SIST EN 1782:2000+A1:2009
(Main)Tracheal tubes and connectors
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
Relations
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
SIST EN 1782:2000+A1:2009
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
EN 1782:1998+A1:2009 (E) 2 Contents Page Foreword .3Introduction .41Scope .52Normative references .53Definitions .54General requirements for tracheal tubes and tracheal tube connectors .75Additional requirements for tracheal tubes with a Murphy eye . 136Requirements for tracheal tubes and tracheal tube connectors supplied sterile . 137Marking . 13Annex A (normative)
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
EN 1782:1998+A1:2009 (E) 3 Foreword This document (EN 1782:1998+A1:2009) has been prepared by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI. This European Standard is based on: ISO 5361-1, Tracheal tubes – Part 1: General requirements ISO 5361-2, Tracheal tubes – Part 2: Oro-tracheal and naso-tracheal tubes of Magill type (plain and cuffed) ISO 5361-3, Tracheal tubes – Part 3: Murphy type ISO 5361-5, Tracheal tubes – Part 5: Requirements and methods of test for cuffs and tubes ISO 7228, Tracheal tube connectors prepared by the International Organisation for Standardisation (ISO). This European Standard differs from ISO 7228 and the ISO 5361 series in that it permits the use of 8,5 mm connectors for the smaller sizes of tracheal tubes. Annexes A, B and C are normative and form part of this European Standard. Annexes D, E and ZA are for information only. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2010, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document includes Amendment 1, approved by CEN on 2009-07-23. This document supersedes EN 1782:1998. The start and finish of text introduced or altered by amendment is indicated in the text by tags !". This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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.
SIST EN 1782:2000+A1:2009
EN 1782:1998+A1:2009 (E) 4 Introduction This European Standard specifies the dimensions, basic properties and method of size designation of the most commonly used types of tracheal tubes made of plastic materials and/or rubber. Tubes with walls reinforced with, e.g. metal or nylon, tubes with shoulders, tapering tubes and the many other types of tubes devised for specialized applications are not specifically covered, although most can be classified by their inside diameter as required by this standard. While the inside diameter has been specified for size designation, the outside diameter should also be marked, since this information is of clinical importance. Clinical considerations have also dictated the apparently excessive specified length of tubes because long tubes, sometimes of relatively narrow diameter, can be urgently required and therefore should be readily available. Provision has also been included for pre-cut tracheal tubes. Cuffed tracheal tubes can be characterized by a combination of the tube inside and outside diameters and by the cuff resting diameter. For tubes intended for re-use, information on the cuff resting diameter should be marked on the package or insert but not on the tube itself. This is because re-use may alter the elastic properties, and thereby the diameter, of the cuff. The relationship of cuff and tracheal diameters dictates the intra-cuff pressures required to provide a seal. Excessive pressure on the tracheal wall can obstruct capillary blood flow. Tracheal tubes are intended to conform, when in position, as closely as possible to human anatomy. WARNING — Whatever type of cuff is used, it is the responsibility of the user to ensure that at any particular time it is inflated with no more than the minimum amount of air required to provide an effective seal at the desired lung inflation pressure. A range of cuff designs is available to meet particular clinical requirements. The resting diameter of the cuff should be marked on the unit package as this information allows the clinician to match the product to the application. Herniation in relation to cuffs is a term widely understood in clinical anaesthetic practice. It is used to describe a cuff which protrudes excessively at its patient end so that it partially or completely occludes the orifice at the bevel. Herniation can be due to a variety of causes, singly or in combination: these can include over-inflation of the cuff, traction of the tube when the cuff is inflated or deterioration of the material of the cuff. It should be noted that although certain requirements for cuffs would apply to tubes with an inside diameter of 2,0 to 4,5, cuffs are infrequently used on these smaller sizes of tubes. Tracheal tube connectors should incorporate 8,5 mm or 15 mm male conical connectors in accordance with EN 1281-1, in order to mate with the appropriate female conical connector of the patient connection port of the breathing system of an anaesthetic machine or ventilator. The designated size of each tracheal tube connector should be not less than that of the tracheal tube with which it is designed to fit, thereby avoiding unnecessary restriction of the gas flow and minimising the risk of inadvertent disconnection. SIST EN 1782:2000+A1:2009
EN 1782:1998+A1:2009 (E) 5 Flammability of tracheal tubes, for example if flammable anaesthetics, electrosurgical units or lasers are used, is a well-recognised hazard1) that is addressed by appropriate clinical management, outside the scope of this standard. 1 Scope 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. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications.
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
EN 1782:1998+A1:2009 (E) 6 3.4 inflating tube tube through which the cuff is inflated [EN ISO 4135:1996] 3.5 inflation lumen lumen within the wall of the tracheal tube for inflating the cuff 3.6 machine end
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
EN 1782:1998+A1:2009 (E) 7 4 General requirements for tracheal tubes and tracheal tube connectors 4.1 Size designation The size of tracheal tubes and tracheal tube connectors shall be designed by the nominal inside diameter expressed in millimetres in accordance with table 1 for tracheal tubes and table 2 for tracheal tube connectors. 4.2 Dimensions 4.2.1 Tracheal tubes 4.2.1.1 The basic dimensions of tracheal tubes shall be in accordance with table 1. 4.2.1.2 The actual inside diameter shall be the marked inside diameter subject to a tolerance of ± 0,15 mm for size 6,0 and smaller, or subject to a tolerance of ± 0,20 mm for size 6,5 and larger. 4.2.1.3 The actual outside diameter (OD) shall be the marked outside diameter (OD) subject to a tolerance of ± 0,15 mm for size 6,0 and smaller, or subject to a tolerance of ± 0,20 mm for size 6,5 and larger (see 7.2.1.1 b)). SIST EN 1782:2000+A1:2009
EN 1782:1998+A1:2009 (E) 8 Table 1 — Basic dimensions of tracheal tubes Dimensions in millimetres Designated size (nominal inside diameter) Minimum length of tube A (see figures 1 a) and 1 b)) Maximum distance C from the patient end of the tube to the machine end of the inflatable length of the cuff 2) Minimum distance of point of separation of the inflating tube from the patient end of the tube dimension S11) 2) (see figures 1 a) and 1 b))
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.
SIST EN 1782:2000+A1:2009
EN 1782:1998+A1:2009 (E) 9 4.2.2 Tracheal tube connectors 4.2.2.1 The basic dimensions of tracheal tube connectors shall be in accordance with table 2. 4.2.2.2 When a tracheal tube is supplied with a tracheal tube connector, the designated size of the connector shall be not less than that of the tracheal tube with which it is provided. 4.2.2.3 The minimum inside diameter of a curved or angled connector shall be not less than 80 % of the designated size and the corresponding cross-sectional area shall not be reduced by more than 10 %. 4.2.2.4 A suction port, if provided, shall be designed so that its closure does not obstruct or narrow the lumen of the connector. NOTE The connector can be straight, curved or angled. If curved or angled, the connector can incorporate a suction port. 4.2.2.5 The machine end of a tracheal tube connector of size 6,0 or smaller shall be an 8,5 mm or 15 mm male conical connector complying with EN 1281-1. The machine end of a tracheal tube connector of size 6,5 or larger shall be a male 15 mm conical connector complying with EN 1281-1. The inside diameter of the (conical) machine end shall be not less than that allowed by table 2 for the patient end. Any transition in inside diameter shall be tapered to give an adequate lead-in for smooth passage of a suction catheter. 4.2.2.6 The basic dimensions of the patient end (see figures 4 and 5) of the connector shall be in accordance with table 2. 4.2.2.7 The opening at the patient end shall have a plane at (90 ± 5)û to the long axis of the patient end of the connector.
SIST EN 1782:2000+A1:2009
EN 1782:1998+A1:2009 (E) 10 Table 2 — Tracheal tube connectors - Size range and basic dimensions of patient end
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.
SIST EN 1782:2000+A1:2009
EN 1782:1998+A1:2009 (E) 11 4.3 Materials Tracheal tubes, including cuffs, and tracheal tube connectors in their ready-for-use state after any preparation for use recommended by the manufacturer shall satisfy appropriate biological safety testing, as indicated in EN 30993-1. !NOTE 1" See annex D for guidance on materials and design. !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 2 Attention is drawn to substances which are carcinogenic, mutagenic or toxic to reproduction." 4.4 Bevel All tubes shall have an angle of bevel of (38 ± 10)û. NOTE The bevel of the tube should have the opening facing to the left when the tube is viewed towards the concave aspect from the machine end (see figures 1a) and 1 b)). 4.5 Cuff 4.5.1 A cuff, if provided, shall be permanently attached to the tube. 4.5.2 The maximum distance from the patient end of the tube to the machine end of the inflatable length of the cuff (dimension C in figures 1 a) and 1 b)) shall be as given in table 1. 4.5.3 The cuff resting diameter shall be within ± 15 % of the marked value (see 7.2.2.1 k)), when determined in accordance with annex A. 4.5.4 When tested for tube collapse according to the method described in annex B, the steel ball shall pass freely through the tube. 4.5.5 When tested for cuff herniation according to the method described in annex C, no part of the inflated cuff shall reach beyond the nearest edge of the bevel (see figure C.1). 4.6 Inflating tubes for cuffs 4.6.1 The inflating tube, if provided, shall have an outside diameter of not more than 3,0 mm and the point of separation shall be situated on the concave aspect of the tracheal tube. The wall around the inflation lumen shall not encroach on the lumen of the tracheal tube by more than 10 % of the inside diameter of the tracheal tube. The dimensions of the inflating tube shall be in accordance with table 1 and figures 1 a) and 1 b)). 4.6.2 The angle between the inflating tube and the tracheal tube at the points of separation (see figures 1 a) and 1 b)) shall not exceed 34 û. 4.6.3 The inflating tube shall have a pilot balloon and/or other device to indicate inflation/deflation of the cuff. NOTE This (these) device(s) can also serve as a pressure indicating or limiting device. 4.6.4 The intentional deflation of the cuff shall not be prevented by the inflating tube, inflating valve or any closure device acting as a non-return valve. SIST EN 1782:2000+A1:2009
EN 1782:1998+A1:2009 (E) 12 4.6.5 The free end of the inflating tube shall be either open or sealed with a closure device or inflation valve, but in all instances it shall be capable of accepting a male conical fitting with a 6 % (Luer) taper, complying with EN 20594-1. 4.6.6 The dimension of the inflating tube (dimension S3 in figures 1a) and 1b)) shall be at least 40 mm unless an inflation valve or clo
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