DIN EN 13544-2-2010 Respiratory therapy equipment - Part 2 Tubing and connectors German version EN 13544-2 2002+A1 2009《呼吸治疗设备 第2部分 管和连接件 德文版本EN 13544-2-2002+A1-2009》.pdf
《DIN EN 13544-2-2010 Respiratory therapy equipment - Part 2 Tubing and connectors German version EN 13544-2 2002+A1 2009《呼吸治疗设备 第2部分 管和连接件 德文版本EN 13544-2-2002+A1-2009》.pdf》由会员分享,可在线阅读,更多相关《DIN EN 13544-2-2010 Respiratory therapy equipment - Part 2 Tubing and connectors German version EN 13544-2 2002+A1 2009《呼吸治疗设备 第2部分 管和连接件 德文版本EN 13544-2-2002+A1-2009》.pdf(23页珍藏版)》请在麦多课文档分享上搜索。
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
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