ISO 80369-7:2021
(Main)Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
This document 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 See Annex A. NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa. This document does not specify requirements for themedical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories. This document does not specify requirements for the following small-bore connectors, which are specified in other documents: - haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 [5] and applicable portion of ISO 8638 [ 6] referencing blood compartment ports); - haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]); - infusion system closure piercing connectors (ISO 8536-4 [4]). NOTE 3 Manufacturers are encouraged to incorporate thesmall-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included. NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document.
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé — Partie 7: Connecteurs pour les applications intravasculaires ou hypodermiques
Le présent document spécifie les dimensions et les exigences relatives à la conception et aux performances fonctionnelles des raccords de petite taille destinés à être utilisés pour effectuer des raccordements dans des applications intravasculaires ou des raccordements hypodermiques dans des applications hypodermiques de dispositifs médicaux et d'accessoires. EXEMPLES Les seringues et aiguilles hypodermiques ou les canules intravasculaires (IV) avec raccords Luer à glissement et raccords Luer à verrouillage mâles et femelles. NOTE 1 Voir l'Annexe A. NOTE 2 À l'origine, le raccord Luer a été conçu pour être utilisé à des pressions maximales de 300 kPa. Le présent document ne spécifie pas les exigences relatives aux dispositifs médicaux ou aux accessoires sur lesquels ces raccords sont utilisés. Ces exigences figurent dans des documents spécifiques traitant de dispositifs médicaux ou d'accessoires particuliers. Le présent document ne spécifie pas d'exigences pour les raccords de petite taille suivants, celles-ci étant spécifiées dans d'autres documents: - orifices du compartiment sanguin des hémodialyseurs, hémodiafiltres et hémofiltres (l'ISO 8637[5] et la partie applicable de l'ISO 8638[6] référencent les orifices du compartiment sanguin); - raccords des appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration (ISO 8637[5]); - raccords du perforateur du système de fermeture des appareils de perfusion (ISO 8536-4[4]). NOTE 3 Les fabricants sont incités à intégrer les raccords de petite taille spécifiés dans le présent document dans les dispositifs médicaux ou accessoires, même si cela n'est pas actuellement requis par les documents appropriés, spécifiques de ces dispositifs médicaux. Il est prévu d'inclure des exigences relatives aux raccords de petite taille, tels que spécifiées dans l'ISO 80369, lors de la révision des documents appropriés spécifiques de ces dispositifs médicaux. NOTE 4 L'Article 7 de l'ISO 80369-1:2018 spécifie d'autres méthodes de vérification de la conformité à l'ISO 80369-1:2018 pour les raccords de petite taille destinés à être utilisés avec des dispositifs médicaux ou des accessoires pour applications intravasculaires ou applications hypodermiques, mais qui ne sont pas conformes au présent document.
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INTERNATIONAL ISO
STANDARD 80369-7
Second edition
2021-05
Small-bore connectors for liquids and
gases in healthcare applications —
Part 7:
Connectors for intravascular or
hypodermic applications
Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 7: Connecteurs pour les applications intravasculaires ou
hypodermiques
Reference number
ISO 80369-7:2021(E)
©
ISO 2021
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ISO 80369-7:2021(E)
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ii © ISO 2021 – All rights reserved
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ISO 80369-7:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 3
4.1 General requirements for Luer connectors . 3
4.2 Type tests . 3
5 Dimensional requirements for Luer connectors . 3
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 . 4
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 .25
Annex D (informative) Assessment of medical devices and their attributes with connections
within this application .32
Annex E (informative) Summary of the usability requirements for Luer connectors for
intravascular or hypodermic applications .34
Annex F (informative) Summary of Luer connector design requirements for intravascular
or hypodermic applications .38
Annex G (informative) Summary of assessment of the design of the Luer connector for
intravascular or hypodermic applications .41
Annex H (informative) Reference to the essential principles .44
Annex I (informative) Reference to the general safety and performance requirements .45
Annex J (informative) Terminology — Alphabetized index of defined terms .46
Bibliography .47
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ISO 80369-7:2021(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 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 medical devices, and IEC/SC62D, Electromedical equipment, in collaboration with
the European Committee for Standardization (CEN) Technical Committee, CEN/CENELEC JTC3/WG 2,
Small-bore connectors, in accordance with the Agreement on technical cooperation between ISO and
CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 80369-7:2016), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— Tolerances of several reference connector dimensions are increased to facilitate easier manufacturing
and certification. Most of the affected tolerances are for features that do not contact the test
connector and therefore do not affect the test results. The angle tolerance for the bearing side of the
threads do contact the connector under test but the change in the tolerance is considered likely have
minimal to no effect on test outcomes.
— Some requirements for Luer connectors have been separated for semi-rigid materials and rigid
materials to better ensure compatibility at the extreme of the design space. Definitions of semi-rigid
material and rigid material have been added.
— The distance from the tip of the connector to the bottom of the first complete thread profile of
the internal thread (t dimension) has been made an auxiliary dimension due to the difficulty in its
measurement. The functional impact of the dimension is evaluated with the resistance to separation
(from axial load) functional test.
— The N1 and N2 dimensions of the female Luer lock connector variant A (with lugs at right angle to
axis) have been changed to allow measurement from the open end of the connector, to better ensure
compatibility at the extreme of the design space.
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.
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ISO 80369-7:2021(E)
Introduction
This document 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.
This document 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 document are dimensionally
incompatible with any of the other connectors for applications identified in the ISO 80369 series of
documents 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 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 a requirement;
— “should” means that conformance with a requirement or a test is recommended but is not mandatory
for conformance with this document;
— “may” indicates a permission;
— "can" indicates a possibility or a capability.
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INTERNATIONAL STANDARD ISO 80369-7:2021(E)
Small-bore connectors for liquids and gases in healthcare
applications —
Part 7:
Connectors for intravascular or hypodermic applications
1 Scope
This document 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 See Annex A.
NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa.
This document does not specify requirements for the medical devices or accessories that use these
connectors. Such requirements are given in particular documents for specific medical devices or
accessories.
This document does not specify requirements for the following small-bore connectors, which are
specified in other documents:
[5]
— haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 and
[6]
applicable portion of ISO 8638 referencing blood compartment ports);
[5]
— haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 );
[4]
— infusion system closure piercing connectors (ISO 8536-4 ).
NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this document into
medical devices or accessories, even if currently not required by the relevant particular medical device documents.
It is expected that when the relevant particular medical device documents are revised, requirements for small-
bore connectors, as specified in ISO 80369, will be included.
NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for
small-bore connectors intended for use with intravascular applications or hypodermic application medical devices
or accessories, which do not conform with this document.
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 14971:2019, Medical devices — Application of risk management to medical devices
ISO 80369-1:2018, 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
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ISO 80369-7:2021(E)
ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications — Part 20:
Common test methods
IEC 62366-1:2015, 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 specified in ISO 80369-1:2018,
ISO 80369-20:2015, ISO 14971:2019, IEC 62366-1:2015 as indicated in Annex J and the following apply.
NOTE For convenience, the sources of all defined terms used in this document are given in Annex J.
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
auxiliary dimension
dimension derived from other dimensions given for information purposes only
[7]
[SOURCE: ISO 10209:2012 , 4.2]
3.2
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.
Note 2 to entry: See Annex A.
3.3
Luer slip connector
Luer connector without a lock
Note 1 to entry: The Luer slip connector is indicated by the abbreviation L1.
Note 2 to entry: See Annex A.
3.4
Luer lock connector
Luer connector that contains a locking mechanism
Note 1 to entry: The Luer lock connector is indicated by the abbreviation L2.
Note 2 to entry: See Annex A.
3.5
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.
[12]
[SOURCE: IEC 60601-1:2005+A1: 2012 , 3.71, modified — replaced “operator” with “user”.]
3.6
rated
term referring to a value assigned by the manufacturer for a specified operating condition
[12]
[SOURCE: IEC 60601-1:2005 , 3.97]
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ISO 80369-7:2021(E)
3.7
rigid material
material with a modulus of elasticity either in flexure or in tension greater than 3 433 MPa
EXAMPLE Metals, glass, some fibre-reinforced polymers and high-performance polymers.
3.8
semi-rigid material
material with a modulus of elasticity either in flexure or in tension, between 700 MPa and 3 433 MPa
EXAMPLE Thermoplastics.
4 General requirements
4.1 General requirements for Luer connectors
Luer connectors made in conformance with this document conform with the general requirements of
ISO 80369-1:2018, unless otherwise indicated in this document.
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 and
thereby these connectors mutually fail when evaluating the non-interconnectable characteristics tests of
ISO 80369-1:2018, Annex B. Additional information is provided in G.2.2.
The reference connectors for evaluation of the non-interconnectable characteristics are described in
Annex C (Figures C.1, C.2, C.4 and C.5, as appropriate).
Where a medical device or accessory is designed to provide features of the Luer connector of this
document, those features shall be included in the verification to this document. When necessary,
install the small-bore connector on the medical device or accessory to demonstrate conformance with
ISO 80369-1:2018, Annex B.
NOTE 1 The summary of medical devices and their attributes with connections within this application is
provided in Annex D.
NOTE 2 The summary of the usability requirements for Luer connectors is provided in Annex E.
NOTE 3 The summary of Luer connectors criteria and requirements is provided in Annex F.
NOTE 4 The summary of assessment of the design of Luer connectors according to ISO 80369-1:2018, 6.1, is
contained in Annex G.
NOTE 5 This document has been prepared to address the relevant essential principles of safety and
[9]
performance of ISO 16142-1:2016 as indicated in Annex H.
NOTE 6 This document has been prepared to address the relevant general safety and performance
[15]
requirements of European regulation (EU) 2017/745 as indicated in Annex I.
4.2 Type tests
Conformance with the requirements of this document shall be determined by type tests.
5 Dimensional requirements for Luer connectors
Luer connectors shall conform 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,
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ISO 80369-7:2021(E)
— 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,
— Figure B.7 and Table B.7 for a female Luer lock connector (L2), with lugs at right angle to axis,
variant B, and
— Figure B.8 and Table B.8 for a female Luer lock connector (L2), with lugs at right angle to axis,
variant C.
Check conformance by confirming the dimensions and tolerances specified in Annex B, for the
appropriate figure and table.
NOTE See Annex A.
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
3
method shall not exceed a leakage rate of 0,005 Pa·m /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.
Check conformance by applying the tests of ISO 80369-20:2015, Annex B, while using the leakage
reference connector specified in Annex C (Figures C.1, C.2, C.4 and C.5, as appropriate). A greater applied
pressure may be used.
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 period of
30 s to 35 s while being subjected to an applied pressure of between 300 kPa and 330 kPa.
Check conformance by applying the tests of ISO 80369-20:2015, Annex C, while using the leakage
reference connector specified in Annex C (Figures C.1, C.2, C.4 and C.5, as appropriate). A greater applied
pressure may be used.
6.2 Sub-atmospheric pressure air leakage
Luer connectors shall be evaluated for sub-atmospheric pressure air leakage. Luer connectors shall
3
not leak by more than 0,005 Pa·m /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.
Check conformance by applying the tests of ISO 80369-20:2015, Annex D, while using the leakage
reference connector specified in Annex C (Figures C.1, C.2, C.4 and C.5, as appropriate). A greater applied
sub-atmospheric pressure may be used.
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ISO 80369-7:2021(E)
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 conformance by applying the tests of ISO 80369-20:2015, Annex E, while using the stress cracking
reference connector specified in Annex C (Figures C.1, C.2, C.4 and C.5, as appropriate).
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.
Check conformance by applying the tests of ISO 80369-20:2015, Annex F, while using the resistance to
separation from axial load reference connector specified in Annex C (Figures C.2, C.3, C.5 and C.6, as
appropriate). A greater disconnection applied axial force or a longer hold period may be used.
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 0,018 N·m to 0,020 N·m.
Check conformance 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 (Figures C.1 and C.4, as
appropriate). A greater applied unscrewing torque or a longer hold period may be used.
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.
Check conformance by applying the tests of ISO 80369-20:2015, Annex H, while using the resistance
to overriding reference connector specified in Annex C (Figures C.3 and C.6, as appropriate). A greater
applied torque or a longer hold period may be used.
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ISO 80369-7:2021(E)
Annex A
(informative)
Rationale and guidance
A.1 General guidance
This annex provides a rationale for some 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 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 document 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 document 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
[14]
system or for hypodermic applications so that they can achieve their intended function .
During the development of this document, the committees frequently debated how Luer connector
activated medical devices (LADs) should be interpreted. In context of this document, “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 conform with this
document. Specifically, they often are made of materials that are softer than semi-rigid 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
document.
The committees, 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 document, 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;
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ISO 80369-7:2021(E)
— non-interconnectable characteristics testing per ISO 80369-1:
...
NORME ISO
INTERNATIONALE 80369-7
Deuxième édition
2021-05
Raccords de petite taille pour liquides
et gaz utilisés dans le domaine de la
santé —
Partie 7:
Connecteurs pour les applications
intravasculaires ou hypodermiques
Small-bore connectors for liquids and gases in healthcare
applications —
Part 7: Connectors for intravascular or hypodermic applications
Numéro de référence
ISO 80369-7:2021(F)
©
ISO 2021
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ISO 80369-7:2021(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2021
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Publié en Suisse
ii © ISO 2021 – Tous droits réservés
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ISO 80369-7:2021(F)
Sommaire Page
Avant-propos .iv
Introduction .vi
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 2
4 Exigences générales . 3
4.1 Exigences générales relatives aux raccords Luer . 3
4.2 Essais de type . 4
5 Exigences dimensionnelles relatives aux raccords Luer . 4
6 Exigences de performance . 4
6.1 Fuite de fluide . 4
6.1.1 Exigence relative à la fuite de fluide . 4
6.1.2 Fuite par baisse de pression . 4
6.1.3 Fuite de liquide sous pression positive . 5
6.2 Fuite d’air sous pression subatmosphérique . 5
6.3 Formation de craquelures sous contrainte . 5
6.4 Résistance à la séparation sous l’effet d’une force axiale . 5
6.5 Résistance à la séparation par dévissage . 5
6.6 Résistance à l’arrachement des filets. 6
Annexe A (informative) Exposé des motifs et recommandations . 7
Annexe B (normative) Raccords Luer .12
Annexe C (normative) Raccords de référence .27
Annexe D (informative) Évaluation des dispositifs médicaux présentant des raccordements
entrant dans le cadre de cette application et de leurs propriétés .34
Annexe E (informative) Récapitulatif des exigences d’aptitude à l’utilisation des raccords
Luer destinés à des applications intravasculaires ou hypodermiques .36
Annexe F (informative) Récapitulatif des exigences de conception des raccords Luer
destinés à des applications intravasculaires ou hypodermiques .41
Annexe G (informative) Récapitulatif de l’évaluation du modèle du raccord Luer destiné à
des applications intravasculaires ou hypodermiques .44
Annexe H (informative) Référence aux principes essentiels .48
Annexe I (informative) Référence aux exigences générales en matière de sécurité et de
performances .49
Annexe J (informative) Terminologie — Index alphabétique des termes définis .50
Bibliographie .51
© ISO 2021 – Tous droits réservés iii
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ISO 80369-7:2021(F)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www
.iso .org/ directives).
L’attention est attirée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de
brevets reçues par l’ISO (voir www .iso .org/ brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion
de l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles
techniques au commerce (OTC), voir le lien suivant: www .iso .org/ iso/ foreword .html.
Le présent document a été élaboré par le comité technique ISO/TC 210, Management de la qualité et
aspects généraux correspondants des dispositifs médicaux, conjointement avec l’IEC/SC62D, Appareils
électromédicaux, en collaboration avec le comité technique CEN/CENELEC JTC3/WG 2, Raccords de petite
taille, du Comité européen de normalisation (CEN), conformément à l’accord de coopération technique
entre l’ISO et le CEN (Accord de Vienne).
Cette deuxième édition annule et remplace la première édition (ISO 80369-7:2016), qui a fait l’objet
d’une révision technique.
Les principales modifications par rapport à l’édition précédente sont les suivantes:
— augmentation des tolérances sur plusieurs dimensions de raccords de référence pour faciliter leur
fabrication et leur certification. La plupart des tolérances concernées portent sur des éléments qui
ne sont pas en contact avec le raccord soumis à essai et qui n’ont donc pas d’incidence sur les résultats
de l’essai. La tolérance angulaire pour la surface portante des filetages implique effectivement un
contact avec le raccord soumis à essai, mais il est considéré que la modification de la tolérance a
probablement une incidence minime, voire nulle, sur les résultats de l’essai;
— application d’une distinction entre matériaux semi-rigides et matériaux rigides pour certaines
exigences relatives aux raccords Luer, afin de mieux garantir la compatibilité aux extrêmes des
tolérances de conception. Les définitions de matériau semi-rigide et de matériau rigide ont été
ajoutées;
— redéfinition de la distance entre l’extrémité du raccord et la base du premier profil de filet complet
du filetage intérieur (dimension t) en cote auxiliaire en raison des difficultés rencontrées pour la
mesurer. L’impact fonctionnel de cette dimension est évalué avec l’essai fonctionnel de résistance à
la séparation (sous l’effet d’une force axiale);
iv © ISO 2021 – Tous droits réservés
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ISO 80369-7:2021(F)
— modification des dimensions N1 et N2 de la variante A du raccord Luer à verrouillage femelle (à
ailettes perpendiculaires à l’axe) pour permettre leur mesure depuis l’extrémité ouverte du raccord
afin de mieux garantir la compatibilité aux extrêmes des tolérances de conception.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes
se trouve à l’adresse www .iso .org/ members .html.
© ISO 2021 – Tous droits réservés v
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ISO 80369-7:2021(F)
Introduction
Le présent document a été élaboré à la suite de plusieurs incidents, qui ont eu des conséquences
catastrophiques et qui résultent de l’administration de médicaments inappropriés, de nutriments
liquides ou d’air par voie intraveineuse. Le signalement d’un grand nombre d’incidents a conduit à
une reconnaissance, à l’échelle internationale, de l’importance de ces problèmes et à l’identification
du besoin de développer des raccords spécifiques pour les dispositifs médicaux et accessoires associés
utilisés pour l’administration de fluides dans d’autres applications.
La série ISO 80369 a été élaborée pour éviter les erreurs de raccordement entre des raccords de petite
taille utilisés dans des applications différentes. L’ISO 80369-1 spécifie les exigences requises pour la
vérification des modèles et des dimensions des raccords de petite taille afin de s’assurer:
a) qu’ils ne risquent pas d’être raccordés par erreur à d’autres raccords de petite taille;
b) qu’ils permettent de raccorder les différents éléments de manière fiable et sûre.
Le présent document spécifie la conception, les dimensions et comprend les schémas des raccords de
petite taille destinés à être utilisés comme assemblages coniques à 6 % (Luer) pour des raccordements
dans le cadre d’applications intravasculaires ou hypodermiques. Les Annexes D à G décrivent les
méthodes selon lesquelles cette conception a été évaluée. Les autres parties de l’ISO 80369 incluent les
exigences relatives aux raccords de petite taille utilisés dans d’autres catégories d’applications.
Les raccords fabriqués aux dimensions spécifiées dans le présent document possèdent des dimensions
incompatibles avec celles de tout autre raccord destiné à des applications identifiées dans la série de
documents ISO 80369 relative aux raccords de petite taille, hormis l’exception identifiée à l’Annexe G.
S’ils sont raccordés aux dispositifs médicaux et accessoires appropriés, il convient que ces raccords
réduisent le risque d’administration d’air, de médicaments non destinés à une injection intravasculaire
et de nutriments liquides par une autre voie, par exemple par voie intraveineuse ou par un appareil
respiratoire.
Dans le présent document, la conjonction « ou» est utilisée comme « ou inclusif»; une affirmation est
donc vraie si une combinaison quelconque des conditions est vraie.
Les formes verbales suivantes sont utilisées dans le présent document:
— «doit» indique une exigence;
— «il convient que/de» signifie que la conformité à une exigence ou à un essai est recommandée, mais
n’est pas obligatoire pour la conformité au présent document;
— «peut/il est autorisé/il est admis de/il est permis de» indique une autorisation;
— «peut/est susceptible de/est en mesure de/il est possible que/de» indique une possibilité ou une
capacité.
vi © ISO 2021 – Tous droits réservés
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NORME INTERNATIONALE ISO 80369-7:2021(F)
Raccords de petite taille pour liquides et gaz utilisés dans
le domaine de la santé —
Partie 7:
Connecteurs pour les applications intravasculaires ou
hypodermiques
1 Domaine d’application
Le présent document spécifie les dimensions et les exigences relatives à la conception et aux
performances fonctionnelles des raccords de petite taille destinés à être utilisés pour effectuer des
raccordements dans des applications intravasculaires ou des raccordements hypodermiques dans des
applications hypodermiques de dispositifs médicaux et d’accessoires.
EXEMPLES Les seringues et aiguilles hypodermiques ou les canules intravasculaires (IV) avec raccords Luer
à glissement et raccords Luer à verrouillage mâles et femelles.
NOTE 1 Voir l’Annexe A.
NOTE 2 À l’origine, le raccord Luer a été conçu pour être utilisé à des pressions maximales de 300 kPa.
Le présent document ne spécifie pas les exigences relatives aux dispositifs médicaux ou aux accessoires
sur lesquels ces raccords sont utilisés. Ces exigences figurent dans des documents spécifiques traitant
de dispositifs médicaux ou d’accessoires particuliers.
Le présent document ne spécifie pas d’exigences pour les raccords de petite taille suivants, celles-ci
étant spécifiées dans d’autres documents:
[5]
— orifices du compartiment sanguin des hémodialyseurs, hémodiafiltres et hémofiltres (l’ISO 8637
[6]
et la partie applicable de l’ISO 8638 référencent les orifices du compartiment sanguin);
[5]
— raccords des appareils d’hémodialyse, d’hémodiafiltration et d’hémofiltration (ISO 8637 );
[4]
— raccords du perforateur du système de fermeture des appareils de perfusion (ISO 8536-4 ).
NOTE 3 Les fabricants sont incités à intégrer les raccords de petite taille spécifiés dans le présent document
dans les dispositifs médicaux ou accessoires, même si cela n’est pas actuellement requis par les documents
appropriés, spécifiques de ces dispositifs médicaux. Il est prévu d’inclure des exigences relatives aux raccords de
petite taille, tels que spécifiées dans l’ISO 80369, lors de la révision des documents appropriés spécifiques de ces
dispositifs médicaux.
NOTE 4 L’Article 7 de l’ISO 80369-1:2018 spécifie d’autres méthodes de vérification de la conformité
à l’ISO 80369-1:2018 pour les raccords de petite taille destinés à être utilisés avec des dispositifs médicaux ou des
accessoires pour applications intravasculaires ou applications hypodermiques, mais qui ne sont pas conformes au
présent document.
2 Références normatives
Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur
contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.
Pour les références non datées, la dernière édition du document de référence s'applique (y compris les
éventuels amendements).
ISO 14971:2019, Dispositifs médicaux — Application de la gestion des risques aux dispositifs médicaux
© ISO 2021 – Tous droits réservés 1
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ISO 80369-7:2021(F)
ISO 80369-1:2018, Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé —
Partie 1: Exigences générales
ISO 80369-6:2016, Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé —
Partie 6: Raccords destinés à des applications en contact avec le système nerveux (neuraxiales)
ISO 80369-20:2015, Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé —
Partie 20: Méthodes d'essai communes
IEC 62366-1:2015, Dispositifs médicaux — Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation
aux dispositifs médicaux
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions de l’ISO 80369-1:2018,
l’ISO 80369-20:2015, l’ISO 14971:2019, l’IEC 62366-1:2015 tels qu’indiqués à l’Annexe J ainsi que les
suivants s’appliquent.
NOTE Pour des raisons pratiques, les sources de tous les termes définis utilisés dans le présent document
sont données à l’Annexe J.
— ISO Online browsing platform: disponible à l’adresse http:// www .iso .org/ obp
— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/
3.1
cote auxiliaire
cote dérivée d’autres cotes et donnée seulement à titre d’information
[7]
[SOURCE: ISO 10209:2012 , 4.2]
3.2
raccord Luer
raccord de petite taille comportant une surface de raccordement conique à 6 % (Luer), destiné à être
utilisé dans des applications intravasculaires ou hypodermiques de dispositifs médicaux et d’accessoires
correspondants
Note 1 à l'article: Le terme raccord Luer est susceptible de désigner soit un raccord Luer à glissement, soit un
raccord Luer à verrouillage.
Note 2 à l'article: Voir l’Annexe A.
3.3
raccord Luer à glissement
raccord Luer sans verrouillage
Note 1 à l'article: On désigne également le raccord Luer à glissement par l’abréviation L1.
Note 2 à l'article: Voir l’Annexe A.
3.4
raccord Luer à verrouillage
raccord Luer comportant un mécanisme de verrouillage
Note 1 à l'article: On désigne également le raccord Luer à verrouillage par l’abréviation L2.
Note 2 à l'article: Voir l’Annexe A.
2 © ISO 2021 – Tous droits réservés
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ISO 80369-7:2021(F)
3.5
utilisation normale
fonctionnement, y compris lors des vérifications périodiques et des réglages faits par un utilisateur,
ainsi que dans l’état en attente, selon les instructions d’utilisation
Note 1 à l'article: Il convient de ne pas confondre utilisation prévue et utilisation normale. Si les deux expressions
intègrent le concept de l’utilisation telle qu’elle est prévue par le fabricant, l’utilisation prévue se concentre sur le
but médical tandis que l’utilisation normale ne se limite pas au but médical mais englobe aussi la maintenance,
l’entretien, le transport, etc.
[12]
[SOURCE: IEC 60601-1:2005+A1: 2012 , définition 3.71 modifiée: remplacement d’«opérateur»
par «utilisateur».]
3.6
assignée
terme qui fait référence à une valeur attribuée par le fabricant pour une condition de
fonctionnement spécifiée
[12]
[SOURCE: IEC 60601-1:2005 , 3.97]
3.7
matériau rigide
matériau dont le module d’élasticité, en flexion ou en traction, est supérieur à 3 433 MPa
EXEMPLE Métaux, verre, certains polymères renforcés de fibres et polymères haute performance.
3.8
matériau semi-rigide
matériau dont le module d’élasticité, en flexion ou en traction, est compris entre 700 MPa et 3 433 MPa
EXEMPLE Thermoplastiques.
4 Exigences générales
4.1 Exigences générales relatives aux raccords Luer
Les raccords Luer fabriqués conformément au présent document sont conformes aux exigences générales
de l’ISO 80369-1:2018, sauf indication contraire dans le présent document.
Dans certaines combinaisons de tolérances, le diamètre intérieur permettant l’écoulement du fluide d’un
raccord Luer mâle peut entrer en contact avec les plans de joint du raccord mâle N1 (N1) tel que spécifié
dans l’ISO 80369-6 dans la condition de minimum de matière (LMC). De ce fait, ces raccords échouent
mutuellement lors des essais d’évaluation des caractéristiques de non-raccordabilité de l’Annexe B de
l’ISO 80369-1:2018. De plus amples informations sont fournies en G.2.2.
Les raccords de référence pour l’évaluation des caractéristiques de non-raccordabilité sont décrits
à l’Annexe C (Figures C.1, C.2, C.4 et C.5, selon le cas).
Lorsqu’un dispositif médical ou un accessoire est conçu pour posséder les caractéristiques d’un raccord
Luer selon le présent document, ces caractéristiques doivent être incluses dans la vérification vis-à-
vis du présent document. Si nécessaire, installer le raccord de petite taille sur le dispositif médical ou
l’accessoire pour démontrer la conformité à l’Annexe B de l’ISO 80369-1:2018.
NOTE 1 Un récapitulatif des dispositifs médicaux présentant des raccordements entrant dans le cadre de cette
application et de leurs propriétés est fourni à l’Annexe D.
NOTE 2 Un récapitulatif des exigences d’aptitude à l’utilisation des raccords Luer est fourni à l’Annexe E.
NOTE 3 Un récapitulatif des critères et exigences relatifs aux raccords Luer est fourni à l’Annexe F.
© ISO 2021 – Tous droits réservés 3
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ISO 80369-7:2021(F)
NOTE 4 Un récapitulatif de l’évaluation du modèle des raccords Luer conformément à l’ISO 80369-1:2018, 6.1,
est fourni à l’Annexe G.
NOTE 5 Le présent document a été élaboré pour satisfaire aux principes essentiels relatifs à la sécurité et à la
[9]
performance de l’ISO 16142-1:2016 indiqués à l’Annexe H.
NOTE 6 Le présent document a été élaboré pour satisfaire aux exigences générales relatives à la sécurité et à
[15]
la performance du Règlement européen (UE) 2017/745 indiquées à l’Annexe I.
4.2 Essais de type
La conformité aux exigences du présent document doit être déterminée par des essais de type.
5 Exigences dimensionnelles relatives aux raccords Luer
Les raccords Luer doivent être conformes aux dimensions et aux tolérances indiquées:
— à la Figure B.1 et dans le Tableau B.1 pour un raccord Luer à glissement (L1) mâle;
— à la Figure B.2 et dans le Tableau B.2 pour un raccord Luer à glissement (L1) femelle;
— à la Figure B.3 et dans le Tableau B.3 pour un raccord Luer à verrouillage (L2) mâle avec collier fixe;
— à la Figure B.4 et dans le Tableau B.4 pour un raccord Luer à verrouillage (L2) mâle avec collier
flottant ou rotatif;
— à la Figure B.5 et dans le Tableau B.5 pour un raccord Luer à verrouillage (L2) femelle;
— à la Figure B.6 et dans le Tableau B.6 pour un raccord Luer à verrouillage (L2) femelle à ailettes
perpendiculaires à l’axe, variante A;
— à la Figure B.7 et dans le Tableau B.7 pour un raccord Luer à verrouillage (L2) femelle à ailettes
perpendiculaires à l’axe, variante B;
— à la Figure B.8 et dans le Tableau B.8 pour un raccord Luer à verrouillage (L2) femelle à ailettes
perpendiculaires à l’axe, variante C.
Vérifier la conformité en contrôlant les dimensions et tolérances spécifiées à l’Annexe B, par rapport à
la Figure et au Tableau correspondants.
NOTE Voir l’Annexe A.
6 Exigences de performance
6.1 Fuite de fluide
6.1.1 Exigence relative à la fuite de fluide
L’étanchéité des raccords Luer doit être évaluée, soit en utilisant la méthode d’essai de fuite par baisse de
pression, soit en employant la méthode d’essai de fuite de liquide sous pression positive.
6.1.2 Fuite par baisse de pression
S’agissant de l’évaluation de la performance pour la fuite de fluide à l’aide de la méthode d’essai de fuite
3
par baisse de pression, le taux de fuite ne doit pas dépasser 0,005 Pa m /s lorsque les raccords Luer sont
soumis à une pression d’application comprise entre 300 kPa et 330 kPa, sur une période de maintien
de 15 s à 20 s, le milieu utilisé étant l’air.
4 © ISO 2021 – Tous droits réservés
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ISO 80369-7:2021(F)
Vérifier la conformité en réalisant les essais de l’Annexe B de l’ISO 80369-20:2015 et en utilisant le
raccord de référence pour les essais d’étanchéité spécifié à l’Annexe C (Figures C.1, C.2, C.4 et C.5, selon
le cas). Une plus grande pression d’application peut être utilisée.
6.1.3 Fuite de liquide sous pression positive
S’agissant de l’évaluation de la performance pour la fuite de fluide à l’aide de la méthode d’essai de fuite de
liquide sous pression positive, les raccords Luer ne doivent présenter aucun signe de fuite suffisamment
importante pour former une goutte d’eau se détachant, sur une période de maintien de 30 s à 35 s,
lorsqu’ils sont soumis à une pression d’application comprise entre 300 kPa et 330 kPa.
Vérifier la conformité en réalisant les essais de l’Annexe C de l’ISO 80369-20:2015 et en utilisant le
raccord de référence pour les essais d’étanchéité spécifié à l’Annexe C (Figures C.1, C.2, C.4 et C.5, selon
le cas). Une plus grande pression d’application peut être utilisée.
6.2 Fuite d’air sous pression subatmosphérique
Les raccords Luer doivent être soumis à une évaluation de la fuite d’air sous pression subatmosphérique.
3
Ils ne doivent pas présenter de fuite supérieure à 0,005 Pa m /s lorsqu’ils sont soumis à une pression
subatmosphérique d’application comprise entre 80,0 kPa et 88,0 kPa, sur une période de maintien
de 15 s à 20 s.
Vérifier la conformité en réalisant les essais de l’Annexe D de l’ISO 80369-20:2015 et en utilisant le
raccord de référence pour les essais d’étanchéité spécifié à l’Annexe C (Figures C.1, C.2, C.4 et C.5, selon
le cas). Une plus grande pression subatmosphérique d’application peut être utilisée.
6.3 Formation de craquelures sous contrainte
Les raccords Luer doivent être soumis à une évaluation de la formation de craquelures sous contrainte.
Ils doivent satisfaire aux exigences de 6.1.1 après avoir été soumis aux contraintes spécifiées
dans l’Annexe E de l’ISO 80369-20:2015.
Vérifier la conformité en réalisant les essais de l’Annexe E de l’ISO 80369-20:2015 et en utilisant le
raccord de référence pour les essais de formation de craquelures sous contrainte spécifié à l’Annexe C
(Figures C.1, C.2, C.4 et C.5, selon le cas).
6.4 Résistance à la séparation sous l’effet d’une force axiale
Les raccords Luer doivent être soumis à une évaluation de leur résistance à la séparation sous l’effet
d’une force axiale. Ils ne doivent pas se désolidariser du raccord de référence, sur une période de
maintien de 10 s à 15 s, lorsqu’ils sont soumis à une force axiale d’application visant à les séparer
comprise entre:
a) 23 N et 25 N pour les raccords Luer à glissement;
b) 32 N et 35 N pour les raccords Luer à verrouillage.
Vérifier la conformité en réalisant les essais de l’Annexe F de l’ISO 80369-20:2015 et en utilisant le
raccord de référence pour les essais de résistance à la séparation sous l’effet d’une force axiale spécifié
à l’Annexe C (Figures C.2, C.3, C.5 et C.6, selon le cas). Une plus grande force axiale ou une période de
maintien plus longue peuvent être utilisées.
6.5 Résistance à la séparation par dévissage
Les raccords Luer à verrouillage doivent être soumis à une évaluation de leur résistance à la séparation
par dévissage. Ils ne doivent pas se désolidariser du raccord de référence sur une période de maintien
de 10 s à 15 s, lorsqu’ils sont soumis à un couple de dévissage compris entre 0,018 N·m et 0,020 N·m.
© ISO 2021 – Tous droits réservés 5
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ISO 80369-7:2021(F)
Vérifier la conformité en réalisant les essais de l’Annexe G de l’ISO 80369-20:2015 et en utilisant le
raccord de référence pour l’essai de résistance à la séparation par dévissage spécifié à l’Annexe C
(Figures C.1 et C.4, selon le cas). Un couple de dévissage d’application supérieur ou une période de
maintien plu
...
INTERNATIONAL ISO
STANDARD 80369-7
Second edition
Small-bore connectors for liquids and
gases in healthcare applications —
Part 7:
Connectors for intravascular or
hypodermic applications
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
PROOF/ÉPREUVE
Reference number
ISO 80369-7:2021(E)
©
ISO 2021
---------------------- Page: 1 ----------------------
ISO 80369-7:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ISO 80369-7:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 3
4.1 General requirements for Luer connectors . 3
4.2 Type tests . 3
5 Dimensional requirements for Luer connectors . 3
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 . 4
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 .25
Annex D (informative) Assessment of medical devices and their attributes with connections
within this application .32
Annex E (informative) Summary of the usability requirements for Luer connectors for
intravascular or hypodermic applications .34
Annex F (informative) Summary of Luer connector design requirements for intravascular
or hypodermic applications .38
Annex G (informative) Summary of assessment of the design of the Luer connector for
intravascular or hypodermic applications .41
Annex H (informative) Reference to the essential principles .44
Annex I (informative) Reference to the general safety and performance requirements .45
Annex J (informative) Terminology — Alphabetized index of defined terms .46
Bibliography .47
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ISO 80369-7:2021(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 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 medical devices, and IEC/SC62D, Electromedical equipment, in collaboration with
the European Committee for Standardization (CEN) Technical Committee, CEN/CENELEC JTC3/WG 2,
Small-bore connectors, in accordance with the Agreement on technical cooperation between ISO and
CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO ISO 80369-7:2016), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— Tolerances of several reference connector dimensions are increased to facilitate easier manufacturing
and certification. Most of the affected tolerances are for features that do not contact the test
connector and therefore do not affect the test results. The angle tolerance for the bearing side of the
threads do contact the connector under test but the change in the tolerance is considered likely have
minimal to no effect on test outcomes.
— Some requirements for Luer connectors have been separated for semi-rigid materials and rigid
materials to better ensure compatibility at the extreme of the design space. Definitions of semi-rigid
material and rigid material have been added.
— The distance from the tip of the connector to the bottom of the first complete thread profile of
the internal thread (t dimension) has been made an auxiliary dimension due to the difficulty in its
measurement. The functional impact of the dimension is evaluated with the resistance to separation
(from axial load) functional test.
— The N1 and N2 dimensions of the female Luer lock connector variant A (with lugs at right angle to
axis) have been changed to allow measurement from the open end of the connector, to better ensure
compatibility at the extreme of the design space.
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.
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ISO 80369-7:2021(E)
Introduction
This document 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.
This document 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 document are dimensionally
incompatible with any of the other connectors for applications identified in the ISO 80369 series of
documents 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 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 a requirement;
— “should” means that conformance with a requirement or a test is recommended but is not mandatory
for conformance with this document;
— “may” indicates a permission;
— "can" indicates a possibility or a capability.
Information marked as “NOTE” is intended to assist the understanding or use of the document. “Notes
to entry” used in Clause 3 provide additional information that supplements the terminological data and
can contain provisions relating to the use of a term.
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INTERNATIONAL STANDARD ISO 80369-7:2021(E)
Small-bore connectors for liquids and gases in healthcare
applications —
Part 7:
Connectors for intravascular or hypodermic applications
1 Scope
This document 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 See Annex A.
NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa.
This document does not specify requirements for the medical devices or accessories that use these
connectors. Such requirements are given in particular documents for specific medical devices or
accessories.
This document does not specify requirements for the following small-bore connectors, which are
specified in other documents:
[5]
— haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 and
[6]
applicable portion of ISO 8638 referencing blood compartment ports);
[5]
— haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 );
[4]
— infusion system closure piercing connectors (ISO 8536-4 ).
NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this document into
medical devices or accessories, even if currently not required by the relevant particular medical device documents.
It is expected that when the relevant particular medical device documents are revised, requirements for small-
bore connectors, as specified in ISO 80369, will be included.
NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for
small-bore connectors intended for use with intravascular applications or hypodermic application medical devices
or accessories, which do not conform with this document.
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 14971:2019, Medical devices — Application of risk management to medical devices
ISO 80369-1:2018, 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
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ISO 80369-7:2021(E)
ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications — Part 20:
Common test methods
IEC 62366-1:2015, 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 specified in ISO 80369-1:2018,
ISO 80369-20:2015, ISO 14971:2019, IEC 62366-1:2015 as indicated in Annex J and the following apply.
NOTE For convenience, the sources of all defined terms used in this document are given in Annex J.
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
auxiliary dimension
dimensions derived from other dimensions given for information purposes only
[7]
[SOURCE: ISO 10209:2012 , 4.2]
3.2
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.
Note 2 to entry: See Annex A.
3.3
Luer slip connector
Luer connector without a lock
Note 1 to entry: The Luer slip connector is indicated by the abbreviation L1.
Note 2 to entry: See Annex A.
3.4
Luer lock connector
Luer connector that contains a locking mechanism
Note 1 to entry: The Luer lock connector is indicated by the abbreviation L2.
Note 2 to entry: See Annex A.
3.5
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.
[12]
[SOURCE: IEC 60601-1:2005+A1: 2012 , 3.71, modified — replaced “operator” with “user”.]
3.6
rated
term referring to a value assigned by the manufacturer for a specified operating condition
[12]
[SOURCE: IEC 60601-1:2005 , 3.97]
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ISO 80369-7:2021(E)
3.7
rigid material
material with a modulus of elasticity either in flexure or in tension greater than 3 433 MPa
EXAMPLE Metals, glass, some fibre-reinforced polymers and high-performance polymers.
3.8
semi-rigid material
material with a modulus of elasticity either in flexure or in tension, between 700 MPa and 3 433 MPa
EXAMPLE Thermoplastics.
4 General requirements
4.1 General requirements for Luer connectors
Luer connectors made in conformance with this document conform with the general requirements of
ISO 80369-1:2018, unless otherwise indicated in this document.
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 and
thereby these connectors mutually fail when evaluating the non-interconnectable characteristics tests of
ISO 80369-1:2018, Annex B. Additional information is provided in G.2.2.
The reference connectors for evaluation of the non-interconnectable characteristics are described in
Annex C (Figures C.1, C.2, C.4 and C.5, as appropriate).
Where a medical device or accessory is designed to provide features of the Luer connector of this
document, those features shall be included in the verification to this document. When necessary,
install the small-bore connector on the medical device or accessory to demonstrate conformance with
ISO 80369-1:2018, Annex B.
NOTE 1 The summary of medical devices and their attributes with connections within this application is
provided in Annex D.
NOTE 2 The summary of the usability requirements for Luer connectors is provided in Annex E.
NOTE 3 The summary of Luer connectors criteria and requirements is provided in Annex F.
NOTE 4 The summary of assessment of the design of Luer connectors according to ISO 80369-1:2018, 6.1, is
contained in Annex G.
NOTE 5 This document has been prepared to address the relevant essential principles of safety and
[9]
performance of ISO 16142-1:2016 as indicated in Annex H.
NOTE 6 This document has been prepared to address the relevant general safety and performance
[15]
requirements of European regulation (EU) 2017/745 as indicated in Annex I.
4.2 Type tests
Conformance with the requirements of this document shall be determined by type tests.
5 Dimensional requirements for Luer connectors
Luer connectors shall conform 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,
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ISO 80369-7:2021(E)
— 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,
— Figure B.7 and Table B.7 for a female Luer lock connector (L2), with lugs at right angle to axis,
variant B, and
— Figure B.8 and Table B.8 for a female Luer lock connector (L2), with lugs at right angle to axis,
variant C.
Check conformance by confirming the dimensions and tolerances specified in Annex B, for the
appropriate figure and table.
NOTE See Annex A.
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
3
method shall not exceed a leakage rate of 0,005 Pa·m /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.
Check conformance by applying the tests of ISO 80369-20:2015, Annex B, while using the leakage
reference connector specified in Annex C (Figures C.1, C.2, C.4 and C.5, as appropriate). A greater applied
pressure may be used.
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 period of
30 s to 35 s while being subjected to an applied pressure of between 300 kPa and 330 kPa.
Check conformance by applying the tests of ISO 80369-20:2015, Annex C, while using the leakage
reference connector specified in Annex C (Figures C.1, C.2, C.4 and C.5, as appropriate). A greater applied
pressure may be used.
6.2 Sub-atmospheric pressure air leakage
Luer connectors shall be evaluated for sub-atmospheric pressure air leakage. Luer connectors shall
3
not leak by more than 0,005 Pa·m /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.
Check conformance by applying the tests of ISO 80369-20:2015, Annex D, while using the leakage
reference connector specified in Annex C (Figures C.1, C.2, C.4 and C.5, as appropriate). A greater applied
sub-atmospheric pressure may be used.
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ISO 80369-7:2021(E)
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 conformance by applying the tests of ISO 80369-20:2015, Annex E, while using the stress cracking
reference connector specified in Annex C (Figures C.1, C.2, C.4 and C.5, as appropriate).
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.
Check conformance by applying the tests of ISO 80369-20:2015, Annex F, while using the separation
from axial load reference connector specified in Annex C (Figures C.2, C.3, C.5 and C.6, as appropriate).
A greater disconnection applied axial force or a longer hold period may be used.
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 0,018 N·m to 0,020 N·m.
Check conformance 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 (Figures C.1 and C.4, as
appropriate). A greater applied unscrewing torque or a longer hold period may be used.
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.
Check conformance by applying the tests of ISO 80369-20:2015, Annex H, while using the resistance
to overriding reference connector specified in Annex C (Figures C.3 and C.6, as appropriate). A greater
applied torque or a longer hold period may be used.
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ISO 80369-7:2021(E)
Annex A
(informative)
Rationale and guidance
A.1 General guidance
This annex provides a rationale for some 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 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 document 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 document 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
[14]
system or for hypodermic applications so that they can achieve their intended function .
During the development of this document, the committees frequently debated how Luer connector
activated medical devices (LADs) should be interpreted. In context of this document, “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 conform with this
document. Specifically, they often are made of materials that are softer than semi-rigid 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
document.
The committees, 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 document, wherever possible, to
address the risk of misconnections to their medical devices. These elements can include the appropriate
combinations of the following
...
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