BS-EN-ISO-8836-2008.pdf
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1、BRITISH STANDARD BS EN ISO 8836:2008 Suction catheters for use in the respiratory tract ICS 11.040.10; 11.040.25 ? Licensed CopyChinese University of Hong Kong, 21/10/2008 07:58, Uncontrolled Copy, (c) BSI BS EN ISO 8836:2008 This British Standard was published under the authority of the Standards P
2、olicy and Strategy Committee on 29 August 2008 BSI 2008 ISBN 978 0 580 61372 2 National foreword This British Standard is the UK implementation of EN ISO 8836:2008. It is identical to ISO 8836:2007. It supersedes BS EN 1733:2002 which is withdrawn. The UK participation in its preparation was entrust
3、ed by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/5, Lung ventilators, tracheal tubes and related equipment. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include a
4、ll the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda issued since publication DateComments Licensed CopyChinese University of Hong Kong, 21/10/2008 07:58,
5、Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8836 June 2008 ICS 11.040.10; 11.040.25Supersedes EN 1733:2002 English Version Suction catheters for use in the respiratory tract (ISO 8836:2007) Sondes daspiration pour les voies respiratoires (ISO 8836:2007) Absaug
6、katheter zur Verwendung im Atemtrakt (ISO 8836:2007) This European Standard was approved by CEN on 16 May 2008. 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 without any alt
7、eration. 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 made by tr
8、anslation 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, France, Ger
9、many, 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 KOMITEE FR NORMUN
10、G Management Centre: rue de Stassart, 36 B-1050 Brussels 2008 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8836:2008: E Licensed CopyChinese University of Hong Kong, 21/10/2008 07:58, Uncontrolled Copy, (c) BSI Foreword The t
11、ext of ISO 8836:2007 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 8836:2008 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secre
12、tariat 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 December 2008, and conflicting national standards shall be withdrawn at the latest by December 2008. Attention is dr
13、awn 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 supersedes EN 1733:2002. According to the CEN/CENELEC Internal Regulations, the nationa
14、l 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, Norway, Pol
15、and, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 8836:2007 has been approved by CEN as a EN ISO 8836:2008 without any modification. BS EN ISO 8836:2008 Licensed CopyChinese University of Hong Kong, 21/10/2008 07:58, Unc
16、ontrolled Copy, (c) BSI iii Contents Page 1Scope 1 2Normative references 1 3Terms and definitions 1 4Size designation and dimension 2 4.1Size designation 2 4.2Dimension designation . 3 5Materials . 3 6Design . 4 6.1Lumen . 4 6.2Patient end . 4 6.3Machine end . 4 7Performance requirements . 6 7.1Secu
17、rity of construction . 6 7.2Shaft . 6 7.3Vacuum control device . 6 8Requirements for suction catheters supplied sterile . 6 8.1Sterility assurance 6 8.2Packaging of suction catheters supplied sterile 6 9Marking . 6 9.1Marking of suction catheters . 6 9.2Use of symbols 7 9.3Labelling of individual pa
18、cks . 7 9.4Labelling of shelf/multi-unit packs 7 Annex A (normative) Test methods 8 Annex B (normative) Measurement of residual vacuum 9 Bibliography . 11 BS EN ISO 8836:2008 Licensed CopyChinese University of Hong Kong, 21/10/2008 07:58, Uncontrolled Copy, (c) BSI Introduction This International St
19、andard specifies dimensions and requirements for suction catheters for use in the respiratory tract. Size is designated by outside diameter which is important when selecting catheters because of its relationship to the ease with which the catheter can be passed through a tracheal or tracheostomy tub
20、e (see ISO 5361 for details of requirements for tracheal tubes and tracheostomy tubes). Flammability of suction catheters, for example if flammable anaesthetics, electrosurgical units or lasers are used, is a well-recognised hazard1) that is addressed by appropriate clinical management and is outsid
21、e the scope of this International Standard. 1)See ISO/TR 11991. BS EN ISO 8836:2008 iv Licensed CopyChinese University of Hong Kong, 21/10/2008 07:58, Uncontrolled Copy, (c) BSI 1 Suction catheters for use in the respiratory tract 1Scope This International Standard specifies requirements for suction
22、 catheters made of plastic materials and intended for use in suction of the respiratory tract. Specialized suction catheters, e.g. those with more than one lumen and suction catheters without a terminal orifice, are excluded from the scope of this International Standard. Angled-tip suction catheters
23、 (e.g. Coud catheters) and suction catheters with aspirator collectors are not considered to be specialized and are therefore included in the scope of this International Standard. 2Normative references The following referenced documents are indispensable for the application of this document. For dat
24、ed references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system ISO 11607:2003, Packaging for
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