Verbindungsstücke mit kleinem Durchmesser für
domaine de la santé - Partie 20: Méthodes d'essai Flüssigkeiten und Gase in medizinischen Anwendungen -
communes (ISO 80369-20:2015) Teil 20: Allgemeine Prüfverfahren (ISO 80369-20:2015)
This European Standard was approved by CEN on 5 March 2015.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland, Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80369-20:2015 E
CEN/CENELE worldwide for CEN national Members and for CENELEC Members.
C

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SIST EN ISO 80369-20:2015
EN ISO 80369-20:2015 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this part of EN ISO 80369 and the essential
requirements of EU Directive 93/42/EEC .4
2

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SIST EN ISO 80369-20:2015
EN ISO 80369-20:2015 (E)
Foreword
This document (EN ISO 80369-20:2015) has been prepared by Technical Committee ISO/TC 210 “Quality
management and corresponding general aspects for medical devices” in collaboration with Technical
Committee CEN/CLC/TC 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 November 2015, and conflicting national standards shall be withdrawn
at the latest by November 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 80369-20:2015 has been approved by CEN as EN ISO 80369-20:2015 without any
modification.
3

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SIST EN ISO 80369-20:2015
EN ISO 80369-20:2015 (E)
Annex ZA
(informative)

Relationship between this part of EN ISO 80369 and the essential
requirements of EU Directive 93/42/EEC
This part of EN ISO 80369 has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means to conforming to essential requirements of the
New Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of
the member states concerning medical devices” (Medical Device Directive).
Once this part of EN ISO 80369 is cited in the Official Journal of the European Union under that directive and
has been implemented as a national standard in at least one member state, compliance with the clauses of
this document given in Table ZA.1 confers, within the limits of the scope of this part of EN ISO 80369, a
presumption of conformity with the corresponding essential requirements of that directive and associated
EFTA regulations.
Table ZA.1 — Correspondence between this part of EN ISO 80369 and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this Essential requirements (ERs) of
Qualifying remarks/notes
part of EN ISO 80369 EU Directive 93/42/EEC
4, Annex B, Annex C 7.5
4, Annex D 7.6
4, Annex F, Annex G, Annex H, 9.1
Annex I
4, Annex E 12.7.1
4 12.7.4
WARNING Other requirements and other EU Directives might be applicable to the products falling within the
scope of this part of EN ISO 80369.
For devices which are also machinery within the meaning of Directive 2006/42/EC on Machinery, Article 2(a),
in accordance with Directive 93/42/EEC, Article 3, the following Table ZA.2 details the relevant essential
health and safety requirements of Directive 2006/42/EC on Machinery to the extent to which they are more
specific than those of Directive 93/42/EEC along with the corresponding clauses of this part of EN ISO 80369.
Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus does
not provide presumption of conformity for the machinery directive.
Table ZA.2 — Relevant Essential Health and Safety Requirements (EHSRs) from Directive 2006/42/EC
on machinery that are addressed by this document
Clause(s)/sub-clause(s) of this EHSR of 2006/42/EC Qualifying remarks/notes
part of EN ISO 80369
4 1.5.4

4

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SIST EN ISO 80369-20:2015
INTERNATIONAL ISO
STANDARD 80369-20
First edition
2015-05-15
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

Reference number
ISO 80369-20:2015(E)

©
ISO 2015

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SIST EN ISO 80369-20:2015
ISO 80369-20:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
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
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Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved

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SIST EN ISO 80369-20:2015
ISO 80369-20:2015(E)

Contents Page
Foreword .iv
Introduction .v
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 (normative) *Leakage by pressure decay test method . 6
Annex C (normative) Falling drop positive-pressure liquid leakage test method .9
Annex D (normative) Subatmospheric-pressure air leakage test method .11
Annex E (normative) Stress cracking test method .15
Annex F (normative) Resistance to separation from axial load test method .17
Annex G (normative) Resistance to separation from unscrewing test method .19
Annex H (normative) Resistance to overriding test method .21
Annex I (normative) Disconnection by unscrewing test method .23
Annex J (informative) Modification of the test methods to generate variable data for
statistical analysis .25
Annex K (informative) Terminology — alphabetized index of defined terms .28
Bibliography .29
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SIST EN ISO 80369-20:2015
ISO 80369-20:2015(E)

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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT), see the following URL: Foreword — Supplementary information.
The committee responsible for this document is ISO/TC 210, Quality management and corresponding
general aspects for medical devices, and IEC/SC62D, Electromedical equipment. The draft was circulated
for voting to the national bodies of both ISO and IEC.
ISO 80369 consists of the following parts, under the general title Small-bore connectors for liquids and
gases in healthcare applications
— Part 1: General requirements
— Part 3: Connectors for enteral applications
— Part 5: Connectors for limb cuff inflation applications
— Part 6: Connectors for neuraxial applications
— Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
— Part 20: Common test methods
The following parts are under preparation:
— Part 2: Connectors for breathing systems and driving gases applications
An additional part on Connectors for urethral and urinary applications is planned.
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SIST EN ISO 80369-20:2015
ISO 80369-20:2015(E)

Introduction
In this part of ISO 80369, the following print types are used:
— requirements and definitions: roman type;
— informative material appearing outside of tables, such as notes, examples, and references: in smaller
type. Normative text of tables is also in a smaller type;
— terms defined in ISO 80369-1 and Clause 3: small capitals.
In this part of ISO 80369, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this International Standard conform to usage described in ISO/IEC Directives,
Part 2, Annex H. For the purposes of this part of ISO 80369, the auxiliary verb
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
part of ISO 80369,
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this part of ISO 80369, and
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.
The following paragraph is directed to authorities with jurisdiction and is not intended to address
clinical implementation.
The attention of Member Bodies and National Committees is drawn to the fact that equipment
manufacturers and testing organizations might need a transitional period following publication of a
new, amended or revised ISO or IEC publication in which to make products in accordance with the new
requirements and to equip themselves for conducting new or revised tests. It is the recommendation of
the committee that the content of this publication be adopted for implementation nationally not earlier
than three years from the date of publication for equipment newly designed and not earlier than five
years from the date of publication for equipment already in production.
This part of ISO 80369 describes the common test methods for evaluating the performance requirements
of the small-bore connectors specified in this series.
During the development of the ISO 80369- series, it became evident that many of the test methods were
very similar for each of the applications. It was therefore decided to standardize all the test methods
into a separate part of the series to prevent unnecessary duplication and minor differences. It is also
recognized that not all connectors can be evaluated using each test method in this part. The test
methods applicable to each connector are specified in the respective part of the ISO 80369- series.
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SIST EN ISO 80369-20:2015

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SIST EN ISO 80369-20:2015
INTERNATIONAL STANDARD ISO 80369-20:2015(E)
Small-bore connectors for liquids and gases in healthcare
applications —
Part 20:
Common test methods
1 *Scope
This part of ISO 80369 specifies the test methods to evaluate the performance requirements for small-
bore connectors specified in the ISO 80369- series.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
NOTE 2 Informative references are listed in the bibliography.
ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications — Part 1:
General requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 80369-1:2010, ISO 14971:2007,
and the following apply.
3.1
test method
definitive procedure for evaluating connectors that produces a test result
3.2
type test
test on a representative
[SOURCE: IEC 60601-1:2005, definition 3.135]
4 Test methods for small-bore connectors
Table 1 contains the list of test methods and their corresponding Annex included in this part of ISO 80369.
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SIST EN ISO 80369-20:2015
ISO 80369-20:2015(E)

Table 1 — Test methods and corresponding Annex of this part of ISO 80369
Test method Annex
Leakage by pressure decay Annex B
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
Modification of the test methods to generate variable data for statistical Annex J
analysis
NOTE Manufacturers can use the modified test methods of Annex J.
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SIST EN ISO 80369-20:2015
ISO 80369-20:2015(E)

Annex A
(informative)

Rationale and guidance
A.1 General guidance
This annex provides a rationale for some requirements of this part of ISO 80369 and is intended for
those who are familiar with the subject of this part of ISO 80369, but who have not participated in
its development. An understanding of the rationale underlying these requirements is considered to
be 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 part of ISO 80369
necessitated by those developments.
The committee attempted to harmonize the functional test methods for the connectors of each
application in this part of ISO 80369. The test method annexes in this part of ISO 80369 describe
a specific test procedure for a type test, but allow for modification to specific test conditions or
acceptance criteria as necessary for each application.
Many of the test methods in this part of ISO 80369 were extracted from the ISO 594- series of standards.
The committee attempted 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
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.
NOTE Manufacturer should also consider performing functional performance testing using a
representative sample of the SMALL BORE CONNECTOR being evaluated with a representative sample of
appropriate mating connectors.
A.2 Rationale for particular clauses and subclauses
The clauses and subclauses in this annex have been numbered to correspond to the numbering of the clauses
and subclauses of this part of ISO 80369 to which they refer. The numbering is, therefore, not consecutive.
Clause 1 Scope
The ease of assembly test method that was part of the ISO 594- series has been removed as a
requirement from the application parts of ISO 80369 and is not present in this part of ISO 80369. The
acceptance criterion of the 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 ISO 80369. Therefore, the ease of assembly test method has been omitted
from the ISO 80369- series of standards.
This part was given the −20 designation to leave space for connectors in new applications that might
be developed in the future using the numbers ISO 80369-8 through ISO 80369-19.
Subclause B.2, C.2, D.2, E.2, F.2, G.2, H.2, I.2 Test conditions
Subclause 2 in each test method includes preconditioning and environmental test requirements.
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SIST EN ISO 80369-20:2015
ISO 80369-20:2015(E)

Temperature and humidity preconditioning requirements from ISO 594-1 and ISO 594-2 also 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 temperature range specified for testing is identical to that specified in ISO 594-1 and ISO 594-2.
However, it is permitted to utilize different ranges if specified in the relevant application part of these
series of standards, to evaluate the performance of connectors exposed to heated solutions and
outdoor conditions.
Annex B Leakage by pressure decay test method
This pressure decay test method is a new test method that was not part of the former ISO 594- series.
However, it is based upon the informative liquid leakage test method of ISO 594-1:1986, Annex A.
Formula B.1
Formula B.1 utilized in this test method is derived from ISO 594-1:1986, Annex A. The following
paragraphs are a discussion of the derivation of Formula B.1 and practicalities of the usage of this formula.
Formula B.1 yields a leakage index as opposed to a more traditional leak rate (mass or volume over
time). In a common leak test, the leak rate is proportional to the applied pressure, requiring the initial
applied pressure to be tightly specified in order to compare results from one test to another. To eliminate
this discrepancy, Formula B.1 includes a term (1/t ) which normalizes the results, making all results
p
comparable to the requirement regardless of different initial applied pressures.
The results from Formula B.1 are approximated from a linear pressure versus time law instead of the
exact exponential relationship that occurs for a compressible fluid and rigid container. Because of this
derivation, the error between the exact and approximated pressure versus time equations is less than
4 % when the recorded pressure decay does not exceed 22 % of the starting pressure.
Formula B.1 neglects a temperature correction. Within the specified range of test condition temperatures,
15°C to 25°C, the error is less than ± 1 %, which is noticeably less than the expected variability range for
a common product, as well as the effects of the linear approximation for pressure decay.
In this test method the use of a compressible fluid, usually air or other gases, is preferable to liquids
because the test, when performed with fluids that are considered incompressible, is strongly biased by
the artifact of the elastic compliance of the components of the connection under test. In this case, the
true effect of the leaking orifice cannot be detected.
Annex C Falling drop positive-pressure liquid leakage test method
This liquid leakage test method is performed in the same manner as in the ISO 594- series.
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
former ISO 594- series. The ISO 594- series test method for subatmospheric-pressure (ISO 594-1, 5.3
and ISO 594-2, 5.3) creates an unspecified subatmospheric test pressure and asks the observer to look
for continued formation of bubbles of an unspecified size. The test method included in this part of
ISO 80369 was developed during the committee drafts of ISO 80369-2 and ISO 80369-6.
Formula D.1
See also rationale for Formula B.1.
Annex E Stress cracking test method
This stress cracking test method is performed in the same manner as in the ISO 594- series. The
acceptance criteria have been changed to require passing a functional leak test after the stress cracking
test has been performed.
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SIST EN ISO 80369-20:2015
ISO 80369-20:2015(E)

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
ISO 594- series. The title and principle have been elaborated to describe the intent of the test.
Annex G Resistance to separation from unscrewing test method
This resistance to separation from unscrewing test method is performed in the same manner as the
ISO 594- series. The title and principle have been elaborated to describe the intent of the test.
Annex H Resistance to overriding test method
This resistance to overriding test method is performed in the same manner as the ISO 594- series.
Annex I Disconnection by unscrewing test method
This disconnection by unscrewing test method replaces the test method described in the ISO 594-
series to account for locking, non-locking (slip) and rotating-collar connectors. It is intended to ensure
that connectors, which can be connected and disconnected multiple times per day, can be successfully
disconnected by the user.
Annex J Alternate test methods to generate variable data for statistical analysis
Multiple test methods in this part of ISO 80369 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 leak rate. Variable data test results determine the value at which
the connector fails, provide a numerical result that can be statistically analysed, and typically
...