EN 1782:1998+A1:2009

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.
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COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
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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

Nasal or oral/nasal Oral 1)
- 2,0 130 110 - - 2,5 140 110 - - 3,0 160 120 - - 3,5 180 130 - - 4,0 200 140 - - 4,5 220 150 - - 5,0 240 160 56 115 5,5 270 170 56 120 6,0 280 190 58 125 6,5 290 210 62 135 7,0 300 230 66 140 7,5 310 240 69 145 8,0 320 250 72 150 8,5 320 260 75 155 9,0 320 270 78 160 9,5 320 280 81 165 10 320 280 85 170 10,5 320 280 85 170 11,0 320 280 85 170 1) Manufacturers desiring to market packaged sterile oral pre-cut tubes with connectors inserted may be guided by the tube lengths shown in the table. However, the user is cautioned that anatomical variations, conditions of use, length of tube inserted or other factors may result in the use of a tracheal tube either too long or too short for a given patient. The necessity remains for expert clinical judgement in selecting the size and length of tracheal tubes. 2) These values are not specified for cuffed tracheal tubes of sizes 4,5 or smaller because cuffed tubes of these sizes are infrequently used.
Dimensions in millimetres Designated size (nominal inside diameter) Inside diameter d (± 0,15) Straight connectors – minimum dimension l1 (effective length)1) (figure 4) Curved connectors – minimum dimension l2 (effective length)1) (figure 5) 2,0 2,5 3,0 3,5 4,0 4,5 5,0 5,5 6,0 6,5 7,0 7,5 8,0 8,5 9,0 9,5 10,0 10,5 11,0 2,0 2,5 3,0 3,5 4,0 4,5 5,0 5,5 6,0 6,5 7,0 7,5 8,0 8,5 9,0 9,5 10,0 10,5 11,0 9 9 9 11 11 12 12 13 13 16 16 16 16 16 16 16 16 16 16 - - - - - - - 8 8 8 8 8 8 8 8 8 8 8 8 1) The effective length of the patient end of tracheal tube connectors is that length available for insertion into the tracheal tube.
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