EN ISO 80369-7:2021

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

This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.
EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors.
NOTE 1 See Annex A.
NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa.
This document does not specify requirements for themedical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories.
This document does not specify requirements for the following small-bore connectors, which are specified in other documents:
- haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 [5] and applicable portion of ISO 8638 [ 6] referencing blood compartment ports);
- haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]);
- infusion system closure piercing connectors (ISO 8536-4 [4]).
NOTE 3 Manufacturers are encouraged to incorporate thesmall-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.
NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document.

Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 7: Verbindungsstücke für intravaskuläre oder hypodermische Anwendungen (ISO 80369-7:2021)

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

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

Le présent document spécifie les dimensions et les exigences relatives à la conception et aux performances fonctionnelles des raccords de petite taille destinés à être utilisés pour effectuer des raccordements dans des applications intravasculaires ou des raccordements hypodermiques dans des applications hypodermiques de dispositifs médicaux et d'accessoires.
EXEMPLES Les seringues et aiguilles hypodermiques ou les canules intravasculaires (IV) avec raccords Luer à glissement et raccords Luer à verrouillage mâles et femelles.
NOTE 1 Voir l'Annexe A.
NOTE 2 À l'origine, le raccord Luer a été conçu pour être utilisé à des pressions maximales de 300 kPa.
Le présent document ne spécifie pas les exigences relatives aux dispositifs médicaux ou aux accessoires sur lesquels ces raccords sont utilisés. Ces exigences figurent dans des documents spécifiques traitant de dispositifs médicaux ou d'accessoires particuliers.
Le présent document ne spécifie pas d'exigences pour les raccords de petite taille suivants, celles-ci étant spécifiées dans d'autres documents:
- orifices du compartiment sanguin des hémodialyseurs, hémodiafiltres et hémofiltres (l'ISO 8637[5] et la partie applicable de l'ISO 8638[6] référencent les orifices du compartiment sanguin);
- raccords des appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration (ISO 8637[5]);
- raccords du perforateur du système de fermeture des appareils de perfusion (ISO 8536-4[4]).
NOTE 3 Les fabricants sont incités à intégrer les raccords de petite taille spécifiés dans le présent document dans les dispositifs médicaux ou accessoires, même si cela n'est pas actuellement requis par les documents appropriés, spécifiques de ces dispositifs médicaux. Il est prévu d'inclure des exigences relatives aux raccords de petite taille, tels que spécifiées dans l'ISO 80369, lors de la révision des documents appropriés spécifiques de ces dispositifs médicaux.
NOTE 4 L'Article 7 de l'ISO 80369-1:2018 spécifie d'autres méthodes de vérification de la conformité à l'ISO 80369-1:2018 pour les raccords de petite taille destinés à être utilisés avec des dispositifs médicaux ou des accessoires pour applications intravasculaires ou applications hypodermiques, mais qui ne sont pas conformes au présent document.

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

General Information

• Status: Published
• Publication Date: 18-May-2021
• Withdrawal Date: 29-Nov-2021
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 19-May-2021
• Completion Date: 19-May-2021
• Ref Project: SIST EN ISO 80369-7:2021 - Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021)

Relations

• Replaces: EN ISO 80369-7:2017 - Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01)
• Effective Date: 14-Aug-2019

Standards Content (Sample)

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

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

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

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

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

European foreword
This document (EN ISO 80369-7:2021) has been prepared by Technical Committee ISO/TC 210 "Quality
management and corresponding general aspects for medical devices" in collaboration with Technical
Committee CEN/CLC/JTC 3 “Quality management and corresponding general aspects for medical
devices” the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2021, and conflicting national standards
shall be withdrawn at the latest by November 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 80369-7:2017.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 80369-7:2021 has been approved by CEN as EN ISO 80369-7:2021 without any
modification.
INTERNATIONAL ISO
STANDARD 80369-7
Second edition
2021-05
Small-bore connectors for liquids and
gases in healthcare applications —
Part 7:
Connectors for intravascular or
hypodermic applications
Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 7: Connecteurs pour les applications intravasculaires ou
hypodermiques
Reference number
ISO 80369-7:2021(E)
©
ISO 2021
ISO 80369-7:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: [phone]
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Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 80369-7:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 3
4.1 General requirements for Luer connectors . 3
4.2 Type tests . 3
5 Dimensional requirements for Luer connectors . 3
6 Performance requirements . 4
6.1 Fluid leakage . 4
6.1.1 Fluid leakage requirement . 4
6.1.2 Leakage by pressure decay . 4
6.1.3 Positive pressure liquid leakage . 4
6.2 Sub-atmospheric pressure air leakage . 4
6.3 Stress cracking . 5
6.4 Resistance to separation from axial load. 5
6.5 Resistance to separation from unscrewing . 5
6.6 Resistance to overriding . 5
Annex A (informative) Rationale and guidance . 6
Annex B (normative) Luer connectors .10
Annex C (normative) Reference connectors .25
Annex D (informative) Assessment of medical devices and their attributes with connections
within this application .32
Annex E (informative) Summary of the usability requirements for Luer connectors for
intravascular or hypodermic applications .34
Annex F (informative) Summary of Luer connector design requirements for intravascular
or hypodermic applications .38
Annex G (informative) Summary of assessment of the design of the Luer connector for
intravascular or hypodermic applications .41
Annex H (informative) Reference to the essential principles .44
Annex I (informative) Reference to the general safety and performance requirements .45
Annex J (informative) Terminology — Alphabetized index of defined terms .46
Bibliography .47
ISO 80369-7:2021(E)
Foreword
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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
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Attention is drawn to the possibility that some of the elements of this document may be the subject of
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This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding
general aspects for medical devices, and IEC/SC62D, Elect
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