Respiratory therapy equipment - Part 3: Air entrainment devices

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.

Atemtherapiegeräte - Teil 3: Luftbeimischgeräte

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'entraînement 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’oxygène désignée au patient, et indique une méthode d’essai permettant de déterminer la concentration en oxygène du mélange air/oxygène produit par le dispositif d’entraînement d’air.
Elle spécifie également les exigences en matière de marquage et propose un système facultatif de code couleur afin d’aider l’utilisateur à identifier la concentration d’oxygène 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

Status
Withdrawn
Publication Date
16-Nov-2009
Withdrawal Date
08-Jun-2022
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
03-Jun-2022
Due Date
26-Jun-2022
Completion Date
09-Jun-2022

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dihalna oprema za zdravljenje - 3. del: Vhodne naprave za zrakAtemtherapiegeräte - Teil 3: LuftbeimischgeräteAppareils de thérapie respiratoire - Partie 3 : Dispositifs d'entraînement d'airRespiratory therapy equipment - Part 3: Air entrainment devices11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN 13544-3:2001+A1:2009SIST EN 13544-3:2002+A1:2009en,fr,de01-december-2009SIST EN 13544-3:2002+A1:2009SLOVENSKI

STANDARD
SIST EN 13544-3:2002+A1:2009
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13544-3:2001+A1
September 2009 ICS 11.040.10 Supersedes EN 13544-3:2001English Version

Respiratory therapy equipment - Part 3: Air entrainment devices Appareils de thérapie respiratoire - Partie 3: Dispositifs d'entraînement d'air

Atemtherapiegeräte - Teil 3: Luftbeimischgeräte This European Standard was approved by CEN on 7 April 2001 and includes Amendment 1 approved by CEN on 30 July 2009.

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 CEN 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 CEN Management Centre has the same status as the official versions.

CEN members are the national standards bodies 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.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,

B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13544-3:2001+A1:2009: ESIST EN 13544-3:2002+A1:2009

EN 13544-3:2001+A1:2009 (E)
Contents
Page

Foreword ...................................................................................................................................................................... 31Scope .............................................................................................................................................................. 42Normative references .................................................................................................................................... 43Terms and definition ..................................................................................................................................... 43.1Air entrainment device .................................................................................................................................. 44Oxygen supply ............................................................................................................................................... 45Connections ................................................................................................................................................... 45.1Oxygen supply inlet ....................................................................................................................................... 45.2Air inlet attachments ..................................................................................................................................... 56Delivered oxygen concentration .................................................................................................................. 57Marking and identification ............................................................................................................................ 57.1Marking ........................................................................................................................................................... 57.2Colour coding ................................................................................................................................................. 68Information supplied by the manufacturer ................................................................................................. 69!!!!Usability ..................................................................................................................................................... 710Clinical evaluation ......................................................................................................................................... 7Annex A (normative)

Method of test for delivered oxygen concentration ........................................................... 8Annex B (informative)

Rationale ............................................................................................................................ 12Annex C (informative)

Colour coding .................................................................................................................... 13Annex ZA (informative)

!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC"""" ............................................................................................ 14Bibliography .............................................................................................................................................................. 15 SIST EN 13544-3:2002+A1:2009

EN 13544-3:2001+A1:2009 (E)

Foreword This document (EN 13544-3:2001+A1:2009) 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 March 2010, and conflicting national standards shall be withdrawn at the latest by March 2010. 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. This document includes Amendment 1, approved by CEN on 2009-07-30. This document supersedes EN 13544-3:2001. The start and finish of text introduced or altered by amendment is indicated in the text by tags !". 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, 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. SIST EN 13544-3:2002+A1:2009

EN 13544-3:2001+A1:2009 (E)

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). EN 738-1, Pressure regulators for use with medical gases – Part 1 : Pressure regulators and pressure regulators 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. prEN 13159, Compatibility of medical equipment with oxygen. 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. SIST EN 13544-3:2002+A1:2009

EN 13544-3:2001+A1:2009 (E)

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 O2 concentration Delivered O2 concentration (%) min. (%) v/v max. (%) v/v 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 and the name and address of the authorized representative where the manufacturer does not have a registered place of business in the European Community;" b) a lot or serial number or da

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