SIST EN 13544-3:2002+A1:2009

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
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 03-Jun-2022
• Due Date: 26-Jun-2022
• Completion Date: 09-Jun-2022
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 13544-3:2001+A1:2009 - Respiratory therapy equipment - Part 3: Air entrainment devices

Relations

• Replaced By: SIST EN ISO 23372:2022 - Anaesthetic and respiratory equipment - Air entrainment devices (ISO 23372:2022)
• Effective Date: 01-Jun-2022
• Consolidates: SIST EN 13544-3:2002 - Respiratory therapy equipment - Part 3: Air entrainment devices
• Effective Date: 19-Jan-2023
• Consolidates: SIST EN 13544-3:2002/kprA1:2009 - Respiratory therapy equipment - Part 3: Air entrainment devices
• Effective Date: 19-Jan-2023
• Consolidates: SIST EN 13544-3:2002 - Respiratory therapy equipment - Part 3: Air entrainment devices
• Effective Date: 18-Jan-2023
• Consolidates: SIST EN 13544-3:2002/kprA1:2009 - Respiratory therapy equipment - Part 3: Air entrainment devices
• Effective Date: 18-Jan-2023
• Consolidates: SIST EN 13544-3:2002 - Respiratory therapy equipment - Part 3: Air entrainment devices
• Effective Date: 01-Dec-2009
• Consolidates: SIST EN 13544-3:2002/kprA1:2009 - Respiratory therapy equipment - Part 3: Air entrainment devices
• Effective Date: 01-Dec-2009

Standards Content (Sample)

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)
2
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 .
...