EN 15546-1:2008
(Main)Small bore connectors for liquids and gases in healthcare applications - Part 1 - General Requirements
Small bore connectors for liquids and gases in healthcare applications - Part 1 - General Requirements
This part of the series of European Standards specifies general requirements for small bore connectors used in specific medical applications to convey liquids or gases to or from a patient or via intermediate systems.
It is intended to be a reference document that can be used as a tool to minimise the risk of misconnections of small bore connectors between different medical applications.
It provides a framework to assess non-interchangeability of small bore connectors based on their inherent design and dimensions.
It does not specify requirements for the medical devices and accessories on which these connectors are provided. Such requirements are given in particular International or European Standards for specific medical devices and accessories.
NOTE 1 It is intended that new designs of small bore connectors should be included in this series of Standards after they have been assessed according to the procedure given in Clause 6.
NOTE 2 Manufacturers are encouraged to incorporate the small bore connectors specified in this series of Standards into medical devices or systems, even if they are not currently required by the particular device standards. It is expected that when the particular device standards are revised, requirements for small bore connectors as specified in the series of Standards will be included.
NOTE 3 Manufacturers and users are encouraged to report their experience with the small bore connectors specified in this series of Standards to the technical committee or task force in charge of the elaboration of the present series of Standards, to consider this feedback during the revision of the relevant part of this series of Standards.
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen
Dieser Teil der Reihe von Europäischen Normen legt allgemeine Anforderungen an Verbindungsstücke mit kleinem Durchmesser in spezifischen medizinischen Anwendungen für demn Patienten mittels zwischenge¬schalteter Systeme zu oder vom Patienten weggeführte Flüssigkeiten und Gase fest.
Diese Europäische Norm versteht sich als Referenzdokument, das als Arbeitsmittel zur Verringerung des Risikos von fehlerhaften Verbindungen mit Verbindungsstücken mit kleinem Durchmesser zwischen verschie¬denen medizinischen Anwendungen dienen kann.
Sie liefert einen Rahmen, um die Nichtaustauschbarkeit von Verbindungsstücken mit kleinem Durchmesser auf der Grundlage ihrer Ausführung und Maße zu beurteilen.
Diese Europäische Norm legt keine Anforderungen an die medizinischen Geräte oder Zubehörteile, für die diese Verbindungsstücke bestimmt sind, fest. Derartige Anforderungen finden sich in den jeweiligen Inter¬nationalen oder Europäischen Normen für die spezifischen medizinischen Geräte und Zubehörteile.
ANMERKUNG 1 Es ist vorgesehen, dass die neuen Ausführungen von Verbindungsstücken mit kleinem Durchmesser in diese Reihe von Normen aufgenommen werden sollten, nachdem diese entsprechend dem in Abschnitt 6 angegebenen Verfahren beurteilt wurden.
ANMERKUNG 2 Die Hersteller werden dazu angehalten, bereits jetzt die in der Normenreihe festgelegten Verbin¬dungsstücke mit kleinem Durchmesser in medizinische Geräte und Systeme zu integrieren, auch wenn dies zur Zeit nicht von den betreffenden Gerätenormen vorgeschrieben ist. Es ist zu erwarten, dass die betreffenden Gerätenormen nach Überarbeitung die Anforderungen an Verbindungsstücke mit kleinem Durchmesser entsprechend den Festlegungen der Normenreihe enthalten werden.
Raccords de petite taille pour liquides et gaz dans les applications médicales - Partie 1 : Exigences générales
La présente partie de cette Norme européenne spécifie les exigences générales relatives aux raccords de
petite taille utilisés dans des applications médicales spécifiques, pour transporter des liquides ou des gaz à
destination ou en provenance d’un patient, ou via des systèmes intermédiaires.
Elle est destinée à être un document de référence pouvant servir d’outil pour réduire le plus possible les
risques d'interversions de raccords de petite taille entre différentes applications médicales.
Elle fournit un cadre de travail permettant d’évaluer la non-interchangeabilité des raccords de petite taille de
par leur conception et leurs dimensions.
Elle ne spécifie pas les exigences relatives aux dispositifs médicaux et accessoires auxquels ces raccords
sont destinés. Ces exigences figurent dans les normes européennes ou internationales traitant des dispositifs
médicaux et accessoires.
NOTE 1 Il est prévu d’inclure les nouveaux modèles de raccords de petite taille dans cette série de normes après
les avoir évalués selon le mode opératoire décrit à l’article 6.
NOTE 2 Les fabricants sont incités à intégrer les raccords de petite taille spécifiés dans cette série de normes dans
les systèmes ou dispositifs médicaux, même si cela n’est pas actuellement requis par les normes relatives à ces
dispositifs. Lors de la révision des normes relatives à ces dispositifs, il est prévu d’inclure des exigences relatives aux
raccords de petite taille selon cette série de normes.
NOTE 3 Les fabricants et les utilisateurs sont incités à faire part de leur expérience des raccords de petite taille
spécifiés dans cette série de normes au comité technique ou au groupe d’étude en charge de l’élaboration de la présente
série de normes, pour que ce dernier puisse prendre en compte ces retours d’expérience lors de la révision de la partie
correspondante de cette série de normes.
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 1. del: Splošne zahteve
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2008
3ULNOMXþNL]PDMKQLPSUHPHURP]DWHNRþLQHLQSOLQH]DXSRUDERY]GUDYVWYXGHO
6SORãQH]DKWHYH
Small bore connectors for liquids and gases in healthcare applications - Part 1 - General
requirements
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und gase in
medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen
Raccords de petite taille pour liquides et gaz dans les applications médicales - Partie 1 :
Exigences générales
Ta slovenski standard je istoveten z: EN 15546-1:2008
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 15546-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2008
ICS 11.040.10
English version
Small bore connectors for liquids and gases in healthcare
applications - Part 1 - General Requirements
Raccords de petite taille pour liquides et gaz dans les Verbindungsstücke mit kleinem Durchmesser für
applications médicales - Partie 1 : Exigences générales Flüssigkeiten und Gase in medizinischen Anwendungen -
Teil 1: Allgemeine Anforderungen
This European Standard was approved by CEN on 21 March 2008.
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 Management Centre or to any CEN or 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/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.
CEN Management Centre: CENELEC Central Secretariat:
rue de Stassart, 36 B-1050 Brussels rue de Stassart, 35 B-1050 Brussels
© 2008 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN 15546-1:2008 E
worldwide for CEN national Members and for CENELEC
Members.
Contents Page
Foreword.3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .6
4 Materials used for small bore connectors .6
5 Small bore connector requirements for specific medical applications .6
6 Procedure to assess proposed new small bore connector for inclusion in this series of
Standards .7
6.1 General.7
6.2 Procedure to be carried out by proposer of new small bore connector to assess the non-
interchangeability with existing small bore connectors .8
6.3 Design review.8
Annex A (informative) Rationale for this Standard .9
Annex B (informative) Overview of small bore connector allocation .17
Annex C (informative) Small bore connectors for vascular systems applications .19
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical devices .25
Bibliography .26
Foreword
This document (EN 15546-1:2008) has been prepared by CEN/BT/TF 123 “‘Small-bore connectors for Iiquids
and gases in healthcare applications”, the secretariat of which is held by AFNOR.
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 November 2008, and conflicting national standards shall be withdrawn at
the latest by November 2008.
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.
Following the recommendations given in the CEN Report 13825, Luer connectors - A report to CEN CHeF
from the CEN forum task group “Luer fittings”, this European Standard has been prepared under a mandate
given to CEN by the European Commission and the European Free Trade Association.
This part 1 of the standard contains general requirements to ensure the prevention of cross-connection
between small bore connectors used in different fields of medical applications. It is intended that subsequent
parts include the dimensions and drawings of connectors allocated to specific medical applications.
This European Standard supports the essential requirements of the EU Directive(s). For relationship with EU
Directive(s), see informative Annex ZA, which is an integral part of this 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, 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.
Introduction
In the 1990s concern grew regarding the proliferation of 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 CEN
Healthcare Forum (CheF) steering group set up a Forum Task Group (FTG) to consider the problem.
The FTG produced CEN Report “CR 13825:2000" [2], in which they concluded that there is a problem arising
from the application of a single connector design to a number of incompatible applications. In a coronary care
unit there are as many as 40 connectors on the devices used with a single patient. Therefore, it is not
surprising that misconnections are made.
For many years medical devices have followed the established principle of “safety under single fault
conditions”. Simply stated, this means that a single fault should not result in a hazard. 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 a patient hazard, the FTG
recommended that the Luer connector should be restricted to devices intended to be connected to the
vascular system or a hypodermic syringe. In addition, new designs of small bore connector should be
developed for non-intravascular applications, and these should be incompatible with Luer connectors and
each other.
NOTE Condition in which a single means for reducing a RISK is defective or a single abnormal condition is
present.
The Medical Device Directive 93/42/EEC addresses this type of problem in Essential Requirement 1.2.
(solutions adopted for the design and construction of devices must conform to safety principles, taking into
account the generally acknowledged state of the art. In seeking the most appropriate solutions, the
manufacturer must apply the following principles in the following order:
eliminate or reduce risk as far as possible (inherently safe design and construction, etc.)
and 9.1 (if the device is intended for use in combination with other devices or equipment, the whole
combination, including the connector system must be safe, etc.)
CEN/BT/Task Force 123 ‘Small bore connectors for liquids and gases in healthcare applications’ was
established to carry forward the recommendations of CR 13825 [2]. It was recognised that small bore
connector systems could not be designed to overcome all chances of misconnection or to eliminate deliberate
misuse. However, a number of steps could be taken that would improve the current situation and lead to
greater patient safety. This will only be achieved through a long-term commitment involving industry,
healthcare professionals, device purchasers and medical device regulatory authorities.
This part 1 of European Standard and its parts are intended to be the reference documents in which all
designs of small bore connectors for medical applications are listed. CEN/BT/TF 123 has developed this
series of Standards in such a way that the standard includes general requirements to ensure the prevention of
cross-connection between connectors used in different fields of medical application.
1 Scope
This part of the series of European Standards specifies general requirements for small bore connectors used
in specific medical applications to convey liquids or gases to or from a patient or via intermediate systems.
It is intended to be a reference document that can be used as a tool to minimise the risk of misconnections of
small bore connectors between different medical applications.
It provides a framework to assess non-interchangeability of small bore connectors based on their inherent
design and dimensions.
It does not specify requirements for the medical devices and accessories on which these connectors are
provided. Such requirements are given in particular International or European Standards for specific medical
devices and accessories.
NOTE 1 It is intended that new designs of small bore connectors should be included in this series of Standards after
they have been assessed according to the procedure given in Clause 6.
NOTE 2 Manufacturers are encouraged to incorporate the small bore connectors specified in this series of Standards
into medical devices or systems, even if they are not currently required by the particular device standards. It is expected
that when the particular device standards are revised, requirements for small bore connectors as specified in the series of
Standards will be included.
NOTE 3 Manufacturers and users are encouraged to report their experience with the small bore connectors specified in
this series of Standards to the technical committee or task force in charge of the elaboration of the present series of
Standards, 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.
prEN 15546-2, Small bore connectors for liquids and gases in healthcare applications - Part 2 - Connectors for
respiratory applications
EN 1707, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -
Lock fittings
EN 20594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment
- Part 1: General requirements (ISO 594-1: 1986)
3 Terms and definitions
For the purpose of this series of Standards, the following terms and definitions apply:
3.1
application (specific application)
medical applications of small bore connectors as listed in Annex B (informative)
3.2
connection
means by which at least two engaged small bore connectors convey a gas or liquid from one device to
another
3.3
rigid material
material with a modulus of elasticity either in flexure or in tension greater than 7 000 kg/cm² (100,000 psi) at
23 °C and 50 % relative humidity when tested in accordance with ASTM methods D 747 or D 790: Test for
stiffness of plastics
3.4
semi-rigid material
material with a modulus of elasticity either in flexure or in tension, between 700 and 7 000 kg/cm² (10,000 and
100,000 psi) at 23 °C and 50 % relative humidity when tested in accordance with ASTM methods D 747 or D
790: Test for stiffness of plastics
3.5
risk
combination of the probability of occurrence of harm and the degree of severity of the harm (term taken from
ISO 14971:2007 [3])
3.6
safety
freedom from unacceptable risk (term taken from ISO 14971:2007 [3])
3.7
small bore connector
connector having a maximum bore diameter of 8,5 mm
4 Materials used for small bore connectors
Small bore connectors shall be made of rigid or semi-rigid materials (see definitions in 3.3 and 3.4).
5 Small bore
...
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