EN ISO 80369-3:2016

Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016)

ISO 80369-3:2016 specifies the dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories.
NOTE 1       Enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes, and patient interface devices including access ports.
It does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.
It does not specify requirements for small-bore connectors that are used for the following:
-      gastric suction-only medical devices;
-      oral-only medical devices;
EXAMPLE       An oral tip syringe that is not intended to connect to another medical device. It is intended to administer directly to the patient's mouth.
-      pressurizing and depressurizing the retention mechanism (e.g. balloon) used to hold invasive enteral medical devices in place;
-      medical devices for rectal drainage, rectal administration of medicines or fluid, and any other rectal access medical device;
-      gastrointestinal endoscopy equipment;
-      skin level gastrostomy medical devices.
NOTE 2       Manufacturers are encouraged to incorporate the small-bore connectors specified in ISO 80369-3 :2016 into enteral medical devices 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 ISO 80369, will be included.

Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 3: Verbindungsstücke für enterale Anwendungen (ISO 80369-3:2016)

Dieser Teil von ISO 80369 legt die Maße und Anforderungen für die Ausführung und funktionelle Leistung der VERBINDUNGSSTÜCKE mit KLEINEM DURCHMESSER für ENTERALE ANWENDUNGEN von MEDIZINPRODUKTEN und ZUBEHÖRTEILEN fest.
ANMERKUNG 1   Die ENTERALEN MEDIZINPRODUKTE schließen ENTERALE Ernährungssets, ENTERALE Spritzen und PATIENTEN-Schnittstellen¬produkte, einschließlich Anschluss-Ports ein.
Dieser Teil von ISO 80369 legt nicht die Maße und Anforderungen für die MEDIZINPRODUKTE oder ZUBEHÖR¬TEILE fest, an denen die Verbindungsstücke angeschlossen werden. Derartige Anforderungen finden sich in den jeweiligen Internationalen Normen für die spezifischen MEDIZINPRODUKTE oder ZUBEHÖRTEILE.
Dieser Teil von ISO 80369 legt nicht die Anforderungen an VERBINDUNGSSTÜCKE mit KLEINEM DURCHMESSER für die folgenden Produkte fest:
   ausschließlich für die Magenabsaugung geeignete MEDIZINPRODUKTE;
   ausschließlich für die orale ANWENDUNG geeignete MEDIZINPRODUKTE;
   aufblasbare Manschetten zur Druckerzeugung oder  entlastung für das Befestigen invasiver ENTERALER MEDIZINPRODUKTE (ISO 80369 7);
   MEDIZINPRODUKTE für die Hautgastrostomie; und
   den Zugang zu ENTERALEN Nahrungsbehältern (ISO 18250 3).
ANMERKUNG 2   HERSTELLER werden zum Einbau der VERBINDUNGSSTÜCKE mit KLEINEM DURCHMESSER nach diesem Teil von ISO 80369 in ENTERALE MEDIZINPRODUKTE oder ZUBEHÖRTEILE angeregt, auch wenn derzeit nach den maßgebenden speziellen Normen zu MEDIZINPRODUKTEN nicht erforderlich. Es ist zu erwarten, dass bei Überarbeitung der maßgebenden speziellen Normen zu MEDIZINPRODUKTEN Anforderungen für VERBINDUNGSSTÜCKE mit KLEINEM DURCHMESSER entsprechend den Festlegungen nach ISO 80369 aufgenommen werden.

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 3: Raccords destinés à des applications entérales (ISO 80369-3:2016)

L'ISO 80369-3 :2016 spécifie les dimensions et exigences relatives à la conception et aux performances fonctionnelles des raccords de petite taille destinés à être utilisés pour effectuer des raccordements à des dispositifs médicaux et des accessoires à usage entéral.
NOTE 1       Les dispositifs médicaux à usage entéral incluent les tubulures de nutrition entérale, les tubulures de drainage entéral, les seringues entérales et les dispositifs d'interface avec le patient, y compris les voies d'abord.
Elle ne spécifie pas les dimensions et exigences relatives aux dispositifs médicaux ou aux accessoires sur lesquels ces raccords sont utilisés. Ces exigences figurent dans des Normes internationales spécifiques traitant de dispositifs médicaux ou d'accessoires particuliers.
Elle ne spécifie pas d'exigences relatives aux raccords de petite taille utilisés pour:
-      les dispositifs médicaux réservés à l'aspiration digestive;
-      les dispositifs médicaux réservés à un usage oral;
EXEMPLE       Une seringue à embout buccal qui n'est pas destinée à être raccordée à un autre dispositif médical. Elle est prévue pour que son contenu soit directement administré dans la bouche du patient.
-      la mise sous pression et la dépressurisation du mécanisme de rétention (par exemple, ballonnet) utilisé pour maintenir les dispositifs médicaux entéraux invasifs en place;
-      les dispositifs médicaux destinés au lavage rectal, à l'administration rectale de médicaments ou de liquides, ainsi que tout autre dispositif médical permettant l'accès au rectum;
-      l'équipement d'endoscopie gastro-intestinale;
-      les dispositifs médicaux de type boutons de gastrostomie.
NOTE 2       Les fabricants sont incités à intégrer les raccords de petite taille spécifiés dans l'ISO 80369-3 :2016 dans les dispositifs médicaux ou accessoires à usage entéral, même si cela n'est pas actuellement requis par les normes appropriées, spécifiques de ces dispositifs médicaux. Il est prévu d'inclure des exigences relatives aux raccords de petite taille, tels que spécifiés dans l'ISO 80369, lors de la révision des normes appropriées spécifiques de ces dispositifs médicaux.

Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 3. del: Priključki za enteralno uporabo (ISO 80369-3:2016)

Ta del standarda ISO 80369 določa mere vmesnikov in zahteve za priključke, namenjene za uporabo v ENTERALNIH PRIPOMOČKIH, ENTERALNIH injekcijskih brizgah in sorodnih DODATKIH. Ta del standarda ISO 80369 ne določa zahtev za PRIKLJUČKE, ki so namenjeni za: – izključno sesalno uporabo; – izključno oralno uporabo; – polnjenje pripomočkov z zadrževalnim balonom; – dostop do rezervoarjev za ENTERALNO hranjenje. Ta del standarda ISO 80369 ne določa zahtev za MEDICINSKE PRIPOMOČKE ali DODATKE, ki uporabljajo te PRIKLJUČKE. Takšne zahteve so podane v zadevnih mednarodnih standardih za posamezne MEDICINSKE PRIPOMOČKE ali DODATKE.
OPOMBA: PROIZVAJALCEM se priporoča, da PRIKLJUČKE Z MAJHNIM PREMEROM, ki so določeni v tem delu standarda ISO 80369, vključijo v MEDICINSKE PRIPOMOČKE, medicinske sisteme ali DODATKE, tudi če zadevni posamezni standardi za MEDICINSKE PRIPOMOČKE tega trenutno ne zahtevajo. Predvideva se, da bodo ob reviziji zadevnih posameznih standardov za MEDICINSKE PRIPOMOČKE vanje vključene zahteve za PRIKLJUČKE Z MAJHNIM PREMEROM, kot so določene v tem delu standarda ISO 80369.

General Information

• Status: Published
• Publication Date: 09-Aug-2016
• Withdrawal Date: 27-Feb-2017
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 10-Aug-2016
• Completion Date: 10-Aug-2016
• 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: SIST EN ISO 80369-3:2016 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016)

Relations

• Amended By: EN ISO 80369-3:2016/A1:2022 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
• Effective Date: 14-Oct-2020
• Amended By: EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
• Effective Date: 28-Jun-2017

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2016
3ULNOMXþNL]PDMKQLPSUHPHURP]DWHNRþLQHLQSOLQH]DXSRUDERY]GUDYVWYXGHO
3ULNOMXþNL]DHQWHUDOQRXSRUDER,62
Small-bore connectors for liquids and gases in healthcare applications - Part 3:
Connectors for enteral applications (ISO 80369-3:2016)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 3: Verbindungsstücke für enterale Anwendungen
(ISO 80369-3:2016)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
3: Raccords destinés à des applications entérales (ISO 80369-3:2016)
Ta slovenski standard je istoveten z: EN ISO 80369-3:2016
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 80369-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2016
ICS 11.040.25
English version
Small-bore connectors for liquids and gases in healthcare
applications - Part 3: Connectors for enteral applications
(ISO 80369-3:2016)
Raccords de petite taille pour liquides et gaz utilisés Verbindungsstücke mit kleinem Durchmesser für
dans le domaine de la santé - Partie 3: Raccords Flüssigkeiten und Gase in medizinischen
destinés à des applications entérales (ISO 80369- Anwendungen - Teil 3: Verbindungsstücke für enterale
3:2016) Anwendungen (ISO 80369-3:2016)
This European Standard was approved by CEN on 25 May 2016.

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.

CEN-CENELEC Management Centre:
Avenue Marnix 17, B-1000 Brussels
© 2016 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 80369-3:2016 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this document and the Essential
Requirements of EU Directive 93/42/EEC . 5

European foreword
This document (EN ISO 80369-3:2016) has been prepared by Technical Committee ISO/TC 210 “Quality
management and corresponding general aspects for medical devices” in collaboration with Technical
Committee CEN-CENELEC/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 February 2017, and conflicting national standards
shall be withdrawn at the latest by February 2017.
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.
For relationship with EU Directive, 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 80369-3:2016 has been approved by CEN as EN ISO 80369-3:2016 without any
modification.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard “within the
meaning of Annex ZA”, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When the ISO or IEC standard is referred to in the ISO text standard, this must be understood as a
normative reference to the parallel EN standard or dated ISO standard, as outlined below, including the
foreword and the Annexes Z.
NOTE The way in which these references documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlations between normative references and dated EN and ISO/IEC standards
Equivalent dated standard
Normative references as listed in
Clause 2
EN ISO/IEC
ISO 5356-1:2004 EN ISO 5356-1:2004 ISO 5356-1:2004
ISO 5356-1:2015 EN ISO 5356-1:2015 ISO 5356-1:2015
ISO 5356-2:2006 EN ISO 5356-2:2007 ISO 5356-2:2006
ISO 5356-2:2012 EN ISO 5356-2:2012 ISO 5356-2:2012
ISO 8185:2007 EN ISO 8185:2009 ISO 8185:2007
EN 13544-2:2002 EN 13544-2:2002 —
EN 13544-2:2002+A1:2009 EN 13544-2:2002+A1:2009 —
ISO 80369-1:2010 EN ISO 80369-1:2010 ISO 80369-1:2010
ISO 80369-6:2016 EN ISO 80369-6:2016 ISO 80369-6:2016
a a a
ISO 80369-7:— EN ISO 80369-7:— ISO 80369-7:—
ISO 80369-20:2015 EN ISO 80369-20:2015 ISO 80369-20:2015
ASTM D638-10 — —
ASTM D790-10 — —
a
To be published.
Annex ZA
(informative)
Relationship between this document 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
Commission and the European Free Trade Association to provide a means of conforming to Essential
Requirements of Directive 93/42/EEC on Medical Devices.
Once this standard 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 normative
clauses of this standard confers, within the limits of the scope of this standard, a presumption of
conformity with the relevant Essential Requirements of that Directive.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC / Directive 90/385/EEC, as amended
by 2007/47/EC. This means that risks have to be reduced “as far as possible”, “to a minimum”, “to the lowest
possible level”, “minimized” or “removed”, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the directive.
NOTE 3 This Annex ZA is based on Normative References according to Table of References, replacing the
references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this document and Directive 93/42/EEC
Clause(s)/subclause(s) of this Essential requirements (ERs) Qualifying remarks/Notes
Document of EU Directive 93/42/EEC
6.1 7.5
4.1, 5, 6.3, 6.4, 6.5, 6.6 9.1
6.2 12.7.4
4.1, 5, 6.3, 6.4, 6.5, 6.6 12.8.1 This Essential Requirement is
partially covered in that by
ensuring that the CONNECTOR
y be
does not leak and can onl
connected to intended MEDICAL
DEVICES or ACCESSORIES it permits
a MEDICAL DEVICE to be capable of
controlling the flowrate.
WARNING — Other requirements and other EU Directives may be applicable to the products falling
within the scope of this document.
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on
Machinery, in accordance with Article 3 of Directive 93/42/EEC 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 Document. 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)/subclause(s) of this EHSR of 2006/42/EC Qualifying remarks/Notes
Document
Clause 4, Clause 5, Clause 6 1.5.4

INTERNATIONAL ISO
STANDARD 80369-3
First edition
2016-07-01
Small-bore connectors for liquids and
gases in healthcare applications —
Part 3:
Connectors for enteral applications
Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 3: Raccords destinés à des applications entérales
Reference number
ISO 80369-3:2016(E)
©
ISO 2016
ISO 80369-3:2016(E)
© ISO 2016, 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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ii © ISO 2016 – All rights reserved

ISO 80369-3:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 * Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 3
4.1 General requirements for the enteral application. 3
4.2 Material used for enteral small-bore connectors . 3
4.3 Type tests . 4
5 Dimensional requirements for enteral small-bore connectors .4
6 Performance requirements . 4
6.1 Fluid leakage . 4
6.1.1 Fluid leakage requirement . 4
6.1.2 Leakage by pressure decay . 4
6.1.3 Positive pressure liquid leakage .
...