BS-EN-ISO-10555-2-1997.pdf
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1、BRITISH STANDARD BS EN ISO 10555-2:1997 Incorporating Technical Corrigendum No. 1 Sterile, single-use intravascular catheters Part 2: Angiographic catheters The European Standard EN ISO 10555-2:1997 has the status of a British Standard ICS 11.040.20 ? Licensed Copy: sheffieldun sheffieldun, na, Fri
2、Nov 17 09:58:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10555-2:1997 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 September 1997 BSI 7 Janu
3、ary 2003 ISBN 0 580 28045 4 National foreword This British Standard is the English language version of EN ISO 10555-2:1997, including Corrigendum July 2002. It is identical with ISO 10555-2:1996, including Technical Corrigendum June 2002. It supersedes BS 7174-2:1990 which is withdrawn. The UK parti
4、cipation in its preparation was entrusted to Technical Committee CH/27, Medical plastics tubing, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep t
5、he UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publica
6、tions referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the neces
7、sary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN ISO title page, the EN
8、 ISO foreword page, the ISO title page, the ISO foreword page, pages 1 to 5 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No.DateComments 14058 Corrigendum No. 1 7 January 2003Deletion of no
9、te in 4.2 and renumbering of notes given in 4.5 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10555-2:1997 BSI 7 January 2003 i Contents Page National forewordInside front cover Text of ISO 10555-21 Licensed Copy: sheffieldun she
10、ffieldun, na, Fri Nov 17 09:58:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10555-2 July 1997 ICS 11.040.20Incorporating corri
11、gendum July 2002 Descriptors: See ISO document English version Sterile, single-use intravascular catheters Part 2: Angiographic catheters (ISO 10555-2:1996) Cathters intravasculaires striles, non rutilisables Partie 2: Cathters angiographiques (ISO 10555-2:1996) Sterile intravaskulre Katheter zur ei
12、nmaligen Verwendung Teil 2: Angiographiekatheter (ISO 10555-2:1996) This European Standard was approved by CEN on 1997-06-09. 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 w
13、ithout any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. The European Standards exist in three official versions (English, French, German). A version in any other language
14、 made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Icel
15、and, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 CEN All rights of expl
16、oitation in any form and by any means reserved worldwide for CEN national Members.Ref. No. EN ISO 10555-2:1997 E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10555-2:1997 BSI 7 January 2003 Foreword The text of the International St
17、andard from Technical Committee ISO/TC 84 “Medical devices for injections” of the International Organization for Standardization (ISO) has been taken over as a European Standard by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by BSI. This European Sta
18、ndard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 1998, and conflicting national standards shall be withdrawn at the latest by January 1998. According to the CEN/CENELEC Internal Regulations, the national st
19、andards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsem
20、ent notice The text of the International Standard ISO 10555-2:1996 has been approved by CEN as a European Standard without any modification. NOTENormative references to International Standards are listed in Annex ZA (normative). Endorsement notice The text of ISO 10555-2:1997/Corr. 1:2002 has been a
21、pproved by CEN as a European Corrigendum without any modifications. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Incorporating Technical Corrigendum 2002-06-15 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:47 GMT+00:00 2006
22、, Uncontrolled Copy, (c) BSI EN ISO 10555-2:1997 BSI 7 January 2003 Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technica
23、l committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely wit
24、h the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of t
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