1、BRITISH STANDARD BS EN 13544-3:2001 +A1:2009 Respiratory therapy equipment Part 3: Air entrainment devices ICS 11.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWNational foreword This British Standard is the UK implementation of EN 13544-3:2001+A1:2009. It supersedes BS
2、 EN 13544-3:2001 which is withdrawn. The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to CEN text carry the number of the CEN amendment. For example, text altered by CEN amendment A1 is indicated by !“. The UK participation in
3、its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to CH/ 121/5, Lung ventilators, tracheal tubes and related equipment. A list of organizations represented on this subcommittee can be obtained on request to its secretary. This publication does not pu
4、rport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. BS EN 13544-3:2001+A1:2009 This British Standard, having been prepared under the direction of the Health a
5、nd Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 July 2001 BSI 2010 Amendments/corrigenda issued since publication Date Comments 31 March 2010 Implementation of CEN amendment A1:2009 ISBN 978 0 580 65094 9 EUROPEAN STANDARD NOR
6、ME EUROPENNE EUROPISCHE NORM EN 13544-3:2001+A1 September 2009 ICS 11.040.10 Supersedes EN 13544-3:2001 English Version Respiratory therapy equipment - Part 3: Air entrainment devices Appareils de thrapie respiratoire - Partie 3: Dispositifs dentranement dair Atemtherapiegerte - Teil 3: Luftbeimisch
7、gerte This European Standard was approved by CEN on 7 April 2001 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 with
8、out 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
9、 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,
10、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 COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITE
11、E FR 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 13544-3:2001+A1:2009: EEN 13544-3:2001+A1:2009 (E) 2 Contents Page Foreword 3 1 Scope 4 2 Normative references 4
12、 3 Terms and definition . 4 3.1 Air entrainment device 4 4 Oxygen supply . 4 5 Connections . 4 5.1 Oxygen supply inlet . 4 5.2 Air inlet attachments . 5 6 Delivered oxygen concentration 5 7 Marking and identification 5 7.1 Marking . 5 7.2 Colour coding . 6 8 Information supplied by the manufacturer
13、. 6 9 ! ! ! !Usability . 7 10 Clinical evaluation . 7 Annex A (normative) Method of test for delivered oxygen concentration . 8 Annex B (informative) Rationale 12 Annex C (informative) Colour coding 13 Annex ZA (informative) ! ! ! !Relationship between this European Standard and the Essential Requir
14、ements of EU Directive 93/42/EEC“ “ “ “ 14 Bibliography 15 BS EN 13544-3:2001+A1:2009EN 13544-3:2001+A1:2009 (E) 3 Foreword This document (EN 13544-3:2001+A1:2009) has been prepared by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment“, the secretariat of which is held by BSI. Th
15、is 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
16、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 13544-3:2001. The start and finish of text int
17、roduced 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)
18、, see informative Annex ZA, which is an integral part of this standard. This European Standard applies to respiratory therapy equipment and has been prepared in three parts. This Part addresses air entrainment devices; part 1 and part 2 address respectively nebulizing systems and tubing and connecto
19、rs. Annex A is normative and forms part of this European Standard. Annexes B, C 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, Bulgari
20、a, 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. BS EN 13544-3:2001+A1:2009EN 13544
21、-3:2001+A1:2009 (E) 4 1 Scope This part of this European Standard specifies minimum performance and safety requirements for air entrainment devices used for delivery of a designated oxygen concentration to patients. It gives a test method to check the oxygen concentration in the air/oxygen mixture g
22、enerated by the air entrainment device. It also specifies marking requirements and gives an optional system of colour coding to assist the user to identify the designated oxygen concentration. This standard does not cover air entrainment devices which are integral with medical devices specified in o
23、ther standards e.g. emergency lung ventilators, humidifiers, nebulizers, etc. 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
24、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 (including amendments
25、). EN 738-1, Pressure regulators for use with medical gases Part 1 : Pressure regulators and pressure regulators with flow metering devices. EN 980, Graphical symbols for use in the labelling of medical devices. EN 1041, Information supplied by the manufacturer with medical devices. prEN 13159, Comp
26、atibility of medical equipment with oxygen. EN ISO 4135, Anaesthetics and respiratory equipment Vocabulary. 3 Terms and definition For the purposes of this part of this European Standard, terms and definitions given in EN ISO 4135 and the following term and definition apply. 3.1 Air entrainment devi
27、ce Device consisting of a jet orifice (to which the oxygen supply is connected) adjacent to a series of air entrainment ports, the distal end of the device being designed for connection to an oxygen delivery system supplying a patient. NOTE These devices are sometimes described as Venturi devices. T
28、his term has been avoided as very few actually use the venturi principle. 4 Oxygen supply The device shall be designed to operate with an oxygen supply controlled by a flowmeter control valve capable of delivering at least 15 l/min of oxygen and complying with EN 738-1 and prEN 13159. 5 Connections
29、5.1 Oxygen supply inlet The inlet for oxygen to the air entrainment device should be a nipple conforming to prEN 13544-2. BS EN 13544-3:2001+A1:2009EN 13544-3:2001+A1:2009 (E) 5 5.2 Air inlet attachments Any air inlet attachment provided with or recommended for use with the air entrainment device sh
30、all neither affect the safety nor the performance of the device nor cover any marking of the device. The attachment shall not become detached when tested as described in A.2.8 (normative). 6 Delivered oxygen concentration When tested as described in annex A, the delivered oxygen concentration shall
31、be as given in Table 1. Table 1 - Delivered oxygen concentration Designated O 2concentration Delivered O 2concentration (%) min. (%) v / vmax. (%) v / v24 23 25 28 27 29 31 30 32 35 33 37 40 38 42 50 47 53 60 56 64 Additional information is given in annex B. 7 Marking and identification EN 980 and E
32、N 1041 apply with the following additions : 7.1 Marking 7.1.1 Each fixed concentration air entrainment device shall be marked with : a) the designated oxygen concentration in characters at least 2,5 mm high ; b) the recommended flow in l/min in characters at least 2,5 mm high. 7.1.2 The immediate pa
33、ckaging of the device shall also carry the above information, together with the following : a) !the name or trade mark of the manufacturer and the name and address of the authorized representative where the manufacturer does not have a registered place of business in the European Community;“ b) a lo
34、t or serial number or date of manufacture ; c) !if designed for single use only, the words “SINGLE USE” or the appropriate symbol. For single use devices the manufacturer shall disclose the risks associated with reusing in the instructions for use or upon request. NOTE The manufacturers attention is
35、 drawn to the regulatory provision for a consistent use of indication for single use devices. “ BS EN 13544-3:2001+A1:2009EN 13544-3:2001+A1:2009 (E) 6 7.1.3 Air entrainment devices with a control to adjust the oxygen concentration shall conform to item b) of 7.1.1 and items a) to c) of 7.1.2 and in
36、 addition with either of the following : a) The minimum and maximum settings shall be marked with their respective oxygen concentrations (see 8 d) in characters at least 2,5 mm high, and the direction of movement of the control to increase the delivered oxygen concentration shall be indicated. b) A
37、scale of delivered oxygen concentration shall be provided, marking each of these designated concentrations listed in Table 1 which is attainable by the adjustment of the control. 7.2 Colour coding 7.2.1 If colour coding is used as an additional means of identification of the designated oxygen concen
38、tration on air entrainment devices, the colour code given in Table 2 shall be used. The colour codes shall be applied directly to the air entrainment device and shall have an area of at least 1 cm 2 . The colour coding shall either be visible through the immediate external packaging or shall be repe
39、ated on the outside of the immediate external packaging. Table 2 - Colour coding Designated O 2concentration Colour % v / v(see annex C for references of colours given as examples) 24 Blue 28 White 31 Orange 35 Yellow 40 Red 50 Pink 60 Green 7.2.2 The colours of the code shall not be used for any pu
40、rpose other than identifying the delivered oxygen concentration. NOTE Air entrainment devices provided with a control to adjust the delivered oxygen concentration may use the colour code given in Table 2 to identify the selected values. 8 Information supplied by the manufacturer With each package of
41、 devices, the manufacturer shall provide operating instructions and information complying with EN 1041 including : a) a table or graph showing the relationship between the oxygen supply flow and the resulting total flow of the delivered air/oxygen mixture ; b) the minimum, recommended and maximum fl
42、ows of oxygen which enable the device to achieve the designed performance ; c) if the device is intended for re-use, details of suitable methods of cleaning, disinfecting and/or sterilization ; d) !for devices in accordance with 7.1.3, a warning that means of determining the patient oxygenation shou
43、ld be used (e.g. pulse oximeter, oxygen monitor). The instructions for use shall contain the date of issue or the latest revision.“ ! BS EN 13544-3:2001+A1:2009EN 13544-3:2001+A1:2009 (E) 7 e) If phthalates are incorporated in parts of the medical devices coming directly or indirectly into contact w
44、ith the patient the medical device shall be labelled accordingly. If such devices are used for the treatment of children or treatment of pregnant or nursing women, the residual risk has to be identified and stated in the instructions for use. NOTE Attention is drawn to substances which are carcinoge
45、nic, mutagenic or toxic to reproduction.“ 9 ! ! ! !Usability The manufacturer shall address in a usability engineering process the risk resulting from poor usability (see EN 60601-1-6 and EN 62366). Check compliance by inspection of the usability engineering file. 10 Clinical evaluation A clinical e
46、valuation shall be performed and documented in the risk management file. Check compliance by inspection of the risk management file.“ BS EN 13544-3:2001+A1:2009EN 13544-3:2001+A1:2009 (E) 8 Annex A (normative) Method of test for delivered oxygen concentration A.1 Apparatus A.1.1 Oxygen supply and fl
47、owmeter with control valve, the flowmeter to be capable of delivering and measuring flows between 3 l/min and 30 l/min with an accuracy of 2,5 %. A.1.2 Sampling T-piece, shown in Figure A.1. NOTE 1 It is essential that the manufacturer designs the T-piece inlet to connect to the particular design of
48、 air entrainment device, and makes details of this T-piece available to test houses. The side branch can be varied to suit the design of oxygen analyser, and it is essential that it provides a close fit to the oxygen sensor or analyser sampling tube in order to prevent leakage to or from the exterio
49、r. NOTE 2 The inclusion of corrugated breathing tubing between the outlet of an air entrainment device and the face mask has been found to modify the inspired oxygen concentration. If an air entrainment device is intended to be used only with a particular delivery system, the manufacturer can perform these tests with the system attached, and shall record this fact in the test report(s). A.1.3 Oxygen analyser, capable of mea
