EESTI STANDARD EVS-EN 28362-3:1999 Süstitavate ravimpreparaatide mahutid ja lisaseadised. Osa 3: Väikeste süstepudelite alumiiniumist korgikapslid Injection containers for injectables and accessories - Part 3: Aluminium caps for injection vials
EESTI STANDARDI EESSÕNA Käesolev Eesti standard EVS-EN 28362-3:1999 sisaldab Euroopa standardi EN 28362-3:1993 ingliskeelset teksti. NATIONAL FOREWORD This Estonian standard EVS-EN 28362-3:1999 consists of the English text of the European standard EN 28362-3:1993. Standard on kinnitatud Eesti Standardikeskuse 12.12.1999 käskkirjaga ja jõustub sellekohase teate avaldamisel EVS Teatajas. This standard is ratified with the order of Estonian Centre for Standardisation dated 12.12.1999 and is endorsed with the notification published in the official bulletin of the Estonian national standardisation organisation. Standard on kättesaadav Eesti standardiorganisatsioonist. The standard is available from Estonian standardisation organisation. ICS 11.040.20 alumiiniumtooted, korgikapslid, mahutid, meditsiiniaparatuur, mõõtmed, parenteraalse infusiooni seadmestik, pudelid, süstitavad ained, tehnilised andmed, tähistus Standardite reprodutseerimis- ja levitamisõigus kuulub Eesti Standardikeskusele Andmete paljundamine, taastekitamine, kopeerimine, salvestamine elektroonilisse süsteemi või edastamine ükskõik millises vormis või millisel teel on keelatud ilma Eesti Standardikeskuse poolt antud kirjaliku loata. Kui Teil on küsimusi standardite autorikaitse kohta, palun võtke ühendust Eesti Standardikeskusega: Aru 10 Tallinn 10317 Eesti; www.evs.ee; Telefon: 605 5050; E-post: info@evs.ee Right to reproduce and distribute belongs to the Estonian Centre for Standardisation No part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, without permission in writing from Estonian Centre for Standardisation. If you have any questions about standards copyright, please contact Estonian Centre for Standardisation: Aru str 10 Tallinn 10317 Estonia; www.evs.ee; Phone: 605 5050; E-mail: info@evs.ee
INTERNATIONAL STANDARD ISO 8362-3 First editisn 1989-11-15 Injection Containers for injectables and accessories - Part 3 : Aluminium taps for injection vials Rkipients et accessoires pour produits injec tables - Partie 3 : Capsules en aluminium pour flacons Reference number ISO 8362-3 : 1989 (El
ISO 8362-3 : 1989 (EI Contents Foreword... iii Introduction... iv 1 Scope... 1 2 Normative reference... 1 3 Dimensions and designation... 1 4 Requirements... 3 5 Packaging... 3 6 Marking... 3 0 ISO 1989 All rights reserved. NO part of this publication may be reproduced or utilized in any ferm or by any means, electronie or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Organization for Standardization Case postale 56 l CH-1211 Geneve 20 l Switzerland Printed in Switzerland
ISO 8362-3 : 1989 (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. Esch 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 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. Draft International Standards adopted by the technical committees are circulated to the member bodies for approval before their acceptance as International Standards by the ISO Council. They are approved in accordance with ISO procedures requiring at least 75 % approval by the member bodies voting. International Standard ISO 8361-3 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipmen t for medical use. ISO 8362 consists of the following Parts, under the general title lnjection Containers for injectables and accessories : - Part 7: lnjection vials made of glass tubing - Part 2 : Closures for injection vials - Part 3 : Aluminium taps for injection vials - Part 4: lnjection vials made of moulded glass
ISO 8362-3 : 1989 (EI Introduction The materials from which injection Containers (including the elastomeric closures) are made are suitable primary packaging materials for storing injectable products until they are administered. However, in this part of ISO 8362, aluminium taps are not considered as primary packaging materials in direct contact with pharmaceutical preparations.
INTERNATIONAL STANDARD ISO 8362-3 : 1989 (E) Injection Containers for injectables and accessories - Part 3 : Aluminium taps for injection vials 1 Scope This part of ISO 8362 specifies aluminium taps for injection vials as described in ISO 8362-1 and ISO 8362-4. Standard indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 8872 : 1988, Aluminium taps for transfusion, infusion and injection bottles - General requirements and test methods. 2 Normative reference The following Standard contains provisions which, through reference in this text, constitute provisions of this part of ISO 8362. At the time of publication, the edition indicated was valid. AJI Standards are subject to revision, and Parties to agreements based on this patt of ISO 8362 are encouraged to investigate the possibility of applying the most recent edition of the 3 Dimensions and designation 3.1 Dimensions The dimensions of aluminium taps shall be as shown in figure 1 and as given in table 1. 1