SIST EN ISO 80369-1:2013

Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

This part of ISO 80369 specifies general requirements for SMALL-BORE CONNECTORS, which convey liquids or gases in healthcare APPLICATIONS. These SMALL-BORE CONNECTORS are used in MEDICAL DEVICES or ACCESSORIES intended for use with a PATIENT. This International Standard also specifies the healthcare fields in which these SMALL-BORE CONNECTORS are intended to be used. These healthcare fields of use include, but are not limited to, APPLICATIONS for:
- BREATHING SYSTEMS and driving gases,
- enteral and gastric,
- urethral and urinary,
- limb cuff inflation,
- neuraxial devices, and
- intravascular or hypodermic.
SMALL-BORE CONNECTORS as specified in this International Standard are NON-INTERCONNECTABLE with:
- the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006;
- the temperature sensor CONNECTOR and mating ports specified in Annex DD of ISO 8185:2007; and
- the nipples of EN 13544-2:2002.
This International Standard provides the methodology to assess NON-INTERCONNECTABLE characteristics of
SMALL-BORE CONNECTORS based on their inherent design and dimensions in order to reduce the RISK of
misconnections between MEDICAL DEVICES or between ACCESSORIES for different APPLICATIONS and to reduce the RISK of misconnections between MEDICAL DEVICES with 6 % Luer CONNECTORS, and all other non-Luer CONNECTORS that will be developed under future parts of this series of standards.
It does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these SMALL-BORE
CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES.
NOTE 1 It is intended that new designs of SMALL-BORE CONNECTORS will be included in this series of standards after they have been assessed according to the PROCEDURE given in Clause 6.
NOTE 2 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this series of
standards into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular MEDICAL DEVICE standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised, requirements for SMALL-BORE CONNECTORS as specified in the series of standards will be included.
NOTE 3 MANUFACTURERS and RESPONSIBLE ORGANIZATIONS are encouraged to report their experience with the SMALLBORE CONNECTORS specified in this series of standards to the Secretariat of ISO/TC 210 to consider this feedback during the revision of the relevant part of this series of standards.

Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen

Dieser Teil von ISO 80369 legt allgemeine Anforderungen für Verbindungsstücke mit kleinem Durchmesser
fest, die Flüssigkeiten oder Gase in Anwendungen der medizinischen Versorgung führen. Diese
Verbindungsstücke mit kleinem Durchmesser werden in Medizinprodukten oder in Zubehörteilen zur
Anwendung am Patienten eingesetzt.
Diese Internationale Norm legt auch die medizinischen Bereiche fest, für die diese Verbindungsstücke mit
kleinem Durchmesser zweckbestimmt sind.
Diese Anwendungsbereiche in der medizinischen Versorgung umfassen, sind jedoch nicht beschränkt auf
Anwendungen für
⎯ Atemsysteme und Antriebsgase,
⎯ enterale und gastrische Anwendungen,
⎯ urethrale und urologische Anwendungen,
⎯ Anwendungen mit aufblasbaren Manschetten für Gliedmaßen
⎯ neuroaxiale Produkte und
⎯ intravaskuläre oder hypodermische Anwendungen.
Verbindungsstücke mit kleinem Durchmesser nach den Festlegungen in dieser Internationalen Norm sind
nicht miteinander verbindbar mit:
⎯ den männlichen und weiblichen Konen der ISO 5356-1:2004 und ISO 5356-2:2006;
⎯ dem Temperaturfühler-Verbindungsstück und den passenden Anschlüssen nach ISO 8185:2007,
Anhang DD; und
⎯ den Nippeln der EN 13544-2:2002.
Diese Internationale Norm liefert die Methodologie, um die Merkmale der nicht miteinander Verbindbarkeit von
Verbindungsstücken mit kleinem Durchmesser auf der Grundlage ihrer Ausführung und Maße zu beurteilen,
um das Risiko von Verbindungsfehlern zwischen Medizinprodukten oder zwischen den Zubehörteilen für
unterschiedliche Anwendungen zu verringern und um das Risiko von Verbindungsfehlern zwischen
Medizinprodukten mit 6 %-Luer-Verbindungsstücken und allen anderen Nicht-Luer(6 %)-Verbindungsstücken
zu verringern, die unter zukünftigen Teilen dieser Normenreihe entwickelt werden.

Joints de petite dimension pour liquides et gaz pour des applications en santé - Partie 1: Exigences générales

L'ISO 80369-1:2010 spécifie les exigences générales pour les raccords de petite taille, qui conduisent des liquides ou des gaz dans le domaine de la santé. Ces raccords de petite taille sont utilisés dans les dispositifs médicaux ou les accessoires destinés à être employés avec un patient.
L'ISO 80369-1:2010 spécifie également les domaines de la santé dans lesquels ces raccords de petite taille sont destinés à être employés.
Ces domaines comprennent, mais sans s'y limiter, les applications suivantes:
systèmes respiratoires et gaz d'entraînement;
dispositifs entéraux et gastriques;
dispositifs urétraux et urinaires;
gonflage de brassards et de cuissards;
dispositifs en contact avec le système nerveux; et
applications intravasculaires ou hypodermiques.
Les raccords de petite taille tels que spécifiés dans la présente Norme internationale sont non raccordables avec
les raccords mâles et femelles de l'ISO 5356-1:2004 et de l'ISO 5356-2:2006,
le raccord de sonde de température et les ports de raccordement spécifiés dans l'Annexe DD de l'ISO 8185:2007,
les embouts de l'EN 13544-2:2002.
L'ISO 80369-1:2010 indique la méthodologie pour l'évaluation des caractéristiques de non‑raccordabilité des raccords de petite taille en s'appuyant sur leur conception et leurs dimensions inhérentes afin de réduire le risque d'erreur de raccordement entre les dispositifs médicaux ou entre les accessoires destinés à différentes applications et pour réduire le risque d'erreur de raccordement entre les dispositifs médicaux avec des raccords Luer à 6 % et tous les autres raccords (à 6 %) qui seront développés dans les futures parties de la présente série de normes.
Elle ne spécifie pas les exigences pour les dispositifs médicaux ou les accessoires utilisant ces raccords de petite taille. Ces exigences figurent dans les Normes internationales traitant des dispositifs médicaux ou des accessoires.

Konektorji z majhnim premerom za tekočine in pline za medicinsko uporabo - 1. del: Splošne zahteve

Ta del standarda ISO 80369 določa splošne zahteve za KONEKTORJE Z MAJHNIM PREMEROM, ki se uporabljajo za prenos tekočin in plinov, za medicinsko UPORABO. Ti KONEKTORJI Z MAJHNIM PREMEROM se uporabljajo v MEDICINSKIH PRIPOMOČKIH ali OPREMI, predvideni za uporabo s PACIENTOM. Ta mednarodni standard tudi določa področja v medicini, na katerih je predvidena uporaba teh KONEKTORJEV Z MAJHNIM PREMEROM. Ta področja v medicini vključujejo v nadaljevanju navedene UPORABE, vendar niso omejena nanje:
– SISTEMI ZA VDIHAVANJE in pogonski plini,
– enteralne in gastrične,
– uretralne in uropoetske,
– polnjenje manšet,
– nevraksialni pripomočki in
– intravaskularne ali hipodermične.
KONEKTORJI Z MAJHNIM PREMEROM, kot so opredeljeni v tem mednarodnem standardu, so MEDSEBOJNO NEPOVEZLJIVI z naslednjimi elementi:
– stožci in vtičnice iz standardov ISO 5356-1:2004 in ISO 5356-2:2006;
– PRIKLJUČEK in stikalni vhodi, določeni v dodatku DD standarda ISO 8185:2007; in
– priključki iz EN 13544-2:2002.
Ta mednarodni standard podaja metodologijo za ocenjevanje lastnosti MEDSEBOJNE NEPOVEZLJIVOSTI KONEKTORJEV Z MAJHNIM PREMEROM na podlagi njihove temeljne oblike in dimenzij, z namenom zmanjševanja TVEGANJ za napačno povezovanje MEDICINSKIH PRIPOMOČKOV ali OPREME, kar zadeva namene UPORABE, in zmanjševanja TVEGANJ za napačno povezovanje MEDICINSKIH PRIPOMOČKOV s KONEKTORJI Luer 6 % in tistih s kakršnimi koli KONEKTORJI, ki niso vrste Luer in bodo pripravljeni v okviru prihodnjih delov te skupine standardov.
Standard ne določa zahtev za MEDICINSKE PRIPOMOČKE ali OPREMO, v katerih se uporabljajo ti KONEKTORJI Z MAJHNIM PREMEROM. Takšne zadeve so podane v zadevnih mednarodnih standardih za posamezne MEDICINSKE PRIPOMOČKE ali OPREMO.
OPOMBA 1: Predvideno je, da se bodo novi modeli KONEKTORJEV Z MAJHNIM PREMEROM vključili v to skupino standardov po opravljenem ocenjevanju po POSTOPKU, podanem v točki 6.
OPOMBA 2: PROIZVAJALCEM se priporoča, da vključijo KONEKTORJE Z MAJHNIM PREMEROM, določene v tej skupini standardov, v MEDICINSKE PRIPOMOČKE, medicinske sisteme ali OPREMO, čeprav tega zadevni posamezni standardi za MEDICINSKE PRIPOMOČKE trenutno ne zahtevajo. Predvideva se, da bodo ob reviziji zadevnih posameznih standardov za MEDICINSKE PRIPOMOČKE vanje vključene zahteve za KONEKTORJE Z MAJHNIM PREMEROM, kot so določene v skupini standardov.
OPOMBA 3: PROIZVAJALCEM in ODGOVORNIM ORGANIZACIJAM se priporoča, da poročajo o izkušnjah s KONEKTORJI Z MAJHNIM PREMEROM, določenih v tej skupini standardov, sekretariatu ISO/TC 210, ki bo povratne informacije upošteval ob reviziji zadevnega dela te skupine standardov.

General Information

• Status: Withdrawn
• Publication Date: 30-Jul-2013
• Withdrawal Date: 20-Dec-2015
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 18-Aug-2015
• Due Date: 10-Sep-2015
• Completion Date: 21-Dec-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 80369-1:2010 - Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)

Relations

• Replaced By: SIST EN ISO 80369-1:2011 - Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
• Effective Date: 18-Dec-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 80369-1:2013
01-september-2013
.RQHNWRUML]PDMKQLPSUHPHURP]DWHNRþLQHLQSOLQH]DPHGLFLQVNRXSRUDER
GHO6SORãQH]DKWHYH
Small bore connectors for liquids and gases in healthcare applications - Part 1: General
requirements
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen
Joints de petite dimension pour liquides et gaz pour des applications en santé - Partie 1:
Exigences générales
Ta slovenski standard je istoveten z: EN ISO 80369-1:2010
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 80369-1:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 80369-1:2013

---------------------- Page: 2 ----------------------

SIST EN ISO 80369-1:2013


EUROPEAN STANDARD
EN ISO 80369-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
December 2010
ICS 11.040.10; 11.040.20 Supersedes EN 15546-1:2008
English version
Small bore connectors for liquids and gases in healthcare
applications - Part 1: General requirements (ISO 80369-1:2010)
Raccords de petite taille pour liquides et gaz utilisés dans Verbindungsstücke mit kleinem Durchmesser für
le domaine de la santé - Partie 1: Exigences générales Flüssigkeiten und Gase in medizinischen Anwendungen -
(ISO 80369-1:2010) Teil 1: Allgemeine Anforderungen (ISO 80369-1:2010)
This European Standard was approved by CEN on 14 December 2010.

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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.






CEN Management Centre: CENELEC Central Secretariat:
Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels
© 2010 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80369-1:2010 E
worldwide for CEN national Members and for CENELEC
Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 80369-1:2013
EN ISO 80369-1:2010 (E)
Contents Page
Foreword .3
Annex ZA .5

2

---------------------- Page: 4 ----------------------

SIST EN ISO 80369-1:2013
EN ISO 80369-1:2010 (E)
Foreword
This document (EN ISO 80369-1:2010) 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 June 2011, and conflicting national standards shall be withdrawn at
the latest by June 2011.
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 supersedes EN 15546-1:2008.
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.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
Compared to EN 15546-1:2008 the following changes were implemented:
a) Clause 3 "Terms and definitions" has been editorially revised and amended by the terms "accessory",
"breathing system", "non-interconnectable", "patient" and "responsible organization". The terms "risk" and
"safety" have been cancelled and replaced by a general reference to the appropriate terms given in EN
ISO 14971 and IEC 62366;
b) Clause 4 on materials has been amended by a reference to two ASTM standards for tests on conformity;
c) Clause 5 on the requirements has been completely revised and amended by a sub-section on
incompatibility;
d) A new Clause 6 on additional applications has been added;
e) Clause 7 (respectively Clause 6 in EN 15546-1) on the assessment of new designs (validation) has been
completely revised, more detailed in the structure and amended. Especially the sections on the proposal
initiation (7.2) and on the procedure to assess acceptability and non-interconnectable characteristics (7.3)
have been stated more detailed;
f) Annex A "Rationale" has been completely revised by providing the reasons for this standard by clauses.
In addition the Table A.1 on risk analysis of possible misconnections has been cancelled;
g) A new Annex B "Mechanical tests for verifying non-interconnectable characteristics" has been added;
h) Annex C "Applications" (respectively Clause B in EN 15546-1) has been editorially revised;
i) Annex C "Small bore connectors for vascular systems applications" of EN 15546-1 has been cancelled;
j) A new Annex D "Reference to the Essential Principles" according ISO/TR 16142 has been added;
k) Annex ZA on the relationship to the Medical Device Directive (93/42/EWG) has been aligned;
l) The Bibliography has been updated and amended;
3

---------------------- Page: 5 ----------------------

SIST EN ISO 80369-1:2013
EN ISO 80369-1:2010 (E)
m) A new clause Terminology has been added at the end of the standard;
n) Editorial revision in alignment with the overtaking of the original European Standard into an International
Standard.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 80369-1:2010 has been approved by CEN as a EN ISO 80369-1:2010 without any
modification.
4

---------------------- Page: 6 ----------------------

SIST EN ISO 80369-1:2013
EN ISO 80369-1:2010 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Union and the
European Free Trade Association to provide a means to conforming to Essential Requirements of the New
576 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 document 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, within the limits of the scope of this document, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Corresponding Essential
Clause/subclause
Requirement Qualifying remarks/notes
of this Document
of Directive 93/42/EEC
all 1, 2
4, 5 7.5, 7.6, 9.1, 12.7.4
6 6 a, 7.5, 7.6, 9.1, 12.7.4
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
585 scope of this International Standard.
5

---------------------- Page: 7 ----------------------

SIST EN ISO 80369-1:2013

---------------------- Page: 8 ----------------------

SIST EN ISO 80369-1:2013

INTERNATIONAL ISO
STANDARD 80369-1
First edition
2010-12-15

Small-bore connectors for liquids and
gases in healthcare applications —
Part 1:
General requirements
Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 1: Exigences générales




Reference number
ISO 80369-1:2010(E)
©
ISO 2010

---------------------- Page: 9 ----------------------

SIST EN ISO 80369-1:2013
ISO 80369-1:2010(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

COPYRIGHT PROTECTED DOCUMENT


©  ISO 2010
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing 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 [e-mail]
Web www.iso.org
Published in Switzerland

ii © ISO 2010 – All rights reserved

---------------------- Page: 10 ----------------------

SIST EN ISO 80369-1:2013
ISO 80369-1:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.2
3 Terms and definitions .2
4 Materials used for SMALL-BORE CONNECTORS.3
5 Requirements for SMALL-BORE CONNECTORS for specific APPLICATIONS.4
5.1 SMALL-BORE CONNECTOR incompatibility.4
5.2 BREATHING SYSTEMS and driving gases APPLICATIONS.4
5.3 Enteral and gastric APPLICATIONS.4
5.4 Urethral and urinary APPLICATIONS.4
5.5 Limb cuff inflation APPLICATIONS.4
5.6 Neuraxial APPLICATIONS.5
5.7 Intravascular or hypodermic APPLICATIONS .5
5.8 Alternative SMALL-BORE CONNECTORS .5
6 Additional SMALL-BORE CONNECTOR APPLICATIONS.5
7 PROCEDURE to assess a proposed new design of SMALL-BORE CONNECTOR for inclusion in
this series of standards .6
7.1 General .6
7.2 Proposal initiation .6
7.3 PROCEDURE to assess acceptability and NON-INTERCONNECTABLE characteristics.6
7.3.1 Design.6
7.3.2 Design realization.6
7.3.3 Design VERIFICATION .7
7.3.4 Design validation.7
7.4 Design review .7
7.5 Subsequent parts of this series of standards .7
Annex A (informative) Rationale.8
Annex B (normative) Mechanical tests for verifying NON-INTERCONNECTABLE characteristics.11
Annex C (informative) APPLICATIONS of SMALL-BORE CONNECTORS .12
Annex D (informative) Reference to the Essential Principles .14
Bibliography.16
Terminology – Alphabetized index of defined terms.17

© ISO 2010 – All rights reserved iii

---------------------- Page: 11 ----------------------

SIST EN ISO 80369-1:2013
ISO 80369-1:2010(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 80369-1 was prepared by a Joint Working Group of Technical Committee ISO/TC 210, Quality
management and corresponding general aspects for medical devices, IEC/TC 62, Electrical equipment,
Subcommittee SC D, Electrical equipment in medical practice and CEN/CENELEC TC 3/WG 2, Small-bore
connectors.
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
The following parts are under preparation:
⎯ Part 2: Connectors for breathing systems and driving gases applications
⎯ Part 3: Connectors for enteral applications
⎯ Part 4: Connectors for urethral and urinary applications
⎯ Part 5: Connectors for limb cuff inflation applications
⎯ Part 6: Connectors for neuraxial applications
⎯ Part 7: Connectors for intravascular or hypodermic applications
iv © ISO 2010 – All rights reserved

---------------------- Page: 12 ----------------------

SIST EN ISO 80369-1:2013
ISO 80369-1:2010(E)
Introduction
In the 1990s concern grew regarding the proliferation of MEDICAL DEVICES fitted with Luer CONNECTORS and the
reports of PATIENT death or injury arising from misconnections that resulted in the inappropriate delivery of
enteral solutions, intrathecal medication or compressed gases.
Concerns regarding the use of Luer CONNECTORS with enteral feeding tubes and gas sampling and gas
delivery systems were raised with CEN/BT and the European Commission. In November 1997 the newly
created CHeF steering group set up a Forum Task Group (FTG) to consider the problem.
The FTG produced CEN Report CR 13825, in which they concluded that there is a problem arising from the
use of a single CONNECTOR design to a number of incompatible APPLICATIONS. In a coronary care unit there are
as many as 40 Luer CONNECTORS on the MEDICAL DEVICES used with a single PATIENT. Therefore it is not
surprising that misconnections are made.
MEDICAL DEVICES have for many years followed the established principle of “safety under single fault
conditions”. Simply stated this means that a single fault should not result in an unacceptable RISK. This
principle is embodied in the requirements of numerous MEDICAL DEVICE standards. Extending this principle to
the application of Luer CONNECTORS, i.e. that misconnection should not result in an unacceptable RISK to a
PATIENT, the FTG recommended that the Luer CONNECTOR should be restricted to MEDICAL DEVICES intended to
be connected to the vascular system or a hypodermic syringe. In addition, new designs of SMALL-BORE
CONNECTORS should be developed for other APPLICATIONS, and these should be NON-INTERCONNECTABLE with
Luer CONNECTORS and each other.
ISO/TR 16142:2006 addresses this type of problem in Essential Principle A.1.2:
The solutions adopted by the manufacturer for the design and construction of the devices should
conform to safety principles, taking into account the generally acknowledged state of the art.
In selecting the most appropriate solutions, the manufacturer should apply the following principles
in the following order:
— identify hazards and the associated risks arising from the intended use and foreseeable
misuse;
— eliminate or reduce risks as far as possible (inherently safe design and construction);
It is understood that SMALL-BORE CONNECTOR systems cannot be designed to overcome all chances of
misconnection or to eliminate deliberate misuse. However, a number of steps that would improve the current
situation and lead to greater PATIENT safety can be taken. This will only be achieved through a long-term
commitment involving industry, healthcare professionals, MEDICAL DEVICE purchasers and MEDICAL DEVICE
regulatory authorities.
This is the first edition of ISO 80369-1 and it cancels and replaces EN 15546-1:2008 which has been
editorially revised.
Part 1 of this International Standard and its parts are intended to be the reference documents in which the
necessary measures and PROCEDURES to prevent misconnection between SMALL-BORE CONNECTORS used in
different APPLICATIONS and designs of SMALL-BORE CONNECTORS for APPLICATIONS are listed. The JWG of
ISO/TC 210 – IEC 62D and CEN/CENELEC TC 3/WG 2 is developing this series of standards in such a way
that ISO 80369-1 includes general requirements to prevent misconnections between SMALL-BORE CONNECTORS
used in different APPLICATIONS.
© ISO 2010 – All rights reserved v

---------------------- Page: 13 ----------------------

SIST EN ISO 80369-1:2013
ISO 80369-1:2010(E)
This part 1 of this International Standard contains general requirements to ensure the prevention of
misconnection between SMALL-BORE CONNECTORS used in different APPLICATIONS. Subsequent parts of this
series of standards are expected to include requirements with regard to the CONNECTORS used in different
APPLICATION categories.
In this standard, 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 CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL
CAPITALS TYPE.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
⎯ “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
⎯ “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
⎯ “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 attention of Member Bodies and National Committees is drawn to the fact that equipment
MANUFACTURERS and testing organizations may 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 3 years
from the date of publication for equipment newly designed and not earlier than 5 years from the date of
publication for equipment already in production.
vi © ISO 2010 – All rights reserved

---------------------- Page: 14 ----------------------

SIST EN ISO 80369-1:2013
INTERNATIONAL STANDARD ISO 80369-1:2010(E)

Small-bore connectors for liquids and gases in healthcare
applications —
Part 1:
General requirements
1 Scope
This part of ISO 80369 specifies general requirements for SMALL-BORE CONNECTORS, which convey liquids or
gases in healthcare APPLICATIONS. These SMALL-BORE CONNECTORS are used in MEDICAL DEVICES or
ACCESSORIES intended for use with a PATIENT.
This International Standard also specifies the healthcare fields in which these SMALL-BORE CONNECTORS are
intended to be used.
These healthcare fields of use include, but are not limited to, APPLICATIONS for:
⎯ BREATHING SYSTEMS and driving gases,
⎯ enteral and gastric,
⎯ urethral and urinary,
⎯ limb cuff inflation,
⎯ neuraxial devices, and
⎯ intravascular or hypodermic.
SMALL-BORE CONNECTORS as specified in this International Standard are NON-INTERCONNECTABLE with:
⎯ the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006;
⎯ the temperature sensor CONNECTOR and mating ports specified in Annex DD of ISO 8185:2007; and
⎯ the nipples of EN 13544-2:2002.
This International Standard provides the methodology to assess NON-INTERCONNECTABLE characteristics of
SMALL-BORE CONNECTORS based on their inherent design and dimensions in order to reduce the RISK of
misconnections between MEDICAL DEVICES or between ACCESSORIES for different APPLICATIONS and to reduce
the RISK of misconnections between MEDICAL DEVICES with 6 % Luer CONNECTORS, and all other non-Luer
CONNECTORS that will be developed under future parts of this series of standards.
It does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these SMALL-BORE
CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES
or ACCESSORIES.
NOTE 1 It is intended that new designs of SMALL-BORE CONNECTORS will be included in this series of standards after
they have been assessed according to the PROCEDURE given in Clause 6.
© ISO 2010 – All rights reserved 1

---------------------- Page: 15 ----------------------

SIST EN ISO 80369-1:2013
ISO 80369-1:2010(E)
NOTE 2 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this series of
standards into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular
MEDICAL DEVICE standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised,
requirements for SMALL-BORE CONNECTORS as specified in the series of standards will be included.
NOTE 3 MANUFACTURERS and RESPONSIBLE ORGANIZATIONS are encouraged to report their experience with the SMALL-
BORE CONNECTORS specified in this series of standards to the Secretariat of ISO/TC 210 to consider this feedback during
the revision of the relevant part of this series of standards.
2 Normative references
The following referenced documents are indispensable for the application 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 5356-1:2004, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5356-2:2006, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded
weight-bearing connectors
ISO 14971:2007, Medical devices — Application of risk management to medical devices
EN 13544-2:2002, Respiratory therapy equipment — Part 2: Tubing and connectors
IEC 62366:2007, Medical devices — Application of usability engineering to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions specified in ISO 14971:2007, IEC 62366:2007
and the following apply. For convenience, the sources of all defined terms used in this document are given in
an index on page 17.
3.1
ACCESSORY
additional part(s) for use with MEDICAL DEVICE in order to:
⎯ achieve the INTENDED USE,
⎯ adapt it to some special use,
⎯ facilitate its use,
⎯ enhance its performance, or
⎯ enable its functions to be integrated with those of other MEDICAL DEVICES
[Modified from IEC 60601-1:2005, definition 3.3]
3.2
APPLICATION
specific healthcare field in which a SMALL-BORE CONNECTOR is intended to be used
NOTE Annex C lists SMALL-BORE CONNECTOR APPLICATIONS.
3.3
BREATHING SYSTEM
inspiratory and expiratory pathways through which gas flows at respiratory pressures and bounded by the port
through which fresh gas enters, the PATIENT CONNECTION port and the exhaust port
2 © ISO 2010 – All rights reserved

---------------------- Page: 16 ----------------------

SIST EN ISO 80369-1:2013
ISO 80369-1:2010(E)
3.4
CONNECTION
union or joining of mating halves of a CONNECTOR
3.5
CONNECTOR
mechanical device, consisting of one of two mating halves and designed to join a conduit to convey liquids or
gases
3.6
NON-INTERCONNECTABLE
having characteristics which incorporate geometries or other characteristics that prevent different
CONNECTORS from being connected
3.7
PATIENT
person undergoing a medical, surgical or dental PROCEDURE
[Modified from IEC 60601-1:2005, definition 3.76]
3.8
RESPONSIBLE ORGANIZATION
entity accountable for the use and maintenance of a MEDICAL DEVICE
NOTE 1 The accountable entity can be, for example, a hospital, an individual clinician or a layperson. In home use
applications, the PATIENT, USER and RESPONSIBLE ORGANIZATION can be one and the same person.
NOTE 2 Education and training is included in “use.”
[Modified from IEC 60601-1:2005, definition 3.101]
3.9
RIGID MATER
...