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EN 12342:1998+A1:2009

(Main)

Breathing tubes intended for use with anaesthetic apparatus and ventilators

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Withdrawn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
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

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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
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

Resistance to air flow . 12Annex B (normative)
Method of testing security of attachment of plain end to appropriately-sized male conical connector . 14Annex C (normative)
Method of testing security of attachment of adaptor to breathing tube . 15Annex D (normative)
Method of testing leakage . 16Annex E (normative)
Method of testing increase in flow resistance with bending . 18Annex F (normative)
Method of testing compliance . 20Annex G (informative)
Recommendations for materials and design . 21Annex H (informative)
Bibliography . 22Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC"""" . 23 SIST EN 12342:2000+A1:2009

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. EN 556:1994, Sterilization of medical devices – Requirement for medical devices to be labelled 'Sterile' EN 868-1, Packaging materials and systems for medical devices which are to be sterilized – Part 1: General requirements and test methods EN 980, Graphical symbols for use in the labelling of medical devices EN 1281-1, Anaesthetic and respiratory equipment – conical connectors – Part 1: Cones and sockets EN 30993-1, Biological evaluation of medical devices – Part 1: Guidance on selection of tests (ISO 10993-1:1992 + Technical Corrigendum 1:1992) EN 60601-1:1990, Medical electrical equipment – Part 1: General requirements for safety (IEC 601-1:1988) ISO 468, Surface roughness – Parameters, their values and general rules for specifying requirements 3 Definitions For the purposes of this European Standard, the following definitions apply: 3.1 APL valve; adjustable pressure limiting valve; pop-off valve pressure limiting valve which releases gas over an adjustable range of pressures [EN ISO 4135:1996] 3.2 breathing tube non-rigid tube used to convey gases and/or vapours between an anaesthetic machine and/or some ventilators, and a patient [EN ISO 4135:1996] SIST EN 12342:2000+A1:2009

4 Materials Breathing tubes, in their ready-for-use state after any preparation recommended by the manufacturer, shall satisfy appropriate biological safety testing, as indicated in EN 30993-1. !If phthalates are incorporated in parts of the medical devices coming directly or indirectly into contact with the patient the medical device shall be labelled accordingly. NOTE Attention is drawn to substances which are carcinogenic, mutagenic or toxic to reproduction." 5 Design Breathing tubes, whether of corrugated constructions or otherwise, shall have plain ends (cylindrical or tapered) and/or assembled ends incorporating 22 mm, 15 mm or 8,5 mm conical connectors complying with EN 1281-1. NOTE 1 A loop for suspending the tube can be provided near one of the ends. NOTE 2 The ends of breathing tubes can be constructed to engage with the recess at the base of a 22 mm male conical connector. NOTE 3 Recommendations for materials and design are
...

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NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

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CEN
EN ISO 80601-2-55:2018/A1:2023(Amendment)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
SIST EN ISO 80601-2-55:2018/A1:2024
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