ISO INTERNATIONAL 8362-3 STANDARD Second edition 2001-12-01 Injection containers and accessories - Part 3: Aluminium caps for injection vials Recipients et accessoires pour produits injectables- Partie 3:Capsules en aluminium pour flacons Reference number ISO 8362-3:2001(E) ISO O ISO2001 8362-3:2001(E) ISO PDF disclaimer This PDF file may contain embedded ypefaces.ln accordance with Adobe'slicensingpolicy,this file may be printed or viewed but shall not be edited unlesstheypefaces which are embedded are licensed to and instlled on the computer performing the editing.Indownloading this fle, parties accept therein the responsibility of not infringing Adobe'licensing policy.The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF fle can be found inthe General Info relative to the file;thePDF-creation parameters were optimized for printing.Every care has been taken toensurethat the fle is suitable for use by ISO member bodies.ln the unlikely event that a problem relating to it is found,please inform the Central Secretariat at the address given below. OISO2001 All rights reserved.Unless otherwise specified,no part of this publication may be reproduced or utized in any form or by any means, electronic or mechanical,including photocopying and microfilm,without permisson in wrting from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56-CH-1211 Geneva 20 Tel.+41227490111 Fax+41227490947 E-mail [email protected] Web www.iso.ch Printed in Switzerland oiso o001_△ll riahte rocorvod Coovriaht Intemational Oraanization for Standardizatior ISO 8362-3:2001(E) Contents Page 1 Scope 2 Normativereference 3 Dimensionsanddesignation 4 Requirements .. 5 Packaging 6 Marking .................. Coovriahtlntemational Oraanization forStandardization icarod 8362-3:2001(E) ISO Foreword IsO (the International Organization for Standardization)is a worldwide federation of national standards bodies (IsO member bodies).The work of preparing Internationai Standards is normally carried out through IsO technical committes.Each member body interested in a subject for which a technical committee has been established has Commission (IEC)on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Attention is drawn to the possibity that some of the elements of this part of isO 8362 may be the subject of patent rights.isO shall not beheld responsible for identifying any or all such patent rights. International Standard ISO 8362-3 was prepared byTechnical Committee ISO/TC 76,Transfusion,infusion and injectionequipmentformedicalandpharmaceuticaluse. This second edition cancels and replaces the first edition(isO 8362-3:1989),which has been technically revised. IsO 8362 consists of the following parts,under the general title Injection containers and accessories: —Part 1:Injection vials made ofglass tubing —Part2:Closures for injection vials -Part3:Aluminium caps for injection vials -Part4:Injection vials madeofmouldedglass Part 5:Freeze drying closures for injection vials Part6:Capsmadeofaluminium-plasticscombinationsforinjectionvials -Part 7:lnjection caps made ofaluminium-plastics combinations without overlapping plastics part oiso o001_ll riahte rocorvod Coovriaht Intemational Oraanization for Standarcdizatic 8362-3:2001(E) ISO Introduction The materials from which injection containers (including the elastomeric closures)are made are suitable primary aluminium caps are not considered as primary packaging materials in direct contact with pharmaceutical preparations. Coovriaht Intemational Oraanization for Standardizafion icarod Coovriah InemationalOraanizationfor Standardizato INTERNATIONAL STANDARD ISO 8362-3:2001(E) Injection containers and accessories - Part 3: Aluminium caps for