EN ISO 80369-20:2015

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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
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.
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
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
ISO 80369-20:2015(E)
© ISO 2015, Published in Switzerland
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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
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 c
...