ISO 80369-7:2021

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

ISO 80369-7:2021

Name:ISO 80369-7:2021   Standard name:Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Standard number:ISO 80369-7:2021   language:English language
Release Date:03-May-2021   technical committee:SC 62D - Particular medical equipment, software, and systems
Drafting committee:JWG 10 - TC 62/SC 62D/JWG 10   ICS number:11.040.25 - Syringes, needles an catheters

INTERNATIONAL ISO
STANDARD 80369-7
Second edition
2021-05
Small-bore connectors for liquids and
gases in healthcare applications —
Part 7:
Connectors for intravascular or
hypodermic applications
Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 7: Connecteurs pour les applications intravasculaires ou
hypodermiques
Reference number
©
ISO 2021
© ISO 2021
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ii © ISO 2021 – All rights reserved

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
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding
general aspects for medical devices, and IEC/SC62D, Electromedical equipment, in collaboration with
the European Committee for Standardization (CEN) Technical Committee, CEN/CENELEC JTC3/WG 2,
Small-bore connectors, in accordance with the Agreement on technical cooperation between ISO and
CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 80369-7:2016), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— Tolerances of several reference connector dimensions are increased to facilitate easier manufacturing
and certification. Most of the affected tolerances are for features that do not contact the test
connector and therefore do not affect the test results. The angle tolerance for the bearing side of the
threads do contact the connector under test but the change in the tolerance is considered likely have
minimal to no effect on test outcomes.
— Some requirements for Luer connectors have been separated for semi-rigid materials and rigid
materials to better ensure compatibility at the extreme of the design space. Definitions of semi-rigid
material and rigid material have been added.
— The distance from the tip of the connector to the bottom of the first complete thread profile of
the internal thread (t dimension) has been made an auxiliary dimension due to the difficulty in its
measurement. The functional impact of the dimension is evaluated with the resistance to separation
(from axial load) functional test.
— The N1 and N2 dimensions of the female Luer lock connector variant A (with lugs at right angle to
axis) have been changed to allow measurement from the open end of the connector, to better ensure
compatibility at the extreme of the design space.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved

Introduction
This document was developed because of several incidents, with catastrophic consequences, resulting
from inappropriate medication, liquid nutritional formula or air being administered intravenously.
Many incidents have been reported leading to international recognition of the importance of these
issues and a need has been identified to develop specific connectors for medical devices and their
accessories used to deliver fluids in other applications.
The ISO 80369 series was developed to prevent misconnection between small-bore connectors used
in different applications. ISO 80369-1 specifies the requirements necessary to verify the designs and
dimensions of small-bore connectors to ensure that
a) they do not misconnect with other small-bore connectors, and
b) they safely and securely connect with their mating half.
This document specifies the design and the dimensions and the drawings of small-bore connectors
intended to be used as conical fittings with a 6 % (Luer) taper for connections in intravascular or
hypodermic applications. Annex D to Annex G describe the methods by which this design has been
assessed. Other parts of ISO 80369 include requirements for small-bore connectors used in different
application categories.
Connectors manufactured to the dimensions set out within this document are dimensionally
incompatible with any of the other connectors for applications identified in the ISO 80369 series of
documents for small-bore connectors, except as indicated in Annex G. If fitted to the relevant medical
devices and accessories, these connectors should reduce the risk of air, non-vascular medication and
liquid nutritional formula being delivered through an alternative route, such as intravenously or
through an airway device.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” means that conformance with a requirement or a test is recommended but is not mandatory
for conformance with this document;
— “may” indicates a permission;
— "can" indicates a possibility or a capability.
INTERNATIONAL STANDARD ISO 80369-7:2021(E)
Small-bore connectors for liquids and gases in healthcare
applications —
Part 7:
Connectors for intravascular or hypodermic applications
1 Scope
This document specifies dimensions and requirements for the design and functional performance of
small-bore connectors intended to be used for connections in intravascular applications or hypodermic
connections in hypodermic applications of medical devices and accessories.
EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip
connectors and Luer lock connectors.
NOTE 1 See Annex A.
NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa.
This document does not specify requirements for the medical devices or accessories that use these
connectors. Such requirements are given in particular documents for specific medical devices or
accessories.
This document does not specify requirements for the following small-bore connectors, which are
specified in other documents:
[5]
— haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 and
[6]
applicable portion of ISO 8638 referencing blood compartment ports);
[5]
— haemo
...

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