ISO-3826-2-2008.pdf
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1、 Reference number ISO 3826-2:2008(E) ISO 2008 INTERNATIONAL STANDARD ISO 3826-2 First edition 2008-08-01 Plastics collapsible containers for human blood and blood components Part 2: Graphical symbols for use on labels and instruction leaflets Poches en plastique souple pour le sang et les composants
2、 du sang Partie 2: Symboles graphiques utiliser sur les tiquettes et les notices dutilisation Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 10/25/2008 05:17:26 MDTNo reproduction or networking permitted w
3、ithout license from IHS -,-,- ISO 3826-2:2008(E) 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 embedded are licensed to and installed on the computer p
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6、al Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2008 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 microfilm, without permission
7、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 Published in Switzerland ii ISO 2008 All rights reserved Co
8、pyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 10/25/2008 05:17:26 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 3826-2:2008(E) ISO 2008 All rights reserved iii Contents Page
9、Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 2 4 Requirements for graphical symbols and their use 2 4.1 Use of symbols . 2 4.2 System of symbols. 2 4.3 Basic symbols. 2 4.4 Compound symbols . 4 4.5 Other symbols. 6 Annex A (informative) Illustrative examp
10、les of symbols used in the labelling of medical devices used for blood treatment and transfusion . 7 Annex B (informative) Symbols as applied to properties of blood or blood components containers 10 Bibliography. 11 Copyright International Organization for Standardization Provided by IHS under licen
11、se with ISO Licensee=Boeing Co/5910770001 Not for Resale, 10/25/2008 05:17:26 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 3826-2:2008(E) iv ISO 2008 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of na
12、tional standards bodies (ISO member bodies). 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. Intern
13、ational organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the
14、rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by
15、at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 3826-2 was prepared by Technical Committee ISO
16、/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. ISO 3826 consists of the following parts, under the general title Plastics collapsible containers for human blood and blood components: Part 1: Conventional containers Part 2: Graphical symbols for use on label
17、s and instruction leaflets Part 3: Blood bag systems with integrated features Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 10/25/2008 05:17:26 MDTNo reproduction or networking permitted without license f
18、rom IHS -,-,- ISO 3826-2:2008(E) ISO 2008 All rights reserved v Introduction This part of ISO 3826 has been prepared to: reduce the need for multiple translations of words into national languages; simplify and rationalize the labelling of blood treatment and transfusion devices which are medical dev
19、ices used in critical situations, thereby reducing risk of misidentification, promoting safety for the patient and reducing the amount of training required by healthcare personnel; promote the movement of blood treatment and transfusion devices across national boundaries; support the essential requi
20、rements of relevant EU Directives. The meaning of many of these graphical symbols should be self-evident. The meaning of others will become clear with use or when viewed in the context of the device itself. If appropriate, the meaning of symbols should be explained in accompanying literature when pr
21、ovided. Annex A provides examples of how the symbols specified in this part of ISO 3826 can be used. These are illustrative only and do not represent the only ways in which requirements of this part of ISO 3826 can be met. Copyright International Organization for Standardization Provided by IHS unde
22、r license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 10/25/2008 05:17:26 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale,
23、 10/25/2008 05:17:26 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 3826-2:2008(E) ISO 2008 All rights reserved 1 Plastics collapsible containers for human blood and blood components Part 2: Graphical symbols for use on labels and instruction lea
24、flets 1 Scope This part of ISO 3826 addresses symbols that may be used to convey certain items of information related to medical devices dedicated to blood collection processes and storage. The information may be required on the device itself, as part of the label, or provided with the device. Many
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