SIST EN ISO 80369-7:2017
(Main)Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016)
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016)
This part of ISO 80369 specifies dimensions and requirements for the design and essential performance of SMALL-BORE CONNECTORS intended to be used on or with intravascular and hypodermic devices. This part of ISO 80369 does not specify the dimensions and requirements for the MEDICAL DEVICES or ACCESSORIES that use these CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES.
NOTE The LUER LOCK CONNECTOR was designed for use at pressures of the order of 300 kPa or lower. Its use in other applications can require consideration to establish its suitability. This part of ISO 80369 does not specify requirements for the following CONNECTORS which are specified in other standards:
- haemodialyser, haemodiafilter and haemofilter blood compartment ports [ISO 8637, ISO 8638]
- cardiovascular and cardiac equipment CONNECTORS [ISO 8637, ISO 8638]
- infusion system closure piercing CONNECTORS [ISO 8536-4]
NOTE Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into medical devices, medical systems or accessories, even if currently not required by the relevant particular device standards. It is expected that when the relevant particular device standards are revised, requirements for small-bore connectors, as specified in this part of ISO 80369 will be included.
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 80369-7:2016)
Der vorliegende Teil der ISO 80369 legt die Anforderungen für VERBINDUNGSSTÜCKE mit KLEINEM DURCH-MESSER für die Verwendung als intravaskuläre VERBINDUNGEN in intravaskulären ANWENDUNGEN oder als hypodermische VERBINDUNGEN in hypodermischen ANWENDUNGEN von MEDIZINPRODUKTEN und ZUBEHÖR-TEILEN fest.
Der vorliegende Teil der ISO 80369 legt Maße und Anforderungen für die Ausführung und funktionale Leistungsfähigkeit dieser VERBINDUNGSSTÜCKE mit KLEINEM DURCHMESSER für die Verwendung mit MEDIZIN-PRODUKTEN fest. Der vorliegende Teil der ISO 80369 legt nicht die Maße und Anforderungen für die MEDIZINPRODUKTE oder ZUBEHÖRTEILE fest, mit denen diese VERBINDUNGSSTÜCKE verwendet werden. Derartige Anforderungen sind in speziellen Internationalen Normen für bestimmte MEDIZINPRODUKTE oder ZUBEHÖRTEILE angegeben.
BEISPIELE Hypodermische Spritzen und Kanülen oder IV-Kanülen mit LUER-STECK-VERBINDUNGSSTÜCKEN und VERRIEGELBAREN LUER-VERBINDUNGSSTÜCKEN mit Außen- bzw. Innenkegel.
ANMERKUNG 1 Hypodermische Verwendung schließt perkutane Infusion und Injektion ebenso ein wie das Aufblasen und Entlasten von aufblasbaren Manschetten zur Fixierung invasiver MEDIZINPRODUKTE.
ANMERKUNG 2 Das LUER-VERBINDUNGSSTÜCK wurde für Drücke bis 300 kPa ausgelegt.
Der vorliegende Teil der ISO 80369 legt nicht die Anforderungen für die folgenden VERBINDUNGSSTÜCKE fest, die in anderen Normen festgelegt sind:
- Ports der Blutbereiche von Hämodialysatoren, Hämodiafiltern und Hämofiltern [ISO 8637 sowie zutreffende Teile der ISO 8638 zu Ports der Blutbereiche];
- VERBINDUNGSSTÜCKE für Ausrüstung von Hämodialysatoren, Hämodiafiltern und Hämofiltern [ISO 8637];
- Einstech-VERBINDUNGSSTÜCKE für Infusionssysteme [ISO 8536 4].
ANMERKUNG 3 HERSTELLER werden zum Einbau der VERBINDUNGSSTÜCKE mit KLEINEM DURCHMESSER nach dem vor-liegenden Teil der ISO 80369 in MEDIZINPRODUKTE, Medizinsysteme oder ZUBEHÖRTEILE angeregt, auch wenn derzeit nach den maßgebenden speziellen Normen zu MEDIZINPRODUKTEN nicht erforderlich. Es ist zu erwarten, dass bei Überarbeitung der maßgebenden speziellen Normen zu MEDIZINPRODUKTEN Anforderungen für VERBINDUNGSSTÜCKE mit KLEINEM DURCHMESSER entsprechend den Festlegungen nach ISO 80369 aufgenommen werden.
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 80369-7:2016)
ISO 80369-7:2016 spécifie les dimensions et 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 L'usage hypodermique inclut la perfusion et l'injection percutanées, ainsi que le gonflage et le dégonflage des dispositifs de rétention (par exemple ballonnet) utilisés pour le maintien en place de dispositifs médicaux invasifs et de dispositifs endoscopiques.
NOTE 2 À l'origine, le raccord Luer a été conçu pour être utilisé à des pressions maximales de 300 kPa.
ISO 80369-7:2016 ne spécifie pas les exigences relatives aux dispositifs médicaux ou aux accessoires sur lesquels ces raccords sont utilisés. Ces exigences figurent dans des Normes internationales 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. Elles sont spécifiées dans d'autres Normes internationales:
- 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 3 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 normes appropriées, 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 normes appropriées spécifiques de ces dispositifs médicaux.
NOTE 4 L'ISO 80369‑1:2010, 5.8, spécifie d'autres méthodes de vérification de la conformité à l'ISO 80369‑1:2010 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.
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 7. del: Priključki za intravaskularno ali podkožno uporabo (ISO 80369-7:2016)
Ta del standarda ISO 80369 določa dimenzije in zahteve za zasnovo ter bistvene lastnosti PRIKLJUČKOV Z MAJHNIM PREMEROM, ki so namenjeni za uporabo v povezavi s pripomočki za intravaskularno ali podkožno uporabo. Ta del standarda ISO 80369 ne določa dimenzij in zahtev za MEDICINSKE PRIPOMOČKE ali DODATKE, v povezavi s katerimi se uporabljajo ti PRIKLJUČKI. Takšne zahteve so podane v posameznih mednarodnih standardih za specifične MEDICINSKE PRIPOMOČKE ali OPREMO. OPOMBA: VARNOSTNI PRIKLJUČEK LUER je bil zasnovan za uporabo pri tlaku reda 300 kPa ali manj. Njegova uporaba v drugih primerih uporabe lahko zahteva pomisleke glede ugotavljanja njegove ustreznosti. Ta del standarda ISO 80369 ne določa zahtev za naslednje PRIKLJUČKE, ki so opredeljeni v drugih standardih: – vrata prostora za kri pri hemodializatorju, hemodiafiltru in hemofiltru [ISO 8637, ISO 8638] – PRIKLJUČKI kardiovaskularne opreme in opreme za srce [ISO 8637, ISO 8638] – PRIKLJUČKI za predrtje zapirala infuzijskega sistema [ISO 8536-4] OPOMBA: Proizvajalcem se priporoča, da priključke z majhnim premerom, ki so določeni v tem delu standarda ISO 80369, vključijo v medicinske pripomočke, medicinske sisteme ali dodatke, tudi če zadevni posamezni standardi za pripomočke tega trenutno ne zahtevajo. Predvideva se, da bodo ob reviziji zadevnih posameznih standardov za pripomočke vanje vključene zahteve za priključke z majhnim premerom, kot so določene v tem delu standarda ISO 80369.
General Information
Relations
Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 80369-7:2017
01-september-2017
1DGRPHãþD
SIST EN 1707:2000
SIST EN 20594-1:2000
SIST EN 20594-1:2000/A1:2000
SIST EN 20594-1:2000/AC:2000
3ULNOMXþNL]PDMKQLPSUHPHURP]DWHNRþLQHLQSOLQH]DXSRUDERY]GUDYVWYXGHO
3ULNOMXþNL]DLQWUDYDVNXODUQRDOLSRGNRåQRXSRUDER ,62
Small-bore connectors for liquids and gases in healthcare applications - Part 7:
Connectors for intravascular or hypodermic applications (ISO 80369-7:2016)
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 80369-7:2016)
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 80369-7:2016)
Ta slovenski standard je istoveten z: EN ISO 80369-7:2017
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 80369-7:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 80369-7:2017
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SIST EN ISO 80369-7:2017
EUROPEAN STANDARD EN ISO 80369-7
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2017
ICS 11.040.25
Supersedes EN 1707:1996, EN 20594-1:1993
English version
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)
Raccords de petite taille pour liquides et gaz utilisés Verbindungsstücke mit kleinem Durchmesser für
dans le domaine de la santé - Partie 7: Raccords à 6 % Flüssigkeiten und Gase in medizinischen
(Luer) destinés aux applications intravasculaires ou Anwendungen - Teil 7: Verbindungsstücke mit einem
hypodermiques (ISO 80369-7:2016, Version corrigée 6% (Luer) Kegel für intravaskuläre oder
2016-12-01) hypodermische Anwendungen (ISO 80369-7:2016,
korrigierte Fassung 2016-12-01)
This European Standard was approved by CEN on 21 May 2017.
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, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Avenue Marnix 17, B-1000 Brussels
© 2017 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 80369-7:2017 E
reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN ISO 80369-7:2017
EN ISO 80369-7:2017 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
2
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SIST EN ISO 80369-7:2017
EN ISO 80369-7:2017 (E)
European foreword
The text of ISO 80369-7:2016, Corrected version 2016-12-01 has been prepared by Technical
Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices”
of the International Organization for Standardization (ISO) and has been taken over as EN
ISO 80369-7:2017 by Technical Committee CEN/CLC/TC 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 2017, and conflicting national standards
shall be withdrawn at the latest by May 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN 1707:1996, EN 20594-1:1993.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard “within the
meaning of Annex ZA", the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When the ISO or IEC standard is referred to in the ISO text standard, this must be understood as a
normative reference to the parallel EN standard or dated ISO standard, as outlined below, including the
foreword and the Annexes ZZ.
NOTE The way in which these references documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
3
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SIST EN ISO 80369-7:2017
EN ISO 80369-7:2017 (E)
Table — Correlations between normative references and
dated EN and ISO/IEC standards
Equivalent dated standard
Normative references as listed in
Clause 2
EN ISO/IEC
ISO 14971:2007 EN ISO 14971:2012 ISO 14971:2007
ISO 5356-1:2004 EN 5356-1:2004 ISO 5356-1:2004
ISO 5356-1:2015 EN 5356-1:2015 ISO 5356-1:2015
ISO 5356-2:2006 EN 5356-2:2007 ISO 5356-2:2006
ISO 5356-2:2006 EN 5356-2:2007 ISO 5356-2:2006
ISO 5356-2:2012 EN 5356-2:2012 ISO 5356-2:2012
ISO 8185:2007 EN 8185:2009 ISO 8185:2007
EN 13544-2:2002 EN 13544-2:2002 —
EN 13544-2:2002+A1:2009 EN 13544- —
2:2002+A1:2009
ISO 80369-1:2010 EN ISO 80369-1:2010 ISO 80369-1:2010
ISO 80369-3:2015 EN ISO 80369-3:2016 ISO 80369-3:2015
ISO 80369-6:2015 EN ISO 80369-6:2016 ISO 80369-6:2015
ISO 80369-20:2015 EN 80369-20:2015 ISO 80369-20:2015
ASTM D638-10 — —
ASTM D790-10 — —
Endorsement notice
The text of ISO 80369-7:2016, Corrected version 2016-12-01 has been approved by CEN as EN
ISO 80369-7:2017 without any modification.
4
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SIST EN ISO 80369-7:2017
EN ISO 80369-7:2017 (E)
Annex ZA
(informative)
Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
1
This European standard has been prepared under a Commission’s standardisation request M/023 to
provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC
of 14 June 1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements of Clause(s) / sub-clause(s) of
Remarks / Notes
Directive 93/42/EEC this EN
7.5 6.1, 6.2 Only the first sentence of
ER 7.5 is met as it relates to
the leakage of a connection.
9.1 5, 6.3, 6.4, 6.5, 6.6 ER 9.1 is met with respect to
the connector dimensions,
resistance to stress cracking,
disconnection, unscrewing
and overriding of threads or
lugs only.
12.7.4 6.3 ER 12.7.4 is met with respect
to stress cracking only.
1
Replace with ‘M/023 concerning the development of European standards related to medical devices’ or
with ‘M/295 concerning the development of European standards related to medical devices’, or with the
reference number and title of any other standardization request as relevant.
5
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SIST EN ISO 80369-7:2017
EN ISO 80369-7:2017 (E)
Essential Requirements of Clause(s) / sub-clause(s) of
Remarks / Notes
Directive 93/42/EEC this EN
12.8.1 4.1, 5, 6.2, 6.4, 6.5, 6.6 ER 12.8.1 is partially covered
in that by ensuring that the
connector does not leak and
can only be connected to
intended medical devices or
accessories it permits a
medical device to be capable
of controlling the flowrate.
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
6
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SIST EN ISO 80369-7:2017
INTERNATIONAL ISO
STANDARD 80369-7
First edition
2016-10-15
Corrected version
2016-12-01
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
Reference number
ISO 80369-7:2016(E)
©
ISO 2016
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SIST EN ISO 80369-7:2017
ISO 80369-7:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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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Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 80369-7:2017
ISO 80369-7:2016(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 Material used for luer connectors . 4
4.3 Type tests . 4
5 * Dimensional requirements for luer connectors . 4
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 . 5
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 .21
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) Terminology — Alphabetized index of defined terms .41
Bibliography .42
© ISO 2016 – All rights reserved iii
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SIST EN ISO 80369-7:2017
ISO 80369-7:2016(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.
This first edition of ISO 80369-7 cancels and replaces ISO 594-1:1986 and ISO 594-2:1998, clauses,
subclauses, tables, figures, and annexes of which have been consolidated and technically revised.
This part of ISO 80369 contains the following major technical revisions to ISO 594-1 and ISO 594-2.
a) New terms and definitions have been added to this part of ISO 80369 to more clearly define the
various types of luer connectors included in the scope of this part of ISO 80369. This part of
ISO 80369 more broadly describes the requirements for the connectors used for intravascular
or hypodermic applications, unlike ISO 594-1 and ISO 594-2 that are replaced by this part
of ISO 80369, which only described the requirements for the fittings (intended connection
surfaces) of these connectors. This distinction is important to define here because the previous
International Standards do not contain the terms connector or connection and ISO 80369- series
does not use the term fitting.
b) Requirements for certain dimensions not previously identified in ISO 594-1 and ISO 594-2 are
added to this part of ISO 80369 to reduce the risk of misconnections between medical devices or
accessories for different applications with the small-bore connectors that are being developed
under other parts of the ISO 80369- series. These new dimensions were selected to represent the
current design and dimensions of luer connectors in clinical use at the time this part of ISO 80369
was developed. The term “6 % (Luer) taper” used throughout the previous standards has also
been clarified to the more commonly used equivalent specified diameters separated by a specified
distance on a common axis.
c) Requirements for gauging of luer connectors made from semi-rigid materials using plug
and ring test gauges have been replaced by dimensional requirements, which are more precise
and essential for reducing the risk of misconnection with the other connectors identified in
ISO 80369-1.
iv © ISO 2016 – All rights reserved
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SIST EN ISO 80369-7:2017
ISO 80369-7:2016(E)
d) Separate requirements for luer connectors made from semi-rigid materials and rigid
materials have been eliminated and combined as one common set of dimensions and requirements.
This consolidation of requirements was made to further reduce the risk of misconnection with
other small-bore connectors.
ISO 80369 consists of the following parts, under the general title Small-bore connectors for liquids and
gases in healthcare applications:
— Part 1: General requirements
— Part 3: Connectors for enteral applications
— Part 5: Connectors for limb cuff inflation applications
— Part 6: Connectors for neuraxial applications
— Part 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic applications
— Part 20: Common test methods
Additional parts on connectors for urethral and urinary applications and for respiratory applications
are planned.
This corrected version of ISO 80369-7:2016 incorporates the following corrections:
— in the Scope, NOTE 1 has been removed and the other notes renumbered accordingly;
— in the second paragraph of 6.6, the reference to the annex has been changed;
— the lower-case greek letter “β” has been changed into a capital greek letter “B” in the notes of
Tables B.5 and B.6;
— the representation of the angle B has been updated in Figure B.7;
— values and angles have been corrected in Figures C.1, C.2, C.3, C.4 and C.6.
© ISO 2016 – All rights reserved v
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SIST EN ISO 80369-7:2017
ISO 80369-7:2016(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
standards 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, Annex H. For the purposes of this part of ISO 80369, the auxiliary verb:
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
part of ISO 80369;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this part of ISO 80369;
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
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 2016 – All rights reserved
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SIST EN ISO 80369-7:2017
INTERNATIONAL STANDARD ISO 80369-7:2016(E)
Small-bore connectors for liquids and gases in healthcare
applications —
Part 7:
Connectors 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 International Standards 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 International Standards:
— 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 standards. It is expected that when the relevant particular medical device standards are
revised, requirements for sm
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