DIN EN ISO 14408-2016 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408 2016) German version EN ISO 14408 2016《激光手术用气管导管 .pdf
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1、July 2016 English price group 11No part of this translation 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!%XL=“2534126www.din.deDIN
2、 EN ISO 14408Tracheal tubes designed for laser surgery Requirements for marking and accompanying information (ISO 14408:2016);English version EN ISO 14408:2016,English translation of DIN EN ISO 14408:2016-07Trachealtuben fr die Laserchirurgie Anforderungen an die Kennzeichnung und die begleitenden I
3、nformationen (ISO 14408:2016);Englische Fassung EN ISO 14408:2016,Englische bersetzung von DIN EN ISO 14408:2016-07Tubes trachaux destins aux oprations laser Exigences relatives au marquage et aux informations daccompagnement (ISO 14408:2016);Version anglaise EN ISO 14408:2016,Traduction anglaise de
4、 DIN EN ISO 14408:2016-07SupersedesDIN EN ISO 14408:2009-08See start of applicationwww.beuth.deDocument comprises 18 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.06.16 DIN EN ISO 14408:2016-07 2 A comma is used as the decima
5、l marker. Start of application The start of application of this standard is 2016-07-01. For DIN EN ISO 14408:2009-08 there is a transition period ending on 31 March 2019. National foreword This document (EN ISO 14408:2016) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respirat
6、ory equipment” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was DIN-Normenausschuss Rettungsdienst und Krankenhaus (DIN Standards Commi
7、ttee Rescue Services and Hospital), Working Committee NA 53-03-02 AA Medizinprodukte fr das Atemwegssystem. This standard contains specifications giving detail to the essential requirements set out in EU Directive 93/42/EEC on medical devices. The DIN Standards corresponding to the International Sta
8、ndards referred to in this document are as follows: ISO 4135 DIN EN ISO 4135 ISO 5361 DIN EN ISO 5361 ISO 7000 DIN ISO 7000 ISO 11990-1 DIN EN ISO 11990-1 ISO 11990-2 DIN EN ISO 11990-2 ISO 15223-1 DIN EN ISO 15223-1 Amendments This standard differs from DIN EN ISO 14408:2009-08 as follows: a) the r
9、equirements for marking, labelling and the information to be supplied by the manufacturer have been revised; it has been specified that packs are to be provided with an indication on the presence of natural rubber (latex), if present in the device; b) the requirements for the graphical representatio
10、n of the test results have been revised with reference to the ISO 11990 standards series; c) Annex ZA “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC” has been revised; d) the standard has been editorially revised. Previous editions DIN EN ISO 14
11、408: 2005-09, 2009-08 DIN EN ISO 14408:2016-07 3 National Annex NA (informative) Bibliography DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 5361, Anaesthetic and respiratory equipment Tracheal tubes and connectors DIN EN ISO 11990-1, Lasers and laser-related equipment
12、Determination of laser resistance of tracheal tubes Part 1: Tracheal tube shaft DIN EN ISO 11990-2, Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 2: Tracheal tube cuffs DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, la
13、belling and information to be supplied Part 1: General requirements DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis DIN EN ISO 14408:2016-07 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14408 March 2016 ICS 11.040.10 Supersedes E
14、N ISO 14408:2009English Version Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information(ISO 14408:2016) Tubes trachaux destins aux oprations laser - Exigences relatives au marquage et aux informations daccompagnement (ISO 14408:2016) Trachealtuben fr die Las
15、erchirurgie - Anforderungen an die Kennzeichnung und die begleitenden Informationen (ISO 14408:2016) This European Standard was approved by CEN on 30 January 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standa
16、rd the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English,
17、 French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulg
18、aria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tu
19、rkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.
20、 Ref. No. EN ISO 14408:2016 EForeword . 6Introduction 71 Scope . 82 Normative references 83 Terms and definitions . 84 Marking and labelling . 94.1 Use of symbols . 94.2 Marking . 94.3 Labelling of packs 104.4 Labelling of shelf or multi-unit containers 105 Information to be supplied by the manufact
21、urer 115.1 Instructions for preparation and use of laser-resistant tracheal tube and tracheal tube treatments . 115.2 Indications for use 115.3 Warnings and precautions about the use of the tube . 115.4 Graph showing test results for laser resistance 11Bibliography .14Contents PageAnnex ZA (informat
22、ive) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 4 European foreword .iv3DIN EN ISO 14408:2016-07 EN ISO 14408:2016 (E) 2 European foreword This document (EN ISO 14408:2016) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
23、respiratory equipment” in collaboration with 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
24、latest by September 2016, and conflicting national standards shall be withdrawn at the latest by March 2019. 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 a
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