EN 13544-2:2002+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 therapeu-tischen 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 sicher-zustellen und damit eine kontinuierliche Behandlung von Patienten in allen klinischen Situationen zu ermöglichen.
Gewichtstragende Schraubverbindungen wurden zur Verwendung für den Ausgang, z. B. von Durchfluss-messgeräten, 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.

Équipement de thérapie respiratoire - Partie 2: Tubes et raccords

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

General Information

• Status: Published
• Publication Date: 08-Sep-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 4 - Tracheal tubes and other equipment
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Completion Date: 15-Mar-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: SIST EN 13544-2:2003+A1:2009 - Respiratory therapy equipment - Part 2: Tubing and connectors

Relations

• Merged From: EN 13544-2:2002/prA1 - Respiratory therapy equipment - Part 2: Tubing and connectors
• Effective Date: 18-Jan-2023
• Merged From: EN 13544-2:2002 - Respiratory therapy equipment - Part 2: Tubing and connectors
• Effective Date: 18-Jan-2023

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 .
...