STD-BST BS EN L228-ENGL 1998 MM 124669 0723660 904 me BRITISH STANDARD BS EN ae, | ¥2181:1998 Oropharyngeal airways Briish Standard ‘The European Standard EN 12181:1998 has the status of a | | | NO COPYING WITHOUT RSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW. Copmright by the Buropean Committee For Standardization Yon apr 11 130539 2041STD-BSI BS EN 22U82-ENGL 1998 MM VL24bb9 07236) B40 Ml BS EN 12181:1998 “rus wri Stara, navn been prepared under the ‘rection ofthe Health and Bmnironment sector Boara, was, bbdished under the authority of {eStandards Board and comes ISBN 0580 20673 3 National foreword ‘This British Standard is the English language version of EN 12181:1998 published by the European Comittee for Standardization (CEN). It supersedes BS 6153:1987 which is withdrawn. ‘The UK participation in ts preparation was entrusted to Technical Committee (CHAS, Tracteal tubes and related equipment, which has the responsibility to: — ald enquirers to understand the text; — present to the responsible European committee any enquiries on the Interpretation, or proposals for change, and keep the UK interests informed; — monitor related international and European developments and promulgate ‘them in the UK A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references ‘The British Standards which implement international or Buropean publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “Intemational Standards Correspondence Index’, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages ‘This document comprises a front cover, an inside front cover, the EN title page, pages 210 8, an inside back cover and a back cover Amendments issued sinee publication ‘Amd.No. [Date Textaffected Copyright by the Furopean Committee For Standardization Yon apr HY 130539 201STD-BST BS EN 12181-ENGL 1998 MM Lb24bb5 O723bb2 757 Mm EUROPEAN STANDARD EN 12181 NORME EUROPEENNE EUROPAISCHE NORM February 1988 res m08030 Descriptors: Medical equipment, pharyngeal cannulae, rubber, places, specifieasions, design, dimensions, characteristics, tess, crushing strong, packing, labelling, graphic symbols English version Oropharyngeal airways Canules oro pharyngées Oropharyngealtuben ‘This European Standard was approved by CEN on 16 January 1998. CEN members are bound to comply with the CENCENELEC Intemal Regulations ‘whieh stipulate the conditions for giving this European Standard the stans of a national standard without any alteration. Uptodate lists and bibliographical references concerning sich national standards may be obtained on application £0 ‘the Central Secretariat or to any CEN member. é This Buropean Standard exists in three official versions (Enslish, French, German), e A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same stans as the official versions. CEN members are the rational standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Tealy Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom CEN Buropean Committee for Standardization Comité Européen de Normalisation Europaisches Komitee fir Normung, Central Secretariat: rue de Stassart 36, B-1050 Brussels © 1908 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members Ref, No, EN 12181:1998 E Copyright by the Furopean Committee For Standardization Yon apr HY 130539 201STD-BST BS EN Y2)81-ENGL 3998 MM Lb24bb9 O723bb3 b)3 Page 2 EN 12181:1998 Foreword This European Standard has been prepared by Technical Committee CEN/T0216, Respiratory and anaesthetic equipment, the secretariat of which is held by BSL ‘This European Standard is based on the reference standard SO 5364, Oropharyngeal airways Ie differs from 180 6364 primarily in that it introduces a limit and tes. for resistance to distortion which is relevant to the ability ofthe oropharyngeal airway to assist in keeping the base of the patient's tongue in a forward position while itis in use {t also mtroduces a ht and test for resstance to collapse of the buccal end, if bitten by the patient. This {s relevant to the ability of te oropharyngeal airway to ‘maintain a patent passage for gases and for passing suction catheter ‘This European Standard also differs from 1S0 6364 in that it excludes metal airways because of their particular association with dental tomes, ‘Annexes A and B are normative and form part of this European Standard. Annexes C and D are for information only. ‘This Buropean Standard shall be given the stazus of a national standard, either by publication of an identical text or by endorsement, atthe latest by August 198, ‘and conthicting national standards shall be witharawn at the latest by August 1998, ‘According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following ‘countries are bound to implement this European ‘Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, ireand, lealy, Luxembourg, Netherlands, Norway, Porbgal Spain, Sweden, Switzerland and the United Kingdom. Copyright by the Furopean Committee For Standardization Yon apr HY 130539 201 Contents Foreword Introduetion Scope Normative references Definitions Size designation and dimensions Materials Design Performance requirements Sterility assurance Packaging of oropharyngeal alrways supplied sterile 10 Marking 11 Information to be supplied by the ‘manufacturer Annex A (normative) Test method for resistance to collapse of the buccal end Annex B (normative) Test method for resistance to distortion Annex C (informative) Guidance on ‘materials and design Annex D (informative) Bibliography Page © BSI 1908STD+BSI BS EN L2)8}-ENGL 1598 Introduction ‘This Puropean Standard specifies dimensions and requirements for oropharyngeal airways. Size is designated by length, which is mportant when selecting. an oropharyngeal airway to hold forward the base of the tongue to prevent obstruction of the ‘human airway by the soft tissue. Flammability of oropharyngeal airways, for example, if flammable anaesthetics, electrosurgical units or lasers are used, is a wellrecognized hazard!) that is addressed by appropriate clinical management, outside the scope of this standard. 1 Scope ‘This European Standard specifies requiremers for ‘oropharyngeal airways of plastics materials aftdior rubber, including those with a reinforcement insert ‘made of plastics materials and/or metal. Metal ‘oropharyngeal airways are excluded from the scape of this European 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 vext 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 956:1904, Storilisation of medical devices EN 868-1, Packaging materials and systems for ‘medical devices which ave to be sterilized — Part 1: General requtrements and test methods EN 980, Graphical symbols for use in the labelling of medion! devices EN 900031, Biological evaluation of medical devices — Part 1: Guidance on selection af tests. (S010292-1:1992 and Technical Corrigendum 1:1992) 3 Definitions For the purposes of this standard, the following definitions apply. 31 oropharyngeal airway device intended to maintain the patency of the respiratory passages through the oral cavity and p TEN 1S0 413-1906) Soe ISOHTE 11991 © Bsr 1098 Copyright by the Furopean Committee For Standardization Yon apr HY 130539 201 WH 3b24bb5 0723664 55T am Page 3 EN 12181:1998 a2 pharyngeal end {hat end of the oropharyngeal airway which is intended to be inserted into the patient's oropharynx. {BN ISO 41351986) 33 buccal end: flanged end that end of the oropharyngeal airway which is flanged and is expected to fit between the teeth or gums at the lips (EN 180 4135:1906) 4 Size designation and dimensions 4.1 Size designation ‘The size of oropharyngeal airways shall be designated by the nominal length (see L, Figure 1) expressed in centimetres, in accordance with Table 1 NOTE. The manufscturer's av sie designation can sionally be givon, bur it snot recoramended Table 1 — Size designation of oropharyngeal airways — Dimensions and tolerances [Beslgnated stze | tength and | Minimum Inalde | cosmftegy | tree) | atneaon on | nm [3 w0t25 [25 | as 5425 30 [4 | 4ot25, 30 bas | 45225 30 Js sot25 a5 | 58 [35 6 | 40 65 | 40 | 7 40 8 9 0 u 050 42 Dimensions 422.1 The length (see L, Figure 1) shall be in accordance with Table 1 4.2.2. The minimum inside dimension at any point along the length of the airway shall be not less than that specified in Table 1 NOTE. This szelevant to che ability to pass other devices, €g. 2 suction catheter tough the aiaSTD-BSI BS EN L2284-ENGL 4998 MM Lb24bb4 O723bb5 4b A Page 4 EN 12181:1998 5 Materials Oropharyngeal airways, in their ready for-use state after any preparation for use recommended by the manufacturer, shall satisfy appropriate blological sarety testing, as indicated in EN 30993-1. 6 Design Edges and comers intended to come into contact with the patient's tissues shall have a minimum radius of curvature of 0.5mm 7 Performance requirements 7.1 Resistance to collapse of the buccal end ‘When tested in accordance with annex A, the minimum inside dimension of the buecal end of the airway shall ‘be not less than 75 % of that given in Table 1 for the size of airway being tested. 7.2 Resistance ta distortion When tested in accordance with annex B, the pharyngeal end of the airway shall not move through an angle of more than 30’. 8 Sterility assurance Oropharyngeal airways 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. 9 Packaging of oropharyngeal airways supplied sterile 9.1. Bach oropharyngeal airway supplied and marked as “STERILE” shall be contained in an individual pack. 9.2. The pack shall serve as an effective barrier to the penetration of micro-organisms and particulate material fn accordance with EN 861 9.3. The pack shall permit the aseptic extraction of the ‘contents and shall nos be capable of reclosure without ‘clearly revealing that it has been opened. 9.4. The designated size of the airway shall be ‘apparent on visual examination of the intact unit container, 9.5 Individual packs shall be contained within a shelf co multiunit pack. Copyright by the Furopean Committee For Standardization Yon apr HY 130539 201 10 Marking NOTE Marking of oropharyngeal airways, of unit packs and of shelf or mula packs and information to be supplied by the ‘anafacturer should comply with prEN 104 101 Use of symbols ‘The requirements of 10.9 and 10.4 can be met by use of appropriate symbols as given in EN 980. 102 Marking of oropharyngeal airways ‘The buccal end of the oropharyngeal airway shall be marked with the following 4) the designated size (nominal length in em) in accordance with 4.1 (wee Figure 2 1b) the name and/or trade mark of the manufacturer and/or supplier (see Figure 2). Markings in accordance with a) and b) shall be visible from the buccal end. 10.3 Marking of unit packs ‘The marking of individual packs or a package insert shall include the following: a) the word “STERILE”, if appropriate, ») for oropharyngeal airways not intended for re-use, the words “single use” or equivalent. [NOTE I is recommended thatthe method of terization be ven 104 Marking of shelf or multi-unit packs ‘The marking of shelf or multi-unit packs shall include ‘the following: a) a description of contents; 1b) the designated size in accordance with 4.1; ©) the name and/or trademark and address of the ‘manufacturer and/or supplier, 4) the batch number; NOTE. Is strongly cerommended thatthe “use bs" date be aver. ©) the word “STERILE”, if appropriate; 1) for oropharyngeal airways not intended for re-use, the words “single use” or equivalent, [NOTE Is recormended tat the method of serization be ven 11 Information to be supplied by the manufacturer Unless the oropharyngeal airway is intended and marked as heing for single use, the manufacturer shall recommend methods of cleaning and disinfection or sterilization, © nt 1008STD-BSI BS EN L2D8}-ENGL 1998 MM 2b24bb9 O713bbb 322 Page 5 EN 12181:1998 o—_{ 1. Buccal end 2 Reinforsement insert, provided For Lsve 4 and 42.1 Figure 1 — Length for size designation of 3 oropharyngeal airways 41 Designaod si 2 Name or trademark of manufacture or sphir NOTE The desions shown in Figures I and 2 are intended to lust Common types af oropharyngeal airways for the purpose of| ‘ize designation and marking but ate not otherwise intended to form 2 par of this European Standard Figure 2— Typical marking of oropharyngeal airways © BSL 1998 Copyright by the Furopean Committee For Standardization Yon apr HY 130539 201STD-BSI BS EN L2D83-ENGL 1998 MH 2624bb9 071367 265 a Page 6 EN 12181:1998 Annex A (normative) ‘Test method for resistance to collapse of ‘the buecal end A.l Principle “The resistance to collapse Is tested by measuring the minimum inside dimension of the buecal end during ‘compression. ‘A2 Apparatus A.2.1 Means of conditioning the orepharyngeat airway, at 23*2)°C and at (5020) % relative Iuumidity and carrying out the test under the same conditions. A.2.2 Moans of applying a foreo, of either (100: 10) N ‘or (200 +20), as appropriate, at a rate of (6045) mmmin, A.2.3 Means of measuring the minimum inside dimension of the buccal end during compression, with an accuracy of *0,10 mm. A.3 Test procedure A.3.1. Condition the oropharyngeal airway at (232) °C and at (60 20) % relative humidity for Lh ‘and carry out the test under the same conditions. ‘A.8.2 Compress the middle of the buccal end (see Figure 1) of the oropharyngeal airway using blocks with a (60+2y included angle and radius of curvature (of (00,5) nu uo dhe nual sustaces an wit a least 2s great as that of the buecal end of the airway being tested (see Figure A.D). A.3.3 For oropharyngeal airways of designated ize 5.5 or smaller, anpy a force of (100+ 10)N at a rate of (60 £5) mmmin-! and maintain that force for a minimum of 10's whilst measuring the minimum ‘mension. A.34 For oropharyngeal airway’ of designated size 6,0 or larger, apply a force of (200 20) N at a rate of (60+ 5) mm-min~ and maintain that force for a minimum of 10's whilst measuring the minimum dimension. Copyright by the Furopean Committee For Standardization Yon apr HY 130539 201 A.4 Expression of result Express the minimum inside dimension of the buccal fend during compression as a percentage of that value specified in Table 1 for the size of airway being tested. 1 Force applied as in A.3.3 oF ABA 2 (@O=2y ncinded ange 3 Radius of curvature (1.0 0,5) min Figure A.1— Apparatus for testing resistance to collapse of the buccal end © Bt 1008STD-BSI BS EN L2U8]-ENGL 1998 MM 1624665 0713bb8 175 Ml Page 7 EN 12181:1998 Annex B (normative) 8.2.2 Mons of alvin, fore of (0 05)N at ‘Test method for resistance to distortion "#* °f 605) mmmin Ba Test procedure Ba Frinciple B.3.1_ Condition the oropharyngeal airway at ‘The resistance to distortion of the airway is tested by (34 2)°C and at not less than 80% relative humidity ease ee me aia gerd 2)°C and at not len thn Fae eS So of donion, LR and ey ote est under the same B2 Apparatus B32. Camp the buccal end of he sway 20 dat B.2.1 Means of conditioning the oropharyngeal does not move, and apply a force of (5,0 * 0,5) N at a airway, at (342) °C and at not less than 80% relative rate of (50* 5) mm-min“! to the pharyngeal end and Eee ne ch hae Or ms Gee has beta comes Paina alk te ele eat B.2.2 Clamp with protractor, for suspending the. BA Expression of result Drange ree and macrng ae Sesee of Expres Oe sgl gets hough which he distortion. pharyngeal cnd moves | SS 30° IS S | Ui) Ui /it/ \ | Rapist | iiss | 3 eae | § Bear i005 Wapato QOS) mn | | $ pS pod! Figore Bl — Apparatus for testing resistance to asrorion ns Copyright by the Furopean Committee For Standardization Yon apr HY 130539 201STD-BSI BS EN L2483-ENGL 1998 Page 8 EN 12181:1998 ‘Annex C (informative) Guidance on materials and design C.1_ Materials and design should be such as to minimize the risk of dental trauma in use, ©2 Unless intended and marked for single use, oropharyngeal airways and any marking materials used on oropharyngeal airways should be resistant to “eterioration by methods of cleaning, disinfection and sterilization as recommended by the manufacturer. ‘The recommended method or methods of sterilization should not produce changes in the materials which will compromise Ute Liolyival safety uf Uwe oropharyngeal airway (see clase 6) 6.3. Oropharyngeal alrways ann any nearkiny smaletials used on oropharyngeal airways under normal conditions of use should be resistant to deterioration by anaesthetic vapours and gases, and commonly used ‘Water-soluble lubricants and topical anaesthetics. CA. Where an insert is used, it should be permanently attached and of a suitable corrosion-resisting type or Mhished with a durable corrosion-resisting finish C5 Oropharyngeal airways should have smooth inside and outside surfaces. Copyright by the Furopean Committee For Standardization Yon apr HY 130539 201 W™ 1624069 0733669 031 Annex D (informative) Bibliography EN 1041, Terminology, symbols and information ‘provided with modieat doviees — Information ‘supplied by the manafacturer with medical devices. EN 150 4135:1996, Anaesthesiclogy— Vocabulary. (450 4135:1905) ISO/TR 11901, Guidance on airway management during laser surgery of upper airway. © BST 1688STD-BSI BS EN L2381-ENGL 1998 MM U624bb5 0713670 853 Ml BS EN 12181:1998 BSL 389 Chiswick High Road London wa aaL. BSI — British Standards Institution BST is the independent national body responsible for preparing British Standards. fe presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions British Standards are updated by amendment or revision. Users of British Standards should make sure that they possess the latest amendments or editions. Itis the constant aim of BSI to unprove the quality of our products and services. We ‘would be grateful if anyone finding an inaccuracy or ambiguity while using this British Standard would inform the Secretary of the technical eammittce respansihle, the identity of which can be found on the inside front cover. Tel: 0181 966 9000. Fax: 0181 996 7400. 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