EN-ISO-15747-2005.pdf
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1、EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15747 March 2005 ICS 11.040.20 English version Plastics containers for intravenous injection (ISO 15747:2003) Rcipients en plastique pour injections intraveineuses (ISO 15747:2003) Kunststoffbehltnisse fr intravense Injektionen (ISO 15747:2003
2、) This European Standard was approved by CEN on 7 March 2005. 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 alteration. Up-to-date lists and bibliographical refe
3、rences concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member i
4、nto 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuani
5、a, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2005 CENAll righ
6、ts of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15747:2005: E -,-,- EN ISO 15747:2005 (E) 2 Foreword The text of ISO 15747:2003 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical a
7、nd pharmaceutical use“ of the International Organization for Standardization (ISO) and has been taken over as EN ISO 15747:2005 by Technical Committee CEN/TC 205 “Non-active medical devices“ the secretariat of which is held by BSI. This European Standard shall be given the status of a national stand
8、ard, either by publication of an identical text or by endorsement, at the latest by September 2005, and conflicting national standards shall be withdrawn at the latest by September 2005. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Tra
9、de Association, and supports essential requirements of EU Directive 93/42/EEC. For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countri
10、es are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerlan
11、d and United Kingdom. Endorsement notice The text of ISO 15747:2003 has been approved by CEN as EN ISO 15747:2005 without any modifications. EN ISO 15747:2005 (E) 3 Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC This E
12、uropean Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide one means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC Medical devices. Once this standard is cited in the Official Journal
13、 of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essentia
14、l Requirements of that Directive, except Essential Requirements 7.3, 8.3, 8.7, 12.8, 12.9 and 13 (excepting 13.3b), and associated EFTA regulations. Table ZA.1 Correspondence between this International Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this International standard Essential
15、requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 4.1.1 1, 2, 3, 8.4 4.1.2 1, 2, 3, 4, 7.5, 7.6, 8.1, 9.2 4.1.3 1, 2, 3, 4, 7.5, 7.6, 8.1, 12.7.1 4.1.4 1, 2 4.1.5 7.5, 7.6 4.1.6 1, 2, 3, 6, 8.1, 8.5 4.1.7 7.5, 7.6, 8.1 4.1.8 1, 2, 9.1 4.1.9 1, 2, 4, 7.5, 7.6, 8.1 4.1.10 7.5, 7.6
16、4.1.11 1, 2, 4 4.1.12 13.3b) 4.2.1 1, 2, 3, 5, 6, 7.1, 7.2 4.2.2 7.2, 7.6 4.3.1 1, 2, 6, 8.1, 4.3.2 1, 2, 6, 7.2, 7.5 6 1, 2, 3, 4, 5 -,-,- -,-,- INTERNATIONAL STANDARD ISO 15747 First edition 2003-11-15 Reference number ISO 15747:2003(E) ISO 2003 Plastics containers for intravenous injection Rcipie
17、nts en plastique pour injections intraveineuses -,-,- ISO 15747:2003(E) ISO 2003 All rights reserved PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embe
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20、lem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2003 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfi
21、lm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org ISO 15747:2003(E) ISO 2003 All right
22、s reserved Contents Page 1Scope 1 2Normative references 1 3Terms and definitions 1 4Requirements . 2 4.1Physical requirements 2 4.2Chemical requirements . 3 4.3Biological requirements . 4 5Identification 4 6Application of tests . 4 Annex A (normative) Physical tests . 6 Annex B (normative) Chemical
23、tests 9 Annex C (normative) Biological tests . 12 Annex D (informative) Further biological tests 15 Bibliography . 16 ISO 15747:2003(E) ISO 2003 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bo
24、dies). The work of preparing International Standards is normally carried out through ISO technical 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 an
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