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PREDSTANDARD
julij 2006
Anestezijska in dihalna oprema - Priključki za plinske vzorčne cevke pri
anestezijski in dihalni opremi
Anaesthetic and respiratory equipment - Connections for gas sampling and gas
return
ICS 11.040.10 Referenčna številka
oSIST prEN 13014:2006(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 13014
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2006
ICS Will supersede EN 13014:2000
English Version
Anaesthetic and respiratory equipment - Connections for gas
sampling and gas return
Équipement respiratoire et anesthésique - Raccordements Anästhesie- und Beatmungsgeräte - Verbindungen für
pour prélèvement de gaz et gaz restitué Gasprobenentnahme und Gasrückführung
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 215.
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 13014:2006: E
worldwide for CEN national Members.
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prEN 13014:2006 (E)
Contents Page
Foreword.3
1 Scope R.3
2 Normative references .4
3 Definitions .4
4 Materials and construction.5
5 Dimensions and tolerances .5
6 Requirements.6
7 Marking .7
8 Information to be supplied by the manufacturer.8
Annex A (informative) Rationale .12
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .13
Annex ZB (informative) Environmental aspects.14
Bibliography .16
2
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prEN 13014:2006 (E)
Foreword
This document (prEN 13014:2006) has been prepared by Technical Committee CEN/TC 215 “Respiratory and
anaesthetic equipment”, the secretariat of which is held by BSI.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 13014:2000.
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(s).
For relationship with EU Directive(s), see informative Annex ZA which is an integral part of this document.
The letter 'R' next to a clause number indicates the presence of a rationale for that clause in annex A.
1 Scope R
This European Standard specifies requirements for construction, dimensions and marking of connectors used
in gas sampling to transfer gas from the breathing system of anaesthetic and respiratory equipment to
diverting gas monitors and back to the breathing system and/or to the anaesthetic gas scavenging system
(AGSS).
This European Standard gives requirements for the following ports and connectors:
gas sampling port on breathing system;
gas return port on breathing system and AGSS;
gas sampling and return ports on diverting gas monitors;
gas sampling tube inlet and outlet connectors;
gas return tube inlet and outlet connectors.
This European Standard does not apply to connection ports intended for connection of sensors in the
breathing system.
According to EN 1707, Luer lock fittings are intended to be used for syringes, needles and certain other
medical equipment. In order to minimize the risk of misconnection, this standard specifies the arrangements of
male and female fittings and the marking requirements to identify the different connectors, ports and tubes.
Tables 1 to 4 specify the type of Luer fitting that is used in actual applications.
NOTE 1 Manufacturers are encouraged to use the ports specified in this standard on diverting gas monitors, breathing
systems and AGS systems even if these are currently not required by the specific device standards. It is expected that
requirements for the application of this standard will be included in these particular standards during forthcoming revisions.
Attention is drawn to pEN ISO/FDIS 21647 concerning respiratory gas monitors and the work of CEN/BT/TF 123 Small-
bore connectors.
NOTE 2 During planning and design manufactures will consider the environmental impact from the product during its life
cycle. Environmental aspects are addressed in Annex ZB. Additional aspects of environmental impact are addressed in
EN ISO 14971.
3
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prEN 13014:2006 (E)
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.
EN 1041:1998, Information supplied by the manufacturer with medical devices
EN 1089-3:1997, Transportable gas cylinders — Cylinder identification — Part 3: Colour coding
EN 1707:1996, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Lock fittings
EN 20594-1:1993, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 1: General requirements (ISO 594-1:1986)
EN 60601-1:1990, Medical electrical equipment — Part 1: General requirements for safety
(IEC 60601-1:1988)
ISO 7000:1989, Graphical symbols for use on equipment — Index and synopsis
3 Definitions
For the purposes of this Standard, the following definitions apply.
3.1
gas sampling port
that port on a breathing system and/or diverting gas monitor to which a gas sampling tube can be connected
and gas can be collected and routed to a sensor in the monitor
3.2
gas return port
that port on a breathing system or AGSS to which a gas return tube can be connected and gas is returned
3.3
diverting gas monitor
gas monitor which transports a portion of a gas mixture from a remote sampling site, through a sampling tube,
to a sensor in the monitor [EN ISO 4135]
3.4
gas sampling tube inlet connector
that connector on a gas sampling tube which is connected to a gas sampling port on a breathing system
3.5
gas sampling tube outlet connector
that connector on a gas sampling tube which is connected to a gas sampling port on a diverting gas monitor
3.6
gas return tube inlet connector
that connector on a gas return tube which can be connected to a gas sampling port on a diverting gas monitor
3.7
gas return tube outlet connector
that connector on a gas return tube which can be connected to a gas return port on a breathing system or
AGSS
4
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prEN 13014:2006 (E)
4 Materials and construction
4.1 Cleaning, disinfection and sterilisation
If connectors are intended for re-use, EN 60601-1:1990, 44.7 shall apply.
NOTE Attention is drawn to the fact that some connectors are used, disinfected, or sterilised at elevated
temperatures, and extra care is required when selecting suitable materials.
4.2 Constructional requirements
Materials used shall be selected with regard to:
a) compatibility with substances and gases with which they come into contact during normal use;
b) toxicity;
c) minimization of health risks due to substances leached from materials.
Compliance shall be checked via manufacturer certification.
NOTE 1 Evidence of compliance with the specification(s), either by test or by other methods should be provided by the
manufacturer to a Notified Body during CE conformity assessment or to appropriate authorities on request.
NOTE 2 Consideration should be given to the disposal of packaging waste.
4.3 Alternative constructions
Gas sampling / return tube connectors and gas sampling / return ports using materials, or having forms of
construction different from those detailed in this standard shall be accepted if it can be demonstrated that an
equivalent degree of safety is obtained.
Evidence shall be provided by the manufacturer.
5 Dimensions and tolerances
5.1 Gas sampling ports on breathing systems
The dimensions and tolerances of the port shall be according to EN 1707:1996 and the port type shall be as
given in Table 1.
5.2 Gas return ports on breathing systems or AGSS
The dimensions and tolerances of the port shall comply with EN 20594-1:1993 and shall be provided with a
sleeve in accordance with Figure 2. The port type shall be as given in Table 1.
5.3 Gas sampling ports on diverting gas monitors
The dimensions and tolerances of the port shall be according to EN 1707:1996 and the port type shall be as
given in Table 2.
5.4 Gas return ports on diverting gas monitors
The dimensions and tolerances of the port shall be according to EN 20954-1:1993 and shall be provided with
a sleeve in accordance with Figure 2. The port type shall be as given in Table 2.
5
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prEN 13014:2006 (E)
5.5 Gas sampling tube connectors
The dimensions and tolerances of the connector s
...