SIST EN 12342:2000+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
Relations
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 . 10Annex A (normative)
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
EN 12342:1998+A1:2009 (E) 3 Foreword This document (EN 12342:1998+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 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 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 2009-07-30. This document supersedes EN 12342:1998. 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. This European Standard is based on the reference standard ISO 5367 "Breathing tubes intended for use with anaesthetic apparatus and ventilators". It differs from ISO 5367 primarily in that all sizes of breathing tubes are included and that each tube is required to be marked with the rated flow that the manufacturer claims can be achieved without exceeding specified limits for resistance. Annexes A, B, C, D, E and F are normative. Annexes G, H and ZA are for information only. 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 12342:2000+A1:2009
EN 12342:1998+A1:2009 (E) 4 Introduction This European Standard is one of a package dealing with anaesthetic and respiratory equipment. It is primarily concerned with basic requirements for breathing tubes, including those breathing tubes used with 8,5 mm connectors. Breathing tubes are characterised by the rated flow that a manufacturer claims can be achieved without exceeding specified limits for resistance. The requirements also include means of connection and several methods of test, some of which have not been included in previous International Standards. Recommendations for materials and design are given in annex G.
SIST EN 12342:2000+A1:2009
EN 12342:1998+A1:2009 (E) 5 1 Scope 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. 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 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
EN 12342:1998+A1:2009 (E) 6 3.3 adaptor specialized connector to establish functional continuity between otherwise disparate or incompatible components, one end of which is intended to be inserted into the end of a breathing tube, the other end having a conical connector complying with EN 1281-1 3.4 assembled end end of a breathing tube incorporating an adaptor 3.5 plain end end of a breathing tube designed to fit directly over a male conical connector complying with EN 1281-1 3.6 patient end that end of the breathing tube which is intended to be connected to the Y-piece or other appropriate component near the patient 3.7 machine end that end of the breathing tube which is intended to be connected to the anaesthetic workstation, ventilator or other breathing attachment furthest from the patient 3.8 antistatic property of breathing tubes and any integrally attached components with electrical conductivity satisfying specified limits under the test conditions 3.9 compliance volume added per unit pressure increase when gas is added to an enclosed space, expressed at the temperature and humidity of that enclosed space and at an ambient atmospheric pressure [EN ISO 4135:1996] 3.10 patient connection port that opening at the patient end of a breathing system intended for connection to a tracheal or tracheostomy tube connector or adaptor, a face mask or a face mask angle piece [5.2.2 of EN ISO 4135:1996] 3.11 3-way breathing system connector; T- or Y-piece 3-way tubular connector for use within a breathing system with a patient connection port and two ports for connection to the breathing system [EN ISO 4135:1996] 3.12 swivel 3-way breathing connector; swivel y-piece specialised 3-way connector which allows variation in the position of its three ports relative to each other [EN ISO 4135:1996] 3.13 rated flow flow that the manufacturer claims results in an increase in pressure of not more than that specified in 7.1 or 7.2, as appropriate SIST EN 12342:2000+A1:2009
EN 12342:1998+A1:2009 (E) 7
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 given in annex G. 6 Length 6.1 The length of breathing tubes shall be designated by their nominal overall length, expressed in metres, when measured in the resting condition (without being held under tension), lying on a horizontal surface. Breathing tubes intended to be extended when used shall be designated by both the unextended and extended lengths. 6.2 The designated length of breathing tubes provided permanently attached to a Y-piece shall include the length of the Y-piece and any assembled ends. 6.3 The actual length shall be within 10 % of the designated length. 7 Resistance to flow 7.1 When a breathing tube supplied ready for use (with assembled ends and Y-piece, if provided) is tested in accordance with Annex A using the rated flow (see 15.2 d) and 15.3 d)), the increase in pressure shall not exceed 0,2 kPa (2,0 cmH2O). 7.2 When breathing tubing supplied to be cut to length is tested in accordance with annex A using the rated flow (see 15.2 e) and 15.3 e)), the increase in pressure shall not exceed 0,1 kPa (1,0 cmH2O) per metre length of tubing. SIST EN 12342:2000+A1:2009
EN 12342:1998+A1:2009 (E) 8
8 Means of connection 8.1 Plain ends of tubes 8.1.1 The axial length of plain ends of breathing tubes, excluding those specified in 8.1.2, when measured in the resting condition, shall be not less than 21 mm for breathing tubes intended to engage with 22 mm conical connectors, not less than 14 mm for breathing tubes intended to engage with 15 mm conical connectors, or not less than 8 mm for breathing tubes intended to engage with 8,5 mm conical connectors. 8.1.2 The axial length of plain ends of breathing tubes that incorporate an internal ridge, intended to engage with the recess at the base of a 22 mm male conical connector as specified in EN 1281-1, shall be not less than 26,5 mm when measured in the resting condition. 8.1.3 When tested as described in annex B, plain ends of breathing tubes shall not become detached from the appropriate male conical connector. 8.2 Adaptor The end of the adaptor which is not intended for attachment to the breathing tube shall have a 22 mm, 15 mm or 8,5 mm conical connector conforming to EN 1281-1. 8.3 Assembled end When tested as described in annex C, the adaptor shall not become detached from the tube. NOTE For the purpose of this requirement, a Y-piece provided permanently attached to a breathing tube is regarded as an adaptor. 8.4 Breathing tubes permanently attached to a Y-piece If breathing tubes are supplied in pairs permanently attached to a Y-piece, the patient connection port of that Y-piece shall be a 22 mm/15 mm or 15 mm/8,5 mm male/female coaxial conical connector conforming to EN 1281-1. 9 Leakage 9.1 When tested in accordance with annex D, single breathing tubes shall not leak at a rate of more than 25 ml min-1. 9.2 When tested in accordance with annex D, breathing tubes supplied in pairs permanently attached to a non-swivel Y-piece, shall not leak at a rate of more than 50 ml min-1. 9.3 When tested in accordance with annex D, breathing tubes supplied in pairs permanently attached to a swivel Y-piece shall not leak at a rate of more than 75 ml min-1. NOTE Requirements for leakage from complete breathing systems including those systems incorporating breathing tubes with swivel Y-pieces are specified in EN 740. SIST EN 12342:2000+A1:2009
EN 12342:1998+A1:2009 (E) 9 10 Increase in flow resistance with bending When tested in accordance with annex E, the pressure at the rated flow when the breathing tube is suspended over the metal cylinder shall not exceed 150 % of the value obtained with the tube straight. 11 Compliance of breathing tubes The compliance of breathing tubes at a pressure of 6 kPa (60 cmH2O) shall not exceed 10 ml kPa-1 (1 ml cmH2O-1) per metre length of tube when tested in accordance with annex F. 12 Information to be supplied by the manufacturer 12.1 The manufacturer shall, when requested, provide information on the maximum recommended safe working temperature of the breathing tube when attached to a heated humidifier. 12.2 Unless the breathing tube is intended and marked as being for single use, the manufacturer shall provide details of recommended methods of cleaning and disinfection or sterilization. ! 12.3 The date of issue or the latest revision of the instructions for use shall be given." 13 Electrical resistance The electrical resistance of breathing tubes and any integrally attached components made of conductive material that are intended for use with flammable anaesthetics shall conform to the requirements for prevention of electrostatic charges specified in sub-clause 39.3b) of EN 60601-1:1990. 14 Requirements for breathing tubes supplied sterile 14.1 Sterility assurance Breathing tubes supplied and marked as 'STERILE' shall satisfy the requirements of 4.1 of EN 556:1994 for the assurance of sterility needed to make the claim of being sterile. 14.2 Packaging of breathing tubes supplied sterile 14.2.1 Breathing tubes s
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