SIST EN 13544-3:2002
(Main)Respiratory therapy equipment - Part 3: Air entrainment devices
Respiratory therapy equipment - Part 3: Air entrainment devices
This part of prEN RESP specifies minimum performance and safety requirements for air entrainment devices and gives a test method to check the oxygen concentration in the air/oxygen mixture generated by the air entrainment device. It also specifies marking requirements and gives an optional system of colour coding to assist the user to identify the designated oxygen concentration. This standard does not cover air entrainment devices which are integral with medical devices specified in other standards e.g. emergency lung ventilators, humidifiers, nebulizers, etc.
Atemtherapiegeräte - Teil 3: Luftbeimischgeräte
Anwendungsbereich
Dieser Teil dieser Europäischen Norm legt Mindestanforderungen an die Leistungsfähigkeit und Sicherheit von
Luftbeimischgeräten fest, die für die Abgabe einer festgelegten Sauerstoffkonzentration an Patienten verwendet
werden. Sie enthält ein Prüfverfahren zur Überprüfung der Sauerstoffkonzentration im Sauerstoff-Luft-Gemisch,
das durch das Luftbeimischgerät erzeugt wird.
Er legt auch Anforderungen an die Kennzeichnung fest und enthält ein wahlweises Farbcodierungssystem, das
den Anwender bei der Erkennung der Nenn-Sauerstoffkonzentration unterstützt.
Diese Norm behandelt keine Luftbeimischgeräte, die ein integraler Teil von medizinischen Geräten sind, für die in
anderen Normen Festlegungen bestehen, z. B. Lungenbeatmungsgeräte für den Notfall, Anfeuchter, Vernebler usw.
Appareils de thérapie respiratoire - Partie 3 : Dispositifs d'entrainement d'air
La présente partie de l'EN 13544 spécifie les performances minimales et les exigences de sécurité relatives aux dispositifs d'entraînement d'air utilisés pour administrer une concentration d'oxygene désignée au patient, et indique une méthode d'essai permettant de déterminer la concentration en oxygene du mélange air/oxygene produit par le dispositif d'entraînement d'air.
Elle spécifie également les exigences en matiere de marquage et propose un systeme facultatif de code couleur afin d'aider l'utilisateur a identifier la concentration d'oxygene désignée.
La présente norme ne traite pas des dispositifs d'entraînement d'air qui sont intégrés dans les dispositifs médicaux et spécifiés dans d'autres normes, comme par exemple les ventilateurs pulmonaires d'urgence, les humidificateurs, les nébuliseurs, etc..
Dihalna oprema za zdravljenje – 3. del: Vhodne naprave za zrak
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 13544-3:2002
01-maj-2002
Dihalna oprema za zdravljenje – 3. del: Vhodne naprave za zrak
Respiratory therapy equipment - Part 3: Air entrainment devices
Atemtherapiegeräte - Teil 3: Luftbeimischgeräte
Appareils de thérapie respiratoire - Partie 3 : Dispositifs d'entrainement d'air
Ta slovenski standard je istoveten z: EN 13544-3:2001
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN 13544-3:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 13544-3:2002
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SIST EN 13544-3:2002
EUROPEAN STANDARD
EN 13544-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2001
ICS 11.040.10
English version
Respiratory therapy equipment - Part 3: Air entrainment devices
Atemtherapiegeräte - Teil 3: Sauerstoffanreicherungsgeräte
This European Standard was approved by CEN on 7 April 2001.
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, 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
© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13544-3:2001 E
worldwide for CEN national Members.
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SIST EN 13544-3:2002
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EN 13544-3:2001
Foreword
This European Standard 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 November 2001, and conflicting national standards shall be withdrawn at the latest
by November 2001.
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).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard.
This European Standard applies to respiratory therapy equipment and has been prepared in three parts. This Part
addresses air entrainment devices; part 1 and part 2 address respectively nebulizing systems and tubing and
connectors.
Annex A is normative and forms part of this European Standard.
Annexes B, C and ZA are for information only.
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, Netherlands, Norway, Portugal, Spain, Sweden,
Switzerland and the United Kingdom.
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SIST EN 13544-3:2002
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EN 13544-3:2001
1 Scope
This part of this European Standard specifies minimum performance and safety requirements for air entrainment
devices used for delivery of a designated oxygen concentration to patients. It gives a test method to check the
oxygen concentration in the air/oxygen mixture generated by the air entrainment device.
It also specifies marking requirements and gives an optional system of colour coding to assist the user to identify
the designated oxygen concentration.
This standard does not cover air entrainment devices which are integral with medical devices specified in other
standards e.g. emergency lung ventilators, humidifiers, nebulizers, etc.
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).
Pressure regulators for use with medical gases – Part 1 : Pressure regulators and pressure regulators
EN 738-1,
with flow metering devices.
EN 980, Graphical symbols for use in the labelling of medical devices.
EN 1041, Information supplied by the manufacturer with medical devices.
Compatibility of medical equipment with oxygen.
prEN 13159,
EN ISO 4135, Anaesthetics and respiratory equipment – Vocabulary.
3 Terms and definition
For the purposes of this part of this European Standard, terms and definitions given in EN ISO 4135 and the
following term and definition apply.
3.1 Air entrainment device
Device consisting of a jet orifice (to which the oxygen supply is connected) adjacent to a series of air entrainment
ports, the distal end of the device being designed for connection to an oxygen delivery system supplying a patient.
NOTE These devices are sometimes described as Venturi devices. This term has been avoided as very few actually use
the venturi principle.
4 Oxygen supply
The device shall be designed to operate with an oxygen supply controlled by a flowmeter control valve capable of
delivering at least 15 l/min of oxygen and complying with EN 738-1 and prEN 13159.
5 Connections
5.1 Oxygen supply inlet
The inlet for oxygen to the air entrainment device should be a nipple conforming to prEN 13544-2.
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EN 13544-3:2001
5.2 Air inlet attachments
Any air inlet attachment provided with or recommended for use with the air entrainment device shall neither affect
the safety nor the performance of the device nor cover any marking of the device.
The attachment shall not become detached when tested as described in A.2.8 (normative).
6 Delivered oxygen concentration
When tested as described in annex A, the delivered oxygen concentration shall be as given in Table 1.
Table 1 - Delivered oxygen concentration
Designated O concentration Delivered O concentration
2 2
(%)
min. (%) max. (%)
24 23 25
28 27 29
31 30 32
35 33 37
40 38 42
50 47 53
60 56 64
Additional information is given in annex B.
7 Marking and identification
EN 980 and EN 1041 apply with the following additions :
7.1 Marking
7.1.1 Each fixed concentration air entrainment device shall be marked with :
a) the designated oxygen concentration in characters at least 2,5 mm high ;
b) the recommended flow in l/min in characters at least 2,5 mm high.
7.1.2 The immediate packaging of the device shall also carry the above information, together with the following :
a) the name or trade mark of the manufacturer ;
b) a lot or serial number or date of manufacture ;
c) if designed for single use only, the words “SINGLE USE” or the appropriate symbol.
7.1.3 Air entrainment devices with a control to adjust the oxygen concentration shall conform to item b) of 7.1.1
and items a) to c) of 7.1.2 and in addition with either of the following :
a) The minimum and maximum settings shall be marked with their respective oxygen concentrations (see 8 d)) in
characters at least 2,5 mm high, and the direction of movement of the control to increase the delivered oxygen
concentration shall be indicated.
b) A scale of delivered oxygen concentration shall be provided, marking each of these designated concentrations
listed in Table 1 which is attainable by the adjustment of the control.
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EN 13544-3:2001
7.2 Colour coding
7.2.1 If colour coding is used as an additional means of identification of the designated oxygen concentration on
air entrainment devices, the colour code given in Table 2 shall be used. The colour codes shall be applied directly
2
to the air entrainment device and shall have an area of at least 1 cm .
The colour coding shall either be visible through the immediate external packaging or shall be repeated on the
outside of the immediate external packaging.
Table 2 - Colour coding
Designated O concentration Colour
2
(see annex C for references of
%
colours given as examples)
24 Blue
28 Wh
...
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