ISO/PRF 80369-7

Small-bore connectors for liquids and gases in healthcare applications

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé

Standards Content (sample)

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
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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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © 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 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

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 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
...

DRAFT INTERNATIONAL STANDARD
ISO/DIS 80369-7
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-10-11 2020-01-03
Small-bore connectors for liquids and gases in healthcare
applications —
Part 7:
Connectors with 6 % (Luer) taper 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

ICS: 11.040.25
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 80369-7:2019(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019
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ISO/DIS 80369-7:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/DIS 80369-7:2019(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ................................................................................................................................................................................................................................vi

1 * Scope ............................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

4 General requirements ..................................................................................................................................................................................... 3

4.1 General requirements for Luer connectors ................................................................................................................. 3

4.2 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 ........................................................................................................................................................................................ 4

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 ...............................................................................................................................................22

Annex D (informative) Assessment of medical devices and their attributes with connections

within this application .................................................................................................................................................................................28

Annex E (informative) Summary of the usability requirements for Luer connectors for

intravascular or hypodermic applications ..............................................................................................................................30

Annex F (informative) Summary of Luer connector design requirements for intravascular

or hypodermic applications ...................................................................................................................................................................34

Annex G (informative) Summary of assessment of the design of the Luer connector for

intravascular or hypodermic applications ..............................................................................................................................37

Annex H (informative) Reference to the essential principles ..................................................................................................40

Annex I (informative) Reference to the general safety and performance requirements ............................41

Annex J (informative) Terminology — Alphabetized index of defined terms .........................................................42

Bibliography .............................................................................................................................................................................................................................43

© ISO 2019 – All rights reserved iii
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ISO/DIS 80369-7:2019(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO's adherence to the WTO principles in the Technical

Barriers to Trade (TBT), see the following URL: Foreword — Supplementary information.

The committee responsible for this document is ISO/TC 210, Quality management and corresponding

general aspects for medical devices, and IEC/SC62D, Electromedical equipment. The draft was circulated

for voting to the national bodies of both ISO and IEC.

The first edition of ISO 80369-7 cancelled and replaced ISO 594-1:1986 and ISO 594-2:1998, clauses,

subclauses, tables, figures, and annexes of which have been consolidated and technically revised.

This second edition of ISO 80369-7 cancels and replaces ISO 80369-7:2016.

This second edition of ISO 80369-7 contains the following major technical revisions to ISO 80369-7:2016.

a) 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 connector test and 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.

b) Reference connectors made to the previous tolerances still conform to the new tolerances.

This part of ISO 80369 contains the following major technical revisions to ISO 594-1 and ISO 594-2.

c) Some requirement 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

materials and rigid materials have been added.
d) Nominal dimensions have changed to be reference dimensions.

e) The distance from the tip of the connector to the bottom of the first complete thread profile of the

internal thread, or the t dimension has been made a reference dimension due to the difficulty in its

measurement. The intent of the dimension is evaluated with the resistance to separation from axial

load functional test.
iv © ISO 2019 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/DIS 80369-7:2019(E)

f) The N1 and N2 dimensions of the female Luer lock connector with lugs at right angle to axis, variant

A have changed to be measured from the open end of the connector to better ensure compatibility

at the extreme of the design space.

Additional parts on connectors for urethral and urinary applications and for respiratory applications are

planned.
© ISO 2019 – All rights reserved v
---------------------- Page: 5 ----------------------
ISO/DIS 80369-7:2019(E)
Introduction

This part of ISO 80369 was developed because of several incidents, with catastrophic consequences,

resulting from inappropriate medication, liquid nutritional formula or air being administered

intravenously. Many incidents have been reported leading to international recognition of the importance

of these issues and a need has been identified to develop specific connectors for medical devices and

their accessories used to deliver fluids in other applications.

The ISO 80369- series was developed to prevent misconnection between small-bore connectors used

in different applications. ISO 80369-1 specifies the requirements necessary to verify the designs and

dimensions of small-bore connectors to ensure that
a) they do not misconnect with other small-bore connectors, and
b) they safely and securely connect with their mating half.

ISO 80369-20 contains the common test methods to support the performance requirements for small-

bore connectors.

This part of ISO 80369 specifies the design and the dimensions and the drawings of small-bore

connectors intended to be used as conical fittings with a 6 % (Luer) taper for connections in intravascular

or hypodermic applications. Annex D to Annex G describe the methods by which this design has been

assessed. Other parts of ISO 80369 include requirements for small-bore connectors used in different

application categories.

Connectors manufactured to the dimensions set out within this part of ISO 80369 are dimensionally

incompatible with any of the other connectors for applications identified in the ISO 80369- series of

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 part of ISO 80369, the following print types are used:
— requirements and definitions: Roman type;

— informative material appearing outside of tables, such as notes, examples and references: in smaller

type. Normative text of tables is also in a smaller type;
— terms defined in Clause 3 or as noted: small capitals.

In this part of ISO 80369, the conjunctive “or” is used as an “inclusive or” so a statement is true if any

combination of the conditions is true.

The verbal forms used in this part of ISO 80369 conform to usage described in the ISO/IEC Directives,

Part 2. For the purposes of this document, the auxiliary verb:

— “shall” means that conformance with a requirement or a test is mandatory for conformance with

this part of ISO 80369;

— “should” means that conformance with a requirement or a test is recommended but is not mandatory

for conformance with this part of ISO 80369;

— “may” is used to describe a permission (e.g. a permissible way to achieve conformance with a

requirement or test);
— "can" is used to describe a possibility or capability; and
— "must" is used to express an external constraint.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates

that there is guidance or rationale related to that item in Annex A.
vi © ISO 2019 – All rights reserved
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DRAFT INTERNATIONAL STANDARD ISO/DIS 80369-7:2019(E)
Small-bore connectors for liquids and gases in healthcare
applications —
Part 7:
Connectors with 6 % (Luer) taper for intravascular or
hypodermic applications
1 * Scope

This part of ISO 80369 specifies dimensions and requirements for the design and functional

performance of small-bore connectors intended to be used for connections in intravascular applications

or hypodermic connections in hypodermic applications of medical devices and accessories.

EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip

connectors and Luer lock connectors.

NOTE 1 The Luer connector was originally designed for use at pressures up to 300 kPa.

This part of ISO 80369 does not specify requirements for the medical devices or accessories that use

these connectors. Such requirements are given in particular documents for specific medical devices or

accessories.

This part of ISO 80369 does not specify requirements for the following small-bore connectors, which are

specified in other documents:

— haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 and applicable

portion of ISO 8638 referencing blood compartment ports);

— haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637);

— infusion system closure piercing connectors (ISO 8536-4).

NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of

ISO 80369 into medical devices or accessories, even if currently not required by the relevant particular medical

device 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 3 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 part of ISO 80369.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

ISO 14971:2019, 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 2019 – All rights reserved 1
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ISO/DIS 80369-7:2019(E)

ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications — Part 20:

Common test methods
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 and the following apply.

Note 1 to entry For convenience, the sources of all defined terms used in this document are given in Annex J.

3.1
* Luer connector

small-bore connector that contains a conical mating surface with a 6 % (Luer) taper intended for use in

intravascular or hypodermic applications of medical devices and related accessories

Note 1 to entry: A Luer connector can be either a Luer slip connector or a Luer lock connector.

3.2
* Luer slip connector
Luer connector without a lock
Note 1 to entry: The Luer slip connector is indicated by the abbreviation L1.
3.3
* Luer lock connector
Luer connector that contains a locking mechanism
Note 1 to entry: The Luer lock connector is indicated by the abbreviation L2.
3.4
normal use

operation, including routine inspection and adjustments by any user, and stand-by, according to the

instructions for use

Note 1 to entry: Normal use should not be confused with intended use. While both include the concept of use as

intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not

only the medical purpose, but maintenance, service, transport, etc. as well.

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

3.5
rated (value)

term referring to a value assigned by the manufacturer for a specified operating condition

[SOURCE: IEC 60601-1:2005, 3.97]
3.6
rigid material

material with a modulus of elasticity either in flexure or in tension greater than 3 433 MPa

EXAMPLE Metals
3.7
semi-rigid material

material with a modulus of elasticity either in flexure or in tension, between 700 MPa and 3 433 MPa

EXAMPLE Thermoplastics
2 © ISO 2019 – All rights reserved
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ISO/DIS 80369-7:2019(E)
4 General requirements
4.1 General requirements for Luer connectors

Luer connectors made in conformance with this part of ISO 80369 conform with the general requirements

of ISO 80369-1:2018, unless otherwise indicated in this part of ISO 80369.

In some tolerance combinations, the inside diameter of the fluid lumen of male Luer connector may

contact the sealing surfaces of the N1 male connector (N1), as specified in ISO 80369-6, in LMC conditions

and thereby these connectors mutually fail when evaluating the non-interconnectable characteristics

tests of ISO 80369-1:2018, 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.

Where the design of a Luer connector of this part of ISO 80369 relies on dimensions or features of the

medical device or accessory to ensure non-interconnectable characteristics, the non-interconnectable

characteristics shall be verified.

Show conformance by applying a computer aided design (CAD) analysis of the dimensions of all of the

ISO 80369 series small bore connectors and the small bore connector under test, in conjunction with

physical testing of the small bore connector to the dimensions of Annex B where the CAD analysis

does not demonstrate the non-interconnectable characteristics. When necessary, install the small-bore

connector on the medical device or accessory to demonstrate conformance with the non-interconnectable

characteristics test requirements of ISO 80369-1:2018, Clause 5, and of ISO 80369-1:2018, Annex B.

NOTE 1 Medical devices using the Luer connectors of this part of ISO 80369 that do not rely on the dimensions

or features of the medical device or accessory to ensure non-interconnectable characteristics are presumed to

conform with the non-interconnectable characteristics test requirements of this part of ISO 80369.

NOTE 2 The summary of medical devices and their attributes with connections within this application is

provided in Annex D.

NOTE 3 The summary of the usability requirements for Luer connectors is provided in Annex E.

NOTE 4 The summary of Luer connectors criteria and requirements is provided in Annex F.

NOTE 5 The summary of assessment of the design of Luer connectors according to ISO 80369-1:2018, 6.1, is

contained in Annex G.
4.2 Type tests

Conformance with the requirements of this part of ISO 80369 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,

— 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,
© ISO 2019 – All rights reserved 3
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ISO/DIS 80369-7:2019(E)

— 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, as appropriate.

6 Performance requirements
6.1 Fluid leakage
6.1.1 Fluid leakage requirement

Luer connectors shall be evaluated for leakage using either the leakage by pressure decay test method or

the positive pressure liquid leakage test method.
6.1.2 Leakage by pressure decay

Luer connectors evaluated for fluid leakage performance with the leakage by pressure decay test method

shall not leak by more than 0,005 Pa·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. Manufacturers

may use a greater applied pressure.

Check conformance by applying the tests of ISO 80369-20:2015, Annex B, while using the leakage

reference connector specified in Annex C.
6.1.3 Positive pressure liquid leakage

Luer connectors evaluated for fluid leakage performance with the positive pressure liquid leakage test

method shall show no signs of leakage, sufficient to form a falling drop of water, over a hold period of 30 s

to 35 s while being subjected to an applied pressure of between 300 kPa and 330 kPa. Manufacturers

may use a greater applied pressure.

Check conformance by applying the tests of ISO 80369-20:2015, Annex C, while using the leakage

reference connector specified in Annex C.
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. Manufacturers may use a

greater applied sub-atmospheric pressure.

Check conformance by applying the tests of ISO 80369-20:2015, Annex D, while using the leakage

reference connector specified in Annex C.
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.
4 © ISO 2019 – All rights reserved
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ISO/DIS 80369-7:2019(E)
6.4 Resistance to separation from axial load

Luer connectors shall be evaluated for separation from axial load. Luer connectors shall not separate

from the reference connector over a hold period between 10 s and 15 s while being subjected to a

disconnection applied axial force between
a) 23 N and 25 N for Luer slip connectors, and
b) 32 N and 35 N for Luer lock connectors.

Manufacturers may use a greater disconnection applied axial force or a longer hold period.

Check 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.
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. Manufacturers may use a greater applied

unscrewing torque or a longer hold period.

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.
6.6 Resistance to overriding

Luer lock connectors shall be evaluated for resistance to overriding. Luer lock connectors shall not

override the threads or lugs of the reference connector while being subjected to an applied torque of

between 0,15 N·m to 0,17 N·m over a hold period between 5 s and 10 s. Manufacturers may use a greater

applied torque or a longer hold period.

Check conformance by applying the tests of ISO 80369-20:2015, Annex H, while using the resistance to

overriding reference connector specified in Annex C.
© ISO 2019 – All rights reserved 5
---------------------- Page: 11 ----------------------
ISO/DIS 80369-7:2019(E)
Annex A
(informative)
Rationale and guidance
A.1 General guidance

This Annex provides a rationale for some requirements of part of ISO 80369 and is intended for those

who are familiar with the subject of part of ISO 80369 but who have not participated in its development.

An understanding of the rationale underlying these requirements is considered to be essential for their

proper use. Furthermore, as clinical practice and technology change, it is believed that a rationale will

facilitate any revision of this part of ISO 80369 necessitated by those developments.

A.2 Rationale for particular clauses and subclauses

The clauses and subclauses in this Annex have been numbered to correspond to the numbering of the

clauses and subclauses of this part of ISO 80369 to which they refer. The numbering is, therefore, not

consecutive.
Clause 1 Scope
The scope includes the fittings described previously in ISO 594-1 and ISO 594-2.

In 2000, a Task Group of the European standards organization CEN proposed a strategy to

reduce incidents of accidental misconnection of patient therapy lines by the use of a series of non-

interconnectable connectors, differentiated by design, for use in different medical applications. The

strategy reserves the use of Luer connectors solely for use in medical devices used

...

PROJET DE NORME INTERNATIONALE
ISO/DIS 80369-7
ISO/TC 210 Secrétariat: ANSI
Début de vote: Vote clos le:
2019-10-11 2020-01-03
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
Small-bore connectors for liquids and gases in healthcare applications —

Part 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic applications

ICS: 11.040.25
CE DOCUMENT EST UN PROJET DIFFUSÉ POUR
OBSERVATIONS ET APPROBATION. IL EST DONC
SUSCEPTIBLE DE MODIFICATION ET NE PEUT

Le présent document est distribué tel qu’il est parvenu du secrétariat du comité.

ÊTRE CITÉ COMME NORME INTERNATIONALE
AVANT SA PUBLICATION EN TANT QUE TELLE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES
FINS INDUSTRIELLES, TECHNOLOGIQUES ET
COMMERCIALES, AINSI QUE DU POINT DE VUE TRAITEMENT PARALLÈLE ISO/CEN
DES UTILISATEURS, LES PROJETS DE NORMES
INTERNATIONALES DOIVENT PARFOIS ÊTRE
CONSIDÉRÉS DU POINT DE VUE DE LEUR
POSSIBILITÉ DE DEVENIR DES NORMES
POUVANT SERVIR DE RÉFÉRENCE DANS LA
RÉGLEMENTATION NATIONALE.
Numéro de référence
LES DESTINATAIRES DU PRÉSENT PROJET
ISO/DIS 80369-7:2019(F)
SONT INVITÉS À PRÉSENTER, AVEC LEURS
OBSERVATIONS, NOTIFICATION DES DROITS
DE PROPRIÉTÉ DONT ILS AURAIENT
ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE. ISO 2019
---------------------- Page: 1 ----------------------
ISO/DIS 80369-7:2019(F)
ISO/DIS 80369-7:2019(F)
Sommaire Page

Avant-propos .................................................................................................................................................................. iv

Introduction ................................................................................................................................................................... vi

1 * Domaine d’application ............................................................................................................................... 1

2 Références normatives .................................................................................................................................. 2

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 ........................................................................................................................... 5

6.1 Fuite de fluide ................................................................................................................................................... 5

6.1.1 Exigence relative à la fuite de fluide ......................................................................................................... 5

6.1.2 Fuite par baisse de pression ........................................................................................................................ 5

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 ................................................................. 6

6.5 Résistance à la séparation par dévissage ............................................................................................... 6

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 ................................................................................................. 24

Annexe D (informative) Évaluation des dispositifs médicaux présentant des raccordements

entrant dans le cadre de cette application et de leurs propriétés .............................................. 31

Annexe E (informative) Récapitulatif des exigences d’aptitude à l’utilisation des raccords Luer

destinés à des applications intravasculaires ou hypodermiques ............................................... 33

Annexe F (informative) Récapitulatif des exigences de conception des raccords Luer destinés à

des applications intravasculaires ou hypodermiques .................................................................... 38

Annexe G (informative) Récapitulatif de l’évaluation du modèle du raccord Luer destiné à des

applications intravasculaires ou hypodermiques ............................................................................ 41

Annexe H (informative) Référence aux principes essentiels .................................................................... 45

DOCUMENT PROTÉGÉ PAR COPYRIGHT

Annexe I (informative) Référence aux exigences générales en matière de sécurité et de

© ISO 2019

performances ................................................................................................................................................. 46

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en oeuvre, aucune partie de cette

publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, Annexe J (informative) Terminologie — Index alphabétique des termes définis ............................. 48

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

Bibliographie................................................................................................................................................................ 49

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Tél.: [phone]
Fax: [phone]
E-mail: [e-mail]
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Website: www.iso.org
Publié en Suisse
ii © ISO 2019 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO/DIS 80369-7:2019(F)
Sommaire Page

Avant-propos .................................................................................................................................................................. iv

Introduction ................................................................................................................................................................... vi

1 * Domaine d’application ............................................................................................................................... 1

2 Références normatives .................................................................................................................................. 2

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 ........................................................................................................................... 5

6.1 Fuite de fluide ................................................................................................................................................... 5

6.1.1 Exigence relative à la fuite de fluide ......................................................................................................... 5

6.1.2 Fuite par baisse de pression ........................................................................................................................ 5

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 ................................................................. 6

6.5 Résistance à la séparation par dévissage ............................................................................................... 6

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 ................................................................................................. 24

Annexe D (informative) Évaluation des dispositifs médicaux présentant des raccordements

entrant dans le cadre de cette application et de leurs propriétés .............................................. 31

Annexe E (informative) Récapitulatif des exigences d’aptitude à l’utilisation des raccords Luer

destinés à des applications intravasculaires ou hypodermiques ............................................... 33

Annexe F (informative) Récapitulatif des exigences de conception des raccords Luer destinés à

des applications intravasculaires ou hypodermiques .................................................................... 38

Annexe G (informative) Récapitulatif de l’évaluation du modèle du raccord Luer destiné à des

applications intravasculaires ou hypodermiques ............................................................................ 41

Annexe H (informative) Référence aux principes essentiels .................................................................... 45

Annexe I (informative) Référence aux exigences générales en matière de sécurité et de

performances ................................................................................................................................................. 46

Annexe J (informative) Terminologie — Index alphabétique des termes définis ............................. 48

Bibliographie................................................................................................................................................................ 49

© ISO 2019 – Tous droits réservés
iii
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ISO/DIS 80369-7:2019(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 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/fr/avant-propos.

Le comité chargé de l’élaboration du présent document est l’ISO/TC 210, Management de la qualité et

aspects généraux correspondants des dispositifs médicaux, conjointement avec l’IEC/SC62D, Appareils

électromédicaux. Ce projet a été soumis aux organismes nationaux de l’ISO et de l’IEC pour vote.

La première édition de l’ISO 80369-7 a annulé et remplacé l’ISO 594-1:1986 et l’ISO 594-2:1998, dont les

articles, paragraphes, tableaux, figures et annexes ont été consolidés et ont fait l’objet d’une révision

technique.
Cette deuxième édition de l’ISO 80369-7 annule et remplace l’ISO 80369-7:2016.
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ISO/DIS 80369-7:2019(F)

Par rapport à l’ISO 80369-7:2016, cette deuxième édition de l’ISO 80369-7 comprend les révisions

techniques majeures suivantes :

a) les tolérances sur plusieurs dimensions de raccords de référence ont été augmentées 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 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 ;

b) les raccords de référence fabriqués selon les anciennes tolérances sont toujours conformes aux

nouvelles tolérances.

Par rapport à l’ISO 594-1 et l’ISO 594-2, la présente partie de l’ISO 80369 comprend les révisions

techniques majeures suivantes :

c) pour certaines exigences relatives aux raccords Luer, une distinction est faite entre matériaux

semi-rigides et matériaux rigides afin de mieux assurer la compatibilité aux extrêmes des tolérances de

conception. Les définitions de matériau semi-rigide et de matériau rigide ont été ajoutées ;

d) les dimensions nominales ont été modifiées en dimensions de référence ;

e) la distance entre l’extrémité du raccord et la base du premier profil de filet complet du filetage

intérieur, c’est-à-dire la dimension t, est devenue une dimension de référence en raison des difficultés

rencontrées pour la mesurer. Le but dans lequel cette dimension est définie est évalué avec l’essai

fonctionnel de résistance à la séparation sous l’effet d’une force axiale ;

f) les dimensions N1 et N2 du raccord Luer à verrouillage femelle à ailettes perpendiculaires à l’axe,

variante A, ont été modifiées pour être mesurées depuis l’extrémité ouverte du raccord afin de mieux

assurer la compatibilité aux extrêmes des tolérances de conception.

Des parties supplémentaires relatives aux raccords destinés à des applications urétrales et urinaires, et à

des applications respiratoires sont prévues.
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ISO/DIS 80369-7:2019(F)
Introduction

La présente partie de l’ISO 80369 a été élaborée suite à 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 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 ; et

b) qu’ils permettent de raccorder les différents éléments de manière fiable et sûre.

L’ISO 80369-20 décrit les méthodes d’essai communes qui permettent de valider les exigences de

performance relatives aux raccords de petite taille.

La présente partie de l’ISO 80369 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 la présente partie de l’ISO 80369 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, ces raccords devraient

réduire 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 la présente partie de l’ISO 80369, les polices et caractères suivants sont employés :

 exigences et définitions : police de caractères romains ;

 éléments informatifs situés hors des tableaux, tels que notes, exemples et références : petits

caractères. Le texte normatif des tableaux apparaît également en petits caractères ;

 termes définis à l’Article 3 ou comme indiqué : petites majuscules.

Dans la présente partie de l’ISO 80369, la conjonction « ou » est utilisée comme « ou inclusif » ; une

affirmation est donc vraie si une combinaison quelconque des conditions est vraie.

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ISO/DIS 80369-7:2019(F)

Les formes verbales utilisées dans la présente partie de l’ISO 80369 sont conformes à l’usage décrit dans

les Directives ISO/IEC, Partie 2. Pour les besoins du présent document, la forme verbale :

 « doit » signifie que la conformité à une exigence ou à un essai est obligatoire pour la conformité à la

présente partie de l’ISO 80369 ;

 « 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 à la présente partie de l’ISO 80369 ;

 « peut » est utilisée pour décrire une autorisation (par exemple, une manière autorisée d’obtenir la

conformité à une exigence ou à un essai) ;

 « est susceptible de/est en mesure de/il est possible que/de » est utilisée pour décrire une possibilité

ou une aptitude ; et
 « est tenu(e) de » est utilisée pour exprimer une contrainte extérieure.

Un astérisque (*) utilisé comme premier caractère d’un titre ou au début d’un paragraphe ou d’un titre de

tableau indique qu’il y a des recommandations ou un exposé des motifs concernant cet élément dans

l’Annexe A.
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PROJET DE NORME INTERNATIONALE ISO/DIS 80369-7:2019(F)
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
1 * Domaine d’application

La présente partie de l’ISO 80369 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 À l’origine, le raccord Luer a été conçu pour être utilisé à des pressions maximales de 300 kPa.

La présente partie de l’ISO 80369 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.

La présente partie de l’ISO 80369 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 et

la partie applicable de l’ISO 8638 référencent les orifices du compartiment sanguin) ;

 raccords des appareils d’hémodialyse, d’hémodiafiltration et d’hémofiltration (ISO 8637) ;

 raccords du perforateur du système de fermeture des appareils de perfusion (ISO 8536-4).

NOTE 2 Les fabricants sont incités à intégrer les raccords de petite taille spécifiés dans la présente partie de

l’ISO 80369 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 spécifiés dans l’ISO 80369, lors de la révision des documents appropriés

spécifiques de ces dispositifs médicaux.

NOTE 3 L’ISO 80369-1:2018, Article 7, 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 à la

présente partie de l’ISO 80369.
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ISO/DIS 80369-7:2019(F)
2 Références normatives

Les documents ci-après, dans leur intégralité ou non, sont des références normatives indispensables à

l’application 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 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
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 ainsi que les suivants s’appliquent.

Note 1 à l’article : Pour des raisons pratiques, les sources de tous les termes définis utilisés dans le présent

document sont données à l’Annexe J.
3.1
* 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.
3.2
* 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.

3.3
* 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.

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ISO/DIS 80369-7:2019(F)
3.4
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.

[SOURCE : IEC 60601-1:2005+A1:2012, définition 3.71 modifiée : remplacement d’« opérateur »

par « utilisateur ».]
3.5
assignée (valeur)

terme qui fait référence à une valeur attribuée par le fabricant pour une condition de fonctionnement

spécifiée
[SOURCE : IEC 60601-1:2005, 3.97]
3.6
matériau rigide

matériau dont le module d’élasticité, en flexion ou en traction, est supérieur à 3 433 MPa

EXEMPLE Métaux.
3.7
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 à la présente partie de l’ISO 80369 sont conformes aux

exigences générales de l’ISO 80369-1:2018, sauf indication contraire dans la présente partie de

l’ISO 80369.

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 les conditions de minimum de matière. 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.

Lorsque la conception d’un raccord Luer de la présente partie de l’ISO 80369 repose sur des dimensions

ou des caractéristiques du dispositif médical ou de l’accessoire pour garantir les caractéristiques de

non-raccordabilité, les caractéristiques de non-raccordabilité doivent être vérifiées.

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ISO/DIS 80369-7:2019(F)

Démontrer la conformité en ayant recours à une analyse avec conception assistée par ordinateur (CAO)

des dimensions de tous les raccords de petite taille de la série ISO 80369 et du raccord de petite taille

soumis à essai, associée à des essais mécaniques du raccord de petite taille selon les dimensions figurant

dans l’Annexe B lorsque l’analyse CAO ne démontre pas les caractéristiques de non-raccordabilité. Si

nécessaire, installer le raccord de petite taille sur le dispositif médical ou l’accessoire pour démontrer la

conformité aux exigences de l’essai des caractéristiques de non-raccordabilité de l’Article 5 et de

l’Annexe B de l’ISO 80369-1:2018.

NOTE 1 Les dispositifs médicaux sur lesquels les raccords Luer de la présente partie de l’ISO 80369 sont

empl
...