ISO INTERNATIONAL STANDARD 3826-3 First edition 2006-09-15 Plastics collapsible containers for human blood and blood components Part 3: Blood bag systems with integrated features Poches en plastique souple pour le sang et les composants du sang Partie 3: Systemes de poches pour le sang avec accessoires intégrés Reference number ISO 3826-3:2006(E) @ISO 2006 ISO 3826-3:2006(E) PDFdisclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by IsO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ?ISO2006 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, ISsO's 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 [email protected] Web www.iso.org Published in Switzerland ii @ ISO 2006 -All rights reserved ISO 3826-3:2006(E) 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 technical committees. Each member body interested in a subject for which a technical committee has been International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. 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 at least 75 % of the member bodies casting a vote rights. IsO shall not be held responsible for identifying any or all such patent rights. ISO 3826-3 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment formedical and pharmaceutical use. blood and blood components: 一 Part 1: Conventional containers Part 3: Blood bag systems with integrated features Part 2, which will cover the use of graphical symbols, is currently in preparation. @ ISO 2006 - All rights reserved ili ISO 3826-3:2006(E) Introduction In some e countries national pharmacopoeias, or other government regulations, are legally binding and these requirements take precedence over this part of isO 3826. materials and their methods of manufacture, details of the manufacture of the plastic containers including the containers or present in the raw material, as well as full details of any additives that have been used. iv @ISO2006-Allrightsreserved INTERNATIONAL STANDARD ISO3826-3:2006(E) Plastics collapsible containers for human blood and blood components Part 3: Blood bag systems with integrated features 1 Scope This part of isO 3826 specifies requirements, including performance requirements, for integrated features on all of the integrated features identified in this document. The integrated features refer to: leucocyte filter; pre-donation sampling device; top-and-bottom bag; platelet storage bag; needle stick protection device. In addition to IsO 3826-1, which specifies the requirements of conventional containers, this part of isO 3826 specifies additional requirements for blood bag systems using multiple units. This part of isO 3826 does not cover automated blood collection systems. Unless otherwise specified, all tests specified in this part of IsO 3826 apply to the plastic container as prepared ready for use. Use chemical, physical and biological tests in accordan