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 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:
- 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 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.

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 A 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€ 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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Published
Publication Date
03-May-2021
Current Stage
PPUB - Publication issued
Completion Date
04-May-2021
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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
---------------------- 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

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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Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
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 2021 – All rights reserved iii
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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.
iv © ISO 2021 – All rights reserved
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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.
© ISO 2021 – All rights reserved v
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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
© ISO 2021 – All rights reserved 1
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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]
2 © ISO 2021 – All rights reserved
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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,

© ISO 2021 – All rights reserved 3
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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

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.
4 © ISO 2021 – All rights reserved
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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 2021 – All rights reserved 5
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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;
6 © ISO 2021 – All rights reserved
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ISO 80369-7:2021(E)
— non-interconnectable characteristics testing per ISO 80369-1:
...

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