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: 29-Nov-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/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
• Effective Date: 28-Jun-2017
• 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

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 80369-3:2016
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
SIST EN ISO 80369-3:2016 en

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

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SIST EN ISO 80369-3:2016
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SIST EN ISO 80369-3:2016
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.
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SIST EN ISO 80369-3:2016
EN ISO 80369-3:2016 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

Annex ZA (informative) Relationship between this document and the Essential

Requirements of EU Directive 93/42/EEC ............................................................................................. 5

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SIST EN ISO 80369-3:2016
EN ISO 80369-3:2016 (E)
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.
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SIST EN ISO 80369-3:2016
EN ISO 80369-3:2016 (E)

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 — —
To be published.
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SIST EN ISO 80369-3:2016
EN ISO 80369-3:2016 (E)
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.
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SIST EN ISO 80369-3:2016
EN ISO 80369-3:2016 (E)

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
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SIST EN ISO 80369-3:2016
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
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SIST EN ISO 80369-3:2016
ISO 80369-3:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© 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

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 80369-3:2016
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 ......................................................................................................................... 4

6.2 Stress cracking ........................................................................................................................................................................................ 4

6.3 Resistance to separation from axial load.......................................................................................................................... 4

6.4 Resistance to separation from unscrewing .................................................................................................................... 5

6.5 Resistance to overriding ................................................................................................................................................................. 5

6.6 Disconnection by unscrewing .................................................................................................................................................... 5

Annex A (informative) Rationale and guidance ........................................................................................................................................ 6

Annex B (normative) Enteral small-bore connectors .............................................................................................................10

Annex C (normative) Reference connectors ...........................................................................................................................................16

Annex D (informative) Assessment of medical devices and their attributes with

connections within this application .........................................................................................................................................21

Annex E (informative) Summary of the usability requirements for small-bore connectors

for enteral applications ...........................................................................................................................................................................22

Annex F (informative) Summary of small-bore connector criteria and requirements for

enteral applications .................................................................................................................................................................................27

Annex G (informative) Summary of assessment of the design of the connectors for

enteral applications .................................................................................................................................................................................30

Annex H (informative) Reference to the essential principles ..................................................................................................36

Annex I (informative) Terminology — Alphabetized index of defined terms .........................................................38

Bibliography .............................................................................................................................................................................................................................39

© ISO 2016 – All rights reserved iii
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SIST EN ISO 80369-3:2016
ISO 80369-3:2016(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/SC 62D, 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 2: Connectors for breathing systems and driving gases applications
— 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

An additional part on connectors for urethral and urinary applications is planned.

iv © ISO 2016 – All rights reserved
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SIST EN ISO 80369-3:2016
ISO 80369-3:2016(E)
Introduction

This part of ISO 80369 was developed because of several incidents, with catastrophic consequences,

resulting from firstly, the administration of inappropriate medication into the alimentary canal and

secondly, from enteral solutions being administered via incorrect routes, including intravenously and

into the airway. Many incidents were reported leading to international recognition of the importance of

these issues, and a need was identified to develop specific connectors for medical devices and their

accessories used to deliver feed via the enteral route.

The ISO 80369 series has been developed to prevent misconnection between small-bore connectors

used in different applications. ISO 80369-1 specifies the requirements necessary to verify the designs

of small-bore connectors to ensure that
a) they do not misconnect with other small-bore connectors, and
b) they safely and securely connect with their mating half.

ISO 80369-20 contains the common test methods to support the performance requirements for

small-bore connectors.

This part of ISO 80369 specifies the design, the dimensions, and the drawings of small-bore

connectors intended to be used in enteral applications. Annex D to Annex G describe the methods

by which this design has been assessed. Other parts of ISO 80369 include requirements for small-bore

connectors used in different application categories.

Connectors manufactured to the dimensions set out within this part of ISO 80369 are dimensionally

incompatible with any of the other connectors for applications identified in the ISO 80369 series

for small-bore connectors, except as indicated in G.2. If fitted to the relevant medical devices

and accessories, these connectors are to reduce the risk of medication and liquid nutritional

formula intended for enteral administration from being delivered via an alternative route, such as

intravenously or via an airway device.

During the development of this International Standard, the committee decided to cover the whole

enteral system but to have a separate International Standard for reservoir connectors. ISO 18250-3

specifies the requirements for enteral reservoir connectors. This part of ISO 80369 includes the

interface dimensions for small-bore connectors for access ports and patient interfaces on enteral

feeding sets and enteral syringes.
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 Clause 3 or as noted: 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.

© ISO 2016 – All rights reserved v
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SIST EN ISO 80369-3:2016
ISO 80369-3:2016(E)

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.
vi © ISO 2016 – All rights reserved
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SIST EN ISO 80369-3:2016
INTERNATIONAL STANDARD ISO 80369-3:2016(E)
Small-bore connectors for liquids and gases in healthcare
applications —
Part 3:
Connectors for enteral applications
1 * Scope

This part of ISO 80369 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.

This part of ISO 80369 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.

This part of ISO 80369 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 this part

of ISO 80369 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.

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.

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
© ISO 2016 – All rights reserved 1
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SIST EN ISO 80369-3:2016
ISO 80369-3:2016(E)

ISO 80369-6:2016, Small-bore connectors for liquids and gases in healthcare applications — Part 6:

Connectors for neuraxial applications

ISO 80369-7:— , Small-bore connectors for liquids and gases in healthcare applications — Part 7:

Connectors with 6% (Luer) taper for intravascular or hypodermic applications

ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications — Part 20:

Common test methods
ASTM D638-10, Standard test method for tensile properties of plastics

ASTM D790-10, Standard test methods for flexural properties of unreinforced and reinforced plastics and

electrical insulating materials
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 80369-1, ISO 80369-7,

ISO 80369-20, and ISO 14971 and the following apply.

NOTE For convenience, the sources of all defined terms used in this part of ISO 80369 are given in Annex I.

3.1
enteral
pertaining to the gastrointestinal tract
3.2
normal use

operation, including routine inspection and adjustments by any user, and stand-by, according to the

instructions for use

Note 1 to entry: Normal use should not be confused with intended use. While both include the concept of use as

intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates

not only the medical purpose, but maintenance, service, transport, etc. as well

[SOURCE: IEC 60601-1:2005+A1:2012, 3.71, modified—replaced “operator” with “user”.]

3.3
rated

term referring to a value assigned by the manufacturer for a specified operating condition

[SOURCE: IEC 60601-1:2005, 3.97]
3.4
user
person interacting with (i.e. operating or handling) the medical device

Note 1 to entry: This includes, but is not limited to, cleaners, maintainers and installers

Note 2 to entry: Patients or other laypersons can be users
[SOURCE: IEC 62366-1:2015, 3.24]
3.5
user profile

summary of the mental, physical, and demographic traits of an intended user population, as well as any

special characteristics that can have a bearing on design decisions, such as occupational skills and job

requirements
[SOURCE: IEC 62366-1:2015, 3.29]
1) To be published.
2 © ISO 2016 – All rights reserved
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SIST EN ISO 80369-3:2016
ISO 80369-3:2016(E)
4 General requirements
4.1 General requirements for the enteral application

Small-bore connectors of medical devices or accessories intended for use in enteral applications

made in co
...