EN ISO 80369-6:2016

Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15)

ISO 80369-6:2016 specifies requirements for small-bore connectors intended to be used for connections in neuraxial applications. Neuraxial applications involve the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes.
NOTE 1       Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain, and the epi-, extra-, or peri-dural space. Neuraxial application anaesthetics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents.
NOTE 2       For the purposes of this part of ISO 80369, local anaesthesia injected hypodermically is not considered a neuraxial application.
EXAMPLES     Intended administration includes intrathecal chemotherapy, local anaesthetics, radiological contrast agents, antibiotics, analgesics.
This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of these small-bore connectors intended to be used with medical devices.
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.
NOTE 3       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 medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for small-bore connectors, as specified in this part of ISO 80369, will be included. Furthermore, it is recognized that standards need to be developed for many medical devices used for neuraxial applications.
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 neuraxial 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 6: Verbindungsstücke für neuroaxiale Anwendungen (ISO 80369-6:2016, korrigierte Fassung 2016-11-15)

Dieser Teil von ISO 80369 legt die Anforderungen an VERBINDUNGSSTÜCKE mit KLEINEM DURCH¬MESSER zur Verwendung für VERBINDUNGEN in neuroaxialen ANWENDUNGEN fest. Neuroaxiale ANWENDUNGEN umfassen die Verwendung von MEDIZINPRODUKTEN zur Verabreichung von Arzneimitteln in neuroaxiale Bereiche, Verabreichung von Wundinfiltrationsanästhesie und Anwendung anderer regionaler Anästhesieverfahren oder zur Überwachung oder Entnahme von Gehirn-Rückenmarksflüssigkeit zu therapeutischen oder diagnostischen Zwecken.
ANMERKUNG 1   Bereiche für die neuroaxiale ANWENDUNG umfassen das Rückenmark, den Intrathekal- oder Subarachnoidalraum, Hirnventrikel und den Epidural-, Extradural- oder Periduralraum. Neuroaxiale anästhetische ANWENDUNGEN können lokal verabreicht, Auswirkung auf einen großen Teil des Körpers, wie z. B. eine Gliedmaße, haben und Plexusblockaden einschließen, wie z. B. Brachialplexusblockaden oder Einzelnervenblockaden. Neuroaxiale ANWENDUNGS-Verfahren umfassen kontinuierliche Wundinfusionen mit Lokalanästhetika.
ANMERKUNG 2   Für die Anwendung von diesem Teil von ISO 80369 wird hypodermisch injizierte Lokalanästhesie nicht als eine neuroaxiale ANWENDUNG betrachtet.
BEISPIELE   Die beabsichtigte Verabreichung schließt intrathekale Chemotherapie, Lokalanästhesie, radiologische Kontrastmittel, Antibiotika und Analgetika ein.
Dieser Teil von ISO 80369 legt Maße und Anforderungen an Ausführung und Funktionsverhalten dieser VERBINDUNGSSTÜCKE mit KLEINEM DURCHMESSER zur Verwendung mit MEDIZINPRODUKTEN fest.
Dieser Teil von ISO 80369 legt nicht die Anforderungen an die MEDIZINPRODUKTE oder das ZUBEHÖR, die/das diese VERBINDUNGSSTÜCKE verwenden, fest. Derartige Anforderungen sind in den speziellen Internationalen Normen für spezifische MEDIZINPRODUKTE oder ZUBEHÖR angegeben.
ANMERKUNG 3   HERSTELLER werden zum Einbau der VERBINDUNGSSTÜCKE mit KLEINEM DURCHMESSER nach diesem Teil von ISO 80369 in MEDIZINPRODUKTE, Medizinsysteme oder ZUBEHÖR angeregt, auch wenn derzeit nach den maßgebenden speziellen Normen für MEDIZINPRODUKTE nicht erforderlich. Es ist zu erwarten, dass bei Überarbeitung der entsprechenden speziellen Normen für MEDIZINPRODUKTE Anforderungen an VERBINDUNGSSTÜCKE mit KLEINEM DURCHMESSER nach diesem Teil von ISO 80369 aufgenommen werden. Des Weiteren wird die Notwendigkeit festgestellt, für viele MEDIZINPRODUKTE für neuroaxiale ANWENDUNGEN Normen zu erarbeiten.
ANMERKUNG 4   ISO 80369-1:2010, 5.8, legt alternative Verfahren der Übereinstimmung mit ISO 80369-1:2010 für VERBINDUNGSSTÜCKE mit KLEINEM DURCHMESSER fest, die zur Nutzung mit MEDIZINPRODUKTEN oder ZUBEHÖR für NEUROAXIALE ANWENDUNGEN vorgesehen sind, und die nicht diesem Teil von ISO 80369 entsprechen.

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 6: Raccords destinés à des applications en contact avec le système nerveux (neuraxiales) (ISO 80369-6:2016, Version corrigée 2016-11-15)

L'ISO 80369-6:2016 spécifie les exigences relatives aux raccords de petite taille destinés à être utilisés pour effectuer des raccordements dans des applications neuraxiales. Les applications neuraxiales impliquent l'utilisation de dispositifs médicaux destinés à l'administration de médicaments au niveau de sites neuraxiaux, à l'administration d'anesthésiques pour l'infiltration des plaies, à d'autres procédures d'anesthésie locorégionale ou à la surveillance ou au retrait de liquide céphalo-rachidien à des fins thérapeutiques ou de diagnostic.
NOTE 1       Les sites des applications neuraxiales comprennent la colonne vertébrale, l'espace intrathécal ou sous-arachnoïdien, les ventricules cérébraux et l'espace épidural, extradural ou péridural. Les anesthésiques pour applications neuraxiales peuvent être administrés localement et agissent sur une grande partie du corps, par exemple un membre. Ce type d'anesthésie inclut les blocs plexiques, tels que les blocs du plexus brachial ou les blocs nerveux. Les procédures relatives aux applications neuraxiales comprennent l'infiltration continue des plaies avec des agents anesthésiques locaux.
NOTE 2       Pour les besoins de la présente partie de l'ISO 80369-6:2016, les anesthésiques locaux injectés par voie sous-cutanée ne sont pas considérés comme une application neuraxiale.
EXEMPLES     Les substances qu'il est prévu d'administrer sont les chimiothérapies par voie intrathécale, les anesthésiques locaux, les agents de contraste radiographiques, les antibiotiques, les analgésiques.
L'ISO 80369-6:2016  spécifie les dimensions et les exigences relatives à la conception et aux performances fonctionnelles de ces raccords de petite taille destinés à être utilisés avec des dispositifs médicaux.
L'ISO 80369-6:2016  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.
NOTE 3       Les fabricants sont incités à intégrer les raccords de petite taille spécifiés dans la présente partie de l'ISO 80369-6:2016 dans les dispositifs médicaux, les systèmes médicaux ou les 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 la présente partie de l'ISO 80369, lors de la révision des normes appropriées spécifiques de ces dispositifs médicaux. En outre, il est communément admis que des normes doivent être élaborées pour de nombreux dispositifs médicaux utilisés dans les applications neuraxiales.
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 à application neuraxiale, 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 - 6. del: Priključki za nevroaksialno uporabo (ISO 80369-6:2016)

Ta del standarda ISO 80369 določa zahteve za PRIKLJUČKE Z MAJHNIM PREMEROM, namenjene za NEVROAKSIALNO UPORABO. Ta del standarda ISO 80369 ne določa zahtev za MEDICINSKE PRIPOMOČKE ali OPREMO, ki uporablja te PRIKLJUČKE. Takšne zahteve so podane v posameznih mednarodnih standardih za specifične MEDICINSKE PRIPOMOČKE ali OPREMO. 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 OPREMO, 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. Poleg tega je znano, da bo treba razviti standarde za vse MEDICINSKE PRIPOMOČKE za NEVROAKSIALNO UPORABO.

General Information

• Status: Published
• Publication Date: 12-Apr-2016
• Withdrawal Date: 30-Oct-2016
• 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: 13-Apr-2016
• Completion Date: 13-Apr-2016
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 80369-6:2016 - Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016)

Relations

• Revised: prEN ISO 80369-6 - Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neural applications (ISO/DIS 80369-6:2023)
• Effective Date: 17-Aug-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2016
3ULNOMXþNL]PDMKQLPSUHPHURP]DWHNRþLQHLQSOLQH]DXSRUDERY]GUDYVWYXGHO
3ULNOMXþNL]DQHYURDNVLDOQRXSRUDER,62
Small bore connectors for liquids and gases in healthcare applications - Part 6:
Connectors for neuraxial applications (ISO 80369-6:2016)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 6: Verbindungsstücke für neuroaxiale Anwendungen
(ISO 80369-6:2016)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
6: Raccords destinés à des applications neuraxiales (ISO 80369-6:2016)
Ta slovenski standard je istoveten z: EN ISO 80369-6:2016
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 80369-6
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2016
ICS 11.040.25
English version
Small bore connectors for liquids and gases in healthcare
applications - Part 6: Connectors for neuraxial applications
(ISO 80369-6:2016)
Raccords destinés à des applications en contact avec le Verbindungsstücke mit kleinem Durchmesser für
système nerveux (neuraxiales) - Partie 6: Raccords Flüssigkeiten und Gase in medizinischen
destinés à des applications en contact avec le système Anwendungen - Teil 6: Verbindungsstücke für
nerveux (neuraxiales) (ISO 80369-6:2016) neuroaxiale Anwendungen (ISO 80369-6:2016)
This European Standard was approved by CEN on 20 February 2016.

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,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

CEN-CENELEC Management Centre:
Avenue Marnix 17, B-1000 Brussels
© 2016 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 80369-6:2016 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 EU Directive 93/42/EEC . 5
European foreword
This document (EN ISO 80369-6:2016) 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/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 October 2016, and conflicting national standards shall
be withdrawn at the latest by October 2016.
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 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, 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, 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 an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO or IEC
standard
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 5356-2:2012 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 80369-1:2010 ISO 80369-1:2010
1) 1) 1)
ISO 80369-3:— EN 80369-3:— ISO 80369-3:—
1) 1) 1)
ISO 80369-5:— EN 80369-5:— ISO 80369-5:—
1) 1) 1)
ISO 80369-7:— EN 80369-7:— ISO 80369-7:—
1)
ISO 80369-20:2015 EN 80369-20:— ISO 80369-20:2015
ASTM D638-10 — —
ASTM D790-10 — —
1 To be published.
Endorsement notice
The text of ISO 80369-6:2016 has been approved by CEN as EN ISO 80369-6:2016 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to Essential
Requirements of Directive 93/42/EEC on Medical Devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
clauses of this standard confers, within the limits of the scope of this standard, a presumption of
conformity with the relevant Essential Requirements of that Directive.
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 / Directive 90/385/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 Table of References, 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 document and Directive 93/42/EEC
Clause(s)/sub-clause(s) of Essential requirements (ERs) of Qualifying remarks/Notes
this Document EU Directive 93/42/EEC
6.2 7.5
4.1, 5, 6.4, 6.5, 6.6, 6.7 9.1
6.3 12.7.4
4.1, 5, 6.2, 6.5, 6.6, 6.7 12.8.1 This Essential Requirement 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: Other requirements and other EU Directives may be applicable to the products falling
within the scope of this document.
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on
Machinery, in accordance with Article 3 of Directive 93/42/EEC the following Table ZA.2 details the
relevant essential health and safety requirements of Directive 2006/42/EC on Machinery to the extent
to which they are more specific than those of Directive 93/42/EEC along with the corresponding
clauses of this Document. Table ZA.2, however, does not imply any citation in the OJEU under the
machinery directive and thus does not provide presumption of conformity for the machinery directive.
Table ZA.2 — Relevant Essential Health and Safety Requirements (EHSRs) from Directive
2006/42/EC on machinery that are addressed by this document
Clause(s)/sub-clause(s) of this EHSR of 2006/42/EC Qualifying remarks/Notes
Document
4, 5, 6 1.5.4
INTERNATIONAL ISO
STANDARD 80369-6
First edition
2016-03-15
Small bore connectors for liquids and
gases in healthcare applications —
Part 6:
Connectors for neuraxial applications
Raccords destinés à des applications en contact avec le système
nerveux (neuraxiales) —
Partie 6: Raccords destinés à des applications en contact avec le
système nerveux (neuraxiales)
Reference number
ISO 80369-6:2016(E)
©
ISO 2016
ISO 80369-6:2016(E)
© 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
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written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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ii © ISO 2016 – All rights reserved

ISO 80369-6:2016(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 the neuraxial application . 3
4.2 * Material used for small-bore connectors . 4
4.3 Type tes ts . 4
5 Dimensional requirements for neuraxial small-bore 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 .
...