EN 28362-4:1993
(Main)Injection containers for injectables and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:1989)
Injection containers for injectables and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:1989)
Injektionsbehältnisse für Injektionspräparate und Zubehör - Teil 4: Injektionsflaschen und Hüttenglas (ISO 8362-4:1989)
Récipients et accessoires pour produits injectables - Partie 4: Flacons en verre moulé (ISO 8362-4:1989)
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 4. del: Viale iz litega stekla (ISO 8362-4:1989)
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 4. del: Viale iz litega stekla (ISO 8362-4:1989)Injektionsbehältnisse für Injektionspräparate und Zubehör - Teil 4: Injektionsflaschen und Hüttenglas (ISO 8362-4:1989)Récipients et accessoires pour produits injectables - Partie 4: Flacons en verre moulé (ISO 8362-4:1989)Injection containers for injectables and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:1989)11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:Ta slovenski standard je istoveten z:EN 28362-4:1993SIST EN 28362-4:2000en01-januar-2000SIST EN 28362-4:2000SLOVENSKI
STANDARD
SIST EN 28362-4:2000
SIST EN 28362-4:2000
SIST EN 28362-4:2000
INTERNATIONAL STANDARD IS0 8362-4 First edition 1989-l l-01 - Injection containers for injectables and accessories - Part 4 3 Injection vials made of moulded glass Rkcipients et accessoires pour produits injectables - Partie 4 : Flacons en verre moulk Reference number IS0 8362-4 : 1989 (E) SIST EN 28362-4:2000
IS0 8362-4 : 1989 (El Contents Foreword . Introduction . 1 Scope . 2 Normative references . 3 Definitions. . . . Page . . . m . III . . iv I . 1 . . 1 . . 1 3 4 Dimensions and designation . L 5 Material . 6 6 Performance . 6 7 Requirements . 6 8 Marking . 6 0 IS0 1989 All rights reserved. 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 in writing from the publisher. International Organization for Standardization Case postale 56 l CH-1211 Geneve 20 o Switzerland Printed in Switzerland ii SIST EN 28362-4:2000
IS0 8362-4 : 1989 (E) Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 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. International organizations, govern- mental and non-governmental, in liaison with ISO, also take part in the work. IS0 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 IS0 Council. They are approved in accordance with IS0 procedures requiring at least 75 % approval by the member bodies voting. International Standard IS0 8362-4 was prepared by Technical Committee lSO/TC 76, Transfusion, infusion and injection equipment for medical use. IS0 8362 consists of the following injectables and accessories : parts under the general title injection containers for - Part 7: Injection vials made of glass tubing - Part 2: C/osures for injection vials - Part 3: Ahminium caps for injection vials - Part 4: Injection vials made of moulded glass SIST EN 28362-4:2000
IS0 8362-4 : 1989 (El Introduction The purpose of this part of IS0 8362 is to specify the dimensions, capacities, form and requirements of glass vials intended for medical use. Containers made from moulded glass are considered to be suitable for the packaging and storage of injectable preparations until they are administered for medicinal purposes. Such containers may be made from different types of glass which can affect the chemical resistance proper- ties. For example, those made from borosilicate glass will have a very high level of chemical resistance whereas others made from soda-lime-silica glass will have a lower, but adequate, chemical resistance for the purpose for which they are intended. The chemical resistance of the internal surface of containers made from soda-lime-silica glass can be improved by a treatment during production to produce a chemical resistance equal to that of those made from borosilicate glass for single use. This level of chemical resistance will be maintained as long as the interior surface is not destroyed by chemical attack, in which case it will be reduced to that of untreated soda-lime-silica glass. Because containers may be made from different types of glass and because it is the chemical behaviour of the internal surface which is important when they are filled with injectable preparations, it is essential to specify test procedures by which this pet-form- ante can be measured. The procedures recommended in this part of IS0 8362 will allow this performance, based on the hydrolytic resistance, to be measured and, from the result of measurement, it is possible to classify containers into their correct category. The procedure also allows containers to be tested and to determine, after an intermediate stage, whether the hydrolytic resistance is produced by the composition of the glass as a material or by a treatment of the internal surface. IV SIST EN 28362-4:2000
INTERNATIONAL STANDARD IS0 8362-4 : 1989 (E) Injection containers for injectables and accessories - Part 4: Injection vials made of moulded glass 1 Scope This part of IS0 8362 specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers shall be made and the performance requirements of those containers. This part of IS0 8362 applies to colourless or amber glass con- tainers made from borosilicate or soda-lime-silica glass, made from moulded glass, whether internally surface-treated or not, and intended to be used in the packaging, storage or transpor- tation of products intended for injection. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of IS0 8362. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of IS0 8362 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 719: 1985, G/ass - Hydrolytic resistance of glass grains at 98°C - Method of test and cfassifica tion. IS0 720: 1985, Glass - Hydrolytic resistance of glass grains at 121 O C - Method of test and clas
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