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
SIST EN ISO 80369-1:2019
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
SIST EN ISO 80369-1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 80369-1:2019
---------------------- Page: 2 ----------------------
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 80369-1:2019
EN ISO 80369-1:2018 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
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.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 80369-1:2019
---------------------- Page: 6 ----------------------
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
---------------------- Page: 7 ----------------------
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
---------------------- Page: 8 ----------------------
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
---------------------- Page: 9 ----------------------
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
---------------------- Page: 10 ----------------------
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
---------------------- Page: 11 ----------------------
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
---------------------- Page: 12 ----------------------
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
---------------------- Page: 13 ----------------------
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)
2 © ISO 2018 – All rights reserved
---------------------- Page: 14 ----------------------
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”.
© ISO 2018 – All rights reserved 3
---------------------- Page: 15 ----------------------
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
...
SLOVENSKI STANDARD
kSIST FprEN ISO 80369-1:2015
01-september-2015
3ULNOMXþNL]PDMKQLPSUHPHURP]DWHNRþLQHLQSOLQH]DXSRUDERY]GUDYVWYXGHO
6SORãQH]DKWHYH ,62',6
Small bore connectors for liquids and gases in healthcare applications - Part 1: General
requirements (ISO/DIS 80369-1:2015)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO/DIS 80369-
1:2015)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
1: Exigences générales (ISO/DIS 80369-1:2015)
Ta slovenski standard je istoveten z: FprEN ISO 80369-1 rev
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
kSIST FprEN ISO 80369-1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
kSIST FprEN ISO 80369-1:2015
---------------------- Page: 2 ----------------------
kSIST FprEN ISO 80369-1:2015
DRAFT INTERNATIONAL STANDARD ISO/DIS 80369-1
ISO/TC 210 Secretariat: ANSI
Voting begins on Voting terminates on
2015-07-23 2015-10-23
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ ORGANISATION INTERNATIONALE DE NORMALISATION
INTERNATIONAL ELECTROTECHNICAL COMMISSION МЕЖДУНАРОДНАЯ ЭЛЕКТРОТЕХНИЧЕСКАЯ КОММИСИЯ COMMISSION ÉLECTROTECHNIQUE
INTERNATIONALE
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
(Revision of first edition [ISO 80369-1:2010])
ICS 11.040.10; 11.040.20
This draft is submitted to a parallel enquiry in ISO and a CDV vote in the IEC.
ISO/CEN PARALLEL PROCESSING
This final draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement. The final draft
was established on the basis of comments received during a parallel enquiry on the draft.
This final draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
two-month approval vote in ISO and formal vote in CEN.
Positive votes shall not be accompanied by comments.
Negative votes shall be accompanied by the relevant technical reasons.
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED
TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY
ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
© International Organization for Standardization, 2015
---------------------- Page: 3 ----------------------
kSIST FprEN ISO 80369-1:2015
ISO/DIS 80369-1
ii © ISOIEC 2003 – All rights reserved
---------------------- Page: 4 ----------------------
kSIST FprEN ISO 80369-1:2015
ISO/DIS 80369-1
14 Contents Page
15 Foreword . 4
16 Introduction . 6
17 1 Scope . 8
18 2 Normative references . 8
19 3 Terms and definitions . 9
20 4 *Materials . 10
21 5 Clinical APPLICATIONS . 10
22 5.1 Incompatibility . 10
23 5.2 BREATHING SYSTEMS and driving gases APPLICATIONS . 11
24 5.3 Enteral APPLICATIONS . 11
25 5.4 Urethral and urinary APPLICATIONS . 11
26 5.5 Limb cuff inflation APPLICATIONS . 11
27 5.6 Neuraxial APPLICATIONS . 11
28 5.7 Intravascular or hypodermic APPLICATIONS . 11
29 5.8 *Additional Clinical APPLICATIONS . 12
30 6 *Alternative SMALL-BORE CONNECTORS . 12
31 Annex A (informative) Rationale . 13
32 Annex B (normative) TEST METHODS for verifying NON-INTERCONNECTABLE characteristics . 16
33 Annex C (normative) Safety signs . 22
34 Annex D (normative) Assessment PROCEDURES SMALL-BORE CONNECTORS . 23
35 Annex E (informative) APPLICATIONS of SMALL-BORE CONNECTORS . 25
36 Annex F (informative) Reference to the Essential Principles . 27
37 Bibliography . 29
38 Terminology – Alphabetized index of defined terms . 30
39
© ISO 2014 – All rights reserved 3
---------------------- Page: 5 ----------------------
kSIST FprEN ISO 80369-1:2015
ISO/DIS 80369-1
40 Foreword
41 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
42 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
43 technical committees. Each member body interested in a subject for which a technical committee has been
44 established has the right to be represented on that committee. International organizations, governmental and
45 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
46 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
47 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
48 The main task of technical committees is to prepare International Standards. Draft International Standards
49 adopted by the technical committees are circulated to the member bodies for voting. Publication as an
50 International Standard requires approval by at least 75 % of the member bodies casting a vote.
51 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
52 rights. ISO shall not be held responsible for identifying any or all such patent rights.
53 ISO 80369-1 was prepared by a Joint Working Group of Technical Committee ISO/TC 210, Quality
54 management and corresponding general aspects for medical devices, IEC/TC 62, Electrical equipment,
55 Subcommittee SC D, Electrical equipment in medical practice and CEN/CENELEC TC 3/WG 2, Small-bore
56 connectors.
57 ISO 80369 consists of the following parts, under the general title, Small-bore connectors for liquids and gases
58 in healthcare applications:
59 Part 1: General requirements
60 The following parts are under preparation:
61 Part 2: Connectors for breathing systems and driving gases applications
62 Part 3: Connectors for enteral applications
1
63 Part 4: Connectors for urethral and urinary applications
64 Part 5: Connectors for limb cuff inflation applications
65 Part 6: Connectors for neuraxial applications
66 Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
67 Part 20: Common TEST METHODs
68 In this standard, the following print types are used:
69 Requirements and definitions: roman type.
70 Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative
71 text of tables is also in a smaller type.
1
Planned but not yet begun
4 © ISO 2014 – All rights reserved
---------------------- Page: 6 ----------------------
kSIST FprEN ISO 80369-1:2015
ISO/DIS 80369-1
72 TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL
73 CAPITALS TYPE.
74 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
75 the conditions is true.
76 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
77 Part 2. For the purposes of this standard, the auxiliary verb:
78 “shall” means that compliance with a requirement or a test is mandatory for compliance with this
79 standard;
80 “should” means that compliance with a requirement or a test is recommended but is not mandatory for
81 compliance with this standard;
82 “may” is used to describe a permissible way to achieve compliance with a requirement or test.
83 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
84 there is guidance or rationale related to that item in Annex A.
85 The attention of Member Bodies and National Committees is drawn to the fact that equipment
86 MANUFACTURERS and testing organizations may need a transitional period following publication of a new,
87 amended or revised ISO or IEC publication in which to make products in accordance with the new
88 requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the
89 committee that the content of this publication be adopted for implementation nationally not earlier than 3 years
90 from the date of publication for equipment newly designed and not earlier than 5 years from the date of
91 publication for equipment already in production.
92
© ISO 2014 – All rights reserved 5
---------------------- Page: 7 ----------------------
kSIST FprEN ISO 80369-1:2015
ISO/DIS 80369-1
93 Introduction
94 In the 1990s concern grew regarding the proliferation of MEDICAL DEVICES fitted with Luer CONNECTORS and the
95 reports of PATIENT death or injury arising from misconnections that resulted in the inappropriate delivery of
96 enteral solutions, intrathecal medication or compressed gases.
97 Concerns regarding the use of Luer CONNECTORS with enteral feeding tubes and gas sampling and gas
98 delivery systems were raised with CEN/BT and the European Commission. In November 1997 the newly
99 created CHeF steering group set up a Forum Task Group (FTG) to consider the problem.
100 The FTG produced CEN Report CR 13825, in which they concluded that there is a problem arising from the
101 use of a single CONNECTOR design to a number of incompatible APPLICATIONS. In a coronary care unit there are
102 as many as 40 Luer CONNECTORS on the MEDICAL DEVICES used with a single PATIENT. Therefore it is not
103 surprising that misconnections are made.
104 MEDICAL DEVICES have for many years followed the established principle of “safety under single fault
105 conditions”. Simply stated this means that a single fault should not result in an unacceptable RISK. This
106 principle is embodied in the requirements of numerous MEDICAL DEVICE standards. Extending this principle to
107 the application of Luer CONNECTORS, i.e. that misconnection should not result in an unacceptable RISK to a
108 PATIENT, the FTG recommended that the Luer CONNECTOR should be restricted to MEDICAL DEVICES intended to
109 be connected to the vascular system or a hypodermic syringe. In addition, new designs of SMALL-BORE
110 CONNECTORS should be developed for other APPLICATIONS, and these should be NON-INTERCONNECTABLE with
111 Luer CONNECTORS and each other.
112 ISO/TR 16142:2006 addresses this type of problem in Essential Principle A.1.2:
113 The solutions adopted by the manufacturer for the design and construction of the devices should
114 conform to safety principles, taking into account the generally acknowledged state of the art.
115 In selecting the most appropriate solutions, the manufacturer should apply the following principles
116 in the following order:
117 — identify hazards and the associated risks arising from the intended use and foreseeable
118 misuse;
119 — eliminate or reduce risks as far as possible (inherently safe design and construction);
120 It is understood that SMALL-BORE CONNECTOR systems cannot be designed to overcome all chances of
121 misconnection or to eliminate deliberate misuse. However, a number of steps that would improve the current
122 situation and lead to greater PATIENT safety can be taken. This will only be achieved through a long-term
123 commitment involving industry, healthcare professionals, MEDICAL DEVICE purchasers and MEDICAL DEVICE
124 regulatory authorities.
125 This is the second edition of ISO 80369-1 and it cancels and replaces ISO 80369-1:2010 which has been
126 technically revised.
127 This series of standards has, wherever possible, restricted the number of CONNECTORS for each APPLICATION
128 to one, unless there is sufficient clinical or technical evidence to have more.
129 It is expected that particular MEDICAL DEVICE standards will reference the interface requirements from the
130 appropriate parts of the 80369 series.
6 © ISO 2014 – All rights reserved
---------------------- Page: 8 ----------------------
kSIST FprEN ISO 80369-1:2015
ISO/DIS 80369-1
131 This Part 1 of the 80369 series specifies the general requirements and TEST METHODs for assessing the NON-
132 INTERCONNECTABLE characteristics of SMALL-BORE CONNECTORS within the 80369 series. Parts 2 to 7 of the
133 80369 series specify the dimensional requirements for the interface CONNECTIONS and the basic performance
134 requirements for assessing the interconnectability of the connector mating halves.
135 Part 20 of the 80369 series specifies the TEST METHODs for assessing the basic performance requirements
136 specified in parts 2 to 7.
137 The designs and dimensions of SMALL-BORE CONNECTORS specified in Parts 2 to 7 of the 80369 series of
138 standards have been successfully assessed according to the requirements in this Part 1, i.e. have been
139 proven to be acceptable with regard to the RISK of misconnection.
140 This Part 1 of this International Standard contains general requirements to ensure the prevention of
141 misconnection between SMALL-BORE CONNECTORS used in different APPLICATIONS. Subsequent parts of this
142 series of standards are expected to include requirements with regard to the CONNECTORS used in different
143 APPLICATION categories.
144
© ISO 2014 – All rights reserved 7
---------------------- Page: 9 ----------------------
kSIST FprEN ISO 80369-1:2015
ISO/DIS 80369-1
145 Small-bore connectors for liquids and gases in healthcare
146 applications —Part 1:
147 General requirements
148 1 Scope
149 This part of ISO 80369 specifies general requirements for SMALL-BORE CONNECTORS, which convey liquids or gases
150 in healthcare APPLICATIONS. These SMALL-BORE CONNECTORS are used in MEDICAL DEVICES or ACCESSORIES
151 intended for use with a PATIENT.
152 This International Standard also specifies the healthcare fields in which these SMALL-BORE CONNECTORS are
153 intended to be used.
154 These healthcare fields of use include, but are not limited to, APPLICATIONS for:
155 BREATHING SYSTEMS and driving gases,
156 enteral,
157 urethral and urinary,
158 limb cuff inflation,
159 neuraxial devices, and
160 intravascular or hypodermic.
161 This International Standard provides the methodology to assess NON-INTERCONNECTABLE characteristics of
162 SMALL-BORE CONNECTORS based on their inherent design and dimensions in order to reduce the RISK of
163 misconnections between MEDICAL DEVICES or between ACCESSORIES for different APPLICATIONS and to reduce
164 the RISK of misconnections between MEDICAL DEVICES with 6 % Luer CONNECTORS, and all other non-Luer
165 CONNECTORS that will be developed under future parts of this series of standards.
166 This standard does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these SMALL-
167 BORE CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL
168 DEVICES or ACCESSORIES.
169 NOTE 1 Subclause 5.8 allows for additional designs of SMALL-BORE CONNECTORS for inclusion in this series of standards
170 for APPLICATIONS other than those already specified.
171 NOTE 2 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this series of
172 standards into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular
173 MEDICAL DEVICE standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised,
174 requirements for SMALL-BORE CONNECTORS as specified in the series of standards will be included.
175 NOTE 3 MANUFACTURERS and RESPONSIBLE ORGANIZATIONS are encouraged to report their experience with the SMALL-
176 BORE CONNECTORS specified in this series of standards to the Secretariat of ISO/TC 210 so that this feedback can be
177 considered during the revision of the relevant part of this series of standards.
178 2 Normative references
179 The following referenced documents are indispensable for the application of this document. For dated
180 references, only the edition cited applies. For undated references, the latest edition of the referenced
181 document (including any amendments) applies.
182 ISO 14971:2007, Medical devices — Application of risk management to medical devices
8 © ISO 2014 – All rights reserved
---------------------- Page: 10 ----------------------
kSIST FprEN ISO 80369-1:2015
ISO/DIS 80369-1
183 IEC 62366-1:2015, Medical devices — Part 1: Application of usability engineering to medical devices
184 ASTM D747-10, Standard TEST METHOD for apparent bending modulus of plastics by means of a cantilever
185 beam
186 ASTM D790-10, Standard TEST METHODs for flexural properties of unreinforced and reinforced plastics and
187 electrical insulating materials
188 3 Terms and definitions
189 For the purposes of this document, the terms and definitions specified in ISO 14971:2007, IEC 62366:2007
190 and the following apply. For convenience, the sources of all defined terms used in this document are given in
191 an index at the end of this standard.
192 3.1
193 ACCESSORY
194 additional part(s) for use with MEDICAL DEVICE in order to:
195 achieve the INTENDED USE,
196 adapt it to some special use,
197 facilitate its use,
198 enhance its performance, or
199 enable its functions to be integrated with those of other MEDICAL DEVICES
200 [SOURCE: IEC 60601-1:2005, definition 3.3, modified — replaced ‘equipment’ with ‘MEDICAL DEVICE’.]
201
202 3.2
203 APPLICATION
204 specific healthcare field in which a SMALL-BORE CONNECTOR is intended to be used
205 NOTE Annex E lists APPLICATIONS of SMALL-BORE CONNECTORS.
206
207 3.3
208 BREATHING SYSTEM
209 inspiratory and expiratory pathways through which gas flows at respiratory pressures and bounded by the port
210 through which fresh gas enters, the PATIENT CONNECTION port and the exhaust port
211 3.4
212 CONNECTION
213 union or joining of mating halves of a CONNECTOR
214 3.5
215 CONNECTOR
216 mechanical device, consisting of one of two mating halves and designed to join a conduit to convey liquids or
217 gases
218 3.6
219 NON-INTERCONNECTABLE
220 having characteristics which incorporate geometries or other characteristics that prevent different
221 CONNECTORS from making a CONNECTION
222 3.7
223 PATIENT
224 person undergoing a medical, surgical or dental PROCEDURE
© ISO 2014 – All rights reserved 9
---------------------- Page: 11 ----------------------
kSIST FprEN ISO 80369-1:2015
ISO/DIS 80369-1
225 [SOURCE: IEC 60601-1:2005+A1:2012, definition 3.76, modified — replaced ‘living being (person or animal)’ with
226 ‘person’.]
227
228 3.8
229 RESPONSIBLE ORGANIZATION
230 entity accountable for the use and maintenance of a MEDICAL DEVICE
231 NOTE to entry: The accountable entity can be, for example, a hospital, an individual clinician or a layperson. In home
232 use applications, the PATIENT, USER and RESPONSIBLE ORGANIZATION can be one and the same person.
233 [SOURCE: IEC 60601-1:2005, definition 3.101, modified — replaced ‘an ME EQUIPMENT or an ME SYSTEM’ with
234 ‘MEDICAL DEVICE’.]
235
236 3.9
237 SMALL-BORE
238 inner-fluid pathway of a CONNECTION with a diameter less than 8,5 mm
239 3.10
240 TEST METHOD
241 definitive PROCEDURE for evaluating CONNECTORS that produces a test result
242
243 3.11
244 TYPE TEST
245 test on a representative sample
246
247 Note to entry: More than one set of representative samples can be required, e.g. testing the SMALL-BORE
248 CONNECTORS produced in each cavity of a multi-cavity mould.
249 4 *Materials
250 SMALL-BORE CONNECTORS specified in this series of standards shall be made of validated using a materials
251 with a modulus of elasticity either in flexure or in tension greater than 700 MPa. Check compliance by
252 application of the tests of ASTM D747 or ASTM D790 at (23 2) °C and (50 5) % relative humidity.
253 NOTE: Materials with a modulus of elasticity either in flexure or in tension less than 700 MPa may be used on the
254 surfaces of the inner fluid pathways to enhance the performance of a CONNECTION in its clinical application.
255 5 Clinical APPLICATIONS
256 5.1 Incompatibility
257 SMALL-BORE CONNECTORS of each APPLICATION category specified in this International Standard shall be NON-
258 INTERCONNECTABLE with any of the SMALL-BORE CONNECTORS of every other APPLICATION category for RISKS to
259 be acceptable, unless otherwise indicated in this standard or within this series of standards.
260 Check compliance by confirming that OBJECTIVE EVIDENCE verifies that RISKS have been reduced to acceptable
261 levels for the acceptability criteria specified in Annex B and other acceptability criteria established by the
262 MANUFACTURER for NON-INTERCONNECTABLE characteristics. Verify that the SMALL-BORE CONNECTOR is NON-
263 INTERCONNECTABLE.
264 NOTE 1: For the purpose of this standard, dimensional compliance with the various APPLICATION parts of this series of
265 standards, is considered sufficient OBJECTIVE EVIDENCE of NON-INTERCONNECTABLE CHARACTERISTICS.
266 NOTE 2: Annex E lists examples of the sort of devices that the SMALL-BORE CONNECTORS within each APPLICATION can be
267 used on.
268
10 © ISO 2014 – All rights reserved
---------------------- Page: 12 ----------------------
kSIST FprEN ISO 80369-1:2015
ISO/DIS 80369-1
269 5.2 BREATHING SYSTEMS and driving gases APPLICATIONS
270 SMALL-BORE CONNECTORS intended to be used either as an ancillary port CONNECTION in a BREATHING SYSTEM
271 or a respirable driving gas APPLICATION of MEDICAL DEVICES and ACCESSORIES shall comply with
272 ISO 80369-2:—, unless the use of these CONNECTORS creates an unacceptable RISK for a specific MEDICAL
273 DEVICE, or shall comply with 6.0.
274 Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
275 the tests of ISO 80369-2:—. See also 6.0 for alternative methods of compliance.
276 5.3 Enteral APPLICATIONS
277 SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in enteral APPLICATIONS shall comply with
278 ISO 80369-3:—, unless the use of these CONNECTORS creates an unacceptable RISK for a specific MEDICAL
279 DEVICE or shall comply with 6.0.
280 Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
281 the tests of ISO 80369-3:—. See also 6.0 for alternative methods of compliance.
282 5.4 Urethral and urinary APPLICATIONS
283 SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in urethral and urinary APPLICATIONS shall
284 comply with ISO 80369-4:—, unless the use of these CONNECTORS creates an unacceptable RISK for a specific
285 MEDICAL DEVICE or shall comply with 6.0.
286 Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
287 the tests of ISO 80369-4:—. See also 6.0 for alternative methods of compliance.
288 5.5 Limb cuff inflation APPLICATIONS
289 SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in limb cuff inflation APPLICATIONS shall comply
290 with ISO 80369-5:—, unless the use of these CONNECTORS creates an unacceptable RISK for a specific
291 MEDICAL DEVICE or shall comply with 6.0.
292 Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
293 the tests of ISO 80369-5:—. See also 6.0 for alternative methods of compliance.
294 5.6 Neuraxial APPLICATIONS
295 SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in neuraxial APPLICATIONS shall comply with
296 ISO 80369-6:—, unless the use of these CONNECTORS creates an unacceptable RISK for a specific MEDICAL
297 DEVICE or shall comply with 6.0.
298 Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
299 the tests of ISO 80369-6:—. See also 6.0 for alternative methods of compliance.
300 5.7 Intravascular or hypodermic APPLICATIONS
301 SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in intravascular or hypodermic APPLICATIONS
302 shall comply with ISO 80369-7:—, unless the use of these CONNECTORS creates an unacceptable RISK for a
303 specific MEDICAL DEVICE or shall comply with 6.0.
304 NOTE Upon its publication, ISO 80369-7:— will supersede ISO 594-1:1986 and ISO 594-2:1998 for the Intravascular
305 or hypodermic APPLICATIONS .
306 Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
307 the tests of ISO 80369-7:—. See also 6.0 for alternative methods of compliance.
© ISO 2014 – All rights reserved 11
---------------------- Page: 13 ----------------------
kSIST FprEN ISO 80369-1:2015
ISO/DIS 80369-1
308 5.8 *Additional Clinical APPLICATIONS
309 Designs of SMALL-BORE CONNECTORS FOR APPLICATIONS other than those specified in 5.2 to 5.7, for inclusion in
310 this series of standards, and used in MEDICAL DEVICES and ACCESSORIES intended for use with a
311 PATIENT, shall meet the requirements of 4, 5.1 and Annex D.
312 6 *Alternative SMALL-BORE CONNECTORS
313 Alternative designs of SMALL-BORE CONNECTORS to those specified in 5.2 to 5.7 may be used in a MEDICAL
314 DEVICE or ACCESSORY, and if used, they shall:
315 a) be NON-INTERCONNECTABLE with the connectors specified within Clause 5, with the exception of
316 connectors within a common therapeutic area within the same APPLICATION;
317 b) not create an unacceptable RISK for a specific MEDICAL DEVICE or ACCESSORY ;
318 c) be evaluated according to Annex B;
319 d) be evaluated according to Annex D.3,
320 e) comply with Clause 4.
321 The MEDICAL DEVICE or ACCESSORY, which incorporates an alternative design SMALL-BORE CONNECTOR, shall:
322 a) be marked with the safety sign ISO7010-M002 (see Table C.1, safety sign consult the accompanying
323 documents is a mandatory action;
324 b) include in its accompanying documents a warning to the effect that “WARNING: As this MEDICAL DEVICE
325 uses an alternative SMALL-BORE CONNECTOR design dif
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.