ISO 80369-1:2025

International
Standard
ISO 80369-1
Third edition
Small-bore connectors for
2025-10
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 2025
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Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Small-bore connector non-interconnectable requirement . 4
5 Small-bore connectors for clinical applications . 5
5.1 Small-bore connectors for new clinical applications .5
5.2 Small-bore connectors for respiratory applications .5
5.3 Small-bore connectors for enteral applications .5
5.4 Small-bore connectors for limb cuff inflation applications .6
5.5 Small-bore connectors for neural applications .6
5.6 Small-bore connectors for intravascular and hypodermic applications .6
5.7 Other use cases utilizing an ISO 80369-7 small-bore connector .6
6 Alternative small-bore connectors . . 7
Annex A (informative) Rationale . 9
Annex B (normative) Process for demonstrating non-interconnectable characteristics .15
Annex C (normative) Assessment procedures for small-bore connectors .30
Annex D (informative) Applications of small-bore connectors and the relevant standard .33
Annex E (informative) Design assessment summary .35
Annex F (informative) Reference to the IMDRF essential principles .38
Annex G (informative) Alphabetized index of defined terms .39
Bibliography . 41

iii
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding
general aspects for products with a health purpose including medical devices, in collaboration with Technical
Committee IEC/SC 62D, Particular medical equipment, software, and systems, and with the European
Committee for Standardization (CEN) Technical Committee CEN/CLC/JTC 3, Quality management and
corresponding general aspects for medical devices, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 80369-1:2018), which has been technically
revised.
The main changes are as follows:
— update of normative references;
— update of the document according to ISO/IEC Directives, Part 2;
— addition of respiratory applications;
— addition of interference test part, misconnection and unintended connection definitions;
— deletion of Clause 4 for materials requirements, as those requirements are or will be placed in the
individual connector parts of the series and normative Annex B describes the analysis and testing
processes for determining non-interconnectable characteristics;
— revision of Annex B by summarising process description and adding figure, editorial changes and adding
the dimensional analysis case “potential misconnection”;
— deletion of the original Annex C, replaced with normative reference to parts of ISO 20417;
— addition of Annex E summarizing the design assessments of the application parts of this series of
documents;
— replacement of contents of Annex F by referencing the relevant essential principles and labelling guidance
of the International Regulators Forum (IMDRF);

iv
— extension of the use of the ISO 80369-7 connector to medical devices and accessories beyond intravascular
and hypodermic applications where the risk is acceptable.
A list of all parts in the ISO and IEC 80369 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

v
Introduction
In the 1990s, concern grew regarding the proliferation of medical devices fitted with Luer connectors
[1]
as specified in the ISO 594 series and the reports of patient death or injury arising from unintended
connections that resulted in the inappropriate delivery of fluids and gases via incorrect routes. In addition to
clinical and workplace protocols and warnings, attention was turned to engineering solutions to reduce the
probability of wrong route administration of liquids and gases.
Concerns regarding the use of Luer connectors with enteral feeding tubes and gas sampling and gas delivery
systems were raised with CEN Bureau Technique (CEN/BT) and the European Commission. In November
1997, the newly created CEN Healthcare Forum (CHeF) steering group set up a Forum Task Group (FTG) to
consider the problem.
[9]
The FTG produced CEN Report, CEN/CR 13825, in which they concluded that there is a problem arising
from the use of a single connector design to several different applications. In a coronary care unit, there could
be as many as 40 Luer connectors on the medical devices used with a single patient until the use of connectors
defined in the ISO and IEC 80369 documents started to be established. Therefore, it is not surprising that
unintended connections were 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
[6]
principle is embodied in the requirements of numerous medical device standards. Extending this principle
to the use of Luer connectors (i.e. that an unintended connection 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, the FTG recommended that
new designs of small-bore connectors should be developed for other applications, and these should be non-
interconnectable with Luer connectors and each other.
[10]
International medical device regulators forum (IMDRF), GRRP N47:2024, Essential Principle 5.1.3,
addresses this type of problem:
Risk control measures adopted by manufacturers for the design and manufacture of the medical device
and IVD medical device should conform to safety principles, taking account of the generally acknowledged
state of the art. When risk reduction is required, manufacturers should control risks so that the residual
risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the
most appropriate solutions, manufacturers should, in the following order of priority:
a) eliminate or appropriately reduce risks through safe design and manufacture;
b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to
risks that cannot be eliminated;
c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate,
training to users.
It is understood that small-bore connector systems cannot be designed to overcome all chances of unintended
connections with the potential for wrong route administration or to eliminate deliberate misuse. With
these application-specific connectors now available, the risk of unintended connections and wrong route
administration is greatly reduced thereby improving patient safety. Introduction of medical devices and
accessories utilizing these small-bore connectors is progressing albeit slowly.
The risks associated with unintended connections and subsequent wrong route administration of liquids and
gases cannot be fully assessed until these small-bore connectors are part of a medical device or accessory.
Therefore, the intended applications specified are recommendations. It is expected that particular medical
device standards will reference the connectors from the relevant parts of the ISO and IEC 80369 series if
considered appropriate.
This document contains the general requirements to reduce connections between small-bore connectors used
in different applications as well as specifying those applications.

vi
It specifies the general requirements and test methods for assessing the non-interconnectable characteristics
of small-bore connectors within the ISO and IEC 80369 series.
The Luer connector as originally defined in the withdrawn ISO 594 series has been widely used on many
medical devices and accessories and in a wide range of clinical applications for many years. The clinical
applications that present the highest risk to a patient from wrong route administration of liquids and
gases have been identified and are those included in the application parts of the ISO and IEC 80369 series.
ISO 80369-7, which replaces the ISO 594 series (i.e. the Luer connector), is intended for use with intravascular
or hypodermic applications.
However, there are currently medical devices and accessories which incorporate a Luer connector, but do not
fall into any of the applications specified by the ISO and IEC 80369 series. There are also some medical devices
and accessories within the applications of the ISO and IEC 80369 series applications that incorporate a Luer
connector. Those that present no unacceptable risk to the patient from an unintended connection to a medical
device or accessory within intravascular or hypodermic application are suitable for consideration for the use
of the Luer connector as specified in ISO 80369-7.
ISO 80369-20 specifies the common test methods for assessing the basic performance requirements specified
in ISO 80369-2, ISO 80369-3, IEC 80369-5, ISO 80369-6 and ISO 80369-7 for small-bore connectors.
ISO 80369-2, ISO 80369-3, IEC 80369-5, ISO 80369-6 and ISO 80369-7 specify the material requirements,
dimensional requirements for the interfaces of the connectors and the specific performance requirements
for assessing the interconnectability of the mating connectors.
The designs and dimensions of small-bore connectors specified in ISO 80369-2, ISO 80369-3, IEC 80369-5,
ISO 80369-6 and ISO 80369-7 have been successfully assessed according to the requirements of this
document (i.e. have been proven to be acceptable with regard to the risk of misconnection with the other
connectors of this series).
The risks of changing to these new small-bore connectors should be assessed before these small-bore
connectors are incorporated into medical devices as they will when the relevant particular medical device
standards are revised.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
the conditions is true.
In this document the following verbal forms are used.
— “Shall” indicates requirements.
— “Should” indicates recommendations.
— “May” indicates permissions.
— "Can" indicates possibility or capability.
This document uses italic type to distinguish defined terms from the rest of the text. It is important for the
correct understanding of this document that those defined terms are identifiable throughout the text of this
document. A list of the defined terms used in italics in this document is given in Annex G.
Requirements in this document have been broken down so that each requirement is clearly delineated and
listed individually. This has been done to support the common practice of automatic tracking of requirements
and automatic verification of the requirements of this document.
Annex A contains guidance and rationale on specific subclauses in this document.

vii
International Standard ISO 80369-1:2025(en)
Small-bore connectors for liquids and gases in healthcare
applications —
Part 1:
General requirements
1 Scope
NOTE Clause A.2 contains guidance or rationale for this Clause.
This document specifies general interface requirements for small-bore connectors that form part of a medical
device or accessory that conveys liquids or gases to a patient.
This document also identifies the applications for which these small-bore connectors are intended to be used,
which include, but are not limited to:
— respiratory;
— enteral;
— limb cuff inflation;
— neural;
— intravascular or hypodermic;
— other use cases utilizing an ISO 80369-7 small-bore connector.
This document provides the methodology to assess non-interconnectable characteristics of small-bore
connectors based on their inherent design in order to reduce the risk of misconnections between medical
devices or between accessories for different applications as specified in this document as well as those that
can be developed under future parts of the ISO and IEC 80369 series.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements 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 14971, Medical devices — Application of risk management to medical devices
ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer
ISO 80369-2, Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for
respiratory applications
ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for
enteral applications
IEC 80369-5, Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for
limb cuff inflation applications
ISO 80369-6, 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 for
intravascular or hypodermic applications
IEC 62366-1:2015+AMD1:2020, Medical devices — Part 1: Application of usability engineering to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14971, IEC 62366-1 and the
following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
NOTE For convenience, the sources of all defined terms that appear in italics in this document are given in
Annex G.
3.1
accessory
additional part(s) for use with a 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
[SOURCE: IEC 60601-1:2005+AMD1:2012+AMD2:2020, 3.3, modified — Replaced “equipment” with “a
medical device”.]
3.2
application
specific healthcare use
Note 1 to entry: Annex D lists examples of uses of the applications of small-bore (3.17) connectors (3.5).
3.3
cone
connector (3.5) with external sealing surface
Note 1 to entry: The sealing surface need not be conical.
Note 2 to entry: This type of connector (3.5) was previously referred to as male.
3.4
connection
union or joining of two connectors (3.5)
3.5
connector
part of a medical device, consisting of one of two mating halves and designed to join a conduit to convey
liquids or gases
3.6
contactable surface
any surface on a connector (3.5) that has an interaction potential in which physical contact occurs with any
other surface on an opposing connector
Note 1 to entry: Contactable surfaces may include, but are not limited to, sealing surfaces as intended by design, crest
geometry of external or internal threads, faces, shrouds, grips. These are surfaces on a connector that can possibly
interact with another connector.
3.7
information for safety
information provided to the user or responsible organization as a risk control measure
EXAMPLE 1 Warnings, precautions or contraindications.
EXAMPLE 2 Instructions for the use of a medical device or accessory (3.1) to prevent use error or avoid a hazardous
situation.
EXAMPLE 3 Explanation of a safety feature of a medical device.
Note 1 to entry: Information for safety can be found in any or all types of information supplied by the manufacturer.
Note 2 to entry: Information for safety can be located on the display of a medical device.
[SOURCE: ISO 20417:2021, 3.9]
3.8
instructions for use
portion of the accompanying information that is essential for the safe and effective use of a medical device or
accessory (3.1) directed to the user of the medical device
Note 1 to entry: For the purposes of this document, a user can be either a lay user or professional user with relevant
specialized training.
[SOURCE: ISO 20417:2021, 3.11, modified — Deleted admitted term “package insert”; deleted Notes 2 to 5
to entry.]
3.9
interference test part
component that physically represents a small-bore (3.17) connector (3.5) or connector feature
Note 1 to entry: An interference test part is used to evaluate whether or not a contactable surface (3.6) can misconnect.
3.10
least material condition
LMC
condition in which a feature contains the least amount of material within the stated tolerance
EXAMPLE Maximum hole diameter, minimum shaft diameter.
3.11
Luer connector
small-bore (3.17) connector (3.5) that contains a conical mating surface with a 6 % (Luer) taper intended for
use in intravascular or hypodermic applications (3.2) of medical devices and related accessories (3.1)
Note 1 to entry: A Luer connector can be either a Luer slip connector or a Luer lock connector.
[SOURCE: ISO 80369-7:2021, 3.2, modified — Deleted Note 2 to entry.]

3.12
marking
information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical device
or accessory (3.1)
Note 1 to entry: For the purposes of this document, the term marked is used to designate the corresponding act.
Note 2 to entry: For the purposes of this document, marking is different from ‘direct marking’ as commonly described
in unique device identification (UDI) standards and regulations. A UDI ‘direct marking’ is a type of marking.
[SOURCE: ISO 20417:2021, 3.16, modified — Deleted Note 3 to entry.]
3.13
maximum material condition
MMC
condition in which a feature contains the maximum amount of material within the stated tolerance
EXAMPLE Minimum hole diameter, maximum shaft diameter.
3.14
misconnection
connection (3.4) between two connectors (3.5) of a different type
3.15
non-interconnectable
having characteristics which incorporate geometries or other features that prevent different connectors
(3.5) from making a connection (3.4)
3.16
patient
person undergoing a medical, surgical or dental procedure
[SOURCE: IEC 60601-1:2005+A1:2012, 3.76, modified — Replaced “living being (person or animal)” with
“person”; deleted the note.]
3.17
small-bore
inner-fluid pathway of a connection (3.4) with a diameter less than 8,5 mm
Note 1 to entry: For the purposes of this document, the 8,5 mm cone (3.3) and socket (3.18) specified in ISO 5356-1 is
not considered a small-bore (3.17) connector (3.5).
3.18
socket
connector (3.5) with internal sealing surface
Note 1 to entry: This type of connector (3.5) was previously referred to as female.
3.19
test method
definitive procedure for evaluating connectors (3.5) that produces a test result
3.20
unintended connection
connection (3.4) between two connectors (3.5) of the same type for different use cases
4 Small-bore connector non-interconnectable requirement
NOTE 1 A.2.3 contains guidance and rationale for this Clause.

Small-bore connectors of each application category specified in this document shall be non-interconnectable
with any of the small-bore connectors of every other application category unless otherwise indicated within
the ISO and IEC 80369 series.
Check conformity by confirming that objective evidence demonstrates that the acceptability criteria specified
in Annex B are met.
The use of a connector specified by the ISO and IEC 80369 series is considered as objective evidence that the
acceptability criteria specified in Annex B are met.
NOTE 2 For the purpose of this document, dimensional conformity and modulus of elasticity conformity with the
requirements of the various application parts of the ISO and IEC 80369 series is considered sufficient objective evidence
of non-interconnectable characteristics.
5 Small-bore connectors for clinical applications
NOTE 1 A.2.4 contains guidance and rationale for this Clause.
NOTE 2 Annex D lists examples of the sort of medical devices or accessories for which the small-bore connectors
within each application are intended.
NOTE 3 Annex E summarizes the assessments of the designs of the small-bore connectors of this series of documents.
NOTE 4 This document has been prepared to address the relevant essential principles and labelling guidances of
the International Regulators Forum (IMDRF) as indicated in Annex F.
5.1 Small-bore connectors for new clinical applications
Designs of small-bore connectors for applications other than those specified in 5.2 to 5.6, for inclusion in the
ISO and IEC 80369 series, and used in medical devices or accessories intended for use with a patient, shall
meet the requirements of Annex C.
Check conformity by application of Annex C.
5.2 Small-bore connectors for respiratory applications
Small-bore connectors intended to be used for connections in the respiratory application shall conform to
a) ISO 80369-2, unless the use of these connectors creates an unacceptable risk for a specific medical device
or accessory, or
b) Clause 6.
Check conformity by inspection of the documentation demonstrating that the small-bore connector conforms
to the requirements of ISO 80369-2 or, in case of alternative connectors as per Clause 6, by applying the
performance tests of ISO 80369-2 using appropriate reference connectors for the alternative design.
5.3 Small-bore connectors for enteral applications
Small-bore connectors intended to be used for connections in the enteral application shall conform to
a) ISO 80369-3, unless the use of these connectors creates an unacceptable risk for a specific medical device
or accessory, or
b) Clause 6.
Check conformity by inspection of the documentation demonstrating that the small-bore connector conforms
to the requirements of ISO 80369-3 or, in case of alternative connectors as per Clause 6, by applying the
performance tests of ISO 80369-3 using appropriate reference connectors for the alternative design.

5.4 Small-bore connectors for limb cuff inflation applications
Small-bore connectors intended to be used for connections in limb cuff inflation application shall conform to
a) IEC 80369-5, unless the use of these connectors creates an unacceptable risk for a specific medical device
or accessory, or
b) Clause 6.
Check conformity by inspection of the documentation demonstrating that the small-bore connector conforms
to the requirements of IEC 80369-5 or, in case of alternative connectors as per Clause 6, by applying the
performance tests of IEC 80369-5 using appropriate reference connectors for the alternative design.
5.5 Small-bore connectors for neural applications
Small-bore connectors intended to be used for connections in neural application shall conform to
a) ISO 80369-6, unless the use of these connectors creates an unacceptable risk for a specific medical device
or accessory, or
b) Clause 6.
Check conformity by inspection of the documentation demonstrating that the small-bore connector conforms
to the requirements of ISO 80369-6 or, in case of alternative connectors as per Clause 6, by applying the
performance tests of ISO 80369-6 using appropriate reference connectors for the alternative design.
5.6 Small-bore connectors for intravascular and hypodermic applications
Small-bore connectors intended to be used for connections in intravascular or hypodermic applications shall
conform to
a) ISO 80369-7, unless the use of these connectors creates an unacceptable risk for a specific medical device
or accessory, or
b) Clause 6.
Check conformity by inspection of the documentation demonstrating that the small-bore connector conforms
to the requirements of ISO 80369-7 or, in case of alternative connectors as per Clause 6, by applying the
performance tests of ISO 80369-7 using appropriate reference connectors for the alternative design.
5.7 Other use cases utilizing an ISO 80369-7 small-bore connector
NOTE 1 A.2.5 contains guidance and rationale for this subclause.
a) Small-bore connectors intended to be used for connections other than those falling into the applications of
5.2, 5.3, 5.4, 5.5 and 5.6 of medical devices and accessories may conform to ISO 80369-7 unless the use of
these connectors creates an unacceptable risk for the specific medical device or accessory.
b) Such a connector shall conform to ISO 80369-7.
c) A medical device or accessory using an ISO 80369-7 connector for such use cases shall meet the following
requirements:
1) The risk of unintended connections with any reasonably foreseeable medical devices or accessories using
the ISO 80369-7 connector shall be:
i) evaluated using ISO 14971;
ii) determined to be an acceptable risk.

NOTE 2  A.2.6 contains guidance and rationale for this requirement.
NOTE 3  See also the N1 cone to L2 cone misconnection in Table E.1.
In determining acceptable risk, the manufacturer shall evaluate the severity of the potential harm
associated with the potential unintended connection with flow in both directions of the connection.
2) Such a medical device or accessory shall be marked in accordance with ISO 20417:2021, 6.1.5.
3) If acceptable risk is achieved by providing information for safety, the medical device or accessory shall
include in its instructions for use a statement to the effect that “As this [insert name of medical device
or accessory here] uses an ISO 80369-7 small-bore connector for other than its intended application,
there is a possibility that an inadvertent connection can occur between this [insert name of medical
device or accessory here] and another medical device or accessory using this connector, which can
result in a hazardous situation causing harm to the patient. Special measures need be taken by the
user to mitigate these reasonably foreseeable risks."
4) It is recommended that the manufacturer of such a medical device or accessory that utilizes a small-bore
connector of the ISO 80369-7 for other than its intended application notify their national standards
body of their utilization.
The notification should include a description of:
i) the connector used;
ii) the medical device or accessory using the connector;
iii) the clinical procedure;
iv) the fluid being used.
Check conformity for a medical device or accessory using a small-bore connector of ISO 80369-7 for other than
the intravascular and hypodermic application by:
— inspection of the documentation demonstrating that the small-bore connector conforms to the
requirements of ISO 80369-7;
— inspection of the risk management file of the medical device or accessory using the connector and confirming
that the risk of any unintended connection is acceptable;
— inspection of the marking;
— inspection of the instructions for use.
6 Alternative small-bore connectors
NOTE A.2.7 contains guidance and rationale for this Clause.
a) Alternative designs of small-bore connectors to those specified in Clause 5 may be used in a medical
device or accessory, and if used, they shall:
1) be evaluated according to Annex B for non-interconnectable characteristics, with the exception of a
connector within the same application to which it is intended to connect;
2) not create an unacceptable risk for a specific medical device or accessory;
3) be evaluated according to the engineering analysis of Clause C.3.
b) The medical device or accessory, which incorporates an alternative design small-bore connector, shall:
1) be marked in accordance with ISO 20417:2021, 6.1.5;

2) if acceptable risk is achieved by providing information for safety, include in its instructions for use
a statement to the effect that “As this [insert name of medical device or accessory here] uses an
alternative small-bore connector design different from those specified in the ISO and IEC 80369
series, there is a possibility that an inadvertent connection can occur between this [insert name of
medical device or accessory here] and a medical device or accessory using a different alternative
small-bore connector, or that compatibility with other alternative small-bore connectors can be
impaired, which can result in a hazardous situation causing harm to the patient. Special measures
need be taken by the user to mitigate these reasonably foreseeable risks.”.
c) An alternative design small-bore connector that conforms with this clause:
1) shall not make generic claims of conformity with the ISO and IEC 80369 series;
2) shall not claim conformity with specific parts of the ISO and IEC 80369 series other than this
document;
3) may claim conformance with this document.
Check conformity by inspection of the risk management file and the instructions for use of the medical device
or accessory using the connector and confirming that the risk of any unintended connection is acceptable.
Confirm conformity with Annex B and the specified portions of Annex C.

Annex A
(informative)
Rationale
A.1 General
This annex provides rationale for important requirements of this document and is intended for those
who are familiar with the subject of this document but who have not participated in its development. An
understanding of the reasons for the requirements is considered essential for its proper application.
Furthermore, as clinical practice and technology change, it is believed that rationale for the present
requirements will facilitate any revision of this document necessitated by those developments.
A.2 Rationale for particular clauses and subclauses
A.2.1 General
The numbering of the following rationales corresponds to the numbering of the clauses and subclauses in
this document. The numbering is, therefore, not consecutive.
A.2.2 Clause 1 Scope
Advances in medicine have led to a significant rise in the number of medical devices attached to patients.
Many of these medical devices fall into the categories of monitoring medical devices, diagnostic medical
devices and drug delivery medical devices.
Such medical devices perform a variety of similar, but not interchangeable, functions. Examples include
intravenous fluid delivery, enteral feeding, respiratory gas sampling, non-invasive blood pressure
measurement and injection of intrathecal medication. Despite the varied nature of the functions performed,
many of these medical devices used a universal system of small-bore connectors based on the Luer connector
(6 % tapered) as formerly specified in the withdrawn ISO 594 series.
The universal nature of the Luer connectors used with medical devices or accessories for different applications
and the proximity of numerous Luer connectors around a single patient increases the potential for unintended
connections and risk of wrong route administration of liquids and gases. The consequences of such wrong
[12][13][14][15][16]
route administration vary, but a significant number have caused patient harm including death .
Serious and often fatal wrong route administration as a consequence of unintended connections include
intravenous injection of air, intravenous injection of enteral feeds and intrathecal injection of vincristine.
Less disastrous wrong route administration from unintended connections, such as enteral administration
of intravenous fluids, might not directly harm the patient but can result in a failure of the intended
administration.
Comité Européen de Normalisation / Bureau Technique / Task Force 123 (CEN BT TF 123) carried out an
extensive risk analysis of possible unintended connections that can result when the same connector is used in
different applications. Reducing the identified unacceptable risks is the basis of the ISO and IEC 80369 series.
Introducing a series of non-interconnectable small-bore connectors for medical devices used for different
applications will help reduce the likelihood of unintended connections, reduce the risk of wrong route
administration and improve patient safety. It was important that the ISO and IEC 80369 series included the
Luer connector, although the first edition of ISO 80369-1 specified the intended usage of ISO 80369-7 for
intravascular or hypodermic applications. In this edition of this document, it was decided to specify, under
specific conditions, the intended usage of ISO 80369-7 for medical devices and accessories where it can be
shown that such usage does not present an unacceptable risk.

Originally, it was hoped that the small-bore connectors included in the ISO and IEC 80369 series could be
designed so that they did not misconnect with other connectors commonly used within similar environments
[8]
and covered by ISO or EN documents (e.g. the nipples in EN 13544-2, the conical connectors in ISO 5356-1,
and the temperature sensor ports specified in ISO 80601-2-74). Since the introduction of the ISO and
IEC 80369 series, these other documents have been updated. EN 13544-2 is being replaced by ISO 17256 and
the dimensions of the nipple connector has been fully specified as have the dimensions of the temperature
sensor ports in ISO 80601-2-74 probe.
During the computer-assisted design (CAD) analysis, it became evident that the dimensions contained
within these documents were not specified in a manner that allows for evaluation of non-interconnectable
characteristics between these connectors and the connectors specified in the ISO and IEC 80369 series.
These connectors were, therefore, not part of the CAD verification/validation or the non-interconnectable
characteristics testing and they can misconnect with the small-bore connectors described in the ISO and
IEC 80369 series.
In the ISO and IEC 80369 series, for clarity, different language is used to describe the two different kinds of
undesirable connections. There are misconnections, which are connections made between two connectors that
are not supposed to physically connect by design (i.e. between different connectors for different applications
in the ISO and IEC 80369 series). There are also unintended connections, which are connections that can be
made unintentionally between medical devices or accessories using the same connector type (i.e. the Luer
connector of an intravenous syringe connected to the Luer connector of an epidural catheter port).
A.2.3 Clause 4 Small-bore connector non-interconnectable requirement
The threshold of the modulus of elasticity greater than 700 MPa was chosen to ensure that connectors
are sufficiently stiff and resistant to deformation under mechanical stress, such as during connection,
disconnection or accidental bending. The higher modulus ensures connectors maintain their precise shape
and dimensions, which is critical for preventing misconnections between incompatible medical devices ‒ a
key safety goal of the ISO and IEC 80369 series.
Although it was the intent of the ISO and IEC 80369 series to create designs of small-bore connectors
that were completely non-interconnectable, this proved to be nearly impossible. There are a few cases of
misconnections between the small-bore connectors specified in the ISO and IEC 80369 series. Each of these
misconnections has been carefully analysed and determined to be an acceptable risk. The risk analysis is
documented in Annex E. Figure A.1 illustrates design space utilized by each of the small-bore connectors of
the ISO and IEC 80369 series. This concept and the drawing were developed by ISO/TC 210/JWG4 experts.

The colours used in Figure A.1 correspond with the colours used in Table E.1.
Key
1 inside diameter
2 outside diameter
ISO 80369-2
ISO 80369-2
ISO 80369-3
IEC 80369-5
ISO 80369-6
ISO 80369-7
Figure A.1 — Illustration of the small-bore connector design space
A.2.4 Clause 5 Small-bore connectors for clinical applications
National regulatory bodies, hospital accreditation organizations, and independent public health
organizations recognize wrong route administration of liquids and gases, resulting from connections
between medical devices of different applications, as a persistent problem with potential consequences of
patient harm. Warnings have been issued and strategies have been developed for healthcare organizations
to reduce risks and for manufacturers to redesign connectors to prevent unintended connections. The ability of
connectors to interconnect is identified as a root cause of unintended connections.

[9]
CEN Report, CEN/CR 13825, identifies possible unintended connections between medical devices involving
the conveyance of a gas or liquid for the different application categories and classifies each according to
the severity of the harm that can occur if wrong route administration of liquids and gases occurs. The
report confirms that the application categories specified in this document are incompatible, i.e. unintended
connections among these application categories can cause seri
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