EN 12342:1998+A1:2009

Breathing tubes intended for use with anaesthetic apparatus and ventilators

This European Standard specifies the basic requirements for breathing tubes and breathing tubing supplied to be cut to length, intended for use with anaesthetic apparatus and ventilators, humidifiers and nebulizers. It also applies to breathing tubes and Y-pieces supplied already assembled and to those supplied as components and assembled in accordance with the manufacturers' instructions.
Provision is made for breathing tubes having ends incorporating adaptors with conical connectors (assembled ends) or with plain ends (either cylindrical or tapered).
Breathing tubes for special purposes, such as those used with ventilators having special compliance requirements and coaxial lumen tubes, are outside the scope of this European Standard.
Unless specified otherwise, the requirements of this European Standard apply equally to breathing tubes intended by the manufacturer for single use and those intended for re-use.

Atemschläuche zur Verwendung mit Anästhesie- und Beatmungsgeräten

Diese Europäische Norm legt Grundanforderungen an Atemschläuche einschließlich der vor Gebrauch auf
Länge zuzuschneidenden Schläuche fest, die zur Verwendung mit Anästhesiegeräten, Beatmungsgeräten,
Anfeuchtern und Verneblern bestimmt sind. Sie gilt auch für Atemschläuche und Y-Stücke, die entweder
bereits montiert oder als Einzelteile geliefert werden, die nach den Anweisungen des Herstellers zusammenzusetzen
sind.
Berücksichtigt werden Atemschläuche, in deren Enden Adapter mit konischen Verbindungsstücken eingebaut
sind (konfektionierte Enden) wie auch Schläuche mit glatten (zylindrischen oder konischen) Enden.
Diese Norm gilt nicht für Atemschläuche für spezielle Zwecke, wie z. B. für Beatmungsgeräte mit speziellen
Anforderungen an die Compliance und Tuben mit koaxialem Lumen.
Sofern nicht anders festgelegt, gelten die Anforderungen dieser Europäischen Norm sowohl für
Atemschläuche zum Einmalgebrauch, als auch für Atemschläuche, die zur Wiederverwendung bestimmt sind.

Tubes (tuyaux) respiratoires destinés à être utilisés avec des appareils d'anesthésie et des ventilateurs

Dihalne cevke za uporabo z anestezijskimi aparati in ventilatorji

General Information

• Status: Withdrawn
• Publication Date: 08-Sep-2009
• Withdrawal Date: 21-Oct-2014
• 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: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 22-Oct-2014
• 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 12342:2000+A1:2009 - Breathing tubes intended for use with anaesthetic apparatus and ventilators

Relations

• Merged From: EN 12342:1998 - Breathing tubes intended for use with anaesthetic apparatus and ventilators
• Effective Date: 19-Jan-2023
• Merged From: EN 12342:1998/prA1 - Breathing tubes intended for use with anaesthetic apparatus and ventilators
• Effective Date: 18-Jan-2023
• Replaced By: EN ISO 5367:2014 - Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
• Effective Date: 08-Aug-2012

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dihalne cevke za uporabo z anestezijskimi aparati in ventilatorjiAtemschläuche zur Verwendung mit Anästhesie- und BeatmungsgerätenTubes (tuyaux) respiratoires destinés à être utilisés avec des appareils d'anesthésie et des ventilateursBreathing tubes intended for use with anaesthetic apparatus and ventilators11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN 12342:1998+A1:2009SIST EN 12342:2000+A1:2009en,fr,de01-december-2009SIST EN 12342:2000+A1:2009SLOVENSKI
STANDARD



SIST EN 12342:2000+A1:2009



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12342:1998+A1
September 2009 ICS 11.040.10 Supersedes EN 12342:1998English Version
Breathing tubes intended for use with anaesthetic apparatus and ventilators
Tubes (tuyaux) respiratoires destinés à être utilisés avec des appareils d'anesthésie et des ventilateurs
Atemschläuche zur Verwendung mit Anästhesie- und Beatmungsgeräten This European Standard was approved by CEN on 30 May 1998 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 12342:1998+A1:2009: ESIST EN 12342:2000+A1:2009



EN 12342:1998+A1:2009 (E) 2 Contents Page Foreword .3Introduction .41Scope .52Normative references .53Definitions .54Materials .75Design .76Length .77Resistance to flow .78Means of connection .89Leakage .810Increase in flow resistance with bending .911Compliance of breathing tubes .912Information to be supplied by the manufacturer .913Electrical resistance .914Requirements for breathing tubes supplied sterile .915Marking
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