Iso 80369-7

INTERNATIONAL ISO
STANDARD 80369-7
First edition
2016-10-15
Hak Cipta ISO Central Secretariat, Copy standar ini dibuat oleh BSN untuk PT. ONEJECT INDONESIA dibawah lisensi
Corrected version
2016-12-01
Small-bore connectors for liquids and

gases in healthcare applications —
Part 7:
Connectors for intravascular or
hypodermic applications
ISO Central Secretariat

Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 7: Raccords à 6 % (Luer) destinés aux applications
intravasculaires ou hypodermiques
Reference number
ISO 80369-7:2016(E)
© ISO 2016
ISO 80369-7:2016(E)
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ii © ISO 2016 – All rights reserved

ISO 80369-7:2016(E)
Contents Page
Foreword ........................................................................................................................................................................................................................................ iv
Introduction................................................................................................................................................................................................................................ vi
1 * Scope ............................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
3 Terms and definitions ..................................................................................................................................................................................... 2
4 General requirements ..................................................................................................................................................................................... 3
4.1 General requirements for luer connectors................................................................................................................ 3
4.2 Material used for luer connectors..................................................................................................................................... 4
4.3 Type tests ..................................................................................................................................................................................................... 4
5 * Dimensional requirements for luer 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 Sub-atmospheric pressure air leakage ............................................................................................................................... 5
6.3 Stress cracking ........................................................................................................................................................................................ 5
6.4 Resistance to separation from axial load.......................................................................................................................... 5

6.5 Resistance to separation from unscrewing .................................................................................................................... 5
6.6 Resistance to overriding ................................................................................................................................................................. 5
Annex A (informative) Rationale and guidance ........................................................................................................................................ 6
Annex B (normative) luer connectors .........................................................................................................................................................10
Annex C (normative) Reference connectors ...........................................................................................................................................21
Annex D (informative) Assessment of medical devices and their attributes with
connections within this application .........................................................................................................................................28
Annex E (informative) Summary of the usability requirements for luer connectors for
intravascular or hypodermic applications ..........................................................................................................................30
Annex F (informative) Summary of luer connector design requirements for intravascular
or hypodermic applications ................................................................................................................................................................34
Annex G (informative) Summary of assessment of the design of the luer connector for
intravascular or hypodermic applications ..........................................................................................................................37
Annex H (informative) Reference to the essential principles..................................................................................................40
Annex I (informative) Terminology — Alphabetized index of defined terms.........................................................41
Bibliography ............................................................................................................................................................................................................................. 42
© ISO 2016 – All rights reserved iii

ISO 80369-7:2016(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/SC62D, Electromedical equipment. The draft was circulated
for voting to the national bodies of both ISO and IEC.
This first edition of ISO 80369-7 cancels and replaces ISO 594-1:1986 and ISO 594-2:1998, clauses,
subclauses, tables, figures, and annexes of which have been consolidated and technically revised.
This part of ISO 80369 contains the following major technical revisions to ISO 594-1 and ISO 594-2.
a) New terms and definitions have been added to this part of ISO 80369 to more clearly define the
various types of luer connectors included in the scope of this part of ISO 80369. This part of
ISO 80369 more broadly describes the requirements for the connectors used for intravascular
or hypodermic applications, unlike ISO 594-1 and ISO 594-2 that are replaced by this part
of ISO 80369, which only described the requirements for the fittings (intended connection
surfaces) of these connectors. This distinction is important to define here because the previous
International Standards do not contain the terms connector or connection and ISO 80369- series
does not use the term fitting.
b) Requirements for certain dimensions not previously identified in ISO 594-1 and ISO 594-2 are
added to this part of ISO 80369 to reduce the risk of misconnections between medical devices or
accessories for different applications with the small-bore connectors that are being developed
under other parts of the ISO 80369- series. These new dimensions were selected to represent the
current design and dimensions of luer connectors in clinical use at the time this part of ISO 80369
was developed. The term “6 % (Luer) taper” used throughout the previous standards has also
been clarified to the more commonly used equivalent specified diameters separated by a specified
distance on a common axis.
c) Requirements for gauging of luer connectors made from semi-rigid materials using plug
and ring test gauges have been replaced by dimensional requirements, which are more precise
and essential for reducing the risk of misconnection with the other connectors identified in
ISO 80369-1.
iv © ISO 2016 – All rights reserved

ISO 80369-7:2016(E)
d) Separate requirements for luer connectors made from semi-rigid materials and rigid
materials have been eliminated and combined as one common set of dimensions and requirements.
This consolidation of requirements was made to further reduce the risk of misconnection with
other small-bore connectors.
ISO 80369 consists of the following parts, under the general title Small-bore connectors for liquids and
gases in healthcare applications:
— Part 1: General requirements
— 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
Additional parts on connectors for urethral and urinary applications and for respiratory applications
are planned.
This corrected version of ISO 80369-7:2016 incorporates the following corrections:
— in the Scope, NOTE 1 has been removed and the other notes renumbered accordingly;

— in the second paragraph of 6.6, the reference to the annex has been changed;
— the lower-case greek letter “β” has been changed into a capital greek letter “B” in the notes of
Tables B.5 and B.6;
— the representation of the angle B has been updated in Figure B.7;
— values and angles have been corrected in Figures C.1, C.2, C.3, C.4 and C.6.
© ISO 2016 – All rights reserved v

ISO 80369-7:2016(E)
Introduction
This part of ISO 80369 was developed because of several incidents, with catastrophic consequences,
resulting from inappropriate medication, liquid nutritional formula or air being administered
intravenously. Many incidents have been reported leading to international recognition of the importance
of these issues and a need has been identified to develop specific connectors for medical devices and
their accessories used to deliver fluids in other applications.
The ISO 80369- series was developed to prevent misconnection between small-bore connectors
used in different applications. ISO 80369-1 specifies the requirements necessary to verify the designs
and dimensions 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 and the dimensions and the drawings of small-bore
connectors intended to be used as conical fittings with a 6 % (Luer) taper for connections in
intravascular or hypodermic 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 of
standards for small-bore connectors, except as indicated in Annex G. If fitted to the relevant medical
devices and accessories, these connectors should reduce the risk of air, non-vascular medication
and liquid nutritional formula being delivered through an alternative route, such as intravenously or
through an airway device.
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 part of ISO 80369 conform to usage described in the 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;
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.
vi © ISO 2016 – All rights reserved

INTERNATIONAL STANDARD ISO 80369-7:2016(E)
Small-bore connectors for liquids and gases in healthcare

applications —
Part 7:
Connectors for intravascular or hypodermic applications
1 * Scope
This part of ISO 80369 specifies dimensions and requirements for the design and functional performance
of small-bore connectors intended to be used for connections in intravascular applications or
hypodermic connections in hypodermic applications of medical devices and accessories.
EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female luer slip
connectors and luer lock connectors.
NOTE 1 The luer connector was originally designed for use at pressures up to 300 kPa.
This part of ISO 80369 does not specify 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 the following small-bore connectors, which
are specified in other International Standards:
— haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 and applicable
portion of ISO 8638 referencing blood compartment ports);
— haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637);
— infusion system closure piercing connectors (ISO 8536-4).
NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part
of ISO 80369 into 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.
NOTE 3 ISO 80369-1:2010, 5.8, specifies alternative methods of compliance with ISO 80369-1:2010, for small-
bore connectors intended for use with intravascular applications or hypodermic application medical
devices or accessories, which do not comply with this part of ISO 80369.
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 80369-6:2016, Small bore connectors for liquids and gases in healthcare applications — Part 6:
Connectors for neuraxial applications
© ISO 2016 – All rights reserved 1

ISO 80369-7:2016(E)
ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications — Part 20:
Common test methods
ASTM D638-14, Standard test method for tensile properties of plastics
ASTM D790-15e2, 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 specified in ISO 80369-1:2010,
ISO 80369-20:2015, ISO 14971:2007 and the following apply.
NOTE For convenience, the sources of all defined terms used in this document are given in Annex I.
3.1
* luer connector
small-bore connector that contains a conical mating surface with a 6 % (Luer) taper intended for use
in intravascular or hypodermic applications of medical devices and related accessories
Note 1 to entry: A luer connector can be either a luer slip connector or a luer lock connector.
3.2
* luer slip connector
luer connector without a lock

Note 1 to entry: The luer slip connector is indicated by the abbreviation L1.
3.3
* luer lock connector
luer connector that contains a locking mechanism
Note 1 to entry: The luer lock connector is indicated by the abbreviation L2.
3.4
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”.]

3.5
rated (value)
term referring to a value assigned by the manufacturer for a specified operating condition
[SOURCE: IEC 60601-1:2005, 3.97]
3.6
user
person interacting with (i.e. operating or handling) the medical device
Note 1 to entry: There can be more than one user of a medical device.
Note 2 to entry: Common users include clinicians, patients, cleaners, maintenance and service personnel.
[SOURCE: IEC 62366-1:2015, 3.24]
2 © ISO 2016 – All rights reserved

ISO 80369-7:2016(E)
3.7
user profile
summary of the mental, physical and demographic traits of an intended user group, as well as any
special characteristics, such as occupational skills and job requirements and working conditions, which
can have a bearing on design decisions
[SOURCE: IEC 62366-1:2015, 3.29]
4 General requirements
4.1 General requirements for luer connectors

luer connectors made in compliance with this part of ISO 80369 comply with the general requirements
of ISO 80369-1:2010, unless otherwise indicated in this part of ISO 80369.
In some tolerance combinations, the inside diameter of the fluid lumen of male luer connector may
contact the sealing surfaces of the N1 male connector (N1), as specified in ISO 80369-6, in LMC
conditions and thereby these connectors mutually fail when evaluating the non-interconnectable
characteristics tests of ISO 80369-1:2010, Annex B. Additional information is provided in
ISO 80369-1:2010, G.2.2.
Because the following connectors are inadequately specified, luer connectors should not, but may
connect with

— the cones and sockets of ISO 5356-1:2004, ISO 5356-1:2015, ISO 5356-2:2006, and ISO 5356-2:2012,
— the temperature sensor connectors and mating ports made in compliance with ISO 8185:2007,
Annex DD, and
— the nipples of EN 13544-2:2002 and EN 13544-2:2002+Amd1:2009.
The reference connectors for evaluation of the non-interconnectable characteristics are described
in Annex C.
Where the design of a luer connector of this part of ISO 80369 relies on dimensions or features
of the medical device or accessory to ensure non-interconnectable characteristics, the non-
interconnectable characteristics shall be verified.
Check compliance by applying the tests of ISO 80369-1:2010, 5.1, and ISO 80369-1:2010, Annex B.
Compliance may be shown by applying a computer aided design (CAD) analysis of the dimensions of
all of the ISO 80369- series small bore connectors and the small bore connector under test, in
conjunction with physical testing of the small bore connector per Annex B where the CAD analysis
does not demonstrate the non-interconnectable characteristics. When necessary, the small-bore
connector may be installed on the medical device or accessory to demonstrate compliance with the
non-interconnectable characteristics test requirements of ISO 80369-1:2010, Annex B.
NOTE 1 Medical devices using the luer connectors of this part of ISO 80369 that do not rely on the
dimensions or features of the medical device or accessory to ensure non-interconnectable characteristics
are presumed to comply with the non-interconnectable characteristics test requirements of this part of
ISO 80369.
NOTE 2 The summary of medical devices and their attributes with connections within this application is
provided in Annex D.
NOTE 3 The summary of the usability requirements for luer connectors is provided in Annex E.
NOTE 4 The summary of luer connectors criteria and requirements is provided in Annex F.
NOTE 5 The summary of assessment of the design of luer connectors according to ISO 80369-1:2010,
Clause 7, is contained in Annex G.

ISO 80369-7:2016(E)
4.2 Material used for luer connectors

In addition to the requirements of ISO 80369-1:2010, Clause 4, luer connectors shall be made of
materials with a nominal modulus of elasticity either in flexure or in tension greater than 700 MPa.
Check compliance by applying the tests of ASTM D638-14 or ASTM D790-15e2.
4.3 Type tests

Compliance with the requirements of this part of ISO 80369 shall be determined by type tests.
5 * Dimensional requirements for luer connectors

luer connectors shall comply with the dimensions and tolerances as given in
— Figure B.1 and Table B.1 for a male luer slip connector (L1),
— Figure B.2 and Table B.2 for a female luer slip connector (L1),
— Figure B.3 and Table B.3 for a male luer lock connector (L2), with fixed collar,
— Figure B.4 and Table B.4 for a male luer lock connector (L2), with floating or rotatable collar,
— Figure B.5 and Table B.5 for a female luer lock connector (L2),

— Figure B.6 and Table B.6 for a female luer lock connector (L2), with lugs at right angle to axis,
variant A,
variant B, and
variant C.
Check compliance by confirming the dimensions and tolerances specified in Annex B, as appropriate.
6 Performance requirements
6.1 Fluid leakage
6.1.1 Fluid leakage requirement
luer connectors shall be evaluated for leakage using either the leakage by pressure decay test
method or the positive pressure liquid leakage test method.
6.1.2 Leakage by pressure decay
luer connectors evaluated for fluid leakage performance with the leakage by pressure decay test
method shall not leak by more than 0,005 Pa·m3/s while being subjected to an applied pressure of
between 300 kPa and 330 kPa over a hold period between 15 s and 20 s using air as the medium.
manufacturers may use a greater applied pressure.
Check compliance by applying the tests of ISO 80369-20:2015, Annex B, while using the leakage
reference connector specified in Annex C.
6.1.3 Positive pressure liquid leakage
luer connectors evaluated for fluid leakage performance with the positive pressure liquid leakage
test method shall show no signs of leakage, sufficient to form a falling drop of water, over a hold

ISO 80369-7:2016(E)
period of 30 s to 35 s while being subjected to an applied pressure of between 300 kPa and 330 kPa.
manufacturers may use a greater applied pressure.
Check compliance by applying the tests of ISO 80369-20:2015, Annex C, while using the leakage
6.2 Sub-atmospheric pressure air leakage
luer connectors shall be evaluated for sub-atmospheric pressure air leakage. luer connectors shall
not leak by more than 0,005 Pa·m3/s while being subjected to an applied sub-atmospheric pressure of
between 80,0 kPa and 88,0 kPa over a hold period of between 15 s and 20 s. manufacturers may use a
greater applied sub-atmospheric pressure.
Check compliance by applying the tests of ISO 80369-20:2015, Annex D, while using the leakage
6.3 Stress cracking

luer connectors shall be evaluated for stress cracking. luer connectors shall meet the requirements
of 6.1.1 after being subjected to stresses of ISO 80369-20:2015, Annex E.
Check compliance by applying the tests of ISO 80369-20:2015, Annex E, while using the stress cracking

6.4 Resistance to separation from axial load
luer connectors shall be evaluated for separation from axial load. luer connectors shall not
separate from the reference connector over a hold period between 10 s and 15 s while being subjected
to a disconnection applied axial force between
a) 23 N and 25 N for luer slip connectors, and
b) 32 N and 35 N for luer lock connectors.
Manufacturers may use a greater disconnection applied axial force or a longer hold period.
Check compliance by applying the tests of ISO 80369-20:2015, Annex F, while using the separation from
axial load reference connector specified in Annex C.
6.5 Resistance to separation from unscrewing

luer lock connectors shall be evaluated for separation from unscrewing. luer lock connectors
shall not separate from the reference connector for a hold period between 10 s and 15 s while being
subjected to an unscrewing torque of between 0,019 8 N·m to 0,020 0 N·m. manufacturers may use a
greater applied unscrewing torque or a longer hold period.
Check compliance by applying the tests of ISO 80369-20:2015, Annex G, while using the resistance to
separation from unscrewing reference connector specified in Annex C.
6.6 Resistance to overriding

luer lock connectors shall be evaluated for resistance to overriding. luer lock connectors shall
not override the threads or lugs of the reference connector while being subjected to an applied torque
of between 0,15 N·m to 0,17 N·m over a hold period between 5 s and 10 s. manufacturers may use a
greater applied torque or a longer hold period.
Check compliance by applying the tests of ISO 80369-20:2015, Annex H, while using the resistance to
overriding reference connector specified in Annex C.

ISO 80369-7:2016(E)
Annex A
(informative)
Rationale and guidance
A.1 General guidance
This Annex provides a rationale for some requirements of part of ISO 80369 and is intended for those
who are familiar with the subject of part of ISO 80369 but who have not participated in its development.
An understanding of the rationale underlying these requirements is considered to be essential for their
proper use. Furthermore, as clinical practice and technology change, it is believed that a rationale will
facilitate any revision of this part of ISO 80369 necessitated by those developments.
A.2 Rationale for particular clauses and subclauses

The clauses and subclauses in this Annex have been numbered to correspond to the numbering of the
clauses and subclauses of this part of ISO 80369 to which they refer. The numbering is, therefore, not
consecutive.

Clause 1 Scope
The scope includes the fittings described previously in ISO 594-1 and ISO 594-2.
In 2000, a Task Group of the European standards organization CEN proposed a strategy to reduce
incidents of accidental misconnection of patient therapy lines by the use of a series of non-
interconnectable connectors, differentiated by design, for use in different medical applications.
The strategy reserves the use of luer connectors solely for use in medical devices used to access the
vascular system or for hypodermic applications so that they can achieve their intended function[13].
During the development of this part of ISO 80369, the committee frequently debated how luer
connector activated medical devices (LADs) should be interpreted. In context of this part of
ISO 80369, “LADs” are considered to be a “component” of the medical device and are typically a female
valve designed to interconnect with male luer connector. The following guidance relates specifically
to the LAD (or female valve end) component only and does not include the rest of a medical device.
A LAD typically includes a valve that opens and permits access to the fluid conduit when a standard
male luer connector is inserted into it. By design, it forms one-half of the connection that establishes
a fluid conduit with a male luer connector. However, such LADs typically do not comply with this
part of ISO 80369. Specifically, they often do not conform to 4.2 regarding materials (since their mating
surfaces often include elastomeric materials) nor do they fully conform dimensionally to Clause 5. Thus,
a typical LAD is not a luer connector. As such, they are not within the scope of this part of ISO 80369.
The committee, however, felt compelled to provide some guidance on the LAD due to the obvious
similarities of intended use with luer connectors. It is advisable that manufacturers of LADs utilize
the features providing non-interconnectable characteristics of this part of ISO 80369, wherever
possible, to address the risk of misconnections to their medical devices. These elements can include
the appropriate combinations of the following:
— materials conformance (i.e. ≥700 MPa) for interference features;
— dimensional conformance (i.e. dimensions H, J, D, and G from Annex B);
— dimensional and/or CAD analysis showing interference features;
— non-interconnectable characteristics testing per ISO 80369-1:2010, Annex B;

ISO 80369-7:2016(E)
— usability testing demonstrating non-interconnectable characteristics.

Additionally, the functional performance requirements of Clause 6 should also be considered for the
LAD component.
In this way, the LADs can be evaluated for both non-interconnectable characteristics and
performance characteristics associated with the ISO 80369- series.
The LADs by definition continue to not be considered a “conforming” luer connector (i.e. not
complying with this part of ISO 80369), however they can be considered ‘compatible with’ a medical
device utilizing a male luer connector (by way of functional performance).
manufacturers and responsible organizations are encouraged to report their experience with the
luer connectors specified in this part of ISO 80369 to the Secretariat of ISO/TC 210, so that it can
consider this feedback during the revision of the relevant part of the ISO 80369- series.
Definition 3.1 luer connector
Definition 3.2 luer slip connector
Definition 3.3 luer lock connector
For clarity, the new terms luer connector, luer slip connector, and luer lock connector replace
conflicting and confusing terms used in ISO 594-1 and ISO 594-2. The new terms align and harmonize
this part of ISO 80369 with ISO 80369-1, which does not utilize the legacy terms fitting, conical, or taper.
The new terms are equivalent to those now generically used to describe the small-bore connectors

commonly named after their inventor, 19th century German medical instrument maker Hermann
Wülfing Lüer.
Clause 5 Dimensional requirements for luer connectors
The separate set of dimensions previously identified for semi-rigid materials and rigid materials
are now merged into one set of dimensions. With modern test equipment and test methods, it is now
practicable to define the dimensions with greater precision, thereby eliminating the need for gauging
for the purposes of a type test.
Legacy Luer gauges cannot be used to verify the performance of connectors that are intended to prevent
misconnection because they lack the dimensions for surfaces not intended to form connections with
luer connectors. Maintenance of production quality (i.e. using gauges) is outside the scope of this part
of ISO 80369. The dimensional requirements in Annex B are a more precise description of the design
and performance characteristics for both intended connections and avoidance of misconnections.
Dimensions and tolerances not previously identified in ISO 594-1 and ISO 594-2 are added to this part
of ISO 80369 to reduce the risk of misconnections between medical devices or between accessories
for different applications with non-luer connectors that are being developed under other parts of
the ISO 80369- series. These new requirements were selected to represent the inherent design and
dimensions of luer connectors in clinical use at the time this part of ISO 80369 was developed.
Since the configurations of the connectors proposed within ISO 80369-7 are small-bore connectors
with or without a threaded collar, the requirements and parameters from ISO 594-1 and ISO 594-2 have
been used where applicable.
The maximum inside diameter at the tip of the male taper (through bore), Øf, of 2,900 mm was chosen
to describe the majority of luer connectors available to users at the time of publication of this part
of ISO 80369. The committee considered the clinical needs of high flow rate intravascular medical
devices and determined that the incremental increase in flow if Øf is increased to a theoretical sharp
edge of 3,50 mm was not warranted in view of the increased risk of misconnection with smaller male
small-bore connectors in the ISO 80369- series.
Commercially developed glass prefilled syringes routinely mate with luer connector equipped
medical devices in order to effectively administer the medication stored within the syringe. Examples:
disposable needles, needleless ports and other forms of Luer access. Current state-of-technology syringe

ISO 80369-7:2016(E)
tip glass forming technology for manufacturing glass-prefilled syringes cannot conform completely to
either previous Luer fitting standard, ISO 594 or this part of ISO 80369. Both the previous standard and
this part of ISO 80369 have been developed using ground glass, metal and injection moulded technology
and plastic resins as the baseline for compliance and capabilities.
The minimum inside diameter at the tip of the male taper (through bore), Øf, is not defined to
accommodate the very small bore of glass syringes.
The committee acknowledges the differences in the manufacturing methodologies and the need for
expanded tolerances in the glass forming manufacturing process. The baseline specifications of the
tapered tip need to remain similar. However to accommodate the glass forming manufacturing process,
there needs to be expanded dimensional tolerances. While these tolerances are outside of the range of
this part of ISO 80369 with respect to some of the dimensions, a glass formed tip does successfully mate
with the injection moulded female luer connectors. Refer to ISO 11040-4 for a listing of those critical
dimensions, their expanded corresponding tolerances and functional test methods that accommodate
the formed tip manufacturing process.
A dimensional analysis of the female luer lock connector (L2), variant A thread form was conducted
during the development of this part of ISO 80369 to ensure both
— proper connection to other male luer connectors, and
— prevention of misconnection to the other connectors of the ISO 80369- series.
The analysis demonstrated that in certain instances the thread form detailed in Figure B.6 and

Table B.6 could, if taken to certain extremes, collide with non-sealing features of the mating male luer
connector (i.e. Figure B.3 and Figure B.4) prior to a fluid tight seal being achieved. Specifically the
diagonal distance between the corners of the right angle thread of the female luer lock connector
of Figure B.6 could bind between adjacent threads of the mating male luer connector. Figure A.1 and
Figure A.2 illustrate this possible interference. This can be worsened by the allowable variations in
thread profile, thread pitch and thread lead, of the features of the mating male luer connector. This
situation is unchanged from the legacy ISO 594-2, the same magnitude of interference was possible
complying connectors.
Due to the proliferation of existing luer connectors and general lack of data indicating a problem in
use, the committee determined that the same level of interference would be permitted by this part of
ISO 80369 (i.e. the permissible design is unchanged).
Key
1 corners that can interfere
Figure A.1 — Lug corners that can interfere

ISO 80369-7:2016(E)
Key
1 area of potential interfere
Figure A.2 — Area of potential interference
In addition, due to the commercial evolution of existing luer connectors, a connector complying
with ISO 594-2:1988, Figure 3, Variant A (female Luer with thread lug at right angle) was elusive to
locate for testing purposes. Most participating manufacturers, who offer a “lug” version of threads,
offer a version that has one side at a right angle with the other inclined at pitch “p”, thus these are
a hybrid between the traditional ISO 594-2:1988, Figure 3, Variant A and ISO 594-2:1988, Figure 4.

Since the diameters provide the features that ensure the non-interconnectable characteristics are
maintained, the committee decided to permit these hybrid thread lugs with the inclusion of features N
and N2 (width of the thread lug at the root of the leading and trailing ends, respectively).
NOTE The same levels of interference as described above (with threads at right angles) is possible within
the tolerances specified. Each manufacturer is encouraged to check the performance of their design to ensure
the risk of leakage is minimized.

ISO 80369-7:2016(E)
Annex B
(normative)
luer connectors
Dimensions in millimetres unless otherwise indicated

Table B.1 contains the dimensions for this figure.
Figure B.1 — Male luer slip connector (L1)
Table B.1 — Male luer slip connector dimensions (L1)

Male luer slip connector (L1)
Dimension
Reference Designation
Minimum Nominal Maximum
Angle of the taper (6 % taper nominal) (degrees,
(α) — (3,44°) —
reference)
Outside diameter at the tip of the male taper at 0,750
Ød (basic dimension) from the tip (small end) of the male 3,970 4,021 4,072
taper
e Length of the male tapera 7,500 8,400 10,500
Øf Inside diameter at the tip of the male taper — 2,100 2,900
Outside diameter of the larger end of the male taper at
Øg 7,500 (basic dimension) from the tip (small end) of the 4,376 4,426 4,476
male taper
r Radius or chamfer at the outside tip of the male taper 0,000 0,250 0,500
a This dimension also defines the extent of the connector. Medical device features beyond the connector may require
evaluation to ISO 80369-1:2010, Annex B, to ensure non-interconnectable characteristics.

ISO 80369-7:2016(E)
Figure B.2 — Female luer slip connector (L1)

Table B.2 — Female luer slip connector dimensions (L1)
Female luer slip connector (L1)
Dimension
Angle of the taper (6 % taper nominal) (degrees,
(α) — (3,44°) —
reference)
Inside diameter at the open end of the female taper at
ØD 0,750 (basic dimension) from the opening (large end) of 4,198 4,248 4,298
the female taper
E Depth of the female tapera 7,500 8,400 10,500
Inside diameter of the smaller end of the female taper at
ØG 7,500 (basic dimension) from the opening (large end) of 3,793 3,843 3,893
the female taper
Outside diameter of the female luer slip connector of
the smallest cylinder of depth of 5,5 mm from the face
ØJ 6,000 6,356 6,730
of the connector that encompasses the outside surfac-
es of external features of the connector
R Radius or chamfer at the entrance of the female taper 0,000 0,250 0,500
a This dimension also defines the extent of the connector. Medical device features beyond the connector may require
evaluation to ISO 80369-1:2010, Annex B, to ensure non-interconnectable characteristics.

ISO 80369-7:2016(E)
Figure B.3 — Male luer lock connector (L2), with fixed collar

ISO 80369-7:2016(E)
Table B.3 — Male luer lock connector with fixed collar dimensions (L2)
Male luer lock connector (L2) with fixed collar
Dimension
Angle of internal thread profile on the non-bearing
β 25,0° 30,0° (57,0°)
surface against separation (degrees)
Projection of the tip of the connector from the
c 2,100 2,150 (2,573)
thread collar
e Length of the male taper 7,500 8,400 10,500
Major inside thread diameter (diameter at the thread
Øh 7,900 8,000 8,100
root)
Minor inside thread diameter (diameter at the
Øj 6,800 7,000 7,200
thread crest)
m Width of the thread profile at the crest 0,300 (0,326) (0,674)
n Width of the thread profile at the root (0,627) 0,875 1,000
Nominal pitch of the double-start, right-hand thread
(p) — (2,500) —
(reference 5 mm lead)
Angle of internal thread profile on the bearing surface
σ 25,0° 27,5° 30,0°
against separation (degrees)

Distance from the tip of the connector to the bottom of
t (2,727) 3,025 3,200
the first complete thread profile of the internal thread
Diameter of the smallest cylinder that encompasses
Øw the outside surfaces of the external features of the 8,800 9,700 11,500
collar a
The design and dimensions of the thread profile (σ, β and m) may vary from those designated provided the connector
meets the performance requirements of Clause 6.
NOTE The design and dimensions of the thread profile (σ, β and m) are not considered important to ensure non-
interconnectable characteristics.
The length of the thread is not specified but shall provide clearance for the thread of the female connector.
The male luer lock connector shall include the dimensions and tolerances of the male luer connector as specified in
Figure B.1 and Table B.1.
a The specified dimensional range shall be maintained for a minimum length of 1 mm from the open end of the collar.
Beyond 1 mm, the diameter may be smaller than the specified minimum. The maximum diameter specified shall be
maintained for a minimum length of e. This dimension may be achieved by either the connector or the medical device
which incorporates this connector. Alternatively, non-interconnectable characteristics may be demonstrated using
ISO 80369-1:2010, Annex B.

ISO 80369-7:2016(E)
Figure B.4 — Male luer lock connector (L2), with rotatable collar
Table B.4 — Male luer lock connector with a rotatable collar dimensions (L2)
Male luer lock connector (L2), with a rotatable collar
Dimension
Projection of the tip of the connector from the
ca 2,100 2,150 (2,573)
thread collar
e Length of the male taper 7,500 8,400 10,500
Distance from the tip of the connector to the bottom of
ta (2,727) 3,150 3,200
the first complete thread profile of the internal thread
The male luer lock connector with rotatable collar shall include the dimensions and tolerances of the male luer
connector as specified in Figure B.3 and Table B.3 except as indicated in this table.
a This dimension is when the floating or rotatable collar is positioned fully toward tip of the connector.

ISO 80369-7:2016(E)
Table B.5 contains the dimensions for this figure. This design and the associated dimensions shall apply to any
female luer lock connector that has threads in a plane inclined to the axis of the connector. There are no
dimensional restrictions on thread length. Figure B.6, Figure B.7 and Figure B.8 apply to designs utilizing lugs that
are at a right angle to axis of the connector.
Figure B.5 — Female luer lock connector (L2)

ISO 80369-7:2016(E)
Table B.5 — Female luer lock connector dimensions (L2)

Female luer lock connector (L2)
Dimension
Angle of the external thread profile on the non-bearing
Β 0,0° 15,0° (53,0°)
E Depth of the female taper 7,500 8,400 10,500
Major outside thread diameter (diameter at thread
crest) for the extent of the thread feature. This defines
the diameter of the smallest cylinder of depth 5,5 mm
ØH from the face of the connector that encompasses the 7,730 7,780 7,830
outside surfaces of the external features of the
connector. This diameter shall not be increased for a
distance from the hub face of 5,5 mm.
Minor outside thread diameter (diameter at the thread
ØJ root) This diameter shall not be increased for a distance 5,515 6,123 6,730
from the hub face of 5,5 mm.
M Width of the thread profile at the crest 0,300 (0,420) (0,967)
Width of the thread profile at the root at a diameter
N (0,533) 1,073 1,200
corresponding to ØJ max (6,730)

Nominal pitch of the double-start, right-hand thread
(P) — (2,500) —
(reference 5 mm lead)
Distance from the face of the connector to the base of
Q 0,000 0,200 0,300
the thread
R Radius or chamfer at the entrance of the female taper 0,000 0.250 0,500
Angle of external thread profile on the bearing surface
Σ 25,0° 27,5° 30,0°
The design and dimensions of the thread profile (Σ, Β and M) may vary from those designated provided the connector
meets the performance requirements of Clause 6.
NOTE The design and dimensions of the thread profile (Σ, Β, M and P) are not considered important to ensure non-
The female luer lock connector shall include the dimensions and tolerances of the female luer connector as specified
in Figure B.2 and Table B.2.

ISO 80369-7:2016(E)
Figure B.6 — Female luer lock connector with lugs at right angle to axis (L2), variant A

ISO 80369-7:2016(E)
*Table B.6 — Female luer lock connector dimensions (L2), variant A

Female luer lock connector (L2), variant A
Dimension
Angle of the external lug profile on the non-bearing
Β 0,0° 15,0° (53,0°)
ØH Major outside lug diameter (diameter at the lug crest) 7,730 7,780 7,830
ØJ Minor outside lug diameter (diameter at the lug root) 5,515 6,123 6,730
M Width of the lug profile at the crest 0,300 (0,659) (0,967)
Width of the lug profile at the root at a diameter
N corresponding to 6,730 on the leading end of the lug as (0,533) 1,073 1,200
it is screwed into a male connector
N2 corresponding to 6,730 on the trailing end of the lug as (0,533) 1,073 2,070
it is screwed into a male connector
Distance from the face of the connector to the base
Q 0,000 0,200 0,300
of the lug
Angle of external lug profile on the bearing surface
Σ 25,0° 27,5° 30,0°

Chord length at the base of the lug in a plane at a right
X angle to the axis of the connector, to be measured on a — 3,400 3,500
chord of a circle, the diameter of which is 7,000
Chord length at the extremity of the lug in a plane at a
Y 2,710 2,810 —
right angle to the axis of the connector
The female luer lock connector with external lugs shall include the dimensions and tolerances of the female luer
connector as specified in Figure B.2 and Table B.2.
Y shall not be greater than X.
NOTE The design and dimensions of the thread profile (Σ, Β and M) are not considered important to ensure non-

ISO 80369-7:2016(E)
Table B.7 contains the dimensions for this figure. This variant is only intended for use in the design of rigid
material metal connectors.
Figure B.7 — Female luer lock connector with lugs at right angle to axis (L2), variant B
Table B.7 — Female luer lock connector dimensions (L2), variant B

Female luer lock connector (L2), variant B
Dimension
Angle of the external lug profile on the non-bearing
Β 0,0° 30,0° (53,0°)
ØJ Minor outside lug diameter (diameter at the lug root) 5,515 5,608 5,700
M Width of the lug profile at the crest 0,000 (0,240) 0,270

ISO 80369-7:2016(E)
Table B.7 (continued)

Female luer lock connector (L2), variant B
Dimension
N (0,300) 0,800 1,300
corresponding to 6,730
Distance from the face of the connector to the base of
Q 0,000 0,200 0,300
the lug
Angle of the external lug profile on the bearing surface
Σ 25,0° 27,5° 30,0°
X angle to the axis of the connector, to be measured on a — 4,900 5,000
chord of a circle, the diameter of which is 7,000
Width across the lugs in a plane at a right angle to axis of
Z 6,400 6,450 6,500
the connector

Table B.8 contains the dimensions for this figure. This variant is only intended for use in the design of rigid
material metal connectors.
Figure B.8 — Female luer lock connector with lugs at right angle to axis (L2), variant C
Table B.8 — Female luer lock connector dimensions (L2), variant C

Female luer lock connector (L2) with external threads
Dimension
X angle to the axis of the connector, to be measured on — 4,900 5,000
a chord of a circle, the diameter of which is 7,000
connector as specified in Figure B.2 and Table B.2 as well as Section B-B of Figure B.7 and Table B.7.

ISO 80369-7:2016(E)
Annex C
(normative)
Reference connectors
C.1 General requirements for reference connectors
Reference connectors shall be manufactured from corrosion-resistant rigid materials with a surface
roughness value, Ra, not exceeding 0,8 μm on critical surfaces.

ISO 80369-7:2016(E)
C.2 Reference connectors

In Figure C.1, all outside edges of lug or thread form shall have a radius between 0,15 mm and 0,20 mm (unless
otherwise specified). R may be × 45° chamfer.
Figure C.1 — Female reference luer lock connector for testing male luer connectors
for leakage, separation from unscrewing, stress cracking and non-interconnectable
characteristics

ISO 80369-7:2016(E)
NOTE 1 Cone taper (0,06:1).
NOTE 2 R may be 0,5 mm (maximum) × 45° chamfer. The minimum length of the male taper of 10,5 mm is
required for testing non-interconnectable characteristics. A minimum length of the male taper of 7,5 mm may
be used for the performance tests of Clause 6.
Figure C.2 — Male reference luer slip connector for testing female luer connectors for
leakage, separation from axial load, stress cracking and non-interconnectable characteristics

ISO 80369-7:2016(E)
In Figure C.3, all outside edges of lug or thread form shall have a radius between 0,15 mm and 0,20 mm (unless
otherwise specified). R may be × 45° chamfer.
Figure C.3 — Female reference connector for testing male luer lock connector for separation
from axial load and resistance to overriding

ISO 80369-7:2016(E)
a Maximum distance from tip of male luer lock connector to the first complete profile of the internal thread
(see Table B.3, dimension t).
b Double-start, right-hand thread of 2,5 mm pitch.
NOTE R may be 0,5 mm (maximum) × 45° chamfer.
Figure C.4 — Male reference luer lock connector for testing female luer connectors
for leakage, separation from unscrewing, stress cracking and non-interconnectable
characteristics

ISO 80369-7:2016(E)
NOTE 1 Cone taper (0,06:1).
NOTE 2 R may be 0,5 mm (maximum) × 45° chamfer. The minimum length of the male taper of 10,5 mm is
required for testing non-interconnectable characteristics. A minimum length of the male taper of 7,5 mm may
be used for the performance tests of Clause 6.
Figure C.5 — Female reference luer slip connector for testing male luer connectors for
leakage, separation from axial load, stress cracking and non-interconnectable characteristics

ISO 80369-7:2016(E)
a Maximum distance from tip of male luer lock connector to the first complete profile of the internal thread
(see Table B.3, dimension t).
b Double-start, right-hand thread of 2,5 mm pitch.
NOTE R may be 0,5 mm (maximum) × 45° chamfer.
Figure C.6 — Male reference connector for testing female luer lock connector for separation
from axial load and resistance to overriding

ISO 80369-7:2016(E)
Annex D
(informative)
Assessment of medical devices and their attributes with
connections within this application
Table D.1 contains examples of medical devices and accessories within intravascular or hypodermic
applications. The table contains an assessment by the working group of the important attributes of
medical devices and accessories as they relate to the intended connection. Each connection is
assessed according to the following index or subgroups:
a) syringe connections;
b) needle connections;
c) IV tubing set connections;
d) IV tubing set port connections;
e) retention mechanism (e.g. balloon) connections used to hold invasive medical devices in place;

f) IV catheter connections;
g) IV catheter port connections;
h) stopcock connections;
i) adaptor connections;
j) medication compounding adaptor connections.

Table D.1 — Examples of medical devices with connections
within this application and their attributes
Type of fluid Type of connection Functionality
Part/component to Flowrate patient Disrupted
Dis- Therapy Infection Flowrate
which the connec- Index range haemorrhage sample Locking Slip
Air Liquid Connection connec- disruption control control
tor is applied ml/min from fluid loss collection needed needed
tion needed
Syringe 1 0 to 1 200 yes yes yes yes yes no yes yes yes yes yes
© ISO 2016 – All rights reserved

Needle 2 0 to 1 200 yes yes yes yes yes yes yes yes yes yes yes
IV tubing set 3 0 to 1 200 yes yes yes yes yes yes yes yes yes yes yes
IV tubing set port 4 0 to 1 200 yes yes yes yes yes yes no yes yes yes yes
Retention mecha-
nism (e.g. balloon)
connections used to 5 0 to 1 200 yes yes yes yes yes no no no yes yes yes
hold invasive medi-
cal devices in place
IV catheter 6 0 to 1 200 yes yes yes yes yes yes yes yes yes yes yes
IV catheter port 7 0 to 1 200 yes yes yes yes yes yes yes yes yes yes yes
Stopcock 8 0 to 1 200 yes yes yes yes yes yes no yes yes yes yes
Adaptor 9 0 to 1 200 yes yes yes yes yes yes yes yes yes yes yes
Medication com-
10 0 to 1 200 yes yes yes yes yes no no yes yes yes yes
pounding adaptor
ISO 80369-7:2016(E)
29
ISO 80369-7:2016(E)
Annex E
(informative)
Summary of the usability requirements for luer connectors for
intravascular or hypodermic applications
E.1 user profile

The user profile is a 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.
users of luer connectors for intravascular or hypodermic applications are comprised of the clinical,
laboratory, or non-clinical persons using, i.e. operating or handling, the medical device, including, but
not limited to, cleaners, maintainers and installers, patients, or other laypersons. users are expected
to perform an intended action in an intended use of a medical device, accessory, process or service
in accordance with the specifications, instructions and information provided by the manufacturer.
users include the following:

a) clinical users, such as
1) physicians who specialize in anaesthesiology, neuro-radiology, paediatrics, oncology,
haematology/nursing, emergency room, medicine, interventional radiology, or as a physician
assistant,
2) nurses, at all levels, including Certified Registered Nurse Anaesthetist (CRNA) etc.,
3) emergency medical technicians, and
4) homecare providers, visiting nurses, relatives;
b) non-clinical users, such as cleaners, maintainers and installers;
c) in vitro diagnostics laboratory and pharmacy users, responsible for mixing of drugs, filling syringes
and reservoirs, storage and dispensing of drugs.
The user profile is summarized in Table E.1.
Table E.1 — User profile

in vitro diagnostic
patients as users Clinical users Non-clinical users laboratory and
pharmacy users
Extensive clinical Limited clinical Bioengineers, central
user skills: No training
training training processing
Direct patient Direct patient Direct patient
patient contact: No patient contact
contact contact contact
E.2 Use scenarios

Use scenarios for luer connectors for intravascular or hypodermic applications can differ by user
group, and are comprised of the multitude of sub-applications of the connectors within different
sub-specialities.

ISO 80369-7:2016(E)
A summary of use scenarios by user group is summarized in Table E.2.
Table E.2 — Use scenarios

in vitro diagnostic
Patients Clinical Non-clinical
Subspeciality use scenario laboratory and
as users users users
pharmacy users
1. Parenteral
— Chemo X X X X
— Insulin, subcutaneous X X X —
— Infusion, IV catheter placements — X X X
— Medication preparation X X X X
— Injections X X X X
— Parenteral nutrition, including TPN (Total
X X X X
parenteral nutrition)
2. Extracorporeal
— Dialysis — — — —
— Peritoneal Dialysis X X X X
— Haemodialysis X X X —
— ECMO (extracorporeal membrane
— X — —
oxygenation)

— Invasive pressure monitoring — X — —
— ICP Intracranial pressure — X — —
— IABP Intra-aortic balloon pump — X — —
— VAD Ventricular assist device — X — —
— Cardio-pulmonary bypass — X — —
— Cardiac catheters — X — —
— Rapid infusers — X — —
— Radiological marker pressure infusers — X — X
3. Irrigation
— Wound care X X X —
— Aspiration X X X —
— Sample collection X X X —
4. Retention mechanism (e.g. balloon) (both gas or liquids)
— Foley catheters X X X —
— Rectal catheters X X X —
— PEGs X X X —
— Tracheal tubes — X — —
— Laryngeal Mask Airways — X — —
— Tracheostomy tubes X X X —
5. Ports
— Subdermal X X X X
— Pain management X X X X
— Gastric Lapbands X X X —
— Implant inflation — X X —
6. Blood
— Sample collection X X X X
— Transfusion X X X —

ISO 80369-7:2016(E)
Table E.2 (continued)

in vitro diagnostic
Patients Clinical Non-clinical
Subspeciality use scenario laboratory and
as users users users
pharmacy users
— Donation/Phlebotomy X X X —
7. Medication preparation
— Add-mixture X X X X
— Compounding X X X X
8. Other
— Thermodilution catheters — X — —
E.3 Use environments

E.3.1 Facilities
Hospitals, surgery suites, patient rooms, home, labour and delivery, intensive care units, doctors’
offices, pain clinics, pharmacy, field hospitals, transport systems, infusion clinics, home assisted care,
emergency medical services.
E.3.2 Use temperature

The following temperature environments are expected for luer connectors:
a) ambient temperature, −40 °C to +60 °C (for field use in emergency medical services);
b) body temperature, to 42 °C;
c) hypothermia treatment, 10 °C (for therapeutic cooling of spinal cord injuries);
d) hypo/normo/hyperthermia treatments, 10 °C to 43 °C (for ECMO treatments).
E.4 Other attributes

The following other attributes are expected for luer connectors:
a) usability under stress (ignoring labels, attempting force-fit);
b) proximity of liquids, use of gloves;
c) proximity of other connector-bearing equipment (e.g. sphygmomanometers, gas measurement).
E.5 Generic user needs

The following user needs attributes are expected for luer connectors:
a) minimal pan-healthcare user training on the use of connectors;
b) easy to manipulate without the use of tools;
c) ease of assembly/disassembly with finger-tip control, especially in wet environment or with the
use of gloves;
d) does not misconnect to other small-bore connectors not intended for the same purpose in the
environment of use (ISO 80369-1);
e) does not leak under normal use;

ISO 80369-7:2016(E)
f) security/integrity of connection, cannot unintentionally self-disconnect;

g) low dead space;
h) ease of fluid passage
1) rate limiting factors;
2) maximum flowrate
i) cardiovascular equipment, diluted blood: 4 l/min, at 3 bar with a dynamic viscosity of
6,89 mPa/s to prevent haemolysis,
ii) dialysis equipment, blood: 600 ml/min at 400 mmHg below atmospheric pressure, and
iii) IV pump, aqueous solutions: 1 200 ml/min at 300 mmHg pressure;
3) Viscosity of solutions
i) aqueous,
ii) chemotherapy,
iii) steroids, and
iv) hyperbaric local anaesthetics;

i) needle-through-needle techniques, needle stylets (guide wires, peripheral catheters, etc.);
NOTE Lumen diameter requirements are medical device specific and can require a medical device-
specific risk assessment to provide for different capabilities.
j) compatible with disinfection, decontamination, sterilization, reprocessing environments;

k) luer slip connectors are required to address several user needs, such as
1) need to align the syringe with the 3-way stopcock,
2) need to prevent movement of needle orientation during connection,
3) cognitive distinction between luer slip connectors and luer lock connectors to prevent a
misperception that the luer slip connector is locked,
4) lightweight and unobtrusive needle hub,
5) little additional cost (making/purchasing), and
6) consider the need for visible fluid paths in specific medical devices.

ISO 80369-7:2016(E)
Annex F
(informative)
Summary of luer connector design requirements for
Table F.1 is a summary of the design requirements for luer connectors for intravascular or hypodermic
applications.
Table F.1 — Luer connector specific design requirements for intravascular or hypodermic
applications
Criteria Requirements Remarks
1 Fluid type a) Liquid
b) Gas —
c) Both c)
2 Operating pressure range maximum pressure 300 kPa
minimum pressure —
sub-atmospheric? (yes/no) Yes, 80 kPa

3 Rated pressure range minimum
—
maximum See Item 2
4 Is there a need for a leak test? a) No
b) Yes b) —
Reference for test method
5 Rated flowrate range minimum 0 ml/min
—
maximum 1 200 ml/min
6 Internal diameter range minimum 0 mm
—
(through bore) maximum 2,9 mm
7 Rated temperature range minimum −40 °C
—
maximum 60 °C
8 Minimum range of connector minimum Not compatible with
mating diameters maximum — other new small-
bore connectors
9 General layout a) Parallel-sided, O-ring seal
b) Parallel-sided, other seal
—
c) Conical c)
d) Other (specify) d)
10 Method of keying a) Collar
b) Plug none —
c) Other (specify)
11 Quick release? a) No a)
b) Yes
i) single-handed operation —
ii) double-handed operation
12 Positive locking/locking a) No
—
feature? b) Yes b)
13 Need for visual indication of a) No a)
locking status? b) Yes —
14 Need for indication of a) No a)

—
evidence of tampering? b) Yes

ISO 80369-7:2016(E)
Table F.1 (continued)

15 Need for a syringe in the a) No
—
application? b) Yes b)
16 Need for an absence of sharp a) No
—
edges? b) Yes b)
17 Minimum axial force in force 23 N luer slip
normal use, to remain connector
attached 32 N luer lock
connector —
Reference for test method ISO 594-1
ISO 594-2
18 Constructional materials a) Rigid material a) i) or ii)
(excluding seals) i) metal
—
ii) plastic
b) Semi-rigid material b) > 700 MPa
19 Need for use of a) No
a) or
semi-rigid material? b) Yes, mating part of
b) —
connector (apart from
seal)
20 MRI compatibility? a) No, with labelling

b) No, without labelling b) or
—
c) Yes, with labelling
d) Yes, without labelling d)
21 Stress-cracking resistance? a) No
b) Yes b) —
Specify limits
22 Externally, how is connector to be distinguishable from This is the
Not applicable
luer connector? (describe) luer connector
23 Proposal for colour-coding? a) No a)
b) Yes —
Reference standard
24 Labelling/Symbols/Marking? a) No (e.g. not for IV) a)
—
b) Yes
25 Other method for indicating a) No a)
intended use? b) Yes —
Indicate method
26 Biocompatibility considered? a) No
—
b) Yes b)
27 Reuse variants a) Multiple patient use a)
b) Single patient use b) or
c) Single use c) —
d) Non-reusable (indicate
method of auto-disabling)
28 Decontamination needed? a) No, single use only a)
b) Yes, cleaning and b) or e.g. isopro-
disinfection; indicate pyl alcohol
method —
c) Yes, cleaning and c)
sterilization; indicate
method
29 How is ISO 80369-2 a) Dimensional a)
incompatibility achieved? b) Other —
Indicate method

ISO 80369-7:2016(E)
Table F.1 (continued)

30 How is ISO 80369-3 a) Dimensional a)
Indicate method
31 How is IEC 80369-5 a) Dimensional a)
Indicate method
32 How is ISO 80369-6 a) Dimensional a) N1 male miscon-
incompatibility achieved? b) Other b) nection possible;
Indicate method see G.2.2.
33 How is ISO 80369-7 a) Dimensional
This is a luer
connector.
(ISO 594-1 and ISO 594-2) Indicate method

ISO 80369-7:2016(E)
Annex G
(informative)
Summary of assessment of the design of the luer connector for
G.1 General
connectors that comply with this part of ISO 80369 were designed and manufactured under the same
essential design and dimensional requirements as those that comply with the previous International
Standards[4].
connectors represented by these standards have been successfully manufactured as components to
medical devices for over 100 years.
G.2 Summary of the engineering analysis of the design

G.2.1 non-interconnectable analysis

A three-dimensional computer aided design (CAD) engineering analysis has been performed using
computational analysis and 3D solid model constructs of all tolerances and material conditions (least,
nominal and maximum) for all connectors represented by the ISO 80369- series. The small-bore
connectors specified in this part of ISO 80369 have been shown by engineering analysis to be non-
interconnectable with the other specified connectors of the ISO 80369- series with the exception of
the following. Table G.1 summarizes the potential misconnections.
A technical report is planned to describe the process for the CAD engineering analysis more completely.
Table G.1 — Summary of possible misconnection from CAD analysis

luer connector Connector Summary Reference
of concern
male N1 male Misconnection possible G.2.2
female slip E1 female Physical testing according ISO 80369-1:2010, Annex B, G.2.3
(except using all plastic parts) results in no connection
female slip N2 male lock Physical testing according ISO 80369-1:2010, Annex B, G.2.4
results in no connection
E1 from ISO 80369-3:2016.
N2 from ISO 80369-6:2016.
G.2.2 luer connector male to N1 male

In the engineering analysis, the inside diameter of the fluid lumen of male luer connector contacts
the sealing surfaces of the N1 male connector, as specified in ISO 80369-6:2016, in LMC conditions
and thereby these connectors will mutually fail the non-interconnectable characteristics tests of
ISO 80369-1:2010, Annex B. Figure G.1 illustrates this misconnection.
Testing was performed according to the test method of ISO 80369-6:2016, Annex H. The connection
did not leak and thereby these connectors mutually fail this non-interconnectable characteristics
test. Both of these connectors are distal to the patient in clinical use in the patient vicinity. In this
environment, this misconnection would connect an infusion source to an infusion source, which is not

ISO 80369-7:2016(E)
hazardous to the patient. In the pharmacy, this misconnection could allow cross filling of vascular and
neuraxial medications.
This misconnection is judged to be an acceptable risk.
Key
1 male luer connector
2 male N1
Figure G.1 — Illustration luer connector male to N1 male misconnection
G.2.3 luer slip connector female to E1 female

Testing was performed according to the test method of ISO 80369-1:2010, Annex B, while substituting
connectors of least material condition (LMC) and worst-case flexural modulus material (700 MPa to
720 MPa) for both the reference luer slip connector female and the E1 connector being evaluated.
The committee considers this modification of the test method to be more conservative.
The test demonstrated that the connectors are non-interconnectable.
G.2.4 luer slip connector female to N2 male lock

Testing was performed according to the test method of ISO 80369-1:2010, Annex B.
The test demonstrated that the connectors are non-interconnectable.
G.3 Summary of the design verification

See G.1 and G.2.
Because of the long and successful history of widespread clinical use, the committee concluded
that it was unnecessary to evaluate further these connector systems according to processes and
procedures of ISO 80369-1:2010, Clause 7. That notwithstanding, performance testing was conducted
on test articles that were available in the marketplace at the time and included components made from
the following materials.
luer connectors from two softer polymers are
— connectors made from two polypropylenes (PP) having a nominal modulus of elasticity (tensile) of
700 MPa, and 950 MPa.
luer connectors from three harder polymers are
— connectors made from styrene acrylonitrile (SAN) having a nominal modulus of elasticity (tensile)
of 3 800 MPa,
— connectors made from acrylonitrile butadiene styrene (ABS) having a nominal modulus of
elasticity (tensile) of 2 400 MPa, and

ISO 80369-7:2016(E)
— connectors made from polycarbonate (PC) having a nominal modulus of elasticity (tensile) of
2 344 MPa.
luer connectors from two metals are
— connectors made from brass and stainless steel.
This range of modulus spans the available common materials most often used in intravascular and
hypodermic applications and meets the requirements of 4.2.
Performance testing was conducted according to ISO 80369-20:2015 as required by Clause 6 using 60
samples per test group.
Conclusion:
The performance test results indicate that luer connector design is compliant with the performance
requirements as specified in Clause 6 using the test methods defined in ISO 80369-20:2015.
G.4 Summary of the design validation

See G.1 and G.2.
The luer connector of this part of ISO 80369 is generally the same design as the current connector
design of ISO 594.

The current connector design has been in use for IV connections in clinical settings since 1930. The
intended use of the ISO 594 Luer for intravenous and hypodermic connections is the same intended
use as the luer connectors of this part of ISO 80369.
The small-bore connectors as defined in ISO 80369-6 have been tested in a human factors study (as
described in ISO 80369-6:2016, G.4), which demonstrated that the misconnection potential between
the male luer connector and male N1 connector of ISO 80369-6 has been reduced to as low as
reasonable practicable.
These studies, along with the CAD validation activities (G.2), ensure that the misconnection potential
has been reduced to as low as reasonable practicable to acceptable levels with the luer connector
design of this part of ISO 80369.
Additionally, the clinical workflow for the ISO 594 connectors and the luer connector design of
this part of ISO 80369 does not change; therefore, no further usability study is needed for the luer
connector design of this part of ISO 80369.
G.5 Summary of the design review

luer connectors, which conform to this part of ISO 80369, also conform to the previous Luer
standards, ISO 594-1 and ISO 594-2.
The committee reviewed the assessment of the design of the luer connectors based on the results
reported in this Annex.
In summary, the design review concludes there is significant objective engineering, technical and
clinical evidence supporting the luer connector for the intended application.

ISO 80369-7:2016(E)
Annex H
(informative)
Reference to the essential principles
This part of ISO 80369 has been prepared to support the essential principles of safety and performance
of small-bore connectors intended to be used for connections in intravascular or hypodermic
applications of medical devices and related accessories according to ISO 16142-1:2016. This part of
ISO 80369 is intended to be acceptable for conformity assessment purposes.
Compliance with this part of ISO 80369 provides one means of demonstrating conformance with the
specific essential principles of ISO 16142-1:2016. Other means are possible. Table H.1 maps the clauses
and subclauses of this part of ISO 80369 with the essential principles of ISO 16142-1:2016.
Table H.1 — Correspondence between this part of ISO 80369 and the essential principles
Essential principle of Corresponding clause(s)/ Qualifying remarks/
ISO 16142-1:2016 subclause(s) of this part of ISO 80369 Notes
8.5 Clause 4, Clause 5, Clause 6 This Essential Principle
is partially covered by

ensuring that the con-
nector does not leak and
can only be connected to
intended medical devic-
es or accessories
12.1 Clause 4, Clause 5, Clause 6 —

ISO 80369-7:2016(E)
Annex I
(informative)
Terminology — Alphabetized index of defined terms
NOTE The ISO Online Browsing Platform (OBP) provides access to terms and definitions.1)
Term Source
accessory ISO 80369-1:2010, 3.1
application ISO 80369-1:2010, 3.2
connection ISO 80369-1:2010, 3.4
connector ISO 80369-1:2010, 3.5
harm ISO 14971:2007, 2.2
intended use ISO 14971:2007, 2.5
luer connector 3.1
luer slip connector 3.2
luer lock connector 3.3

manufacturer ISO 14971:2007, 2.8
medical device ISO 14971:2007, 2.9
non-interconnectable ISO 80369-1:2010, 3.6
normal use 3.4
patient ISO 80369-1:2010, 3.7
procedure ISO 14971:2007, 2.12
process ISO 14971:2007, 2.13
rated 3.5
responsible organization ISO 80369-1:2010, 3.8
rigid material ISO 80369-1:2010, 3.9
risk ISO 14971:2007, 2.16
risk assessment ISO 14971:2007, 2.18
semi-rigid material ISO 80369-1:2010, 3.10
small-bore ISO 80369-1:2010, 3.11
test method ISO 80369-20:2015, 3.1
type test ISO 80369-20:2015, 3.2
user 3.6
user profile 3.7
verification (verified) ISO 14971:2007, 2.28
1) Available at: https://www.iso.org/obp/ui/#home

ISO 80369-7:2016(E)
Bibliography
[1] ISO 178, Plastics — Determination of flexural properties
[2] ISO 527-2, Plastics — Determination of tensile properties — Part 2: Test conditions for moulding
and extrusion plastics
[3] ISO 594-1:1986, Luer conical fittings with a 6 % (Luer) taper for syringes, needles and certain other
medical equipment — Part 1: General requirements
[4] ISO 594-2:1998, Luer conical fittings with a 6 % (Luer) taper for syringes, needles and certain other
medical equipment — Part 1: Luer lock fittings
[5] ISO 3040:1990, Technical drawings— Dimensioning and tolerancing — Cones2)
[6] ISO 5356-1:2004, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones
and socket 3)
[7] ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones
and sockets
[8] ISO 5356-2:2006, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-
threaded weight-bearing connectors4)

[9] ISO 5356-2:2012, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-
threaded weight-bearing connectors
[10] ISO 8185:2007, Respiratory tract humidifiers for medical use — Particular requirements for
respiratory humidification systems
[11] ISO 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
[12] ISO 8537, Sterile single-use syringes, with or without needle, for insulin
[13] ISO 8638, Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for
haemodialysers, haemodiafilters and haemofilters
[14] ISO 3040:2009, Geometrical product specifications (GPS) — Dimensioning and tolerancing — Cones5)
[15] ISO 10241-1, Terminological entries in standards — Part 1: General requirements and examples of
presentation
[16] ISO 10241-2, Terminological entries in standards — Part 2: Adoption of standardized
terminological entries
[17] ISO 11040-4, Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled
syringes ready for filling
[18] ISO 14971:2007, Medical devices — Application of risk management to medical devices
[19] ISO 16142-1:2016, Medical devices — Recognized essential principles of safety and performance of
medical devices — Part 1: General essential principles and additional specific essential principles for
all non-IVD medical devices and guidance on the selection of standards
2) Withdrawn.
3) Withdrawn.
4) Withdrawn.
5) Withdrawn.

ISO 80369-7:2016(E)
[20] ISO 80369-2:— 6), Small-bore connectors for liquids and gases in healthcare applications — Part 2:
Connectors for breathing systems and driving gases applications
[21] ISO 80369-3:2016, Small-bore connectors for liquids and gases in healthcare applications — Part 3:
Connectors for enteral applications
[22] IEC 60601-1:2005+AMD1:2012, Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
[23] IEC 60601-1-11:2015, Medical electrical equipment — Part 1-11: General requirements for basic
safety and essential performance — Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment
[24] IEC 60601-1-12:2014, Medical electrical equipment — Part 1-12: General requirements for basic
safety and essential performance — Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems intended for use in the emergency medical services
environment
[25] IEC 62366-1:2015, Medical devices — Part 1: Application of usability engineering to medical devices
[26] IEC 80369-5, Small-bore connectors for liquids and gases in healthcare applications -- Part 5:
Connectors for limb cuff inflation applications
[27] CEN/CR 13825, Luer connectors — A report to CEN CHeF from the CEN forum task group “Luer
fittings”

[28] EN 13544-2:2002, Respiratory therapy equipment — Part 2: Tubing and connectors
[29] EN 13544-2:2002+Amd1:2009, Respiratory therapy equipment — Tubing and connectors
6) Under development.

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Small-bore connectors for liquids and

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Small-bore connectors for liquids and gases in healthcare

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© ISO 2016 – All rights reserved 1

3 Terms and definitions

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

[SOURCE: IEC 62366-1:2015, 3.24]

2 © ISO 2016 – All rights reserved

4.1 General requirements for luer connectors

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© ISO 2016 – All rights reserved 3

4.2 Material used for luer connectors

4.3 Type tests

5 * Dimensional requirements for luer connectors

ISO Central Secretariat

6.1 Fluid leakage

6.1.1 Fluid leakage requirement

6.1.2 Leakage by pressure decay

6.1.3 Positive pressure liquid leakage

4 © ISO 2016 – All rights reserved

6.3 Stress cracking

ISO Central Secretariat

6.5 Resistance to separation from unscrewing

6.6 Resistance to overriding

© ISO 2016 – All rights reserved 5

Rationale and guidance

A.2 Rationale for particular clauses and subclauses

ISO Central Secretariat

6 © ISO 2016 – All rights reserved

— usability testing demonstrating non-interconnectable characteristics.

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© ISO 2016 – All rights reserved 7

ISO Central Secretariat

Figure A.1 — Lug corners that can interfere

8 © ISO 2016 – All rights reserved

Figure A.2 — Area of potential interference

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© ISO 2016 – All rights reserved 9

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Figure B.1 — Male luer slip connector (L1)

Table B.1 — Male luer slip connector dimensions (L1)

10 © ISO 2016 – All rights reserved

Dimensions in millimetres unless otherwise indicated

Figure B.2 — Female luer slip connector (L1)