prEN ISO 80369-7

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic applications (ISO/DIS 80369-7:2019)

Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 7: Verbindungsstücke mit einem 6 % (Luer) Kegel für intravaskuläre oder hypodermische Anwendungen (ISO/DIS 80369-7:2019)

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 (ISO/DIS 80369-7:2019)

Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 7. del: Priključki s 6 % (Luerjevim) nastavkom za intravaskularno ali podkožno uporabo (ISO/DIS 80369-7:2019)

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN ISO 80369-7:2019
01-december-2019

Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 7. del:

Priključki s 6 % (Luerjevim) nastavkom za intravaskularno ali podkožno uporabo
(ISO/DIS 80369-7:2019)
Small-bore connectors for liquids and gases in healthcare applications - Part 7:

Connectors with 6 % (Luer) taper for intravascular or hypodermic applications (ISO/DIS

80369-7:2019)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in

medizinischen Anwendungen - Teil 7: Verbindungsstücke mit einem 6 % (Luer) Kegel für

intravaskuläre oder hypodermische Anwendungen (ISO/DIS 80369-7:2019)

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

(ISO/DIS 80369-7:2019)
Ta slovenski standard je istoveten z: prEN ISO 80369-7
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 80369-7:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 80369-7:2019
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oSIST prEN ISO 80369-7:2019
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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oSIST prEN ISO 80369-7:2019
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.
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ii © ISO 2019 – All rights reserved
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oSIST prEN ISO 80369-7:2019
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

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oSIST prEN ISO 80369-7:2019
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.
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oSIST prEN ISO 80369-7:2019
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.
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oSIST prEN ISO 80369-7:2019
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.
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oSIST prEN ISO 80369-7:2019
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
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oSIST prEN ISO 80369-7:2019
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
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oSIST prEN ISO 80369-7:2019
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,
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oSIST prEN ISO 80369-7:2019
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.
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oSIST prEN ISO 80369-7:2019
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 pe
...