ISO INTERNATIONAL STANDARD 15137 First edition 2005-07-15 Self-adhesive hanging devices for infusion bottles and injection vials Requirements and test methods Systemesde suspensionautoadhesifspourflaconsdeperfusion- Exigences etmethodes d'essai Reference number ISO 15137:2005(E) @ISO2005 hout license from IHS Not for Resale ISO15137:2005(E) PDF disclaimer 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 the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO2005 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, ISO's member body in the country of the requester. ISO copyright office Case postale 56·CH-1211Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland Copyigh Intematilnal organizationfor Standardzation @ ISO 2005 - All rights reserved tted without license from IHS Not for Resale ISO15137:2005(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 non-governmental, in liaison with IsO, also take part in the work. Iso collaborates closely y with the InternationalElectrotechnicalCommission(lEC)onallmattersofelectrotechnicalstandardization. International Standards are drafted in accordance with the rules given in the ISO/lEc 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 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 15137 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment formedicalandpharmaceuticaluse ili Copyrghtintematignaloanzansandardzalon'ghtsreserved Not for Resale ISO15137:2005(E) Introduction Self-adhesive hanging devices s have become a common method for hanging infusion containers. The devices is to provide a simple and safe hanging of infusion containers during the administration of liquid pharmaceutical products. @ISo 2005Allrights reserved or networking perm mited without ficense from IHS Not for Resale INTERNATIONAL STANDARD ISO15137:2005(E) Self-adhesive hanging devices for infusion bottles and injection vials Requirements andtest methods 1 Scope This International Standard specifies requirements and test methods for self-adhesive hanging devices (SAHD) used in combination with infusion containers, e.g. infusion glass bottles (see ISO 8536-1). The purpose of this International Standard is to establish a safe SAHD for prescribed infusion containers while administering their content so as to ensure a safe application for the patient and for the user. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. Iso2768-1:1989, General tolerances - Part1: Tolerances for linear and angular dimensions without individual tolerance indications 3 Termsanddefinitions For the purposes of this document, the following terms and definitions apply. 3.1 self-adhesi