SIST EN ISO 80369-3:2016

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

2

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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.
3

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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 — —
a
To be published.
4

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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.
5

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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

6

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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. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
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
1)
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
...