SIST EN 13544-2:2003+A1:2009

Respiratory therapy equipment - Part 2: Tubing and connectors

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.

Atemtherapiegeräte - Teil 2: Schlauchsysteme und Verbindungsstücke

Dieser Teil von EN 13544 legt die Anforderungen an Schlauchsysteme fest, die für Geräte zur therapeutischen
Verabreichung von Beatmungsgasen bei der häuslichen Pflege, ambulanten Behandlung und in der
Krankenhauspraxis verwendet werden. Festgelegt sind auch die Schnittstellen zu diesen Geräten, z. B. Nippel
und Schraubverbindungen. Diese Schlauchsysteme werden hauptsächlich für Sauerstoff, Luft oder Gemische
dieser Gase verwendet.
Schnittstellen wurden festgelegt, um die Austauschbarkeit von Geräten für die Atmungstherapie sicherzustellen
und damit eine kontinuierliche Behandlung von Patienten in allen klinischen Situationen zu
ermöglichen.
Gewichtstragende Schraubverbindungen wurden zur Verwendung für den Ausgang, z. B. von Durchflussmessgeräten,
festgelegt, an denen Geräte wie Anfeuchter oder Vernebler angeschlossen werden können.
ANMERKUNG In dieser Norm werden nicht die Geräte festgelegt, für die diese Verbindungen zu verwenden sind. Es
wird erwartet, dass spezielle Produktnormen die Geräte festlegen, für die diese Verbindungsstücke zu verwenden sind,
z. B. EN ISO 10651-4, EN 738-1 und EN 13220.

Equipement de thérapie respiratoire - Partie 2: Tubes et raccords

Dihalna oprema za zdravljenje - 2. del: Cevke in priključki

General Information

• Status: Published
• Publication Date: 12-Oct-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 22-Sep-2009
• Due Date: 27-Nov-2009
• Completion Date: 13-Oct-2009
• 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 13544-2:2002+A1:2009 - Respiratory therapy equipment - Part 2: Tubing and connectors

Relations

• Consolidates: SIST EN 13544-2:2003 - Respiratory therapy equipment - Part 2: Tubing and connectors
• Effective Date: 19-Jan-2023
• Consolidates: SIST EN 13544-2:2003/kprA1:2009 - Respiratory therapy equipment - Part 2: Tubing and connectors
• Effective Date: 19-Jan-2023
• Consolidates: SIST EN 13544-2:2003/kprA1:2009 - Respiratory therapy equipment - Part 2: Tubing and connectors
• Effective Date: 18-Jan-2023
• Consolidates: SIST EN 13544-2:2003 - Respiratory therapy equipment - Part 2: Tubing and connectors
• Effective Date: 18-Jan-2023
• Consolidates: SIST EN 13544-2:2003/kprA1:2009 - Respiratory therapy equipment - Part 2: Tubing and connectors
• Effective Date: 01-Nov-2009
• Consolidates: SIST EN 13544-2:2003 - Respiratory therapy equipment - Part 2: Tubing and connectors
• Effective Date: 01-Nov-2009

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Atemtherapiegeräte - Teil 2: Schlauchsysteme und VerbindungsstückeEquipement de thérapie respiratoire - Partie 2: Tubes et raccordsRespiratory therapy equipment - Part 2: Tubing and connectors11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN 13544-2:2002+A1:2009SIST EN 13544-2:2003+A1:2009en,fr,de01-november-2009SIST EN 13544-2:2003+A1:2009SLOVENSKI
STANDARD



SIST EN 13544-2:2003+A1:2009



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13544-2:2002+A1
September 2009 ICS 11.040.10 Supersedes EN 13544-2:2002English Version
Respiratory therapy equipment - Part 2: Tubing and connectors Equipement de thérapie respiratoire - Partie 2: Tubes et raccords
Atemtherapiegeräte - Teil 2: Schlauchsysteme und Verbindungsstücke This European Standard was approved by CEN on 1 August 2002 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 13544-2:2002+A1:2009: ESIST EN 13544-2:2003+A1:2009



EN 13544-2:2002+A1:2009 (E) 2 CONTENTS
Page Foreword . 31Scope . 42Normative references . 43Nipples . 43.1Dimensions . 43.2Performance . 44Weight-bearing screw-threaded connectors . 45Tubing . 45.1General . 46Marking of tubing, labels and packaging . 77Packaging . 78Usability . 89Clinical evaluation . 8Annex A (normative)
Test methods . 9A.1Apparatus . 9A.2Method of test for strength of nipple .
...