SIST EN 1733:2003
(Main)Suction catheters for use in the respiratory tract
Suction catheters for use in the respiratory tract
Migrated from Progress Sheet (TC Comment) (2000-07-10): Contact Trevor x 850 when progressing this through any stage
Absaugkatheter zur Verwendung im Atemtrakt
Sondes d'aspiration pour les voies respiratoires
La présente Norme européenne spécifie les exigences relatives aux sondes en matiere plastique, prévues pour l'aspiration dans les voies respiratoires. Les sondes d'aspiration spécialisées telles que celles qui comportent plusieurs lumieres, sont exclues du domaine d'application de la présente norme. Les sondes a bout coudé (sondes Coudé, par exemple) ne sont pas considérées comme des sondes spécialisées et relevent donc du domaine d'application.
Aspiracijski katetri za čiščenje dihalnih poti
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 1733:2003
01-marec-2003
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SIST EN 1733:2000
SIST EN 1733:2000/AC:2000
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Suction catheters for use in the respiratory tract
Absaugkatheter zur Verwendung im Atemtrakt
Sondes d'aspiration pour les voies respiratoires
Ta slovenski standard je istoveten z: EN 1733:2002
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN 1733:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 1733:2003
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SIST EN 1733:2003
EUROPEAN STANDARD
EN 1733
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2002
ICS 11.040.10; 11.040.20 Supersedes EN 1733:1998
English version
Suction catheters for use in the respiratory tract
Sondes d'aspiration pour les voies respiratoires Absaugkatheter zur Verwendung im Atemtrakt
This European Standard was approved by CEN on 16 October 2002.
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. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Management Centre or to any CEN 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 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, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1733:2002 E
worldwide for CEN national Members.
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SIST EN 1733:2003
EN 1733:2002 (E)
Contents
page
Foreword . 3
Introduction . 4
1 Scope. 5
2 Normative references. 5
3 Terms and definitions. 5
4 Size designation and dimensions . 6
5 Materials. 8
6 Design . 8
7 Performance requirements . 9
8 Requirements for suction catheters supplied sterile. 10
9 Marking. 10
Annex A (informative) Guidance on design and materials. 13
Annex B (normative) Test method for security of construction . 14
Annex C (normative) Test method for residual vacuum . 15
Bibliography . 17
2
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SIST EN 1733:2003
EN 1733:2002 (E)
Foreword
This document (EN 1733:2002) has been prepared by Technical Committee CEN/TC 215,
"Respiratory and anaesthetic equipment", the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2003, and conflicting national standards shall be
withdrawn at the latest by May 2003.
This document supersedes EN 1733:1998.
This European Standard is based on ISO 8836:1997 Suction catheters for use in the respiratory tract,
prepared by ISO/TC 121.
It differs from ISO 8836:1997 in that it recognises a distinction between tracheal and endobronchial
suction catheters.
Annex A is informative. Annexes B and C are normative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta,
Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
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SIST EN 1733:2003
EN 1733:2002 (E)
Introduction
This European Standard specifies dimensions and requirements for suction catheters for use in the
respiratory tract.
Size is designated by outside diameter which is important when selecting catheters, because of its
relationship to the ease with which the catheter can be passed through a tracheal or tracheostomy tube
(see EN 1782 for details of tracheal tube standards and EN 1282-1 and EN 1282-2 for details of
tracheostomy tube standards). Requirements for suction catheters made of rubber have been deleted
because such catheters are no longer in general use.
This European Standard recognises the potential for damage to the mucosa through the use of suction
catheters with a terminal orifice only and restricts this tip configuration to endobronchial suction catheters,
which are used under visual guidance.
Flammability of suction catheters, for example if flammable anaesthetics or lasers are used, is a well-
recognized hazard that is addressed by appropriate clinical management, and is outside the scope of
this standard (See ISO/TR 11991)
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SIST EN 1733:2003
EN 1733:2002 (E)
1 Scope
This European Standard specifies requirements for suction catheters made of plastics materials and intended for use in
suction of the respiratory tract. Specialized suction catheters, e.g. those with more than one lumen, are excluded from
the scope of this standard. Angled tip suction catheters (e.g. Coudé catheters) are not considered to be specialized and
are therefore included in the scope.
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 revisions 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 (including amendments).
EN 556-1:2001, Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" -
Part 1: Requirements for terminally sterilized medical devices
EN 868-1, Packaging materials and systems for medical devices which are to be sterilized - Part 1: General
requirements and test methods
EN ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997)
3 Terms and definitions
For the purposes of this European Standard, the following terms and definitions apply.
3.1
adaptor
specialized connector to establish functional continuity between otherwise disparate or incompatible components
[EN ISO 4135:2001]
3.2
connector
fitting to join together two or more components
[EN ISO 4135:2001]
3.3
eye
lateral aperture near the patient end of a suction catheter
[EN ISO 4135:2001]
3.4
machine end
that end of a suction catheter which is intended to be connected to a source of vacuum
[EN ISO 4135:2001]
3.5
patient end
that end of a suction catheter which is intended to be inserted into a patient
[EN ISO 4135:2001]
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SIST EN 1733:2003
EN 1733:2002 (E)
3.6
residual vacuum
negative pressure at the patient end of a suction catheter when the vacuum control device is in the relief position
3.7
shaft
that part of a suction catheter between the connector or conical expansion at the machine end and the tip
[EN ISO 4135:2001]
3.8
tracheal suction catheter
flexible tube designed for introduction into a respiratory tract to remove material by suction
3.9
endobronchial suction catheter
flexible tube designed for introduction into a bronchial tree to remove material by suction under visual guidance
3.10
terminal orifice
central aperture at the patient end of a suction catheter
[EN ISO 4135:2001]
3.11
tip
extremity of the patient end of a suction catheter
[EN ISO 4135:2001]
3.12
vacuum control device
means provided at the machine end of a suction catheter to control the flow of air and entrained material
[EN ISO 4135:2001]
4 Size designation and dimensions
4.1 Size designation
4.1.1 The size of suction catheters shall be designated by the following:
a) the nominal outside diameter of the shaft, expressed in millimetres.
NOTE The size can additionally be expressed in French (Charrière) gauge size.
b) the nominal shaft length, expressed in millimetres.
4.1.2 If a colour code is additionally used to designate the size of the suction catheter, it shall be in accordance
with Table 1. The colour coding shall be applied at the machine end of the suction catheter.
NOTE Use and choice of colour coding for designated sizes not listed in Table 1 are at the manufacturer’s discretion.
4.2 Dimensions
4.2.1 The outside diameter and the minimum inside diameter of suction catheters, excluding the tip, shall be in
accordance with Table 2.
NOTE For the purposes of this European Standard, the French (Charrière) gauge system of size is based on the outside
diameter of the shaft gauged in steps of thirds of a millimetre (1 millimetre corresponds to 3F); the French gauge size is not an
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SIST EN 1733:2003
EN 1733:2002 (E)
SI unit. Size designation in millimetres facilitates matching suction catheter outside diameter to the inside diameter of the
tracheal or tracheostomy tube.
4.2.2 The minimum inside diameter at the tip shall be not less than 90 % of the minimum inside diameter
specified in Table 2.
4.2.3 The actual shaft length shall be the marked shaft length subject to a tolerance of ± 5 %.
Table 1 - Colour identification for designated size of suction catheter
Designated size Colour
Nominal outside diameter French (Charrière) size
equivalent
mm
1,67 5 grey
2,0 6 light green
2,5 7,5 pink
2,67 8 light blue
3,0 9 turquoise
3,33 10 black
4,0 12 white
4,67 14 green
5,0 15 brown
5,33 16 orange
6,0 18 red
6,67 20 yellow
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SIST EN 1733:2003
EN 1733:2002 (E)
Table 2 - Basic dimensions of suction catheters - Metric sizes
Designated size Outside diameter Minimum inside
tolerance diameter
Nominal outside French (Charrière)
mm mm
diameter size equivalent
mm F or Ch
1,33 4 ± 0,10 0,55
1,5 4,5 ± 0,10 0,70
1,67 5 ± 0,10 0,80
2 6 ± 0,10 1,05
2,5
...
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