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)
ISO 80369-7:2016 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 Hypodermic use includes percutaneous infusion and injection as well as pressurizing and depressurizing the retention mechanisms (e.g. balloon) used to hold invasive medical devices in place and endoscopic devices.
NOTE 2 The luer connector was originally designed for use at pressures up to 300 kPa.
ISO 80369-7:2016 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 3 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 small-bore connectors, as specified in ISO 80369, will be included.
NOTE 4 ISO 80369‑1:2010, 5.8, specifies alternative methods of compliance with ISO 80369‑1:2010, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not comply with this part of ISO 80369.
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.
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2017
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SIST EN 1707:2000
SIST EN 20594-1:2000
SIST EN 20594-1:2000/A1:2000
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3ULNOMXþNL]PDMKQLPSUHPHURP]DWHNRþLQHLQSOLQH]DXSRUDERY]GUDYVWYXGHO
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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
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 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.
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
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.
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.
Annex ZA
(informative)
Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
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.
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.
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.
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
ISO 80369-7:2016(E)
© ISO 2016, Published in Switzerland
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ii © ISO 2016 – All rights reserved
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 .
...
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