1、January 2010DEUTSCHE NORM English price group 12No 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!$t“1568159ww
2、w.din.deDDIN EN 13544-2Respiratory therapy equipment Part 2: Tubing and connectors (includes Amendment A1:2009)English version of DIN EN 13544-2:2010-01Atemtherapiegerte Teil 2: Schlauchsysteme und Verbindungsstcke (enthlt nderung A1:2009)Englische Fassung DIN EN 13544-2:2010-01SupersedesDIN EN 1354
3、4-2:2003-01See start of validitywww.beuth.deDocument comprises pages23Start of validity This standard takes effect on 1 January 2010. DIN EN 13544-2:2003-01 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Technical Committee CEN/TC 215 “Respiratory a
4、nd 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 document inc
5、ludes 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 consist
6、s 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 13544-2:2003-01 as follows: a) The following clauses, subclauses
7、 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 medica
8、l devices and EU Directive 98/8/EC on the placing on the market of biocidal products: 1) The requirement has been included that tubing, labels and/or packaging shall be marked with the name and address of the authorized representative of the manufacturer where the manufacturer does not have a regist
9、ered place of business in the European Community (6). 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 consistently marked a
10、cross the Community (6). 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 groups, the residual risk h
11、as to be identified and stated in the instructions for use (5.1 d). 4) The requirement has been included that the instructions for use shall contain the date of issue or the latest revision (6). 2 DIN EN 13544-2:2010-01 5) A NOTE has been included drawing attention to substances which are carcinogen
12、ic, mutagenic or toxic to reproduction (5.1 d). 6) Requirements relating to usability (8) and clinical evaluation (9) have been included. 7) The Bibliography has been updated. 8) Table ZA.1 (Correspondence between clauses/subclauses of this standard and the essential requirements of Directive 93/42/
13、EEC on medical devices) has been revised. Previous editions DIN EN 13544-2: 2003-01 3 DIN EN 13544-2:2010-01 4 This page is intentionally blank DIN EN 13544-2:2010-01 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13544-2:2002+A1 September 2009 ICS 11.040.10 Supersedes EN 13544-2:2002English V
14、ersion Respiratory therapy equipment Part 2: Tubing and connectors Equipement de thrapie respiratoire Partie 2: Tubes et raccords Atemtherapiegerte Teil 2: Schlauchsysteme und Verbindungsstcke This European Standard was approved by CEN on 1 August 2002 and includes Amendment 1 approved by CEN on 30
15、July 2009. 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 obt
16、ained 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Manage
17、ment Centre 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
18、, Poland, 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
19、 by any means reserved worldwide for CEN national Members. Ref. No. EN 13544-2:2002+A1:2009: EEN 13544-2:2002+A1:2009 (E) 2 CONTENTS Page Foreword 31 Scope 42 Normative references 43 Nipples 43.1 Dimensions . 43.2 Performance . 44 Weight-bearing screw-threaded connectors 45 Tubing . 45.1 General 46
20、Marking of tubing, labels and packaging 77 Packaging . 78 Usability 89 Clinical evaluation . 8Annex A (normative) Test methods . 9A.1 Apparatus . 9A.2 Method of test for strength of nipple . 9A.3 Method of test for resistance to gas flow of tubing . 12A.4 Method of test for security of connection be
21、tween end connector and tubing 13A.5 Method of test for security of connection of end connectors and nipple . 13A.6 Method of test for resistance to kinking . 14Annex B (normative) Weight-bearing screw-threaded connectors for oxygen and air . 16Annex C (informative) Information on method of testing
22、security of connections 17Annex ZA (informative) !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC“ 18DIN EN 13544-2:2010-01 Bibliography . 19EN 13544-2 :2002+A1:2009 (E) 3 Foreword This document (EN13544-2:2002+A1:2009) has been prepared by Techni
23、cal 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 st
24、andards 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 Amendme
25、nt 1, approved by CEN on 2009-07-30. This document supersedes EN 13544-2:2002. 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 T
26、rade Association, and supports essential requirements of EU Directive(s). Annexes A and B are normative. Annex C is informative. For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. EN 13544 consists of the following parts, under the general ti
27、tle Respiratory therapy equipment. Part 1: Nebulizing systems and their components Part 2: Tubing and connectors Part 3: Air entrainment devices According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Sta
28、ndard: 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. DI
29、N EN 13544-2:2010-01 EN 13544-2:2002+A1:2009 (E) 4 1 Scope This part of EN 13544 specifies requirements for tubing to be used with equipment for the therapeutic administration of respirable gases in domiciliary, ambulance and hospital practice including the interface to the equipment i.e. nipples an
30、d screw threaded connectors. This tubing is mainly used with oxygen, air or mixtures of these gases. The interface specifications are given to ensure interchangeability of respiratory therapy equipment thereby enabling patients to receive continuous treatment in all these clinical situations. Weight
31、-bearing screw-threaded connectors are specified for use at the outlet of e.g. flowmeters to which devices such as humidifiers or nebulizers can be attached. NOTE This standard does not specify the devices where these connectors have to be used. It is expected that specific device standards will spe
32、cify the devices where these connectors are going to the used e.g. EN ISO 10651-4, EN 738-1 and EN 13220. 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 th
33、e 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 a
34、pplies (including amendments). EN 980, Graphical symbols for use in the labelling of medical devices. 3 Nipples 3.1 Dimensions The dimensions of nipples for the attachment of tubing to respiratory therapy equipment shall conform to the dimensions given in Figure 1 a), and also, if corrugated, shall
35、conform to 1 b). 3.2 Performance When tested as described in A.2, nipples shall neither fracture nor distort by more than 2 mm. 4 Weight-bearing screw-threaded connectors 4.1 Weight-bearing screw-threaded connectors for oxygen shall comply with Figure B.1. 4.2 Weight-bearing screw-threaded connector
36、s for air shall comply with Figure B.2. 5 Tubing 5.1 General Material used for tubing shall be : a) compatible with oxygen or air or any other gas mixture specified by the manufacturer ; b) non-toxic ; DIN EN 13544-2:2010-01 EN 13544-2 :2002+A1:2009 (E) 5 c) designed and manufactured to minimize hea
37、lth risks by leaching of substances from tubing during normal use to levels below those assumed to be non-toxic; ! d) 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. If such d
38、evices 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 carcinogenic, mutagenic or toxic to reproduction.“ Evidence shall be provided by the
39、 manufacturer on request. 5.1.1 Resistance to gas flow of tubing When tested as described in A.3, the resistance to flow shall not exceed 0,9 kPa/m. 5.1.2 End connectors Tubing for respiratory therapy equipment shall terminate at each end with a connector able to produce a secure connection conformi
40、ng to 5.1.4 to the nipple specified in clause 3. NOTE Connectors can either be formed in the material of the tubing or can be joined to the tubing by e.g. welding or adhesives. DIN EN 13544-2:2010-01 EN 13544-2:2002+A1:2009 (E) 6 Dimensions in millimetres 6.356.03.52 inc.l1l2Key l1 10 mm datum l212
41、mm minimum to shoulder or projection NOTE The axis of the nipple can be curved. a) Basic profile and nominal dimensions of nipple 6.353.52 inc.l1l2Key l110 mm datum with a minimum of two corrugations within this length l212 mm minimum to shoulder or projection NOTE The external diameter of all corru
42、gations falls on the profile of the nipple as shown in 1a. The shape of the corrugations is given as an example. b) Dimensions for corrugated nipple Figure 1 Nipple for respiratory therapy equipment 5.1.3 Security of joint between end connector and tubing When tested as described in A.4, if the end
43、connector is joined to the tubing, the end connector shall not become detached from the tubing. DIN EN 13544-2:2010-01 EN 13544-2 :2002+A1:2009 (E) 7 5.1.4 Security of connection of end connectors to nipple When tested as described in A.5, heavy duty tubing shall not become detached from the test ni
44、pple. NOTE See annex C for information on the method of testing the security of connection between an end connector and a nipple. 5.1.5 Resistance to kinking When tested as described in A.6, the flow through the kinked tubing shall be not less than 75 % of the initial flow. 6 Marking of tubing, labe
45、ls and packaging Tubing, labels, and/or packaging shall contain the following as applicable : !name and address of the manufacturer and the name and address of authorized representative where the manufacturer does not have a registered place of business in the European Community;“ !if the intended p
46、urpose of the device is not obvious to the operator, the device shall be provided with instructions for use. The instructions for use shall contain the date of issue or the latest revision;“ device identification and content information ; symbol STERILE in accordance with EN 980 together with the me
47、thod of sterilization ; batch code, preceded by the symbol LOT in accordance with EN 980, or serial number ; declaration of the maximum pressure the tubing shall withstand at ambient conditions specified in Table A.1 ; !date by which the device can be used, expressed as the year and month. For singl
48、e use devices the manufacturer shall disclose the risks associated with reusing in the instructions for use or upon request; NOTE Manufacturers attention is drawn to the regulatory provision for a consistent use of indication for single use devices. “ indication that the device is for single use ; a
49、ny special storage and/or handling conditions ; any warning and/or precaution to take ; recommended method(s) of cleaning, disinfection and sterilization ; device packaging and/or labelling shall differentiate between the same or similar products, both sterile and non-sterile, placed on the market by the same manufacturer ; packages containing parts made of antistatic or conductive material shall be clearly marked with the word “ANTISTATI
