EN 12342:1998+A1:2009

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 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

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
...