SIST EN ISO 8362-4:2011

SLOVENSKI STANDARD
SIST EN ISO 8362-4:2011
01-december-2011
1DGRPHãþD
SIST EN ISO 8362-4:2005
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 4. del: Viale iz
litega stekla (ISO 8362-4:2011)
Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO
8362-4:2011)
Injektionsbehältnisse und Zubehör - Teil 4: Injektionsflaschen aus Hüttenglas (ISO 8362-
4:2011)
Récipients et accessoires pour produits injectables - Partie 4: Flacons en verre moulé
(ISO 8362-4:2011)
Ta slovenski standard je istoveten z: EN ISO 8362-4:2011
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8362-4:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8362-4:2011

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SIST EN ISO 8362-4:2011


EUROPEAN STANDARD
EN ISO 8362-4

NORME EUROPÉENNE

EUROPÄISCHE NORM
September 2011
ICS 11.040.20 Supersedes EN ISO 8362-4:2004
English Version
Injection containers and accessories - Part 4: Injection vials
made of moulded glass (ISO 8362-4:2011)
Récipients et accessoires pour produits injectables - Partie Injektionsbehältnisse und Zubehör - Teil 4:
4: Flacons en verre moulé (ISO 8362-4:2011) Injektionsflaschen aus Hüttenglas (ISO 8362-4:2011)
This European Standard was approved by CEN on 31 August 2011.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8362-4:2011: E
worldwide for CEN national Members.

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SIST EN ISO 8362-4:2011
EN ISO 8362-4:2011 (E)
Contents Page
Foreword .3

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SIST EN ISO 8362-4:2011
EN ISO 8362-4:2011 (E)
Foreword
This document (EN ISO 8362-4:2011) has been prepared by Technical Committee ISO/TC 76 "Transfusion,
infusion and injection, and blood processing equipment for medical and pharmaceutical use".
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by March 2012, and conflicting national standards shall be withdrawn at
the latest by March 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8362-4:2004.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 8362-4:2011 has been approved by CEN as a EN ISO 8362-4:2011 without any modification.

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SIST EN ISO 8362-4:2011

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SIST EN ISO 8362-4:2011

INTERNATIONAL ISO
STANDARD 8362-4
Third edition
2011-09-01

Injection containers and accessories —
Part 4:
Injection vials made of moulded glass
Récipients et accessoires pour produits injectables —
Partie 4: Flacons en verre moulé




Reference number
ISO 8362-4:2011(E)
©
ISO 2011

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SIST EN ISO 8362-4:2011
ISO 8362-4:2011(E)

COPYRIGHT PROTECTED DOCUMENT


©  ISO 2011
All rights reserved. Unless otherwise specified, 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 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. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland

ii © ISO 2011 – All rights reserved

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SIST EN ISO 8362-4:2011
ISO 8362-4:2011(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
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC 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 8362-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood
processing equipment for medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 8362-4:2003), of which it constitutes a minor
revision.
The principle changes to the second edition are the updating of normative references to ISO 4802-1 and
ISO 4802-2, and the revision of Figure 2 and Table 2.
ISO 8362 consists of the following parts, under the general title Injection containers and accessories:
 Part 1: Injection vials made of glass tubing
 Part 2: Closures for injection vials
 Part 3: Aluminium caps for injection vials
 Part 4: Injection vials made of moulded glass
 Part 5: Freeze drying closures for injection vials
 Part 6: Caps made of aluminium-plastics combinations for injection vials
 Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part
© ISO 2011 – All rights reserved iii

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SIST EN ISO 8362-4:2011
ISO 8362-4:2011(E)
Introduction
The purpose of this part of ISO 8362 is to specify the shape, dimensions and capacities of, and performance
requirements for, 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 can be made from different types of glass, which can affect the chemical
resistance properties. For example, those made from borosilicate glass will have a very high level of chemical
resistance, whereas those made from soda-lime-silica glass will have a lower chemical resistance but one that
is adequate for the purpose for which the containers 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 containers 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 can be made from different types of glass and because it is the chemical behaviour of the
internal surface that is important when they are filled with injectable preparations, it is essential to specify test
procedures by which this performance can be measured. The procedures specified in this part of ISO 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 procedures also allow
containers to be tested and to determine whether the hydrolytic resistance is due to the com
...