SIST EN 13544-2:2003
(Main)Respiratory therapy equipment - Part 2: Tubing and connectors
Respiratory therapy equipment - Part 2: Tubing and connectors
Specifies dimensions and performance of tubing and convectors used in conjunction with nebulizers and air-entrainment devices.
Atemtherapiegeräte - Teil 2: Schlauchsysteme und Verbindungsstücke
Equipement de thérapie respiratoire - Partie 2: Tubes et raccords
La présente partie de l'EN 13544 spécifie les exigences relatives aux tubes a utiliser avec des équipements pour l'administration thérapeutique de gaz respirables dans des pratiques domiciliaires, ambulancieres et hospitalieres, y compris l'interface avec les équipements, a savoir les embouts et les raccords filetés. Ces tubes sont utilisés principalement pour de l'oxygene, de l'air ou des mélanges de ces gaz.
Les spécifications de l'interface sont données afin de garantir l'interchangeabilité de l'équipement de thérapie respiratoire, permettant ainsi aux patients de bénéficier de soins permanents dans toutes ces situations cliniques.
Les raccords filetés résistants a la traction sont spécifiés pour une utilisation par exemple au niveau de la sortie de débitmetres auxquels peuvent etre raccordés des dispositifs tels que humidificateurs ou nébuliseurs.
NOTE La présente norme ne spécifie pas les dispositifs avec lesquels ces raccords doivent etre utilisés. Il est vraisemblable que des normes spécifiques aux dispositifs préciseront les dispositifs avec lesquels ces raccords vont etre utilisés, par exemple l'EN ISO 10651 4, l'EN 738-1 et l'EN 13220.
Dihalna oprema za zdravljenje - 2. del: Cevke in priključki
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 13544-2:2003
01-marec-2003
'LKDOQDRSUHPD]D]GUDYOMHQMHGHO &HYNHLQSULNOMXþNL
Respiratory therapy equipment - Part 2: Tubing and connectors
Atemtherapiegeräte - Teil 2: Schlauchsysteme und Verbindungsstücke
Equipement de thérapie respiratoire - Partie 2: Tubes et raccords
Ta slovenski standard je istoveten z: EN 13544-2:2002
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN 13544-2:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 13544-2:2003
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SIST EN 13544-2:2003
EUROPEAN STANDARD
EN 13544-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2002
ICS 11.040.10
English version
Respiratory therapy equipment - Part 2: Tubing and connectors
Equipement de thérapie respiratoire - Partie 2: Tubes et Atemtherapiegeräte - Teil 2: Schlauchsysteme und
raccords Verbindungsstücke
This European Standard was approved by CEN on 1 August 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 13544-2:2002 E
worldwide for CEN national Members.
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SIST EN 13544-2:2003
EN 13544-2:2002 (E)
CONTENTS
Page
Foreword.3
1 Scope .4
2 Normative references .4
3 Nipples .4
3.1 Dimensions.4
3.2 Performance .4
4 Weight-bearing screw-threaded connectors.4
5 Tubing .4
5.1 General.4
6 Marking of tubing, labels and packaging .7
7 Packaging .7
Annex A (normative) Test methods.8
A.1 Apparatus .8
A.2 Method of test for strength of nipple .8
A.3 Method of test for resistance to gas flow of tubing .11
A.4 Method of test for security of connection between end connector and tubing .12
A.5 Method of test for security of connection of end connectors and nipple.12
A.6 Method of test for resistance to kinking.13
Annex B (normative) Weight-bearing screw-threaded connectors for oxygen and air .15
Annex C (informative) Information on method of testing security of connections .16
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other
provisions of EU Directives .17
Bibliography .18
2
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SIST EN 13544-2:2003
EN 13544-2 :2002 (E)
Foreword
This document (EN13544-2:2002) 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 April 2003, and conflicting national standards shall be withdrawn at the latest by
April 2003.
This European Standard 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).
Annexes A and B are normative. Annex C is informative.
For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document.
EN 13544 consists of the following parts, under the general title Respiratory therapy equipment.
Part 1: Nebulizing systems and their components
Part 2: Tubing and connectors
Part 3: Air entrainment devices
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.
3
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SIST EN 13544-2:2003
EN 13544-2:2002 (E)
1 Scope
This part of EN 13544 specifies requirements for tubing to be used with equipment for the therapeutic
administration of respirable gases in domiciliary, ambulance and hospital practice including the interface to the
equipment i.e. nipples and screw threaded connectors. This tubing is mainly used with oxygen, air or mixtures of
these gases.
The interface specifications are given to ensure interchangeability of respiratory therapy equipment thereby
enabling patients to receive continuous treatment in all these clinical situations.
Weight-bearing screw-threaded connectors are specified for use at the outlet of e.g. flowmeters to which devices
such as humidifiers or nebulizers can be attached.
NOTE This standard does not specify the devices where these connectors have to be used. It is expected that specific
device standards will specify the devices where these connectors are going to the used e.g. EN ISO 10651-4, EN 738-1 and
EN 13220.
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 980, Graphical symbols for use in the labelling of medical devices.
3 Nipples
3.1 Dimensions
The dimensions of nipples for the attachment of tubing to respiratory therapy equipment shall conform to the
dimensions given in Figure 1 a), and also, if corrugated, shall conform to 1 b).
3.2 Performance
When tested as described in A.2, nipples shall neither fracture nor distort by more than 2 mm.
4 Weight-bearing screw-threaded connectors
4.1 Weight-bearing screw-threaded connectors for oxygen shall comply with Figure B.1.
4.2 Weight-bearing screw-threaded connectors for air shall comply with Figure B.2.
5 Tubing
5.1 General
Material used for tubing shall be :
a) compatible with oxygen or air or any other gas mixture specified by the manufacturer ;
b) non-toxic ;
4
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SIST EN 13544-2:2003
EN 13544-2 :2002 (E)
c) designed and manufactured to minimize health risks by leaching of substances from tubing during normal use
to levels below those assumed to be non-toxic.
Evidence shall be provided by the manufacturer on request.
5.1.1 Resistance to gas flow of tubing
When tested as described in A.3, the resistance to flow shall not exceed 0,9 kPa/m.
5.1.2 End connectors
Tubing for respiratory therapy equipment shall terminate at each end with a connector able to produce a secure
connection conforming to 5.1.4 to the nipple specified in clause 3.
NOTE Connectors can either be formed in the material of the tubing or can be joined to the tubing by e.g. welding or
adhesives.
5
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SIST EN 13544-2:2003
EN 13544-2:2002 (E)
Dimensions in millimetres
l
1
l
2
Key
l 10 mm datum
1
l 12 mm minimum to shoulder or projection
2
NOTE The axis of the nipple can be curved.
a) Basic profile and nominal dimensions of nipple
l
1
l
2
Key
l 10 mm datum with a minimum of two corrugations within this length
1
l 12 mm minimum to shoulder or projection
2
NOTE The external diameter of all corrugations falls on the profile of the nipple as shown in 1a. The shape of the
corrugations is given as an example.
b) Dimensions for corrugated nipple
Figure 1 — Nipple for respiratory therapy equipment
6
2 ˚ inc.
2 ˚ inc.
6.35
6.35
3.5
3.5
6.0
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SIST EN 13544-2:2003
EN 13544-2 :2002 (E)
5.1.3 Security of joint between end connector and tubing
When tested as described in A.4, if the end connector is joined to the tubing, the end connector shall not become
detached from the tubing.
5.1.4 Security of connection of end connectors to nipple
When tested as described in A.5, heavy duty tubing shall not become detached from the test nipple.
NOTE See annex C for information on the method of testing the security of connection between an end connector and a
nipple.
5.1.5 Resistance to kinking
When tested as described in A.6, the flow through the kinked tubing shall be not less than 75 % of the initial flow.
6 Marking of tubing, labels and packaging
Tubing, labels, and/or packaging shall contain the following as applicable :
name and address of the manufacturer ;
if the intended purpose of the device is not obvious to the operator, the device shall be provided with
instructions for use ;
device identification and content information ;
symbol STERILE in accordance with EN 980 together with the method of sterilization ;
batch code, preceded by the symbol LOT in accordance with EN 980, or serial number ;
declaration of the maximum pressure the tubing shall withstand at ambient conditions specified in Table A.1 ;
date by which the d
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