EN ISO 80369-6:2016

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
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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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
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 . 4
6.1.3 Positive pressure liquid leakage . 4
6.2 Subatmospheric 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) * Small-bore connectors for neuraxial applications .11
Annex C (normative) Reference connectors for testing small-bore connectors for
neuraxial applications .20
Annex D (informative) Assessment of medical devices and their attributes with
connections within this application .26
Annex E (informative) Summary of the usability requirements for small-bore connectors
for neuraxial applications .27
Annex F (informative) Summary of small-bore connector design requirements for
neuraxial applications .30
Annex G (informative) Summary of assessment of the design of the small bore connectors
for neuraxial applications .33
Annex H (normative) Mechanical tests for verifying non-interconnectable characteristics .37
Annex I (informative) Reference to the essential principles .41
Annex J (informative) Terminology — alphabetized index of defined terms .43
Bibliography .44
ISO 80369-6:2016(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.
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
An additional part on connectors for urethral and urinary applications is planned.
iv © ISO 2016 – All rights reserved

ISO 80369-6:2016(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
neuraxially. 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 drawings of small-bore
connectors intended to be used in neuraxial 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.
There is international evidence that ‘wrong-route’ medication errors with neuraxial medical devices
have caused deaths and severe harm. There are reports of non-epidural medications being administered
into the epidural space and local anaesthetic solutions intended for epidural administration being
[1] [9] [14] [15] [19]
administered by the intravenous route. There is also a report where an anaesthetic
agent for intravenous use was administered into the cerebrospinal fluid via an external ventricular
[11]
drain and earlier reports of antibiotics being inappropriately administered by this route.
In July 2007, the World Health Organization’s World Alliance for Patient Safety issued Alert 115
describing four incidents in different countries in which vincristine had been accidentally administered
[1]
by the intrathecal route instead of intravenous route, as intended. The Alert indicated that, since
1968, this same error had been reported 55 times from a variety of institutional settings.
These incidents occurred despite repeated warnings of the risk and the introduction of extensive
labelling requirements and recommendations, intended to standardize practice and reduce risks.
Other health organizations around the world have also issued detailed guidance to minimize the risk
[9] [15] [20] [21]
of these ‘wrong-route’ errors.
Nevertheless, reports of fatal incidents following the administration of vinca alkaloids continue to be
[22]
reported internationally. In 2009, the Food and Drug Administration in the USA issued a Medical
[12]
Devices Calendar, which included an example of a case study of a neuraxial misconnection.
Connectors manufactured to the dimensions set out within this International Standard 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 G.2. 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 via an alternative route, such as
neuraxially, intravenously, or via an airway device.
In this International Standard, 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 ISO 80369-1 and Clause 3: small capitals.
ISO 80369-6:2016(E)
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 International Standard conform to usage described in 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, and
— “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

INTERNATIONAL STANDARD ISO 80369-6:2016(E)
Small bore connectors for liquids and gases in healthcare
applications —
Part 6:
Connectors for neuraxial applications
1 * Scope
This part of ISO 80369 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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
requirements
ISO 80369-6:2016(E)
ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications — Part 20:
Common test methods
ASTM D638-10, Standard test method for tensile properties of plastics
ASTM D790-10, Standard test methods for flexural properties of unreinforced and reinforced plastics and
electrical insulating materials
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14971:2007, ISO 80369-1:2010,
and ISO 80369-20:2015 and the following apply.
NOTE For convenience, the sources of all defined terms used in this document are given in Annex J.
3.1
lock connector
connector with a locking mechanism
3.2
normal use
operation, including routine inspection and adjustments by any user, and stand-by, according to the
instructions for use
Note 1 to entry: Normal use should not be confused with intended use. While both include the concept of use as
intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates
not only the medical purpose, but maintenance, service, transport, etc. as well.
[SOURCE: IEC 60601-1:2005/Amd1:2012, 3.97, modified replaced ‘operator’ with ‘user’]
3.3
rated
term referring to a value assigned by the manufacturer for a specified operating condition
[SOURCE: IEC 60601-1:2005, 3.97]
3.4
slip connector
connector without a locking mechanism
3.5
user
person interacting with (i.e. operating or handling) the medical device
Note 1 to entry: There can be more than one user of a medical device.
Note 2 to entry: Common users include clinicians, patients, cleaners, maintenance and service personnel.
[SOURCE: IEC 62366-1:2015, 3.24]
3.6
user profile
summary of the mental, physical and demographic traits of an intended user group, as well as any
special characteristics, such as occupational skills, job requirements and working conditions, which
can have a bearing on design decisions
[SOURCE: IEC 62366-1:2015, 3.29]
2 © ISO 2016 – All rights reserved

ISO 80369-6:2016(E)
4 General requirements
4.1 General requirements for the neuraxial application
Small-bore connectors of medical devices or accessories intended for use in neuraxial
applications made in compliance with this part of ISO 80369 comply with ISO 80369-1:2010, unless
otherwise indicated in this part of ISO 80369.
The inside diameter of the fluid lumen of male luer connector, as specified in ISO 80369-7:—, may
contact the sealing surfaces of the N1 male connector in LMC conditions when evaluating the non-
interconnectable characteristics tests of ISO 80369-1:2010, Annex B. Additional information is
provided in G.2.
The sealing surface of female E1 connector, as specified in ISO 80369-3:—, may contact the thread
surfaces of the N2 female connector in LMC conditions when evaluating the non-interconnectable
characteristics tests of ISO 80369-1:2010, Annex B. Additional information is provided in G.2.
Because the following connectors are inadequately specified, small-bore connectors for use in
neuraxial applications should not, but may connect with:
— the cones and sockets of ISO 5356-1:2004, ISO 5356-1:2015, ISO 5356-2:2006 and ISO 5356-2:2012;
— the temperature sensor connector and mating ports made in compliance with
ISO 8185:2007, Annex DD;
— the nipples of EN 13544-2:2002 and EN 13544-2:2002+Amd1:2009.
The reference connectors for evaluation of the non-interconnectable characteristics are described
in Annex C.
The test of Annex H shall replace ISO 80369-1:2010, Annex B.
NOTE 1 Annex H describes a deviation to the physical test non-interconnectable characteristics of
ISO 80369-1:2010, Annex B. A rationale for the deviation is provided in Annex A. For neuraxial small-bore
connectors, Annex H, supersedes ISO 80369-1:2010, Annex B.
Where the design of the small-bore connectors of this part of ISO 80369 relies on dimensions or
features of the medical device or accessory to ensure non-interconnectable characteristics, the
non-interconnectable characteristics shall be verified.
Check compliance by applying the tests of Annex H. Compliance also may be shown by applying a
computer aided design (CAD) analysis of the dimensions of all of the ISO 80369 series small bore
connectors and the small bore connector under test, in conjunction with physical testing of
the small bore connector per Annex B where the CAD analysis does not demonstrate the non-
interconnectable characteristics. When necessary, the small-bore connector may be installed
on the medical device or accessory to demonstrate compliance with the non-interconnectable
requirements of Annex H.
NOTE 2 Medical devices using the small-bore connectors of this part of ISO 80369 that do not rely on the
dimensions or features of the medical device or accessory to ensure non-interconnectable characteristics
are presumed to comply with the non-interconnectable characteristics of this part of ISO 80369.
NOTE 3 The summary of medical devices and their attributes with connections within this application is
provided in Annex D.
NOTE 4 The summary of the usability requirements for connectors for this application is provided in
Annex E.
NOTE 5 The summary of criteria and requirements for connectors for this application is provided in
Annex F.
ISO 80369-6:2016(E)
NOTE 6 The summary of assessment of the design of connectors for this application according to
ISO 80369-1:2010, Clause 7, is contained in Annex G.
4.2 * Material used for small-bore connectors
In addition to the requirements of ISO 80369-1:2010, Clause 4, neuraxial small-bore connectors shall
be made of materials with a nominal modulus of elasticity either in flexure or in tension greater than
950 MPa.
Check compliance by application of the tests of ASTM D638-10 or ASTM D790-10.
4.3 Type tests
Compliance with the requirements of this part of ISO 80369 shall be determined by type tests.
5 Dimensional requirements for neuraxial small-bore connectors
Neuraxial small-bore connectors shall comply with the dimensions and tolerances as given in
— Figure B.1 and Table B.1 for an N1 male slip connector.
— Figure B.2 and Table B.2 for an N2 male lock connector.
— Figure B.3 and Table B.3 for an N2 male lock connector with rotatable collar.
— Figure B.4 and Table B.4 for an N2 female connector with swept threads.
— Figure B.5 and Table B.5 for an N2 female connector with lugs.
Check compliance by verifying the relevant dimensions and tolerances specified in Annex B.
6 Performance requirements
6.1 Fluid leakage
6.1.1 Fluid leakage requirement
Neuraxial small-bore connectors shall be evaluated for leakage using either the leakage by pressure
decay test method or the positive pressure liquid leakage test method.
6.1.2 Leakage by pressure decay
Neuraxial small-bore connectors evaluated for fluid leakage performance with the leakage by
pressure decay test method shall not leak by more than 0,005 Pa·m /s while being subjected to an
applied pressure of between 300 kPa and 330 kPa over a hold period between 15 s and 20 s using air as
the medium. manufacturers may use a greater applied pressure or longer hold period.
Check compliance by applying the tests of ISO 80369-20:2015, Annex B, while using the leakage
reference connector specified in Annex C.
6.1.3 Positive pressure liquid leakage
Neuraxial small-bore connectors evaluated for fluid leakage performance with the positive pressure
liquid leakage test method shall show no signs of leakage, sufficient to form a falling drop of water,
over a hold period of 30 s to 35 s while being subjected to an applied pressure of between 300 kPa and
330 kPa. manufacturers may use a greater applied pressure or a longer hold period.
4 © ISO 2016 – All rights reserved

ISO 80369-6:2016(E)
Check compliance by applying the tests of ISO 80369-20:2015, Annex C, while using the leakage
reference connector specified in Annex C.
6.2 Subatmospheric pressure air leakage
Neuraxial small-bore connectors shall be evaluated for subatmospheric pressure air leakage.
Neuraxial small-bore connectors shall not leak by more than 0,005 Pa·m /s while being subjected to
an applied subatmospheric pressure of between 80,0 kPa and 88,0 kPa over a hold period of between
15 s and 20 s. Manufacturers may use a greater applied subatmospheric pressure.
Check compliance by applying the tests of ISO 80369-20:2015, Annex D, while using the stress cracking
reference connector specified in Annex C.
6.3 Stress cracking
Neuraxial small-bore connectors shall be evaluated for stress cracking. Neuraxial small-bore
connectors shall meet the requirements of 6.1.2 after being subjected to stresses of ISO 80369-20:2015,
Annex E.
Check compliance by applying the tests of ISO 80369-20:2015, Annex E, while using the stress cracking
reference connector specified in Annex C.
6.4 Resistance to separation from axial load
Neuraxial small-bore connectors shall be evaluated for separation from axial load. Neuraxial small-
bore connectors shall not separate from the reference connector over a hold period between 10 s
and 15 s while being subjected to a disconnection applied axial force between,
a) 23 N and 25 N for a slip connector, and
b) 32 N and 35 N for a lock connector.
Manufacturers may use a greater disconnection applied axial force or a longer hold period.
Check compliance by applying the tests of ISO 80369-20:2015, Annex F, while using the separation from
axial load reference connector specified in Annex C.
6.5 Resistance to separation from unscrewing
Lock connectors shall be evaluated for separation from unscrewing. A lock connector shall not
separate from the reference connector for a hold period between 10 s and 15 s while being subjected
to an unscrewing torque of between 0,0198 N·m to 0,0200 N·m. Manufacturers may use a greater
applied unscrewing torque or a longer hold period.
Check compliance by applying the tests of ISO 80369-20:2015, Annex G, while using the separation from
axial load reference connector specified in Annex C.
6.6 Resistance to overriding
Neuraxial small-bore connectors shall be evaluated for resistance to overriding. Neuraxial small-
bore connectors shall not override the threads or lugs of the reference connector while being
subjected to an applied torque of between 0,15 N·m to 0,17 N·m over a hold period between 5 s and 10 s.
Manufacturers may use a greater applied torque or a longer hold period.
Check compliance by applying the tests of ISO 80369-20:2015, Annex H, while using the separation from
axial load reference connector specified in Annex C.
ISO 80369-6:2016(E)
Annex A
(informative)
Rationale and guidance
A.1 General guidance
This Annex provides a rationale for some requirements of this part of ISO 80369, and is intended for
those who are familiar with the subject of this part of ISO 80369 but who have not participated in
its development. An understanding of the rationale underlying these requirements is considered to
be essential for their proper application. Furthermore, as clinical practice and technology change, it
is believed that a rationale will facilitate any revision of this part of ISO 80369 necessitated by those
developments.
A.2 Rationale for particular clauses and subclauses
The clauses and subclauses in this Annex have been numbered to correspond to the numbering of the
clauses and subclauses of this part of ISO 80369 to which they refer. The numbering is, therefore, not
consecutive.
Clause 1 Scope
In 2000, a Task Group of the European standards organization CEN proposed a strategy to reduce
incidents of accidental misconnection of patient therapy lines by the use of a series of non-
interconnectable connectors, differentiated by design, for use in different medical applications.
[8]
The strategy reserves the use of luer connectors solely for use in medical devices used to access
[7]
the vascular system or for hypodermic syringes so that they can achieve their intended function. The
connectors of this part of ISO 80369 are reserved for neuraxial applications.
Manufacturers and responsible organizations are encouraged to report their experience with
the small-bore connectors specified in this part of ISO 80369 to the Secretariat of ISO/TC 210, so
that it can consider this feedback during the revision of the relevant part of this series of International
Standards.
4.2 Material used for small-bore connectors
The minimum value of the nominal flexural or tensile modulus of 950 MPa was chosen for neuraxial
applications predominantly due to current use of polypropylenes for syringe manufacturing. Usability
testing, in several cases, demonstrated misconnections with other small-bore connectors of the
ISO 80369 series when using low modulus materials. It is highly recommended that manufacturers
choose the highest modulus material possible for their medical device with preference to be 1 500 MPa
or higher wherever possible.
Annex B
Dimension ‘K’ and ‘k’ are defined to ensure an understanding by manufacturers of the extent of the
connector. Failure to comply with these minimum dimensions could result in the inability to properly
connect to neuraxial connectors produced by other manufacturers. Figure A.1 and Figure A.2
illustrate this concern.
All surface finishes of parts of these connectors which do not form part of the mating surfaces should
be constructed so as to avoid the possibility of any another connector, which could be present in the
clinical environment, from being able to form a fluid-tight connection to the connectors specified
within this part of ISO 80369. This ensures that attempts made to connect any other connector (not
complying with this part of ISO 80369) to one specified within this part of ISO 80369 results in fluid
6 © ISO 2016 – All rights reserved

ISO 80369-6:2016(E)
leakage and the failure to establish a fluid-tight path into the connectors specified within this part of
ISO 80369.
Annex B defines a maximum internal diameter of the male connector, to prevent inadvertent male-
to-male connectivity between the connectors defined within this part of ISO 80369 and any other
small-bore connectors from the ISO 80369 series.
NOTE 1 Table B.4 contains the dimensions for this figure.
NOTE 2 The cones form a seal properly.
Figure A.1 — Extent of the connector, compliant with this part of ISO 80369 (K > 8,6 mm)
ISO 80369-6:2016(E)
NOTE 1 Table B.4 contains the dimensions for this figure.
NOTE 2 The cones do not form a seal properly.
Figure A.2 — Extent of the connector, not compliant with this part of ISO 80369 (K < 8,6 mm)
H.1 Purpose
Several deviations from the physical testing for non-interconnectable characteristics test method
of ISO 80369-1:2010, Annex B were developed. These include the following:
a) axial force up to 7
...