SIST EN 15546-1:2008
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
The Standard is intended to provide a reference document that can be used as a tool to prevent interchangeability of small-bore connectors used in medical practice to convey liquids or gases to or from a patient, directly or indirectly, via intermediate systems. This is to prevent cross-connections between different applications in order to maximize patient safety. It is to intend to be used as a framework to assess non-interchangeability of small-bore connectors based on their inherent design and dimensions. This Standard includes advice on connector design and on assessment of non-interchangeability between applications, and suggested connector designs for some applications. This Standard does not specify any other requirements of medical devices and accessories for which these connections are provided. These requirements are given in particular International or European Standards for specific medical devices and accessories.
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 a destination ou en provenance d’un patient, directement, ou indirectement au travers de systemes intermédiaires.
Elle est destinée a etre 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 modeles de raccords de petite taille dans cette série de normes apres les avoir évalués selon le mode opératoire décrit a l’article 10.
NOTE 2 Les fabricants sont incités a intégrer les raccords de petite taille spécifiés dans cette série de normes dans les systemes ou dispositifs médicaux, meme si cela n’est pas actuellement requis par les normes relatives a ces dispositifs. Lors de la révision des normes relatives a 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 a faire part de leur expérience des raccords de petite taille spécifiés dans cette série de normes au secrétariat du CEN/BT/TF 123, 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
SIST EN 15546-1:2008
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
SIST EN 15546-1:2008 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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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.
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EN 15546-1:2008 (E)
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
2
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EN 15546-1:2008 (E)
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.
3
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EN 15546-1:2008 (E)
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.
4
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EN 15546-1:2008 (E)
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)
5
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EN 15546-1:2008 (E)
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 connector requirements for specific medical applications
5.1 General
Small bore connectors for different applications shall not be compatible.
5.2 Small bore connector applications
5.2.1 General
The specific medical applications and requirements of small bore connectors included in this series of
Standards or given in other standards shall be as follows:
NOTE An overview of the allocation of small bore connectors, including some typical examples, is given in Annex B
(informative).
6
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EN 15546-1:2008 (E)
5.2.2 Small bore connectors for vascular or hypodermic applications
Small bore connectors intended to be used for connections in vascular or hypodermic applications shall be in
accordance with EN 1707 and EN 20594-1.
NOTE Specific hypodermic applications include e.g. subcutaneous, intra-muscular and intraperitoneal injections and
infiltrations.
5.2.3 Small bore connectors for enteral applications
Small bore connectors intended to be used for connections in enteral applications shall be in accordance with
the requirements given in the relevant part of this Standard.
5.2.4 Small bore connectors for respiratory applications
Small bore connectors intended to be used for connections in respiratory applications shall be in accordance
with the requirements given in prEN 15546-2.
5.2.5 Small bore connectors for neuraxial applications
Small bore connectors intended to be used for connections in neuraxial applications shall be in accordance
with the requirements given in the relevant part of this Standard.
5.2.6 Small bore connectors for urethral / urinary applications
Small bore connectors intended to be used for connections in urethral/urinary applications shall be in
accordance with the requirements given in the relevant part of this Standard.
5.2.7 Small bore connector for circumferential cuff inflation system (for limbs) applications
Small bore connectors intended to be used for connections in circumferential cuff inflation system (for limbs)
applications shall be in accordance with the requirements given in the relevant part of this Standard.
5.2.8 Alternative connectors
Small bore connectors different from those detailed in this part of Standard shall be presumed to be in
compliance with the safety objectives of this standard if it can be demonstrated that an equivalent degree of
safety is obtained (i.e. compliance with requirements presumes that risks have been mitigated to acceptable
levels) unless objective evidence to the contrary becomes available.
NOTE 1 Objective evidence is usually obtained through post-market surveillance.
Evidence of an equivalent degree of safety shall be provided by the manufacturer.
NOTE 2 Regional or national regulations usually require the provision of evidence to competent authority or a
conformity assessment body e.g. notified body in the European Economic Area (EEA) upon request.
6 Procedure to assess proposed new small bore connector for inclusion in this
series of Standards
6.1 General
To ensure that new designs of small bore connectors are non-interchangeable with the small bore connectors
covered by this series of Standards, or other small bore connectors commonly known to be used in the same
patient environment, the procedure shall be as follows:
• Make a paper comparison of the design of the proposed small bore connector with the design details in
this series of Standards;
• Produce test samples and carry out practical tests as described below;
• Confirm the results of the design review and practical tests with at least two other parties with sufficient
expertise.
7
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EN 15546-1:2008 (E)
NOTE 1 The three parties involved in the design review and practical tests should originate from three different
member bodies. The parties involved in the design review may also carry out the practical tests.
NOTE 2 Attention is drawn to the possibility that new designs may be subject to patent rights. CEN cannot be held
responsible for identifying any or all such patents rights
6.2 Procedure to be carried out by proposer of new small bore connector to assess the non-
interchangeability with existing small bore connectors
• Select at least three parties to carry out the design review and practical tests and ensure that they have
sufficient technical expertise;
• Obtain all necessary documentation, including dimension requirements and drawings of small bore
connectors already included in this series of Standards, or due to be included by amendment or revision.
Compare with dimension requirements and drawings of proposed new small bore connector to ensure
theoretical non-interchangeability;
• Produce sufficient test samples and carry out practical tests to ensure non-interchangeability with small
bore connectors already included in this series of Standards or due to be included by amendment or
revision;
• Prepare reports of three or more design reviews and practical tests and submit them for consideration to
the technical committee or task force in charge of the elaboration of the present series of Standards.
6.3 Design review
• A group with sufficient technical expertise within the technical committee or task force in charge of the
elaboration of the present series of standards shall be assigned the responsibility of reviewing the design
and practical test results;
• The group shall be given a time scale to carry out the review and the proposer notified of this time scale;
• The group shall assess the results and prepare a report to the technical committee or task force in charge
of the elaboration of the present series of standards giving its conclusions;
• Results shall be presented and discussed within the technical committee or task force in charge of the
elaboration of the present series of standard for deciding whether or not the proposed small bore
connector is suitable for inclusion in this series of Standards for the application intended;
• Proposer shall be informed of the conclusion;
• If the proposed small bore connector is suitable for inclusion in this series of Standards, the relevant
committee shall initiate the appropriate steps to include the new design by amendment or revision of the
relevant part of this series of Standards.
8
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EN 15546-1:2008 (E)
Annex A
(informative)
Rationale for this Standard
Advances in modern medicine have led to a significant rise in the number of medical devices attached to
patients. Many of these devices fall into the categories of monitoring devices, diagnostic devices and drug
delivery devices.
Such devices perform a variety of similar, but not interchangeable functions. Examples include: intravenous
fluid delivery, enteral feeding, respiratory gas sampling, non-invasive blood pressure measurement and the
injection of intrathecal medication. Despite the varied nature of the functions performed, many of these
devices continue to use a universal system of small bore connectors based on the 6 % Luer tapered
connector.
The universal nature of the connectors used, and the proximity of several different connectors around a single
patient make accidental misconnections inevitable. The consequences of such misconnections are variable
but a significant number are actually or potentially fatal.
Serious and usually fatal misconnections include the intravenous injection of air, the intravenous injection of
enteral feeds and the intrathecal injection of vincristine. Less disastrous misconnections such as the enteral
administration of intravenous fluids may not directly harm the patient but will lead to a failure of the intended
administration.
Introducing a series of non-interchangeable, small bore connectors for medical devices made from rigid or
semi-rigid materials will help to reduce the incidence of misconnections and lead to a direct improvement in
patient safety. Rigid or semi-rigid materials have been specified to eliminate the possibility of forcing a fit
between incompatible connectors made from flexible materials. Any such series must also include the 6 %
Luer which should be reserved for connections in vascular applications or with a hypodermic syringe intended
for specific other medical applications such as subcutaneous, intra-muscular and intraperitoneal injections and
infiltrations.
CEN/BT/TF 123 carried out an extensive risk analysis of possible misconnections that might result when Luer
connectors are used in different applications. The results of this analysis are shown in Table A.1
Terms and definitions used in the risk analysis table:
Severity level (SL) 1 = minor injury or discomfort
2 = reversible injury
3 = death or irreversible injury
Probability level (PL) 1 = low
2 = medium
3 = high
2 2
Risk category (RC) RC = SL x PL
9
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EN 15546-1:2008 (E)
Criteria for classification of the risk category:
1 = broadly acceptable
2 to 8 = ALARP (as low as reasonable technical/economically practicable) (8 = maximum tolerable)
> 8 = intolerable
Summary of risk analysis of possible misconnections:
1640 possible connections have been assessed using this table;
654 possible connections were considered to be broadly acceptable;
608 possible connections were considered as low as reasonably practicable;
378 possible connections were considered to be intolerable.
10
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EN 15546-1:2008 (E)
Table A 1
Risk analysis of possible misconnections (part 1 of 6)
connector to deliver to
or divert from the device
connector on the
device/patient
SL PL RC SL PL RC SL PL RC SL PL RC SL PL RC SL PL RC SL PL RC
Enteral
>>>> i u <<<<
enteral giving sets 11 1 1 1 1 11 1 1 1 1 11 1 1 1 1
gravity, pump, connecting 1 1 1 >>>> i u <<<< 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
>>>> i u <<<<
medication ports (Y-ports, T-sets) 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
enteral tubes (nasal, gastric, duodenal, jejunal) 1 1 1 1 1 1 1 1 1 >>>> i u <<<< 1 1 1 1 1 1 1 1 1
>>>> i u <<<<
percutaneous (PEG, PEJ, buttons) 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
enteral pouches 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 >>>> i u <<<< 1 1 1
syringes (medication, irrigation, inflation) 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 >>>> i u <<<<
Respiratory
gas sampling port on HME 3 19 3 1 9 3 19 3 1 9 3 19 3 1 9 2 1 4
gas sampling port on breathing system 3 1 9 3 1 9 3 1 9 3 1 9 3 1 9 3 1 9 2 1 4
gas sampling port on gas monitor 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
gas return port on breathing system 2 1 4 2 1 4 2 1 4 2 1 4 2 1 4 2 1 4 2 1 4
gas return port on gas monitor 1 1 1 1 1 1 2 1 4 2 1 4 2 1 4 2 1 4 1 1 1
pressure measuring port on breathing system 2 1 4 2 1 4 2 1 4 2 1 4 2 1 4 2 1 4 2 1 4
expiratory valve conrol port on breathing system 3 1 9 3 1 9 3 1 9 3 1 9 3 1 9 3 1 9 3 1 9
nebulizer driving gas port on breathing system 2 1 4 2 1 4 3 1 9 3 1 9 3 1 9 3 1 9 2 1 4
oxygen supply port on breathing system 3 1 9 3 1 9 3 1 9 3 1 9 3 1 9 3 1 9 2 1 4
liquid injection port on breathing system 2 1 4 2 1 4 2 1 4 2 1 4 2 1 4 2 1 4 2 1 4
water supply port on breathing system 2 1 4 2 1 4 2 1 4 2 1 4 2 1 4 2 1 4 2 2 16
inflation port on tracheal tube 3 2 36 3 2 36 2 2 16 3 2 36 3 2 36 3 1 9 2 3 36
inflation port on face mask 1 1 1 1 1 1 11 1 1 1 1 11 1 1 1 1 12 4
gas sampling port on tracheal tube 3 2 36 3 2 36 2 2 16 3 2 36 3 2 36 3 1 9 2 2 16
gas injection port on tracheal tube 3 2 36 3 2 36 3 2 36 3 2 36 3 2 36 3 1 9 2 1 4
Intravascular
infusion line 3 2 36 3 2 36 3 2 36 3 2 36 3 2 36 3 1 9 3 2 36
needles 3 236 3 236 3 236 3 236 3 236 3 1 9 3 2 36
pressure measuring access to intravascular 3 236 3 236 3 236 3 236 3 236 3 1 9 3 2 36
central venous catheters 3 236 3 236 3 236 3 236 3 236 3 1 9 3 2 36
Neuraxial
spinal needles 3 19 3 1 9 3 19 2 1 4 2 14 2 1 4 3 1 9
epidural needles 3 1 9 3 1 9 3 1 9 2 1 4 2 1 4 2 1 4 3 1 9
epidural catheters 3 1 9 3 1 9 3 1 9 3 1 9 3 1 9 2 1 4 3 2 36
spinal catheters 3 19 3 1 9 3 19 3 1 9 3 19 2 1 4 3 2 36
Non invasive blood pressure
NIBP-cuff connection ports 1 1 1 1 1 1 3 1 9 3 1 9 3 1 9 3 1 9 1 1 1
tourniquet cuff or tubing 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
Urethral / urinary
pleural catheters 2 216 2 216 2 216 2 216 2 216 2 2 16 2 2 16
urinal catheters 2 14 2 1 4 1 11 1 1 1 1 11 1 1 1 1 1 1
suction catheters 2 14 2 1 4 2 14 2 1 4 2 14 2 1 4 2 1 4
peritoneal dialysis in-/output port 2 1 4 2 1 4 2 1 4 2 1 4 2 1 4 1 1 1 1 1 1
cystostomy catheters 2 14 2 1 4 2 14 2 1 4 2 14 1 1 1 1 1 1
Endoscopy
cleaning port on endoscopes 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
insufflation port on endoscopes 1 11 1 1 1 1 11 1 1 1 1 11 1 1 1 1 1 1
liquid injection port on endoscope 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
suction port on endoscope 1 1 1 1 1 1 11 1 1 1 1 11 1 1 1 1 11 1
11
Enteral
enteral giving sets
gravity, pump, connecting
medication ports (Y-ports, T-sets)
enteral tubes (nasal, gastric, duodenal, jejunal)
percutaneous (PEG, PEJ, buttons)
enteral pouches
syringes (medication, irrigation, inflation)
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EN 15546-1:2008 (E)
Table A 1 (continued)
Risk analysis of possible misconnections (part 2 of 6)
connector to deliver to
or divert from the device
connector on the
device/patient
SL PL RC SL PL RC SL PL RC SL PL RC SL PL RC SL PL RC SL PL RC SL PL RC
Enteral
enteral giving sets 1 1 1 1 1 1 21 4 2 1 4 21 4 1 1 1 2 1 4 2 14
gravity, pump, connecting 1 1 1 1 1 1 2 1 4 2 1 4 2 1 4 1 1 1 2 1 4 2 1 4
medication ports (Y-ports, T-sets) 1 1 1 1 1 1 2 1 4 2 1 4 2 1 4 1 1 1 2 1 4 2 1 4
enteral tubes (nasal, gastric, duodenal, jejunal) 1 1 1 1 1 1 2 1 4 2 1 4 2 1 4 1 1 1 2 1 4 2 1 4
percutaneous (PEG, PEJ, buttons) 1 1 1 1 1 1 2 1 4 2 1 4 2 1 4 1 1 1 2 1 4 2 1 4
enteral pouches 1 1 1 1 1 12 1 4 2 1 42 1 4 1 1 12 1 4 2 1 4
syringes (medication, irrigation, inflation) 1 1 1 1 1 1 2 1 4 2 1 4 2 1 4 1 1 1 2 1 4 2 1 4
Respiratory
gas sampling port on HME >>>> i u <<<< 1 2 4 1 1 1 1 2 4 1 1 1 1 2 4 1 1 1 2 2 16
gas sampling port on breathing system 1 2 4 >>>> i u <<<< 1 1 1 1 2 4 1 1 1 1 2 4 1 1 1 2 2 16
gas sampling port on gas monitor 1 1 1 1 1 1 >>>> i u <<<< 1 1 1 1 1 1 1 2 4 1 1 1 1 1 1
>>>> i u <<<<
gas return port on breathing system 1 1 1 1 1 1 1 1 1 1 1 1 1 2 4 1 1 1 2 2 16
gas return port on gas monitor 1 1 1 11 1 1 1 1 11 1 >>>> i u <<<< 1 2 4 1 1 1 1 11
pressure measuring port on breathing system 1 1 1 1 1 1 1 1 1 1 2 4 1 1 1 >>>> i u <<<< 1 1 1 2 2 16
>>>> i u <<<<
expiratory valve conrol port on breathing system 2 1 4 2 1 4 2 1 4 2 2 16 2 1 4 1 2 4 2 2 16
>>>> i u <<<<
nebulizer driving gas port on breathing system 2 1 4 2 1 4 2 2 16 1 2 4 1 1 1 1 2 4 1 1 1
oxygen
...
SLOVENSKI oSIST prEN 15546-1:2006
PREDSTANDARD
september 2006
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu –
1. del: Splošne zahteve
Small bore connectors for liquids and gases in healthcare applications - Part 1:
General requirements
ICS 11.040.01 Referenčna številka
oSIST prEN 15546-1:2006(en)
© Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno
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EUROPEAN STANDARD
DRAFT
prEN 15546-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2006
ICS
English Version
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
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the CEN/BT/TF 123.
If this draft becomes a European Standard, CEN 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 in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 15546-1:2006: E
worldwide for CEN national Members.
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prEN 15546-1:2006 (E)
Contents Page
Foreword.3
Introduction .4
1 Scope.5
2 Normative references.5
3 Terms and definitions .6
3.1 Application (specific application).6
3.2 Connection.6
3.3 Driving gas.6
3.4 Harm.6
3.5 Hazard.6
3.6 Normal condition.6
3.7 Normal use.6
3.8 Operator.6
3.9 Patient.6
3.10 Responsible organisation (user).6
3.11 Risk.7
3.12 Safety.7
3.13 Single fault condition.7
3.14 Small bore connector.7
4 Design allocation of small bore connectors .7
4.1 General.7
4.2 Existing designs.7
4.3 New designs.7
5 Materials, design and constructions of small bore connectors .7
6 Particular small bore connector requirements for specific medical applications.8
6.1 Small bore connectors for vascular and specific other medical applications.8
6.2 Small bore connectors for enteral applications .8
6.3 Small bore connectors for respiratory applications .8
6.4 Small bore connectors for neuraxial applications .8
6.5 Small bore connectors for urethral / urinary applications .8
6.6 Small bore connector for circumferential cuff inflation system (for limbs) applications .8
7 Procedure to assess proposed new small bore connector for inclusion in this series of
Standards .9
7.1 General.9
7.2 Procedure to be carried out by proposer of new small bore connector to assess the non-
interchangeability with existing small bore connectors .9
7.3 Consideration of design review and practical test results by CEN BT TF 123 .9
8. Cleaning, disinfection, sterilisation and disposal .10
8.1 Small bore connectors “not for re-use” .10
8.2 Reusable small bore connectors .10
Annex A (informative) Rationale for this Standard .11
Annex B (informative) Overview of small bore connector allocation .19
Annex C (informative) Small bore connectors for vascular systems applications .21
Annex D (informative) Glossary Terminology - Index of defined terms .26
Bibliography .27
Annex ZA (informative) Reference to the Essential Requirements.28
2
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prEN 15546-1:2006 (E)
Foreword
This document (prEN 15546-1:2006) has been prepared by Technical Committee CEN/BT/TF 123 “Small bore
connectors for liquids and gases in healthcare applications", the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
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 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.
Annexes A, B, C and D are informative.
3
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prEN 15546-1:2006 (E)
Introduction
In the 1990’s 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”, 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.
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. 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 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 standard includes general requirements to ensure the prevention of cross-
connection between connectors used in different fields of medical application. Subsequent parts of this series
include the dimensions and drawings of connectors allocated to specific medical applications.
4
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prEN 15546-1:2006 (E)
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, directly or indirectly, 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 of medical devices and accessories for which these connectors are provided.
Such requirements are given in particular International or European Standards for specific medical devices
and accessories.
Note1: 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 10.
Note 2: Manufacturers are encouraged to incorporate the small bore connectors specified in this series of Standards into
medical devices or systems, even if currently not 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 secretariat of CEN/BT/TF 123, so that CEN/BT/TF 123 can consider this feedback
during the revision of the relevant part of this series of Standards
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications.
These normative references are cited at the appropriate places in the text and the publications are listed
hereafter. For dated references, subsequent amendments to or revision of any of these publications apply to
this European Standard only when incorporated in it by amendment or revision. For undated references the
latest edition of the publication referred to applies.
ISO 594 / 1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical
equipment – Part 1: General requirements
ISO 594 / 2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical
equipment – Part 2: Lock fittings
EN 1707:1996 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)
EN ISO 17664 Information to be provided by the manufacturer for the reprocessing of re-sterilisable
medical devices
5
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prEN 15546-1:2006 (E)
3 Terms and definitions
For the purpose of this series of Standards, the following definitions apply:
3.1 Application (specific application)
Medical applications of small bore connectors as listed in annex B (informative).
3.2 Connection
A means by which at least two engaged small bore connectors convey a gas or liquid from one device to
another.
3.3 Driving gas
Gas that powers a medical device.
3.4 Harm
Physical injury or damage to the health of people or damage to property or the environment (term taken from
ISO 14971: 2000)
3.5 Hazard
Potential source of harm (term taken from ISO 14971: 2000)
3.6 Normal condition
Condition in which all means provided for protection against hazards are intact.
3.7 Normal use
Operation, including routine inspection and adjustments by the operator, and stand-by, according to the
instructions for use.
3.8 Operator
Person handling equipment.
3.9 Patient
Human being undergoing a medical, surgical or dental procedure.
3.10 Responsable organisation (user)
Entity accountable for the use and maintenance of an equipment or a system.
NOTE 1 The accountable entity can be a hospital, the operator, or a lay person. In home use applications, the patient,
operator and responsible organisation may be one and the same person.
NOTE 2 Education and training is included in "use."
6
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prEN 15546-1:2006 (E)
3.11 Risk
Combination of the probability of occurrence of harm and the degree of severity of the harm (term taken from
ISO 14971: 2000)
3.12 Safety
Freedom from unacceptable risk (term taken from ISO 14971: 2000)
3.13 Single fault condition
Condition in which a single means for reducing a RISK is defective or a single abnormal condition is present
3.14 Small bore connector
A connector having a maximum bore diameter of 8,5 mm.
4 Design allocation of small bore connectors
4.1 General
This part 1 of standard is intended to be the guidance and the reference document that leads to the allocation
of different small bore connectors to specific applications. The dimensions and drawings of these designs and
their allocation to specific medical applications are intended to be given in subsequent parts of this series of
Standards.
4.2 Existing designs
Some designs of small bore connectors have already been or are being developed for specific applications,
see annex C, e.g. Luer connectors as specified in EN 20594-1 or EN 1707.
4.3 New designs
Standards groups wishing to introduce new designs of small bore connectors should make this request to
CEN/CMC according to the procedure set out in clause 7 after which the relevant part of this series of
Standards will be amended or revised, in accordance with the CEN procedures.
5 Materials, design and constructions of small bore connectors
Materials and construction used shall be selected with regard to:
a) Compatibility with liquids, gases and other substances with which they will come into contact during use;
b) Non-toxicity;
c) Environmental conditions (e.g. temperature, pressure, humidity, electromagnetic fields) to which they will
be exposed;
d) Minimisation of health risks due to substances leached from materials;
e) The recommended reprocessing procedures (e.g. disinfectants, elevated temperatures, radiation) they
should be able to withstand.
7
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prEN 15546-1:2006 (E)
f) Environmental aspects during normal use and at the time of disposal at the end of the life time.
Compliance with the above shall be confirmed by evidence provided by the manufacturer.
6 Particular small bore connector requirements for specific medical applications
The specific medical applications and requirements of small bore connectors included in this series of
Standards or given in other standards are as follows :
Note: An overview of the allocation of small bore connectors to specific medical applications, including some typical
examples, is given in annex B (informative).
6.1 Small bore connectors for vascular and specific other medical applications
Small bore connectors intended to be used for connections in vascular applications or with a hypodermic
syringe intended for a specific other medical application shall be in accordance with the requirements given in
annex C (informative). Small bore connectors for the applications specified in clause 6.2 to 6.6 shall not be
connectable with the connectors specified in annex C (informative).
Note: Specific other medical applications for which these connectors are commonly used include, e.g. subcutaneous,
intra-muscular and intraperitoneal injections and infiltrations.
6.2 Small bore connectors for enteral applications
Small bore connectors intended to be used for connections in enteral applications shall be in accordance with
the requirements given in part 2 of this Standard.
6.3 Small bore connectors for respiratory applications
Small bore connectors intended to be used for connections in respiratory applications shall be in accordance
with the requirements given in part 3 of this Standard.
6.4 Small bore connectors for neuraxial applications
Small bore connectors intended to be used for connections in neuraxial applications shall be in accordance
with the requirements given in part 4 of this Standard.
6.5 Small bore connectors for urethral / urinary applications
Small bore connectors intended to be used for connections in urethral/urinary applications shall be in
accordance with the requirements given in part 5 of this Standard.
6.6 Small bore connector for circumferential cuff inflation system (for limbs) applications
Small bore connectors intended to be used for connections in circumferential cuff inflation system (for limbs)
applications shall be in accordance with the requirements given in part 6 of this Standard.
8
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prEN 15546-1:2006 (E)
7 Procedure to assess proposed new small bore connector for inclusion in this
series of Standards
7.1 General
To ensure that proposed new small bore connectors are non-interchangeable with the small bore connectors
covered by this series of Standards, the procedure shall be as follows :
• Ensure that there are no outstanding intellectual property right issues.
• Make a paper comparison of the design of the proposed small bore connector with the design details in
this series of Standards;
• Produce test samples and carry out practical tests as described below;
• Confirm the results of the design review and practical tests with at least two other parties with sufficient
expertise.
Note: The three parties involved in the design review and practical tests should originate from three different member
bodies. The same party involved in the design review may also carry out the practical tests.
7.2 Procedure to be carried out by proposer of new small bore connector to assess the non-
interchangeability with existing small bore connectors
• Select at least three parties to carry out the design review and practical tests and ensure that they have
sufficient technical expertise;
• Obtain all necessary documentation, including dimension requirements and drawings, of small bore
connectors already included in this series of Standards, or due to be included by amendment or revision.
Compare with dimension requirements and drawings of proposed new small bore connector to ensure
theoretical non-interchangeability;
• Produce sufficient test samples and carry out practical tests, to ensure non-interchangeability with small
bore connectors already included in this series of Standards, or due to be included by amendment or
revision;
• Prepare reports of three or more design reviews and practical tests and submit them for consideration to
CEN/BT/TF 123 via the Secretariat.
7.3 Consideration of design review and practical test results by CEN/BT/TF 123
• The review of the design review and practical test results shall be assigned to a group within CEN/BT/TF
123 with sufficient technical expertise ;
• The group shall be given a time scale to carry out the review and the proposer notified of this time scale ;
• The group shall assess the results and prepare a report to CEN/BT/TF 123 giving its conclusions ;
• The results shall be presented and discussed during the next meeting of CEN/BT/TF 123 or circulated by
correspondence and a consensus shall be reached as to the suitability of the proposed small bore
connector for inclusion in this series of Standards for the application intended ;
Note: Consensus is understood to be absence of major disagreement.
• The proposer shall be informed of the conclusion ;
9
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prEN 15546-1:2006 (E)
• If the proposed small bore connector is suitable for inclusion in this series of Standards, the Secretariat of
CEN/BT/TF 123 shall initiate the appropriate steps to include the new design by amendment or revision of
the relevant part of this series of Standards.
8. Cleaning, disinfection, sterilisation and disposal
8.1 Small bore connectors “not for re-use”
If the small bore connector is specified “not for re-use” the manufacturer shall provide any information
necessary for safe disposal of the small bore connector.
8.2 Reusable small bore connectors
If the small bore connector is reusable (indicated by the absence of the “not for re-use” marking) the
manufacturer shall provide any information necessary so that the small bore connector can be processed
safely and will continue to meet its performance specification.
If small bore connectors are specified to be re-sterilisable, the manufacturer shall provide information in
accordance with EN ISO 17664 : 2003.
The manufacturer shall determine if processing in accordance with the provided instructions leads to a
degradation that will limit the useful life of the small bore connector. Where such degradation is predicted, the
manufacturer shall provide an indication of the number of reprocessing cycles that can normally be tolerated,
or some other indication of the end of the small bore connector’s ability to safely fulfil its intended use.
10
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prEN 15546-1:2006 (E)
Annex A
(informative)
Rationale for this Standard
Advances in modern medicine have led to a significant rise in the number of medical devices attached to
patients. Many of these devices fall into the categories of monitoring devices, diagnostic devices and drug
delivery devices.
Such devices perform a variety of similar, but not interchangeable functions. Examples include: intravenous
fluid delivery, enteral feeding, respiratory gas sampling, non-invasive blood pressure measurement and the
injection of intrathecal medication. Despite the varied nature of the functions performed, many of these
devices continue to use a universal system of small bore connectors based on the 6% Luer tapered connector.
The universal nature of the connectors used, and the proximity of several different connectors around a single
patient, make accidental misconnections inevitable. The consequences of such misconnections are variable
but a significant number are actually or potentially fatal.
Serious and usually fatal misconnections include the intravenous injection of air, the intravenous injection of
enteral feeds and the intrathecal injection of vincristine. Less disastrous misconnections such as the enteral
administration of intravenous fluids may not directly harm the patient but will lead to a failure of the intended
administration.
Introducing a series of non-interchangeable, small bore connectors for medical devices will reduce the
incidence of misconnections and lead to a direct improvement in patient safety. Any such series must also
include the 6% Luer which should be reserved for connections in vascular applications or with a hypodermic
syringe intended for specific other medical applications such as subcutaneous, intra-muscular and
intraperitoneal injections and infiltrations.
CEN/BT/TF 123 carried out an extensive risk analysis of possible misconnections that might result when Luer
connectors are used in different applications. The results of this analysis are shown in table A.1
Terms and definitions used in the risk analysis table
Severity level (SL) 1 = minor injury or discomfort
2 = reversible injury
3 = death or irreversible injury
Probability level (PL) 1 = low
2 = medium
3 = high
2 2
Risk category (RC) RC = SL x PL
11
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prEN 15546-1:2006 (E)
Criteria for classification of the risk category
1 = broadly acceptable
1 to 8 = ALARP (as low as reasonable technical/economically practicable) (8 = maximum tolerable)
> 8 = intolerable
Summary of risk analysis of possible misconnections
164
...
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