EN 1782:1998+A1:2009

Tracheal tubes and connectors

This European Standard specifies requirements for oro-tracheal and naso-tracheal tubes (plain and cuffed) made of plastics materials and/or rubber and requirements for tracheal tube connectors. Specialized tubes are excluded from the scope of this standard.

Trachealtuben und Verbindungsstücke

Diese Europäische Norm legt Anforderungen an Oro  und Naso Trachealtuben (mit und ohne Cuff) aus Kunststoffen und/oder Gummi sowie Anforderungen an Verbindungsstücke für Trachealtuben fest. Spezial¬tuben gehören nicht zum Anwendungsbereich dieser Norm.

Tubes trachéaux et raccords

La présente norme européenne spécifie les prescriptions relatives aux tubes orotrachéaux et nasotrachéaux (avec et sans ballonnets), fabriqués en matière plastique et/ou en caoutchouc, et les prescriptions relatives aux raccords de tubes trachéaux. Les tubes destinés à être utilisés dans le cadre d'applications spécialisées ne font pas partie du domaine d'application de la présente norme européenne.

Sapnični (endotrahealni) tubusi in priključki

General Information

• Status: Withdrawn
• Publication Date: 18-Aug-2009
• Withdrawal Date: 30-Sep-2012
• 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
• Start Date: 01-Oct-2012
• Completion Date: 01-Oct-2012
• 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 1782:2000+A1:2009 - Tracheal tubes and connectors

Relations

• Merged From: EN 1782:1998 - Tracheal tubes and connectors
• Effective Date: 19-Jan-2023
• Merged From: EN 1782:1998/prA1 - Tracheal tubes and connectors
• Effective Date: 27-Jun-2009
• Replaced By: EN ISO 5361:2012 - Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2012)
• Effective Date: 12-Dec-2012

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Trachealtuben und VerbindungsstückeTubes trachéaux et raccordsTracheal tubes and connectors11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN 1782:1998+A1:2009SIST EN 1782:2000+A1:2009en,de01-oktober-2009SIST EN 1782:2000+A1:2009SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1782:1998+A1
August 2009 ICS 11.040.10 Supersedes EN 1782:1998English Version
Tracheal tubes and connectors
Tubes trachéaux et raccords
Trachealtuben und Verbindungsstücke This European Standard was approved by CEN on 2 March 1998 and includes Amendment 1 approved by CEN on 23 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 1782:1998+A1:2009: ESIST EN 1782:2000+A1:2009

Test method for determining the resting diameter of the cuff . 21Annex B (normative)
Test method for tube collapse . 22Annex C (normative)
Test method for cuff herniation . 25Annex D (informative)
Guidance on materials and design . 27Annex E (informative)
Bibliography . 29Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC"""" . 30 SIST EN 1782:2000+A1:2009

These normative references are cited at the appropriate places in the text and the cited 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 – Requirements 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 20594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment – Part 1: General requirements (ISO 594-1:1986) EN 30993-1, Biological evaluation of medical devices – Part 1: Guidance on selection of tests
(ISO 10993-1:1992 – Technical Corrigendum 1:1992) 3 Definitions For the purposes of this European Standard, the following definitions apply: 3.1 angle of bevel acute angle between the plane of the bevel and the longitudinal axis of the tracheal tube at the patient end [EN ISO 4135:1996] 3.2 bevel slanted portion at the patient end of the tracheal tube [EN ISO 4135:1996] 3.3 cuff inflatable balloon permanently attached around the tracheal tube near the patient end to provide a seal between the tube and the trachea
1) See ISO/TR 11991. SIST EN 1782:2000+A1:2009

a) that end of a tracheal tube which is intended to project from a patient [EN ISO 4135:1996]; or b) that portion of a tracheal tube connector intended to mate with the breathing system of an anaesthetic machine or ventilator. 3.7 Murphy eye hole through the wall of a tracheal tube near the patient end and on the side opposite to the bevel 3.8 naso-tracheal tube tracheal tube for insertion through the nose into the trachea [EN ISO 4135:1996] 3.9 oro-tracheal tube tracheal tube for insertion through the mouth into the trachea [EN ISO 4135:1996] 3.10 patient end
a) that end of a tracheal tube which is intended to be inserted into the trachea [EN ISO 4135:1996]; or b) that end of a tracheal tube connector nearest to the patient, which is inserted into the tracheal tube. 3.11 pilot balloon balloon fitted to an inflating tube to indicate inflation of a cuff [EN ISO 4135:1996] 3.12 tracheal tube tube designed for insertion through the larynx into the trachea to convey gases and vapours to and from the trachea [EN ISO 4135:1996] 3.13 tracheal tube connector tubular component that fits directly into a tracheal tube [EN ISO 4135:1996] 3.14 tracheal tube of the "Magill" type tracheal tube with a radius of curvature (see 4.7) SIST EN 1782:2000+A1:2009
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