SIST EN ISO 80369-1:2019
(Main)Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2018)
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2018)
This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient.
This document also specifies the healthcare fields in which these small-bore connectors are intended to be used.
These healthcare fields include, but are not limited to:
— breathing systems and driving gases;
— enteral;
— limb cuff inflation;
— neuraxial;
— intravascular or hypodermic.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that will be developed under future parts of the ISO 80369 series.
This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.
NOTE 1 Clause 7 allows for additional designs of small-bore connectors for new applications for inclusion in the ISO 80369 series.
NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO 80369 series 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, the risks associated with changing to the new small-bore connectors as specified in the ISO 80369 series of standards will be considered.
NOTE 3 The connectors specified in the ISO 80369 series are intended for use only in their specified application. Use of these connectors for other applications increases risk that a hazardous misconnection could occur.
NOTE 4 Manufacturers and responsible organizations are encouraged to report their experience with the small-bore connectors specified in the ISO 80369 series to the Secretariat of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of the ISO 80369 series.
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO 80369-1:2018)
Dieses Dokument legt allgemeine Anforderungen für VERBINDUNGSSTÜCKE MIT KLEINEM DURCHMESSER fest, die Flüssigkeiten oder Gase in ANWENDUNGEN der medizinischen Versorgung führen. Diese VERBINDUNGSSTÜCKE MIT KLEINEM DURCHMESSER werden bei MEDIZINPRODUKTEN oder ZUBEHÖR zur ANWENDUNG bei PATIENTEN eingesetzt.
Dieses Dokument legt auch die medizinischen Bereiche fest, für die diese VERBINDUNGSSTÜCKE MIT KLEINEM DURCHMESSER zweckbestimmt sind.
Diese Anwendungsbereiche der medizinischen Versorgung umfassen folgende ANWENDUNGEN, sind aber nicht darauf beschränkt:
— ATEMSYSTEME und Antriebsgase;
— enterale ANWENDUNGEN;
— urethrale und urologische ANWENDUNGEN;
— aufblasbare Manschetten für Gliedmaßen;
— neuroaxiale Produkte;
— intravaskuläre oder hypodermische ANWENDUNGEN.
Dieses Dokument liefert die Methodologie zur Beurteilung der Merkmale der NICHT MITEINANDER VERBINDBARKEIT von VERBINDUNGSSTÜCKEN MIT KLEINEM DURCHMESSER auf der Grundlage ihrer inhärenten Ausführung und Maße, mit dem Ziel, das RISIKO von Fehlverbindungen zwischen MEDIZINPRODUKTEN oder zwischen den ZUBEHÖR¬teilen für unterschiedliche ANWENDUNGEN, die in diesem Dokument festgelegt sind, sowie wie auch für allen anderen, die nach den zukünftigen Teilen der Normenreihe ISO 80369 entwickelt werden, herabzusetzen.
Dieses Dokument legt keine Anforderungen an MEDIZINPRODUKTE oder ZUBEHÖR fest, die diese VERBINDUNGS-STÜCKE MIT KLEINEM DURCHMESSER nutzen. Derartige Anforderungen finden sich in den jeweiligen Internationalen Normen für bestimmte(s) MEDIZINPRODUKTE oder ZUBEHÖR.
ANMERKUNG 1 Abschnitt 7 berücksichtigt zusätzliche Ausführungen von VERBINDUNGSSTÜCKEN MIT KLEINEM DURCHMESSER für neue ANWENDUNGEN zur Aufnahme in die Normenreihe ISO 80369.
ANMERKUNG 2 Die HERSTELLER werden bestärkt, die in der Normenreihe ISO 80369 festgelegten VERBINDUNGSSTÜCKE MIT KLEINEM DURCHMESSER in MEDIZINPRODUKTE, Medizinsysteme oder ZUBEHÖR zu integrieren, auch wenn dies von den jeweils zutreffenden Normen für MEDIZINPRODUKTE gegenwärtig nicht gefordert wird. Es wird erwartet, dass bei der Überarbeitung der jeweils zutreffenden Normen für MEDIZINPRODUKTE die Anforderungen an VERBINDUNGSSTÜCKE MIT KLEINEM DURCHMESSER entsprechend den Festlegungen in der Normenreihe ISO 80369 aufgenommen werden.
ANMERKUNG 3 Die in der Normenreihe ISO 80369 festgelegten VERBINDUNGSSTÜCKE sind für ihre festgelegte ANWENDUNG zweckbestimmt. Der Einsatz dieser VERBINDUNGSSTÜCKE für andere Zwecke erhöht das RISIKO, dass eine gefährliche Verbindung entstehen könnte.
ANMERKUNG 4 Die HERSTELLER und VERANTWORTLICHEN ORGANISATIONEN sind angehalten, ihre Erfahrungen mit den in der Normenreihe ISO 80369 festgelegten VERBINDUNGSSTÜCKEN MIT KLEINEM DURCHMESSER dem Sekretariat des ISO/TC 210 mitzuteilen, so dass diese Rückmeldungen bei der Überarbeitung des entsprechenden Teils der Normenreihe ISO 80369 berücksichtigt werden können.
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 1: Exigences générales (ISO 80369-1:2018)
Le présent document spécifie les exigences générales relatives aux raccords de petite taille qui transportent des liquides ou des gaz dans les applications de soins de santé. Ces raccords de petite taille sont utilisés dans des dispositifs médicaux ou des accessoires destinés à être employés sur un patient.
Le présent document spécifie également les domaines de la santé dans lesquels ces raccords de petite taille sont destinés à être employés.
Ces domaines comprennent, sans toutefois s'y limiter, les éléments suivants:
— systèmes respiratoires et gaz d'entraînement;
— applications entérales;
— applications de gonflage autour des membres;
— applications en contact avec le système nerveux;
— applications intravasculaires ou hypodermiques.
Le présent document indique la méthodologie à suivre pour évaluer les caractéristiques de non-raccordabilité des raccords de petite taille en s'appuyant sur leur conception et leurs dimensions intrinsèques, afin de réduire le risque d'erreur de raccordement entre des dispositifs médicaux ou entre des accessoires destinés à différentes applications qui sont spécifiées dans le présent document ou qui seront développées dans les futures parties de la série ISO 80369.
Le présent document ne spécifie pas d'exigences relatives aux dispositifs médicaux ou aux accessoires sur lesquels ces raccords de petite taille sont utilisés. Ces exigences figurent dans des Normes internationales spécifiques traitant de dispositifs médicaux ou d'accessoires particuliers.
NOTE 1 L'Article 7 permet l'intégration de modèles de raccords de petite taille supplémentaires destinés à de nouvelles applications dans la série ISO 80369.
NOTE 2 Les fabricants sont incités à intégrer les raccords de petite taille spécifiés dans la série ISO 80369 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 de considérer les risques associés au remplacement des raccords de petite taille spécifiés dans la série de normes ISO 80369 lors de la révision des normes appropriées spécifiques de ces dispositifs médicaux.
NOTE 3 Les raccords spécifiés dans la série ISO 80369 sont destinés à être utilisés uniquement pour l'application spécifiée. L'utilisation de ces raccords pour d'autres applications augmente le risque d'erreur de raccordement dangereuse.
NOTE 4 Les fabricants et les organismes responsables sont incités à faire part de leur expérience concernant les raccords de petite taille spécifiés dans la série ISO 80369 au Secrétariat de l'ISO/TC 210, de sorte que leurs commentaires puissent être pris en compte lors de la révision de la partie appropriée de la série ISO 80369.
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 1. del: Splošne zahteve (ISO 80369-1:2018)
Ta dokument določa splošne zahteve za priključke z majhnim premerom, ki se uporabljajo za prenos tekočin in plinov, za uporabo v zdravstvu. Ti priključki z majhnim premerom se uporabljajo v medicinskih pripomočkih ali dodatkih, predvidenih za uporabo s pacientom.
Ta dokument določa tudi zdravstvena področja, na katerih je predvidena uporaba teh priključkov z majhnim premerom.
Ta zdravstvena področja med drugim vključujejo:
– dihalne sisteme in pogonske pline;
– enteralno uporabo;
– raztegljivo manšeto za okončine;
– nevroaksialno uporabo;
– intravaskularno ali hipodermično uporabo.
Ta dokument podaja metodologijo za ocenjevanje lastnosti medsebojne povezljivosti priključkov z majhnim premerom na podlagi njihove zasnove in dimenzij za zmanjšanje tveganja napačnih povezav med medicinskimi pripomočki ali med dodatki za različne vrste uporabe, kot je določeno v tem dokumentu, in tistimi, ki bodo razviti v prihodnjih delih skupine standardov ISO 80369.
Ta dokument ne določa zahtev za medicinske pripomočke ali dodatke, ki uporabljajo te priključke z majhnim premerom. Takšne zahteve so podane v ustreznih mednarodnih standardih za posamezne medicinske pripomočke ali dodatke.
OPOMBA 1: Točka 7 omogoča obravnavo dodatnih zasnov priključkov z majhnim premerom za nove načine uporabe za vključitev v skupino standardov ISO 80369.
OPOMBA 2: Proizvajalcem se priporoča, da priključke z majhnim premerom, opredeljene v skupini standardov
ISO 80369, vključijo v medicinske pripomočke, medicinske sisteme ali dodatke, tudi če ustrezni posamezni standardi za medicinske pripomočke trenutno tega ne zahtevajo. Predvideva se, da se ob reviziji ustreznih posameznih standardov za medicinske pripomočke upoštevajo tudi tveganja, povezana s prehodom na priključke z majhnim premerom, kot so določeni v skupini standardov ISO 80369.
OPOMBA 3: Priključki, opredeljeni v skupini standardov ISO 80369, so namenjeni samo za predvidene načine
uporabe. Drugi načini uporabe tovrstnih pripomočkov povečujejo tveganje za vzpostavitev nevarne nepravilne povezave.
OPOMBA 4: Proizvajalcem in odgovornim organizacijam se priporoča, da poročajo o izkušnjah s priključki z majhnim premerom, opredeljenimi v skupini standardov ISO 80369, sekretariatu ISO/TC 210, ki bo povratne informacije upošteval pri reviziji ustreznega dela skupine standardov ISO 80369.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2019
1DGRPHãþD
SIST EN ISO 80369-1:2011
3ULNOMXþNL]PDMKQLPSUHPHURP]DWHNRþLQHLQSOLQH]DXSRUDERY]GUDYVWYXGHO
6SORãQH]DKWHYH ,62
Small bore connectors for liquids and gases in healthcare applications - Part 1: General
requirements (ISO 80369-1:2018)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO 80369-1:2018)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
1: Exigences générales (ISO 80369-1:2018)
Ta slovenski standard je istoveten z: EN ISO 80369-1:2018
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 80369-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2018
ICS 11.040.10; 11.040.20
Supersedes EN ISO 80369-1:2010
English version
Small-bore connectors for liquids and gases in healthcare
applications - Part 1: General requirements (ISO 80369-
1:2018)
Raccords de petite taille pour liquides et gaz utilisés Verbindungsstücke mit kleinem Durchmesser für
dans le domaine de la santé - Partie 1: Exigences Flüssigkeiten und Gase in medizinischen
générales (ISO 80369-1:2018) Anwendungen - Teil 1: Allgemeine Anforderungen
(ISO/FDIS 80369-1:2018)
This European Standard was approved by CEN on 20 November 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:
Rue de la Science 23, B-1040 Brussels
© 2018 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 80369-1:2018 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 80369-1:2018) has been prepared by Technical Committee ISO/TC 210 "Quality
management and corresponding general aspects for medical devices" in collaboration with Technical
Committee CEN/CLC/JTC 3 “Quality management and corresponding general aspects for medical
devices” the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2019, and conflicting national standards shall be
withdrawn at the latest by May 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 80369-1:2010.
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.
Endorsement notice
The text of ISO 80369-1:2018 has been approved by CEN as EN ISO 80369-1:2018 without any
modification.
INTERNATIONAL ISO
STANDARD 80369-1
Second edition
2018-11
Small-bore connectors for liquids and
gases in healthcare applications —
Part 1:
General requirements
Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 1: Exigences générales
Reference number
ISO 80369-1:2018(E)
©
ISO 2018
ISO 80369-1:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
ISO 80369-1:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 *Scope . 1
2 *Normative references . 2
3 Terms and definitions . 2
4 *Materials . 4
5 Small-bore connector incompatibility . 4
6 *Clinical applications . 4
6.1 *Additional small-bore connector designs . 4
6.2 Enteral applications . 5
6.3 Limb cuff inflation applications . 5
6.4 Neuraxial applications . 5
6.5 Intravascular or hypodermic applications . 5
7 *Alternative small-bore connectors. 5
Annex A (informative) Rationale . 7
Annex B (normative) Test methods for demonstrating non-interconnectable characteristics .11
Annex C (informative) Symbols and safety signs .24
Annex D (normative) Assessment procedures small-bore connectors .25
Annex E (informative) Applications of small-bore connectors .27
Annex F (informative) Reference to the Essential Principles .29
Bibliography .30
Alphabetized index of defined terms.31
ISO 80369-1:2018(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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 210, Quality management and
corresponding general aspects for medical devices, in collaboration with IEC/TC 62, Electrical equipment
in medical practice, Subcommittee SC D, Electromedical equipment and CEN/CENELEC TC 3/WG 2, Small-
bore connectors.
This second edition cancels and replaces the first edition (ISO 80369-1:2010), which has been technically
revised.
A list of all parts in the ISO 80369 series can be found on the ISO website.
The main changes compared to the previous edition are as follows:
— the normative references have been updated;
— the requirement for Alternative small-bore connectors, including disclosure and marking
requirements have been updated;
— in Annex B, the Test methods for demonstrating non-interconnectable characteristics to
reflect the testing used in the development of ISO 80369-2, ISO 80369-3, IEC 80369-5, ISO 80369-6
and ISO 80369-7 have been updated;
— Annex D has been created with the Assessment procedures small-bore connectors which
replaces Clause 7 of the previous edition and contains a description of the computer aided design
(CAD) analysis that was used in the evaluation of the non-interconnectable characteristics.
A list of all parts in the ISO 80369 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2018 – All rights reserved
ISO 80369-1:2018(E)
Introduction
In the 1990s, concern grew regarding the proliferation of medical devices fitted with Luer connectors
as specified in ISO 80369-7 and the reports of patient death or injury arising from misconnections that
resulted in the inappropriate delivery of enteral solutions, intrathecal medication or compressed gases.
Concerns regarding the use of Luer connectors with enteral feeding tubes and gas sampling and gas
delivery systems were raised with CEN/BT and the European Commission. In November 1997, the
newly created CHeF steering group set up a Forum Task Group (FTG) to consider the problem.
[12]
The FTG produced CEN Report, CR 13825 , in which they concluded that there is a problem arising
from the use of a single connector design to a number of incompatible applications. In a coronary
care unit, there are as many as 40 Luer connectors on the medical devices used with a single patient.
Therefore, it is not surprising that misconnections are made.
Medical devices have, for many years, followed the established principle of “safety under single fault
conditions”. Simply stated, this means that a single fault should not result in an unacceptable risk. This
[10]
principle is embodied in the requirements of numerous medical device standards . Extending this
principle to the use of Luer connectors, i.e. that misconnection should not result in an unacceptable
risk to a patient, the FTG recommended that the Luer connector should be restricted to medical
devices intended to be connected to the vascular system or a hypodermic syringe. In addition, new
designs of small-bore connectors should be developed for other applications, and these should be
non-interconnectable with Luer connectors and each other.
ISO 16142-1 addresses this type of problem in Essential Principle B.1.2 (see Annex F):
— The solutions adopted by the manufacturer for the design and manufacture of the medical device
should conform to safety principles, taking into account the generally acknowledged state of the
art. When risk reduction is required the manufacturer should control the risks so that the residual
risk associated with each hazard is judged acceptable. The manufacturer should apply the following
principles in the priority order listed:
a) identify known or foreseeable hazards and estimate the associated risks arising from the
intended use and foreseeable misuse;
b) eliminate risks as far as reasonably practicable through inherently safe design and
manufacture;
c) reduce as far as reasonably practicable the remaining risks by taking adequate protection
measures, including alarms, or information for safety;
d) inform users of any residual risk.
It is understood that small-bore connector systems cannot be designed to overcome all chances of
misconnection or to eliminate deliberate misuse. However, a number of steps that would improve the
current situation and lead to greater patient safety can be taken. This will only be achieved through
a long-term commitment involving industry, healthcare professionals, medical device purchasers and
medical device regulatory authorities.
The ISO 80369 series has, wherever practicable, restricted the number of connectors for each
application to one, unless there is sufficient clinical or technical evidence to have more.
It is expected that particular medical device standards will reference the interface requirements from
the appropriate parts of the ISO 80369 series.
This document contains the general requirements to ensure the prevention of misconnection between
small-bore connectors used in different applications as well as defining those applications.
It specifies the general requirements and test methods for assessing the non-interconnectable
characteristics of small-bore connectors within the ISO 80369 series.
ISO 80369-1:2018(E)
ISO 80369-20 specifies the test methods for assessing the basic performance requirements specified
in ISO 80369-2 to ISO 80369-7 for small-bore connectors.
ISO 80369-2 to ISO 80369-7 specify the dimensional requirements for the interfaces of the connectors
and the basic performance requirements for assessing the connection interconnectability of the
connector-mating halves.
The designs and dimensions of small-bore connectors specified in ISO 80369-2 to ISO 80369-7 have
been successfully assessed according to the requirements of this document (i.e. have been proven to be
acceptable with regard to the risk of misconnection with the other connectors of this series).
Subsequent parts of this series are expected to include requirements with regard to the connectors
used in different application categories.
In this document, the following print types are used:
— requirements and definitions: roman type;
— informative material appearing outside of tables, such as notes, examples and references, and normative text
of tables: in smaller type;
— terms defined in Clause 3 of this document or as noted: small capitals type.
In this document, 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 document conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
document;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this document;
— “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.
The attention of Member Bodies is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised
ISO publication in which to make products in accordance with the new requirements and to equip
themselves for conducting new or revised tests. It is the recommendation of the committee that the
content of this publication be adopted for implementation nationally not earlier than three years from
the date of publication for equipment newly designed and not earlier than five years from the date of
publication for equipment already in production.
vi © ISO 2018 – All rights reserved
INTERNATIONAL STANDARD ISO 80369-1:2018(E)
Small-bore connectors for liquids and gases in healthcare
applications —
Part 1:
General requirements
1 *Scope
This document specifies general requirements for small-bore connectors, which convey liquids or
gases in healthcare applications. These small-bore connectors are used in medical devices or
accessories intended for use with a patient.
This document also specifies the healthcare fields in which these small-bore connectors are intended
to be used.
These healthcare fields include, but are not limited to:
— breathing systems and driving gases;
— enteral;
— limb cuff inflation;
— neuraxial;
— intravascular or hypodermic.
This document provides the methodology to assess non-interconnectable characteristics of
small-bore connectors based on their inherent design and dimensions in order to reduce the risk
of misconnections between medical devices or between accessories for different applications
as specified in this document as well as those that will be developed under future parts of the
ISO 80369 series.
This document does not specify requirements for the medical devices or accessories that use these
small-bore connectors. Such requirements are given in particular International Standards for
specific medical devices or accessories.
NOTE 1 Clause 7 allows for additional designs of small-bore connectors for new applications for inclusion
in the ISO 80369 series.
NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the
ISO 80369 series 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, the risks associated with changing to the new small-bore connectors as specified in the
ISO 80369 series of standards will be considered.
NOTE 3 The connectors specified in the ISO 80369 series are intended for use only in their specified
application. Use of these connectors for other applications increases risk that a hazardous misconnection
could occur.
NOTE 4 Manufacturers and responsible organizations are encouraged to report their experience with
the small-bore connectors specified in the ISO 80369 series to the Secretariat of ISO/TC 210 so that this
feedback can be considered during the revision of the relevant part of the ISO 80369 series.
ISO 80369-1:2018(E)
2 *Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors
for enteral applications
IEC 80369-5, Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors
for limb cuff inflation applications
ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors
for neuraxial applications
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14971 and IEC 62366-1 and
the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at https: //www .electropedia .org/
3.1
accessory
additional part(s) for use with medical device in order to:
— achieve the intended use;
— adapt it to some special use;
— facilitate its use;
— enhance its performance;
— or enable its functions to be integrated with those of other medical devices
[SOURCE: IEC 60601-1:2005, 3.3, modified — replaced “equipment” with “medical device”.]
3.2
application
specific healthcare field in which a small-bore connector is intended to be used
Note 1 to entry: Annex E lists applications of small-bore connectors.
3.3
connection
union or joining of mating halves of a connector (3.4)
2 © ISO 2018 – All rights reserved
ISO 80369-1:2018(E)
3.4
connector
mechanical device, consisting of one of two mating halves and designed to join a conduit to convey
liquids or gases
3.5
contactable surface
any surface on a connector that has an interaction potential in which physical contact occurs with any
other surface on a specific opposing connector
Note 1 to entry: Contactable surfaces may include, but are not limited to, sealing surfaces as intended by design,
crest geometry of external or internal threads, faces, shrouds, grips, etc. These are surfaces on a connector that
can possibly interact with another connector.
3.6
least material condition
LMC
condition in which a feature contains the least amount of material within the stated tolerance
EXAMPLE Maximum hole diameter, minimum shaft diameter.
3.7
maximum material condition
MMC
condition in which a feature contains the maximum amount of material within the stated tolerance
EXAMPLE Minimum hole diameter, maximum shaft diameter.
3.8
nominal (value)
value quoted for reference purposes that is subject to agreed tolerances
[SOURCE: IEC 60601-1:2005, 3.69]
3.9
non-contactable surface
any surface on a connector that is unable to come into contact, during an interaction, with any other
surface on an opposing connector
Note 1 to entry: Non-Contactable surfaces may include, but are not limited to, root geometry of external
or internal threads, internal bore geometry that cannot be accessed by other connectors, geometry that is
intended to be covered by tubing or shrouds and grips, etc.
3.10
non-interconnectable
having characteristics which incorporate geometries or other characteristics that prevent different
connectors from making a connection
3.11
patient
person undergoing a medical, surgical or dental procedure
[SOURCE: IEC 60601-1:2005+A1: 2012, 3.76, modified — replaced “living being (person or animal)” with
“person” and deleted the note.]
3.12
responsible organization
entity accountable for the use and maintenance of a medical device
Note 1 to entry: The accountable entity can be, for example, a hospital, an individual clinician or a layperson. In
home use applications, the patient, user and responsible organization can be one and the same person.
Note 2 to entry: Education and training is included in “use”.
ISO 80369-1:2018(E)
[SOURCE: IEC 60601-1:2005, 3.101, modified — replaced “an me equipment or an me system” with
“medical device”.]
3.13
small-bore
inner-fluid pathway of a connection with a diameter less than 8,5 mm
Note 1 to entry: For the purposes of this document, the 8,5 mm cone and socket of ISO 5356-1 is not considered a
small-bore connector
3.14
target interference connector or feature
component that physically represents a small-bore connector or connector feature that is used
to evaluate whether a contactable surface (3.5) can misconnect with the small-bore connector
being evaluated
Note 1 to entry: Contactable surfaces are identified during the dimensional analysis per B.2.
3.15
test method
definitive procedure for evaluating connectors that produces a test result
4 *Materials
The surfaces of small-bore connectors necessary to ensure non-interconnectable characteristics
shall be made of materials with a nominal modulus of elasticity either in flexure or in tension greater
than 700 MPa, unless specified otherwise in the ISO 80369 series. Surfaces, other than those necessary
to ensure non-interconnectable characteristics, need not comply with this requirement.
[13] [14]
Check compliance by applying the tests of ASTM D638-14 , ISO 527, ASTM D790-17 or ISO 178 or
for metallic materials, the tests of ISO 6892-1.
NOTE A correlation between the ISO and ASTM test methods is found in Reference [15].
5 Small-bore connector incompatibility
Small-bore connectors of each application category specified in this document shall be non-
interconnectable with any of the small-bore connectors of every other application category,
unless otherwise indicated in this document or within the ISO 80369 series.
Check compliance by confirming that objective evidence demonstrates that risks have been reduced
to acceptable levels for the acceptability criteria specified in Annex B and other acceptability criteria
established by the manufacturer for non-interconnectable characteristics. Confirm that the
small-bore connector is non-interconnectable.
NOTE 1 For the purpose of this document, dimensional compliance and modulus of elasticity compliance with
the requirements of the various application parts of the ISO 80369 series is considered sufficient objective
evidence of non-interconnectable characteristics.
NOTE 2 Annex E lists examples of the sort of medical devices or accessories for which the small-bore
connectors within each application are intended.
6 *Clinical applications
6.1 *Additional small-bore connector designs
Designs of small-bore connectors other than those specified in 6.2 to 6.5, for inclusion in the
ISO 80369 series, and used in medical devices or accessories intended for use with a patient, shall
meet the requirements of Clause 4, Clause 7 and Annex D.
4 © ISO 2018 – All rights reserved
ISO 80369-1:2018(E)
When an additional small-bore connector is created or proposed for a new application, Annex D
requires a new part of the ISO 80369 series to be created.
Check compliance by application of Clause 4, Clause 7 and Annex D.
6.2 Enteral applications
Small-bore connectors intended to be used for connections in the enteral application shall comply
with ISO 80369-3, unless the use of these connectors creates an unacceptable risk for a specific
medical device or accessory, or shall comply with Clause 7.
Check compliance by inspection of the documentation demonstrating that the small-bore connector
conforms to the requirements of ISO 80369-3 or, in case of alternative connectors as per Clause 7, by
applying the tests of ISO 80369-3. See also Clause 7 for alternative methods of compliance.
6.3 Limb cuff inflation applications
Small-bore connectors intended to be used for connections in limb cuff inflation application
shall comply with IEC 80369-5, unless the use of these connectors creates an unacceptable risk for a
specific medical device or accessory, or shall comply with Clause 7.
Check compliance by inspection of the documentation demonstrating that the small-bore connector
conforms to the requirements of IEC 80369-5 or, in case of alternative connectors as per Clause 7, by
applying the tests of IEC 80369-5. See also Clause 7 for alternative methods of compliance.
6.4 Neuraxial applications
Small-bore connectors intended to be used for connections in neuraxial application shall comply
with ISO 80369-6, unless the use of these connectors creates an unacceptable risk for a specific
medical device or accessory, or shall comply with Clause 7.
Check compliance by inspection of the documentation demonstrating that the small-bore connector
conforms to the requirements of ISO 80369-6 or, in case of alternative connectors as per Clause 7, by
applying the tests of ISO 80369-6. See also Clause 7 for alternative methods of compliance.
6.5 Intravascular or hypodermic applications
Small-bore connectors intended to be used for connections in intravascular or hypodermic
application shall comply with ISO 80369-7, unless the use of these connectors creates an unacceptable
risk for a specific medical device or accessory, or shall comply with Clause 7.
Check compliance by inspection of the documentation demonstrating that the small-bore connector
conforms to the requirements of ISO 80369-7 or, in case of alternative connectors as per Clause 7, by
applying the tests of ISO 80369-7. See also Clause 7 for alternative methods of compliance.
7 *Alternative small-bore connectors
Alternative designs of small-bore connectors to those specified in Clause 6 may be used in a medical
device or accessory, and if used, they shall:
a) be evaluated according to Clause 5 for non-interconnectable characteristics, with the exception
of a connector within the same application to which it is intended to connect;
b) not create an unacceptable risk for a specific medical device or accessory;
c) be evaluated according to the engineering analysis of D.3;
d) comply with the materials characteristics of Clause 4.
ISO 80369-1:2018(E)
The medical device or accessory, which incorporates an alternative design small-bore
connector, shall:
e) be marked with either
— the symbol ISO 15223-1:2016, 5.4.3 (see Table C.1, symbol “consult the instructions for use”), or
— the safety sign ISO 7010-M002 (see Table C.1, safety sign “consult the accompanying documents
is a mandatory action”);
f) include in its accompanying documents a warning to the effect that “warning: As this medical
device uses an alternative small-bore connector design different from those specified in the
ISO 80369 series, there is a possibility that a misconnection can occur between this medical device
and a medical device using a different alternative small-bore connector, which can result in a
hazardous situation causing harm to the patient. Special measures need be taken by the user to
mitigate these reasonable foreseeable risks.”
An alternative design small-bore connector that complies with this subclause may claim compliance
or conformance with this document, but shall not claim compliance or conformance with the other
parts of the ISO 80369 series. Generic claims of compliance or conformance to the ISO 80369 series
shall not be made.
Check compliance by confirming that objective evidence demonstrates that risks have been reduced
to meet the acceptability criteria specified in Annex B and other acceptability criteria established by
the manufacturer for non-interconnectable characteristics for the medical device or accessory.
Confirm compliance with Clause 4, Clause 5 and the specified portions of Annex D.
6 © ISO 2018 – All rights reserved
ISO 80369-1:2018(E)
Annex A
(informative)
Rationale
This annex provides rationale for the important requirements of this document and is intended for those
who are familiar with the subject of this document but who have not participated in its development.
An understanding of the reasons for the main requirements is considered to be essential for its proper
application. Furthermore, as clinical practice and technology change, it is believed that rationale for the
present requirements will facilitate any revision of this document necessitated by those developments.
The clauses in this annex have been so numbered to correspond to the clauses in this document to
which they refer. The numbering is, therefore, not consecutive.
Clause 1 Scope
Advances in modern medicine have led to a significant rise in the number of medical devices attached
to patients. Many of these medical devices fall into the categories of monitoring devices, diagnostic
devices and drug delivery devices.
Such medical devices perform a variety of similar, but not interchangeable, functions. Examples include
intravenous fluid delivery, enteral feeding, respiratory gas sampling, non-invasive blood pressure
measurement and injection of intrathecal medication. Despite the varied nature of the functions
performed, many of these medical devices use a universal system of small-bore connectors
based on the 6 % Luer tapered connector as formerly specified in ISO 594 series. ISO 594 series is
now withdrawn and replaced by ISO 80369-7 with the important difference that the latter applies to
intravascular or hypodermic applications only.
The universal nature of the connectors used and the proximity of several different connectors
around a single patient makes accidental misconnections inevitable. The consequences of such
[16][17][18][19][20]
misconnections vary, but a significant number is actually or potentially fatal .
Serious and usually fatal misconnections include intravenous injection of air, intravenous injection of
enteral feeds and intrathecal injection of vincristine. Less disastrous misconnections such as enteral
administration of intravenous fluids might not directly harm the patient but cause a failure of the
intended administration.
Introducing a series of non-interconnectable, small-bore connectors for medical devices will
help reduce the likelihood of misconnections and lead to a direct improvement in patient safety. It was
important that any series also included the 6 % Luer, although this is now restricted to intravascular or
hypodermic applications.
CEN BT TF 123 carried out an extensive risk analysis of possible misconnections that might result
when the same connector is used in different applications. Reducing the identified unacceptable
risks is the basis of the ISO 80369 series.
Originally, it was hoped that the small-bore connectors included in the ISO 80369 series could
be designed so that they did not misconnect with other connectors commonly used within similar
[11]
environments and covered by ISO/EN standards. (e.g. the nipples in EN 13544-2 ,the conical
connectors in ISO 5356-1 and the temperature sensor ports specified in ISO 80601-2-74).
During the CAD (computer-assisted design) analysis, it became evident that the dimensions contained
within these International Standards were not specified in a manner that allows for evaluation of non-
interconnectable characteristics between these connectors and the connectors specified in the
ISO 80369 series. These connectors were, therefore, not part of the CAD verification/validation
ISO 80369-1:2018(E)
or the non-interconnectable characteristics testing and might misconnect with the small-bore
connectors described in the ISO 80369 series.
Clause 2 Normative references
For various reasons the respiratory part of the series of standards (intended to be published as
ISO 80369-2) was not available to be referenced at the point in time the voting of this standard was
performed. However, it is the clear and confirmed intention of ISO/TC 210/JWG 4 that the respiratory
part of the series of standards become part of the ISO 80369 series and that ISO 80369-2 will be added
as a normative reference to this standard as soon as this document becomes available so that the
content of ISO 80369-2 will — in whole or in part — constitute requirements of this document.
Clause 4 Materials
To prevent misconnection between medical devices that should not connect, the rigidity of the
materials from which small-bore connectors are made has been specified to eliminate the possibility
of forcing a fit between incompatible small-bore connectors made from flexible materials. To achieve
this, the committee determined that the previous semi-rigid requirement had to be increased to a more
rigid (greater than 700 MPa) material.
NOTE ISO 80369-6 requires the nominal modulus of elasticity to be greater than 950 MPa.
It is understood that small-bore connector systems cannot be designed to overcome all chances of
misconnection or to eliminate deliberate misuse. For example, the possibility of the misconnection of a
small-bore connector to a specialized patient-access port can still exist. Specialized patient-access
ports often require the use of flexible materials which are intended to permit access by a range of
medical devices or accessories, such as, endoscopes, bronchoscopes, and surgical instruments. These
access ports can permit interconnection with some small-bore connectors. The risks associated with
the use of these specialized patient-access ports are not addressed by this document. Manufacturers
of medical devices or accessories and the committees responsible for the development of standards
for medical devices or accessories that incorporate these specialized patient-access ports will need
to assess these risks.
Clause 6 Clinical applications
National regulatory bodies, hospital accreditation organizations, and independent public health
organizations recognize misconnections as a persistent problem with potentially lethal consequences.
Warnings have been issued and strategies have been offered for healthcare organizations to reduce
risks and manufacturers to redesign connectors to prevent misconnections. The ability of
connectors to interconnect is identified as a root cause of misconnections.
[12]
CEN Report, CR 13825 , identifies possible misconnections between medical devices involving the
conveyance of a gas or liquid for the different application categories and classifies each according to
the severity of the harm that can occur. The report confirms that the application categories specified
in this document are incompatible, i.e. misconnections among these application categories can cause
serious injury or death.
The committee reviewed this report and agreed that these application categories were the highest
areas of risk to public health from medical device misconnection if a misconnection were to occur.
This determination comes from years of adverse event reports, literature reviews and research on
medical device misconnection. It is noted that the identified application categories do not encompass
all medical areas to which medical devices are intended to be used and therefore, all potential
areas of misconnection might not be addressed by this document. It is intended that the application
categories in this clause represent a majority of medical devices containing small-bore connectors
and therefore, the use of these small-bore connectors will bring the risk of misconnection to an
acceptable level.
This clause specifies the applications for each of the standard series parts. The purpose of including
these applications is to reduce the risk of misconnection between these categories to a minimum.
For new designs of small-bore connector, by providing objective evidence that the small-bore
8 © ISO 2018 – All rights reserved
ISO 80369-1:2018(E)
connector meets the requirements set forth in Clause 4, Clause 5, Annex B and Annex D, the risk of
misconnection between applications has been shown to have been minimized.
For various reasons the respiratory part of the series of standards (intended to be published as
ISO 80369-2) was not available to be referenced at the point in time the voting of this standard was
performed. However, it is the clear and the confirmed intention of ISO/TC 210 to amend this document
on
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