1、January 2010DEUTSCHE NORM English price group 11No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.10!$r=“1567926w
2、ww.din.deDDIN EN 13544-3Respiratory therapy equipment Part 3: Air entrainment devices (includes Amendment A1:2009)English version of DIN EN 13544-3:2010-01Atemtherapiegerte Teil 3: Luftbeimischgerte (enthlt nderung A1:2009)Englische Fassung DIN EN 13544-3:2010-01SupersedesDIN EN 13544-3:2001-12See s
3、tart of validitywww.beuth.deDocument comprises pages18DIN EN 13544-3:2010-01 Start of validity This standard takes effect on 1 January 2010. DIN EN 13544-3:2001-12 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Technical Committee CEN/TC 215 “Respir
4、atory and anaesthetic equipment” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Working Committee NA 053-03-01 AA Ansthesie und Beatmung. This docum
5、ent includes Amendment A1, approved by CEN on 2009-07-30. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“ This standard contains specifications meeting the essential requirements set out in EU Directives 93/42/EEC on medical devices. DIN EN 13544 c
6、onsists of the following parts, under the general title Respiratory therapy equipment: Part 1: Nebulizing systems and their components Part 2: Tubing and connectors Part 3: Air entrainment devices Amendments This standard differs from DIN EN 13544-3:2001-12 as follows: a) The following clauses, subc
7、lauses and Annexes have been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and 93/42/EEC on
8、medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products: 1) The requirement has been included that the immediate packaging of the device shall be marked with the name and address of the authorized representative of the manufacturer where the manufacturer does not h
9、ave a registered place of business in the European Community (7.1.2 a). 2) The requirement has been included that for single use devices the manufacturer shall disclose the risks associated with reuse in the instructions for use or upon request, including a NOTE that single use devices should be con
10、sistently marked across the Community (7.1.2 c). 3) The requirement has been included that if phthalates are incorporated in medical devices coming into contact with the patient, these devices are to be labelled accordingly by the manufacturer and, if such devices are used for particular patient gro
11、ups, the residual risk has to be identified and stated in the instructions for use (8 e). 4) The requirement has been included that the instructions for use shall contain the date of issue or the latest revision (8 d). 2 DIN EN 13544-3:2010-01 5) A NOTE has been included drawing attention to substan
12、ces which are carcinogenic, mutagenic or toxic to reproduction (8 e). 6) Requirements relating to usability (9) and clinical evaluation (10) have been included. 7) The Bibliography has been updated. 8) Table ZA.1 (Correspondence between clauses/subclauses of this standard and the essential requireme
13、nts of Directive 93/42/EEC on medical devices) has been revised. Previous editions DIN EN 13544-3: 2001-12 3 DIN EN 13544-3:2010-01 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13544-3:2001+A1 September 2009 ICS 11.040.10 Supersedes EN 13544-3:2001English V
14、ersion Respiratory therapy equipment Part 3: Air entrainment devices Appareils de thrapie respiratoire Partie 3: Dispositifs dentranement dair Atemtherapiegerte Teil 3: Luftbeimischgerte This European Standard was approved by CEN on 7 April 2001 and includes Amendment 1 approved by CEN on 30 July 20
15、09. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained o
16、n 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Ce
17、ntre has the same status as theofficial 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, Polan
18、d, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any
19、 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 Foreword3 1 Scope 4 2 Normative references 4 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
20、 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 .6 9 !Usability.7 10 Clinical evaluation .7 Annex A (normative) Method of test for delivered oxygen concentration8 Annex B (informativ
21、e) Rationale 11 Annex C (informative) Colour coding12 Annex ZA (informative) !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC“ 13 Bibliography 14 DIN EN 13544-3:2010-01 EN 13544-3:2001+A1:2009 (E) 3 Foreword This document (EN 13544-3:2001+A1:2009)
22、 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, a
23、nd 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
24、 document includes Amendment 1, approved by CEN on 2009-07-30. This document supersedes EN 13544-3:2001. 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 Commissi
25、on 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 applies to respiratory therapy equipment and has been prepared in th
26、ree parts. This Part addresses air entrainment devices; part 1 and part 2 address respectively nebulizing systems and tubing and connectors. 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,
27、 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,
28、 Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. DIN EN 13544-3:2010-01 EN 13544-3:2001+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
29、of a designated oxygen concentration to patients. It gives a test method to check the oxygen concentration in the air/oxygen mixture generated 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 design
30、ated oxygen concentration. This standard does not cover air entrainment devices which are integral with medical devices specified in other standards e.g. emergency lung ventilators, humidifiers, nebulizers, etc. 2 Normative references This European Standard incorporates by dated or undated reference
31、, 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
32、in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). 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
33、 for use in the labelling of medical devices. EN 1041, Information supplied by the manufacturer with medical devices. prEN 13159, Compatibility of medical equipment with oxygen. EN ISO 4135, Anaesthetics and respiratory equipment Vocabulary. 3 Terms and definition For the purposes of this part of th
34、is European Standard, terms and definitions given in EN ISO 4135 and the following term and definition apply. 3.1 Air entrainment device 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 desi
35、gned for connection to an oxygen delivery system supplying a patient. NOTE These devices are sometimes described as Venturi devices. This 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
36、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 5.1 Oxygen supply inlet The inlet for oxygen to the air entrainment device should be a nipple conforming to prEN 13544-2. DIN EN 13544-3:2010-01 EN 13544-3:2001+A1:20
37、09 (E) 5 5.2 Air inlet attachments Any air inlet attachment provided with or recommended for use with the air entrainment device shall 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
38、 A.2.8 (normative). 6 Delivered oxygen concentration When tested as described in annex A, the delivered oxygen concentration shall be as given in Table 1. Table 1 - Delivered oxygen concentration Designated O2concentration Delivered O2concentration (%) min. (%) v/vmax. (%) v/v24 23 25 28 27 29 31 30
39、 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 EN 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 ch
40、aracters 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 packaging 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 authoriz
41、ed representative where the manufacturer does not have a registered place of business in the European Community;“ b) a lot 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 dis
42、close the risks associated with reusing in the instructions for use or upon request. NOTE The manufacturers attention is drawn to the regulatory provision for a consistent use of indication for single use devices. “ DIN EN 13544-3:2010-01 EN 13544-3:2001+A1:2009 (E) 6 7.1.3 Air entrainment devices w
43、ith 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 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, a
44、nd the direction of movement of the control to increase the delivered oxygen concentration shall be indicated. b) A 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 C
45、olour coding 7.2.1 If colour coding is used as an additional means of identification of the designated oxygen concentration 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 a
46、t least 1 cm2. The colour coding shall either be visible through the immediate external packaging or shall be repeated on the outside of the immediate external packaging. Table 2 - Colour coding Designated O2concentration Colour % v/v(see annex C for references of colours given as examples) 24 Blue2
47、8 White 31 Orange 35 Yellow 40 Red 50 Pink60 Green 7.2.2 The colours of the code shall not be used for any purpose 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 give
48、n in Table 2 to identify the selected values. 8 Information supplied by the manufacturer With each package of 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
49、and the resulting total flow of the delivered air/oxygen mixture ; b) the minimum, recommended and maximum flows 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 should be used (e.g. pulse oximeter, oxygen monitor). The instructions for use shall contain the date of issue or the latest revision.“ DIN EN 135
