SIST EN ISO 80369-1:2011
(Main)Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
This part of ISO 80369 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 International Standard also specifies the healthcare fields in which these SMALL-BORE CONNECTORS are intended to be used. These healthcare fields of use include, but are not limited to, APPLICATIONS for: - BREATHING SYSTEMS and driving gases, - enteral and gastric, - urethral and urinary, - limb cuff inflation, - neuraxial devices, and - intravascular or hypodermic. SMALL-BORE CONNECTORS as specified in this International Standard are NON-INTERCONNECTABLE with: - the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006; - the temperature sensor CONNECTOR and mating ports specified in Annex DD of ISO 8185:2007; and - the nipples of EN 13544-2:2002.
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO 80369-1:2010)
Dieser Teil der Reihe von Internationalen Normen legt allgemeine Anforderungen für die Anwendung von
Verbindungsstücken mit kleinem Durchmesser zum Einsatz in Medizinprodukten und in Zubehörteilen
fest, die Flüssigkeiten oder Gase zu- oder vom Patienten wegführen.
Diese Anwendungen umfassen Verbindungsstücke für Atemsysteme und Antriebsgase, enterale,
urethrale und urologische Anwendungen sowie Anwendungen mit aufblasbaren Manschetten für Gliedmaßen
und neuroaxiale Produkte, sind jedoch nicht darauf beschränkt. Verbindungsstücke mit kleinem
Durchmesser nach den Festlegungen in dieser Internationalen Norm sind nicht miteinander verbindbar
mit:
⎯ den männlichen und weiblichen Konen der ISO 5356-1:2004 und ISO 5356-2:2006; und
⎯ den Nippeln der EN 13544-2:2002.
Die Norm liefert die Methodologie, um die Merkmale der nicht miteinander Verbindbarkeit von
Verbindungsstücken mit kleinem Durchmesser auf der Grundlage ihrer Ausführung und Maße zu
beurteilen, um das Risiko von Verbindungsfehlern zwischen Medizinprodukten oder zwischen den
Zubehörteilen für unterschiedliche Anwendungen zu verringern und um das Risiko von Verbindungsfehlern
zwischen Medizinprodukten mit 6 %-Luer-Verbindungsstücken und allen anderen
Nicht-Luer(6 %)-Verbindungsstücken zu verringern, die unter zukünftigen Teilen dieser Normenreihe
entwickelt werden.
Diese Norm legt keine Anforderungen an Medizinprodukte oder Zubehörteile fest, die diese
Verbindungsstücke mit kleinem Durchmesser anwenden. Derartige Anforderungen finden sich in den
jeweiligen Internationalen Normen für die spezifischen Medizinprodukte oder Zubehörteile.
ANMERKUNG 1 Es ist vorgesehen, dass die neuen Ausführungen von Verbindungsstücken mit kleinem
Durchmesser in diese Reihe von Normen aufgenommen werden, nachdem diese entsprechend dem in Abschnitt 6
angegebenen Verfahren beurteilt wurden.
Joints de petite dimension pour liquides et gaz pour des applications en santé - Partie 1: Exigences générales (ISO 80369-1:2010)
L'ISO 80369-1:2010 spécifie les exigences générales pour les raccords de petite taille, qui conduisent des liquides ou des gaz dans le domaine de la santé. Ces raccords de petite taille sont utilisés dans les dispositifs médicaux ou les accessoires destinés à être employés avec un patient.
L'ISO 80369-1:2010 spécifie également les domaines de la santé dans lesquels ces raccords de petite taille sont destinés à être employés.
Ces domaines comprennent, mais sans s'y limiter, les applications suivantes:
systèmes respiratoires et gaz d'entraînement;
dispositifs entéraux et gastriques;
dispositifs urétraux et urinaires;
gonflage de brassards et de cuissards;
dispositifs en contact avec le système nerveux; et
applications intravasculaires ou hypodermiques.
Les raccords de petite taille tels que spécifiés dans la présente Norme internationale sont non raccordables avec
les raccords mâles et femelles de l'ISO 5356-1:2004 et de l'ISO 5356-2:2006,
le raccord de sonde de température et les ports de raccordement spécifiés dans l'Annexe DD de l'ISO 8185:2007,
les embouts de l'EN 13544-2:2002.
L'ISO 80369-1:2010 indique la méthodologie pour l'évaluation des caractéristiques de non‑raccordabilité des raccords de petite taille en s'appuyant sur leur conception et leurs dimensions inhérentes afin de réduire le risque d'erreur de raccordement entre les dispositifs médicaux ou entre les accessoires destinés à différentes applications et pour réduire le risque d'erreur de raccordement entre les dispositifs médicaux avec des raccords Luer à 6 % et tous les autres raccords (à 6 %) qui seront développés dans les futures parties de la présente série de normes.
Elle ne spécifie pas les exigences pour les dispositifs médicaux ou les accessoires utilisant ces raccords de petite taille. Ces exigences figurent dans les Normes internationales traitant des dispositifs médicaux ou des accessoires.
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 1. del: Splošne zahteve (ISO 80369-1:2010)
Ta del ISO 80369 določa splošne zahteve za PRIKLJUČKE Z MAJHNIM PREMEROM, po katerih se prenašajo tekočine in plini za UPORABO v zdravstvu. Ti PRIKLJUČKI Z MAJHNIM PREMEROM se uporabljajo v MEDICINSKIH NAPRAVAH ali PRIPOMOČKIH za uporabo pri BOLNIKU. Ta mednarodni standard prav tako določa področja zdravstva, na katerem se ti PRIKLJUČKI Z MAJHNIM PREMEROM uporabljajo. Ta področja zdravstva vključujejo, vendar niso omejena na naslednje UPORABE: – za SISTEME ZA DIHANJE in pogonske pline; – enteralne in gastrične; – sečevodne in sečne; – pri oteklosti udov; pri nevraksialnih napravah; ter pri intravaskularni ali podkožni uporabi. PRIKLJUČKI Z MAJHNIM PREMEROM, kot so določeni v tem mednarodnem standardu, NISO MEDSEBONO ZDRUŽLJIVI s: – konusi in spoji iz ISO 5356-1:2004 in ISO 5356-2:2006; – PRIKLJUČKOM temperaturnega senzorja in paritvenimi vrati, določenimi v dodatku DD iz ISO 8185:2007; ter cuclji iz EN 13544-2:2002.
General Information
Relations
Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 80369-1:2011
01-marec-2011
1DGRPHãþD
SIST EN 15546-1:2008
3ULNOMXþNL]PDMKQLPSUHPHURP]DWHNRþLQHLQSOLQH]DXSRUDERY]GUDYVWYXGHO
6SORãQH]DKWHYH ,62
Small bore connectors for liquids and gases in healthcare applications - Part 1: General
requirements (ISO 80369-1:2010)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO 80369-1:2010)
Joints de petite dimension pour liquides et gaz pour des applications en santé - Partie 1:
Exigences générales (ISO 80369-1:2010)
Ta slovenski standard je istoveten z: EN ISO 80369-1:2010
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 80369-1:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 80369-1:2011
---------------------- Page: 2 ----------------------
SIST EN ISO 80369-1:2011
EUROPEAN STANDARD
EN ISO 80369-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2010
ICS 11.040.10; 11.040.20 Supersedes EN 15546-1:2008
English version
Small bore connectors for liquids and gases in healthcare
applications - Part 1: General requirements (ISO 80369-1:2010)
Raccords de petite taille pour liquides et gaz utilisés dans Verbindungsstücke mit kleinem Durchmesser für
le domaine de la santé - Partie 1: Exigences générales Flüssigkeiten und Gase in medizinischen Anwendungen -
(ISO 80369-1:2010) Teil 1: Allgemeine Anforderungen (ISO 80369-1:2010)
This European Standard was approved by CEN on 14 December 2010.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.
CEN Management Centre: CENELEC Central Secretariat:
Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels
© 2010 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80369-1:2010 E
worldwide for CEN national Members and for CENELEC
Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 80369-1:2011
EN ISO 80369-1:2010 (E)
Contents Page
Foreword .3
Annex ZA .5
2
---------------------- Page: 4 ----------------------
SIST EN ISO 80369-1:2011
EN ISO 80369-1:2010 (E)
Foreword
This document (EN ISO 80369-1:2010) has been prepared by Technical Committee ISO/TC 210 "Quality
management and corresponding general aspects for medical devices" in collaboration with Technical
Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by June 2011, and conflicting national standards shall be withdrawn at
the latest by June 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 15546-1:2008.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
Compared to EN 15546-1:2008 the following changes were implemented:
a) Clause 3 "Terms and definitions" has been editorially revised and amended by the terms "accessory",
"breathing system", "non-interconnectable", "patient" and "responsible organization". The terms "risk" and
"safety" have been cancelled and replaced by a general reference to the appropriate terms given in EN
ISO 14971 and IEC 62366;
b) Clause 4 on materials has been amended by a reference to two ASTM standards for tests on conformity;
c) Clause 5 on the requirements has been completely revised and amended by a sub-section on
incompatibility;
d) A new Clause 6 on additional applications has been added;
e) Clause 7 (respectively Clause 6 in EN 15546-1) on the assessment of new designs (validation) has been
completely revised, more detailed in the structure and amended. Especially the sections on the proposal
initiation (7.2) and on the procedure to assess acceptability and non-interconnectable characteristics (7.3)
have been stated more detailed;
f) Annex A "Rationale" has been completely revised by providing the reasons for this standard by clauses.
In addition the Table A.1 on risk analysis of possible misconnections has been cancelled;
g) A new Annex B "Mechanical tests for verifying non-interconnectable characteristics" has been added;
h) Annex C "Applications" (respectively Clause B in EN 15546-1) has been editorially revised;
i) Annex C "Small bore connectors for vascular systems applications" of EN 15546-1 has been cancelled;
j) A new Annex D "Reference to the Essential Principles" according ISO/TR 16142 has been added;
k) Annex ZA on the relationship to the Medical Device Directive (93/42/EWG) has been aligned;
l) The Bibliography has been updated and amended;
3
---------------------- Page: 5 ----------------------
SIST EN ISO 80369-1:2011
EN ISO 80369-1:2010 (E)
m) A new clause Terminology has been added at the end of the standard;
n) Editorial revision in alignment with the overtaking of the original European Standard into an International
Standard.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 80369-1:2010 has been approved by CEN as a EN ISO 80369-1:2010 without any
modification.
4
---------------------- Page: 6 ----------------------
SIST EN ISO 80369-1:2011
EN ISO 80369-1:2010 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Union and the
European Free Trade Association to provide a means to conforming to Essential Requirements of the New
576 Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the
Member States concerning medical devices” (Medical Device Directive).
Once this document is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
document given in Table ZA.1, within the limits of the scope of this document, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Corresponding Essential
Clause/subclause
Requirement Qualifying remarks/notes
of this Document
of Directive 93/42/EEC
all 1, 2
4, 5 7.5, 7.6, 9.1, 12.7.4
6 6 a, 7.5, 7.6, 9.1, 12.7.4
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
585 scope of this International Standard.
5
---------------------- Page: 7 ----------------------
SIST EN ISO 80369-1:2011
---------------------- Page: 8 ----------------------
SIST EN ISO 80369-1:2011
INTERNATIONAL ISO
STANDARD 80369-1
First edition
2010-12-15
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 80369-1:2010(E)
©
ISO 2010
---------------------- Page: 9 ----------------------
SIST EN ISO 80369-1:2011
ISO 80369-1:2010(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2010
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2010 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 80369-1:2011
ISO 80369-1:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.2
3 Terms and definitions .2
4 Materials used for SMALL-BORE CONNECTORS.3
5 Requirements for SMALL-BORE CONNECTORS for specific APPLICATIONS.4
5.1 SMALL-BORE CONNECTOR incompatibility.4
5.2 BREATHING SYSTEMS and driving gases APPLICATIONS.4
5.3 Enteral and gastric APPLICATIONS.4
5.4 Urethral and urinary APPLICATIONS.4
5.5 Limb cuff inflation APPLICATIONS.4
5.6 Neuraxial APPLICATIONS.5
5.7 Intravascular or hypodermic APPLICATIONS .5
5.8 Alternative SMALL-BORE CONNECTORS .5
6 Additional SMALL-BORE CONNECTOR APPLICATIONS.5
7 PROCEDURE to assess a proposed new design of SMALL-BORE CONNECTOR for inclusion in
this series of standards .6
7.1 General .6
7.2 Proposal initiation .6
7.3 PROCEDURE to assess acceptability and NON-INTERCONNECTABLE characteristics.6
7.3.1 Design.6
7.3.2 Design realization.6
7.3.3 Design VERIFICATION .7
7.3.4 Design validation.7
7.4 Design review .7
7.5 Subsequent parts of this series of standards .7
Annex A (informative) Rationale.8
Annex B (normative) Mechanical tests for verifying NON-INTERCONNECTABLE characteristics.11
Annex C (informative) APPLICATIONS of SMALL-BORE CONNECTORS .12
Annex D (informative) Reference to the Essential Principles .14
Bibliography.16
Terminology – Alphabetized index of defined terms.17
© ISO 2010 – All rights reserved iii
---------------------- Page: 11 ----------------------
SIST EN ISO 80369-1:2011
ISO 80369-1:2010(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 80369-1 was prepared by a Joint Working Group of Technical Committee ISO/TC 210, Quality
management and corresponding general aspects for medical devices, IEC/TC 62, Electrical equipment,
Subcommittee SC D, Electrical equipment in medical practice and CEN/CENELEC TC 3/WG 2, Small-bore
connectors.
ISO 80369 consists of the following parts, under the general title, Small-bore connectors for liquids and gases
in healthcare applications:
⎯ Part 1: General requirements
The following parts are under preparation:
⎯ Part 2: Connectors for breathing systems and driving gases applications
⎯ Part 3: Connectors for enteral applications
⎯ Part 4: Connectors for urethral and urinary applications
⎯ Part 5: Connectors for limb cuff inflation applications
⎯ Part 6: Connectors for neuraxial applications
⎯ Part 7: Connectors for intravascular or hypodermic applications
iv © ISO 2010 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 80369-1:2011
ISO 80369-1:2010(E)
Introduction
In the 1990s concern grew regarding the proliferation of MEDICAL DEVICES fitted with Luer CONNECTORS 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.
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
principle is embodied in the requirements of numerous MEDICAL DEVICE standards. Extending this principle to
the application 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/TR 16142:2006 addresses this type of problem in Essential Principle A.1.2:
The solutions adopted by the manufacturer for the design and construction of the devices should
conform to safety principles, taking into account the generally acknowledged state of the art.
In selecting the most appropriate solutions, the manufacturer should apply the following principles
in the following order:
— identify hazards and the associated risks arising from the intended use and foreseeable
misuse;
— eliminate or reduce risks as far as possible (inherently safe design and construction);
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.
This is the first edition of ISO 80369-1 and it cancels and replaces EN 15546-1:2008 which has been
editorially revised.
Part 1 of this International Standard and its parts are intended to be the reference documents in which the
necessary measures and PROCEDURES to prevent misconnection between SMALL-BORE CONNECTORS used in
different APPLICATIONS and designs of SMALL-BORE CONNECTORS for APPLICATIONS are listed. The JWG of
ISO/TC 210 – IEC 62D and CEN/CENELEC TC 3/WG 2 is developing this series of standards in such a way
that ISO 80369-1 includes general requirements to prevent misconnections between SMALL-BORE CONNECTORS
used in different APPLICATIONS.
© ISO 2010 – All rights reserved v
---------------------- Page: 13 ----------------------
SIST EN ISO 80369-1:2011
ISO 80369-1:2010(E)
This part 1 of this International Standard contains general requirements to ensure the prevention of
misconnection between SMALL-BORE CONNECTORS used in different APPLICATIONS. Subsequent parts of this
series of standards are expected to include requirements with regard to the CONNECTORS used in different
APPLICATION categories.
In this standard, the following print types are used:
⎯ Requirements and definitions: roman type.
⎯ Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative
text of tables is also in a smaller type.
⎯ TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL
CAPITALS TYPE.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
⎯ “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
⎯ “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
⎯ “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 and National Committees 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 or IEC 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 3 years
from the date of publication for equipment newly designed and not earlier than 5 years from the date of
publication for equipment already in production.
vi © ISO 2010 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 80369-1:2011
INTERNATIONAL STANDARD ISO 80369-1:2010(E)
Small-bore connectors for liquids and gases in healthcare
applications —
Part 1:
General requirements
1 Scope
This part of ISO 80369 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 International Standard also specifies the healthcare fields in which these SMALL-BORE CONNECTORS are
intended to be used.
These healthcare fields of use include, but are not limited to, APPLICATIONS for:
⎯ BREATHING SYSTEMS and driving gases,
⎯ enteral and gastric,
⎯ urethral and urinary,
⎯ limb cuff inflation,
⎯ neuraxial devices, and
⎯ intravascular or hypodermic.
SMALL-BORE CONNECTORS as specified in this International Standard are NON-INTERCONNECTABLE with:
⎯ the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006;
⎯ the temperature sensor CONNECTOR and mating ports specified in Annex DD of ISO 8185:2007; and
⎯ the nipples of EN 13544-2:2002.
This International Standard 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 and to reduce
the RISK of misconnections between MEDICAL DEVICES with 6 % Luer CONNECTORS, and all other non-Luer
CONNECTORS that will be developed under future parts of this series of standards.
It 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 It is intended that new designs of SMALL-BORE CONNECTORS will be included in this series of standards after
they have been assessed according to the PROCEDURE given in Clause 6.
© ISO 2010 – All rights reserved 1
---------------------- Page: 15 ----------------------
SIST EN ISO 80369-1:2011
ISO 80369-1:2010(E)
NOTE 2 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this series of
standards into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular
MEDICAL DEVICE standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised,
requirements for SMALL-BORE CONNECTORS as specified in the series of standards will be included.
NOTE 3 MANUFACTURERS and RESPONSIBLE ORGANIZATIONS are encouraged to report their experience with the SMALL-
BORE CONNECTORS specified in this series of standards to the Secretariat of ISO/TC 210 to consider this feedback during
the revision of the relevant part of this series of standards.
2 Normative references
The following referenced documents are indispensable for the application 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 5356-1:2004, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5356-2:2006, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded
weight-bearing connectors
ISO 14971:2007, Medical devices — Application of risk management to medical devices
EN 13544-2:2002, Respiratory therapy equipment — Part 2: Tubing and connectors
IEC 62366:2007, Medical devices — Application of usability engineering to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions specified in ISO 14971:2007, IEC 62366:2007
and the following apply. For convenience, the sources of all defined terms used in this document are given in
an index on page 17.
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
[Modified from IEC 60601-1:2005, definition 3.3]
3.2
APPLICATION
specific healthcare field in which a SMALL-BORE CONNECTOR is intended to be used
NOTE Annex C lists SMALL-BORE CONNECTOR APPLICATIONS.
3.3
BREATHING SYSTEM
inspiratory and expiratory pathways through which gas flows at respiratory pressures and bounded by the port
through which fresh gas enters, the PATIENT CONNECTION port and the exhaust port
2 © ISO 2010 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 80369-1:2011
ISO 80369-1:2010(E)
3.4
CONNECTION
union or joining of mating halves of a CONNECTOR
3.5
CONNECTOR
mechanical device, consisting of one of two mating halves and designed to join a conduit to convey liquids or
gases
3.6
NON-INTERCONNECTABLE
having characteristics which incorporate geometries or other characteristics that prevent different
CONNECTORS from being connected
3.7
PATIENT
person undergoing a medical, surgical or dental PROCEDURE
[Modified from IEC 60601-1:2005, definition 3.76]
3.8
RESPONSIBLE ORGANIZATION
entity accountable for the use and maintenance of a MEDICAL DEVICE
NOTE 1 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 Education
...
SLOVENSKI STANDARD
oSIST prEN ISO 80369-1:2009
01-november-2009
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 80369-1:2009)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO/DIS 80369-
1:2009)
Joints de petite dimension pour liquides et gaz pour des applications en santé - Partie 1:
Exigences générales (ISO/DIS 80369-1:2009)
Ta slovenski standard je istoveten z: prEN ISO 80369-1
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
oSIST prEN ISO 80369-1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 80369-1:2009
---------------------- Page: 2 ----------------------
oSIST prEN ISO 80369-1:2009
EUROPEAN STANDARD
DRAFT
prEN ISO 80369-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 11.040.10; 11.040.20 Will supersede EN 15546-1:2008
English version
Small bore connectors for liquids and gases in healthcare
applications - Part 1: General requirements (ISO/DIS 80369-
1:2009)
Joints de petite dimension pour liquides et gaz pour des Verbindungsstücke mit kleinem Durchmesser für
applications en santé - Partie 1: Exigences générales Flüssigkeiten und Gase in medizinischen Anwendungen -
(ISO/DIS 80369-1:2009) Teil 1: Allgemeine Anforderungen (ISO/DIS 80369-1:2009)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/CLC/TC 3.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN and CENELEC in three official versions (English, French, German). A version in any
other language made by translation under the responsibility of a CEN and or CENELEC member into its own language and notified to the
CEN Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria,
Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and
United Kingdom.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
CEN Management Centre: CENELEC Central Secretariat:
Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels
© 2009 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 80369-1:2009 E
worldwide for CEN national Members and for CENELEC
Members.
---------------------- Page: 3 ----------------------
oSIST prEN ISO 80369-1:2009
prEN ISO 80369-1:2009 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
oSIST prEN ISO 80369-1:2009
prEN ISO 80369-1:2009 (E)
Foreword
This document (prEN ISO 80369-1:2009) has been prepared by Technical Committee ISO/TC 210 "Quality
management and corresponding general aspects for medical devices" in collaboration with Technical
Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the
secretariat of which is held by NEN.
This document is currently submitted to the parallel Enquiry.
This document will supersede EN 15546-1:2008.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive(s).
Endorsement notice
The text of ISO/DIS 80369-1:2009 has been approved by CEN as a prEN ISO 80369-1:2009 without any
modification.
3
---------------------- Page: 5 ----------------------
oSIST prEN ISO 80369-1:2009
---------------------- Page: 6 ----------------------
oSIST prEN ISO 80369-1:2009
DRAFT INTERNATIONAL STANDARD ISO/DIS 80369-1
ISO/TC 210 Secretariat: ANSI
Voting begins on Voting terminates on
2009-06-18 2009-11-18
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
Joints de petite dimension pour liquides et gaz pour des applications en santé —
Partie 1: Exigences générales
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 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.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
In accordance with the provisions of Council Resolution 15/1993 this document is circulated
in the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est
distribué en version anglaise seulement.
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, 2009
---------------------- Page: 7 ----------------------
oSIST prEN ISO 80369-1:2009
ISO/DIS 80369-1
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not
be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading
this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in
this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the
unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be reproduced,
stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or
otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s member
body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2009 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 80369-1:2009
ISO/DIS 80369-1
1 Contents Page
2 1 Scope.1
3 2 Normative references .1
4 3 Terms and definitions.2
5 4 Materials used for small-bore connectors .7
6 5 Requirements for small-bore connectors for specific applications.7
7 5.1 Small-bore connector incompatibility .7
8 5.2 Intravascular or hypodermic applications .8
9 5.3 Breathing systems and driving gases applications .8
10 5.4 Enteral applications.8
11 5.5 Urethral and urinary applications .8
12 5.6 Limb cuff inflation applications .8
13 5.7 Neuraxial applications.9
14 5.8 Alternative small-bore connectors .9
15 6 Procedure to assess a proposed new design of small-bore connector for inclusion in this
16 series of Standards.9
17 6.1 General .9
18 6.2 Proposal initiation.9
19 6.3 Procedure to assess acceptability and non-interconnectable characteristics .10
20 6.3.1 Design.10
21 6.3.2 Design realization .10
22 6.3.3 Design verification.10
23 6.3.4 Design validation .10
24 6.4 Design review.11
25 6.5 Subsequent parts of this series of Standards .11
26 Annex A (informative) Rationale.12
27 Annex B (normative) Mechanical tests for verifying non-interconnectable characteristics.14
28 Annex C (informative) Applications of small-bore connectors.15
29 Annex D (informative) Reference to the Essential Principles .17
30 Annex ZA (informative) Relationship between this Document and the Essential Requirements of
31 EU Directive 93/42/EEC.19
32
© ISO 2009 – All rights reserved iii
---------------------- Page: 9 ----------------------
oSIST prEN ISO 80369-1:2009
ISO/DIS 80369-1
33 Foreword
34 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
35 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
36 technical committees. Each member body interested in a subject for which a technical committee has been
37 established has the right to be represented on that committee. International organizations, governmental and
38 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
39 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
40 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
41 The main task of technical committees is to prepare International Standards. Draft International Standards
42 adopted by the technical committees are circulated to the member bodies for voting. Publication as an
43 International Standard requires approval by at least 75 % of the member bodies casting a vote.
44 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
45 rights. ISO shall not be held responsible for identifying any or all such patent rights.
46 ISO/IEC 80369-1 was prepared by a Joint Working Group of Technical Committee ISO/TC 210, Quality
47 management and corresponding general aspects for medical devices, IEC/TC 62, Electrical equipment,
48 Subcommittee SC D, Electrical equipment in medical practice and CEN/CENELEC TC3/WG 2, Small-bore
49 connectors.
50 This is the first edition of ISO 80369-1 cancels and replaces EN 15546-1:2008 which has been editorially
51 revised.
52 ISO 80369 consists of the following parts, under the general title, Small-bore connectors for liquids and gases
53 in healthcare applications:
54 ⎯ Part 1: General Requirements
55 ⎯ Part 2: Connectors for breathing systems and driving gases applications for respiratory use
56 ⎯ Part 3: Connectors for enteral applications
57 ⎯ Part 4: Connectors for urethral and urinary applications
58 ⎯ Part 5: Connectors for limb cuff inflation applications
59 ⎯ Part 6: Connectors for neuraxial applications
60 In this standard, the following print types are used:
61 ⎯ Requirements and definitions: roman type.
62 ⎯ Test specifications: italic type.
63 ⎯ Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative
64 text of tables is also in a smaller type.
65 ⎯ Terms defined in Clause 3 of the general standard, in this particular standard or as noted: bolded
66 roman type.
iv © ISO 2009 – All rights reserved
---------------------- Page: 10 ----------------------
oSIST prEN ISO 80369-1:2009
ISO/DIS 80369-1
67 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
68 the conditions is true.
69 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part
70 2. For the purposes of this standard, the auxiliary verb:
71 ⎯ “shall” means that compliance with a requirement or a test is mandatory for compliance with this
72 standard;
73 ⎯ “should” means that compliance with a requirement or a test is recommended but is not mandatory for
74 compliance with this standard;
75 ⎯ “may” is used to describe a permissible way to achieve compliance with a requirement or test.
76 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
77 there is guidance or rationale related to that item in Annex A.
78 The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers
79 and testing organizations may need a transitional period following publication of a new, amended or revised
80 ISO or IEC publication in which to make products in accordance with the new requirements and to equip
81 themselves for conducting new or revised tests. It is the recommendation of the committee that the content of
82 this publication be adopted for implementation nationally not earlier than 3 years from the date of publication
83 for equipment newly designed and not earlier than 5 years from the date of publication for equipment already
84 in production.
85
© ISO 2009 – All rights reserved v
---------------------- Page: 11 ----------------------
oSIST prEN ISO 80369-1:2009
ISO/DIS 80369-1
86 Introduction
87 In the 1990s concern grew regarding the proliferation of medical devices fitted with Luer connectors and the
88 reports of patient death or injury arising from misconnections that resulted in the inappropriate delivery of
89 enteral solutions, intrathecal medication or compressed gases.
90 Concerns regarding the use of Luer connectors with enteral feeding tubes and gas sampling and gas delivery
91 systems were raised with CEN/BT and the European Commission. In November 1997 the newly created
92 CHeF steering group set up a Forum Task Group (FTG) to consider the problem.
93 The FTG produced CEN Report CR 13825, in which they concluded that there is a problem arising from the
94 use of a single connector design to a number of incompatible applications. In a coronary care unit there are
95 as many as 40 Luer connectors on the medical devices used with a single patient. Therefore it is not
96 surprising that misconnections are made.
97 Medical devices have for many years followed the established principle of “safety under single fault
98 conditions”. Simply stated this means that a single fault should not result in an unacceptable risk. This
99 principle is embodied in the requirements of numerous medical device standards. Extending this principle to
100 the application of Luer connectors, i.e. that misconnection should not result in an unacceptable risk to a
101 patient, the FTG recommended that the Luer connector should be restricted to medical devices intended to
102 be connected to the vascular system or a hypodermic syringe. In addition, new designs of small-bore
103 connectors should be developed for other applications, and these should be incompatible with Luer
104 connectors and each other.
105 ISO/TR 16142:2006 addresses this type of problem in Essential Principle A.1.2:
106 The solutions adopted by the manufacturer for the design and construction of the devices should
107 conform to safety principles, taking into account the generally acknowledged state of the art.
108 In selecting the most appropriate solutions, the manufacturer should apply the following principles
109 in the following order:
110 - identify hazards and the associated risks arising from the intended use and foreseeable misuse;
111 - eliminate or reduce risks as far as possible (inherently safe design and construction);
112 It is understood that small-bore connector systems cannot be designed to overcome all chances of
113 misconnection or to eliminate deliberate misuse. However, a number of steps that would improve the current
114 situation and lead to greater patient safety can be taken. This will only be achieved through a long-term
115 commitment involving industry, healthcare professionals, medical device purchasers and medical device
116 regulatory authorities.
117 Part 1 of this International Standard and its parts are intended to be the reference documents in which the
118 necessary measures and procedures to prevent misconnection between small-bore connectors used in
119 different applications and designs of small-bore connectors for applications are listed. The JWG of
120 ISO/TC 210 – IEC 62D and CEN/CENELEC TC3/WG 2 is developing this series of standards in such a way
121 that ISO 80369-1 include general requirements to prevent misconnections between small-bore connectors
122 used in different applications.
123 This part 1 of this International Standard contains general requirements to ensure the prevention of
124 misconnection between small-bore connectors used in different applications. Subsequent parts of this
125 series of standards are expected to include requirements with regard to the connectors used in different
126 application categories.
127
vi © ISO 2009 – All rights reserved
---------------------- Page: 12 ----------------------
oSIST prEN ISO 80369-1:2009
DRAFT INTERNATIONAL STANDARD ISO/DIS 80369-1
128 Small bore connectors for liquids and gases in healthcare
129 applications — Part 1: General requirements
130 1 Scope
131 This part of the series of International Standards specifies general requirements, by application, for small-
132 bore connectors used in medical devices and accessories that contain or convey liquids or gases to or
133 from a patient.
134 These applications include, but are not limited to connections for breathing systems and driving gases,
135 and enteral, urethral and urinary limb cuff inflation and neuraxial devices. Small-bore connectors as
136 specified in this International Standards are non-interconnectable with:
137 ⎯ the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006; and
138 ⎯ the nipples of EN 13544-2:2002.
139 It provides the methodology to assess non-interconnectable characteristics of small-bore connectors
140 based on their inherent design and dimensions in order to reduce the risk of misconnections between
141 medical devices or between accessories for different applications and to reduce the risk of misconnections
142 between medical devices with 6 % Luer connectors, and all other non-Luer (6 %) connectors that will be
143 developed under future parts of this series of standards.
144 It does not specify requirements for the medical devices or accessories that use these small-bore
145 connectors. Such requirements are given in particular International Standards for specific medical devices
146 or accessories.
147 NOTE 1 It is intended that new designs of small-bore connectors will be included in this series of standards after they
148 have been assessed according to the procedure given in Clause 6.
149 NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in this series of
150 Standards into medical devices, medical systems or accessories, even if currently not required by the relevant particular
151 medical device standards. It is expected that when the relevant particular medical device standards are revised,
152 requirements for small-bore connectors as specified in the series of standards will be included.
153 NOTE 3 Manufacturers and responsible organizations are encouraged to report their experience with the small-
154 bore connectors specified in this series of standards to the Secretariat of ISO/TC 210 to consider this feedback during
155 the revision of the relevant part of this series of Standards.
156 2 Normative references
157 The following referenced documents are indispensable for the application of this document. The way in which
158 these referenced documents are cited in normative requirements determines the extent (in whole or in part) to
159 which they apply. For dated references, only the edition cited applies. For undated references, the latest
160 edition of the referenced document (including any amendments) applies.
161 ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
162 equipment – Part 1: General requirements
© ISO 2009 – All rights reserved 1
---------------------- Page: 13 ----------------------
oSIST prEN ISO 80369-1:2009
ISO/DIS 80369-1
163 ISO 594-2:1998, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
164 equipment – Part 2: Lock fittings
165 ISO 5356-1:2004, Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets
166 ISO 5356-2:2006, Anaesthetic and respiratory equipment -- Conical connectors -- Part 2: Screw-threaded
167 weight-bearing connectors
168 ISO 5359:2008, Low-pressure hose assemblies for use with medical gases
169 EN 13544-2:2002, Respiratory therapy equipment - Part 2: Tubing and connectors
170 ISO 14971:2007, Medical devices - Application of risk management to medical devices
171 ISO/TR 16142:2006, Medical devices - Guidance on the selection of standards in support of recognized
172 essential principles of safety and performance of medical devices
173 IEC 62366:2007, Medical devices - Application of usability engineering to medical devices
1)
174 ISO 80369-2:— , Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors
175 for breathing systems and driving gases applications
2)
176 ISO 80369-3— , Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors
177 for enteral applications
3)
178 ISO 80369-4:— , Small-bore connectors for liquids and gases in healthcare applications - Part 4: Connectors
179 for urethral and urinary applications
4)
180 ISO 80369-5:— , Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors
181 for limb cuff inflation applications
5)
182 ISO 80369-6:— , Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors
183 for neuraxial applications
184 ASTM D747-02, Standard test method for apparent bending modulus of plastics by means of a cantilever
185 beam
186 ASTM D790-07, 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 following terms and definitions apply. For convenience, the sources of
190 all defined terms used in this document are given in an index on page 21.
191 3.1
192 accessory
193 additional part(s) for use with medical device in order to:
1) To be published.
2) To be published.
3) To be published.
4) To be published.
5) To be published.
2 © ISO 2009 – All rights reserved
---------------------- Page: 14 ----------------------
oSIST prEN ISO 80369-1:2009
ISO/DIS 80369-1
194 ⎯ achieve the intended use,
195 ⎯ adapt it to some special use,
196 ⎯ facilitate its use,
197 ⎯ enhance its performance, or
198 ⎯ enable its functions to be integrated with those of other medical devices
199 [Modified from IEC 60601-1:2005, definition 3.3]
200 3.2
201 application
202 specific healthcare field of use of a type of small-bore connector
203 Note Annex C contains a list of small-bore connector applications.
204 3.3
205 breathing system
206 inspiratory and expiratory pathways through which gas flows at respiratory pressures and bounded by the port
207 through which fresh gas enters, the patient connection port and the exhaust port
208 3.4
209 connection
210 union or joining of mating halves of a connector
211 3.5
212 connector
213 mechanical device, consisting of one of two mating halves and designed to join a conduit to convey liquids or
214 gases
215 3.6
216 harm
217 physical injury or damage to the health of people, or damage to property or the environment
218 [ISO 14971:2007, definition 2.2]
219 3.7
220 hazard
221 potential source of harm
222 [ISO 14971:2007, definition 2.3]
223 3.8
224 hazardous situation
225 circumstance in which people, property, or the environment are exposed to one or more hazard(s)
226 NOTE See ISO 14971:2007, Annex E for an explanation of the relationship between “hazard” and “hazardous
227 situation”.
228 [ISO 14971:2007, definition 2.4]
229 3.9
230 intended use
231 use for which a product, process or service is intended according to the specifications, instructions and
232 information provided by the manufacturer
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.