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

Status
Published
Public Enquiry End Date
29-Sep-2015
Publication Date
09-Dec-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
04-Dec-2018
Due Date
08-Feb-2019
Completion Date
10-Dec-2018

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SLOVENSKI STANDARD
SIST EN ISO 80369-1:2019
01-januar-2019
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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
SIST EN ISO 80369-1:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 80369-1:2019
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SIST EN ISO 80369-1:2019
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.
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SIST EN ISO 80369-1:2019
EN ISO 80369-1:2018 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 80369-1:2019
EN ISO 80369-1:2018 (E)
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.
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SIST EN ISO 80369-1:2019
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SIST EN ISO 80369-1:2019
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
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SIST EN ISO 80369-1:2019
ISO 80369-1:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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SIST EN ISO 80369-1:2019
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 2018 – All rights reserved iii
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SIST EN ISO 80369-1:2019
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
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SIST EN ISO 80369-1:2019
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 2018 – All rights reserved v
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SIST EN ISO 80369-1:2019
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
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SIST EN ISO 80369-1:2019
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 2018 – All rights reserved 1
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SIST EN ISO 80369-1:2019
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)
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SIST EN ISO 80369-1:2019
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”.
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SIST EN ISO 80369-1:2019
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 connecto
...

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