SIST EN ISO 80369-7:2021

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021)

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.

Steckverbinder mit kleiner Bohrung für Flüssigkeiten und Gase im Gesundheitswesen - Teil 7: Steckverbinder für intravaskuläre oder subkutane Anwendungen (ISO 80369-7:2021)

Dieses Dokument legt die Maße und Anforderungen an die Ausführung sowie die funktionelle Leistung von Verbindungsstücken mit kleinem Durchmesser fest, die für die Verwendung als Verbindungen bei intravaskulären Anwendungen oder als hypodermische Verbindungen bei hypodermischen Anwendungen von Medizinprodukten und Zubehör vorgesehen sind.
BEISPIEL Hypodermische Spritzen und Kanülen oder IV(intravaskulär)-Kanülen mit Luer-Steck-Verbindungsstücken und verriegelbaren Luer-Verbindungsstücken mit Außen- bzw. Innenkegel.
ANMERKUNG 1 Siehe Anhang A.
ANMERKUNG 2 Das Luer-Verbindungsstück wurde ursprünglich für Drücke bis 300 kPa ausgelegt.
Dieses Dokument legt nicht die Anforderungen an Medizinprodukte oder Zubehör fest, für die (das) diese Verbindungsstücke verwendet werden. Diese Anforderungen sind in eigenen Dokumenten für die jeweiligen Medizinprodukte oder das Zubehör enthalten.
Dieses Dokument legt nicht die Anforderungen für die folgenden Verbindungsstücke mit kleinem Durchmesser fest, die in anderen Dokumenten festgelegt sind:
- Anschlüsse der Blutbereiche von Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO 8637 [5] sowie zutreffende Teile der ISO 8638 [6] zu Anschlüssen der Blutbereiche);
- Verbindungsstücke für Ausrüstung von Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO 8637 [5]);
- Einstech-Verbindungsstücke für Infusionssysteme (ISO 8536-4 [4]).
ANMERKUNG 3 Hersteller werden zum Einbau der Verbindungsstücke mit kleinem Durchmesser nach diesem Dokument in Medizinprodukte oder Zubehör angeregt, auch wenn dies derzeit nach den maßgebenden speziellen Dokumenten zu Medizinprodukten nicht erforderlich ist. Es ist zu erwarten, dass bei Überarbeitung der maßgebenden speziellen Dokumente zu Medizinprodukten Anforderungen für Verbindungsstücke mit kleinem Durchmesser entsprechend den Festlegungen nach ISO 80369 aufgenommen werden.
ANMERKUNG 4 ISO 80369-1:2018, Abschnitt 7 legt alternative Verfahren der Übereinstimmung mit ISO 80369-1:2018 für Verbindungsstücke mit kleinem Durchmesser fest, die für intravaskuläre oder hyperdermische Anwendungen von Medizinprodukten oder Zubehör vorgesehen sind und die nicht diesem Dokument entsprechen.

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 7: Connecteurs pour les applications intravasculaires ou hypodermiques (ISO 80369-7:2021)

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.

Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 7. del: Priključki za intravaskularno ali podkožno uporabo (ISO 80369-7:2021)

General Information

• Status: Published
• Public Enquiry End Date: 19-Dec-2019
• Publication Date: 29-Jun-2021
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 11-Jun-2021
• Due Date: 16-Aug-2021
• Completion Date: 30-Jun-2021
• Ref Project: EN ISO 80369-7:2021 - Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021)

Relations

• Replaces: SIST EN ISO 80369-7:2017 - Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016)
• Effective Date: 01-Sep-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2021
Nadomešča:
SIST EN ISO 80369-7:2017
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 7. del:
Priključki za intravaskularno ali podkožno uporabo (ISO 80369-7:2021)
Small-bore connectors for liquids and gases in healthcare applications - Part 7:
Connectors for intravascular or hypodermic applications (ISO 80369-7:2021)
Steckverbinder mit kleiner Bohrung für Flüssigkeiten und Gase im Gesundheitswesen -
Teil 7: Steckverbinder für intravaskuläre oder subkutane Anwendungen (ISO 80369-
7:2021)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
7: Connecteurs pour les applications intravasculaires ou hypodermiques (ISO 80369-
7:2021)
Ta slovenski standard je istoveten z: EN ISO 80369-7:2021
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 80369-7
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2021
ICS 11.040.25
Supersedes EN ISO 80369-7:2017
English version
Small-bore connectors for liquids and gases in healthcare
applications - Part 7: Connectors for intravascular or
hypodermic applications (ISO 80369-7:2021)
Raccords de petite taille pour liquides et gaz utilisés Steckverbinder mit kleiner Bohrung für Flüssigkeiten
dans le domaine de la santé - Partie 7: Connecteurs und Gase im Gesundheitswesen - Teil 7:
pour les applications intravasculaires ou Steckverbinder für intravaskuläre oder subkutane
hypodermiques (ISO 80369-7:2021) Anwendungen (ISO 80369-7:2021)
This European Standard was approved by CEN on 29 October 2020.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2021 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 80369-7:2021 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3

European foreword
This document (EN ISO 80369-7:2021) has been prepared by Technical Committee ISO/TC 210 "Quality
management and corresponding general aspects for medical devices" in collaboration with Technical
Committee CEN/CLC/JTC 3 “Quality management and corresponding general aspects for medical
devices” the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2021, and conflicting national standards
shall be withdrawn at the latest by November 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 80369-7:2017.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 80369-7:2021 has been approved by CEN as EN ISO 80369-7:2021 without any
modification.
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
ISO 80369-7:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

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
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.
iv © ISO 2021 – All rights reserved

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.
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
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]
2 © ISO 2021 – All rights reserved

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,
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
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
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.
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 80369-1:2018, Annex B;
— 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 conforming
with this document), 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 document 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 3.2 Luer connector
Definition 3.3 Luer slip connector
Definition 3.4 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
document 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
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
document. 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
document 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 document was developed.
Since the configurations of the connectors proposed within this document 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
document. The committees 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.
[8]
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
tip glass forming technology for manufacturing glass-prefilled syringes cannot conform completely to
either previous Luer fitting standard, ISO 594 or this document. Both the previous standard and this
document have been developed using ground glass, metal and injection moulded technology and plastic
resins as the baseline for conformance and capabilities.
ISO 80369-7:2021(E)
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 committees acknowledge 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 document with respect to some of the dimensions, a glass formed tip does successfully mate
[8]
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 document 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
with conforming connectors.
Due to the proliferation of existing Luer connectors and general lack of data indicating a problem in use,
the committees determined that the same level of interference would be permitted by this document
(i.e. the permissible design is unchanged).
Key
1 corners that can interfere
Figure A.1 — Lug corners that can interfere
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ISO 80369-7:2021(E)
Key
1 area of potential interfere
Figure A.2 — Area of potential interference
The analysis also demonstrated that in certain instances the taper surfaces of male and female Luer lock
connectors made from semi-rigid materials, if taken to certain extremes, might not engage deep enough
to allow the threads to engage properly. In these instances, the resulting connection is only equal to
a Luer slip connector and does not benefit from the additional retention of the locking threads. This
potential is mitigated by the deformability of the semi-rigid materials from which most connectors are
made that allow the tapers to engage further as they deform as they are connected. There is a general
lack of data indicating a problem in actual use. For these reasons the dimensions have not been changed
to eliminate this potential, but a newly recommended (informative) minimum value for the ØD and
ØG dimensions has been added. Conforming with this recommendation reduces the likelihood of this
possibility. All connectors are still required to conform with the resistance to separation from axial load
functional test of 6.4.
The distance from the tip of the connector to the bottom of the first complete thread profile of the
internal thread, the t dimension, is also essential for an effective locking connection. It has also been
noted that there is a general lack of data indicating there is a problem even when many of the current
male Luer lock connectors on the market made from semi-rigid materials do not meet the ideal maximum
dimension of 3,200 mm. For this reason, combined with the difficulty in measuring this feature,
the recommended dimension for connectors made from semi-rigid materials has changed and have
been made an auxiliary dimension. All connectors are still required to conform with the resistance to
separation from axial load functional test of 6.4.
In addition, due to the commercial evolution of existing Luer connectors, a connector conforming with
ISO 594-2:1988, Figure 3, Variant A (female Luer connector 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
committ
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