EN ISO 8362-2:2015

SLOVENSKI STANDARD
01-januar-2016
1DGRPHãþD
SIST EN ISO 8362-2:2010
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala
za viale (ISO 8362-2:2015)
Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-
2:2015)
Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO 8362-
2:2015)
Récipients et accessoires pour produits injectables - Partie 2 : Bouchons pour flacons
(ISO 8362-2:2015)
Ta slovenski standard je istoveten z: EN ISO 8362-2:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 8362-2
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2015
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8362-2:2010
English Version
Injection containers and accessories - Part 2: Closures for
injection vials (ISO 8362-2:2015)
Récipients et accessoires pour produits injectables - Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für
Partie 2 : Bouchons pour flacons (ISO 8362-2:2015) Injektionsflaschen (ISO 8362-2:2015)
This European Standard was approved by CEN on 29 August 2015.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8362-2:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 8362-2:2015) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection 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 April 2016, and conflicting national standards shall be
withdrawn at the latest by April 2016.
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 8362-2:2010.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 8362-2:2015 has been approved by CEN as EN ISO 8362-2:2015 without any
modification.
INTERNATIONAL ISO
STANDARD 8362-2
Third edition
2015-10-01
Injection containers and
accessories —
Part 2:
Closures for injection vials
Récipients et accessoires pour produits injectables —
Partie 2: Bouchons pour flacons
Reference number
ISO 8362-2:2015(E)
©
ISO 2015
ISO 8362-2:2015(E)
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
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ii © ISO 2015 – All rights reserved

ISO 8362-2:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Classification . 1
4 Shape and dimensions . 2
5 Designation . 3
6 Material . 3
7 Performance requirements . 4
7.1 General . 4
7.2 Physical requirements . 4
7.2.1 Hardness . 4
7.2.2 Penetrability . 4
7.2.3 Fragmentation . 4
7.2.4 Self-sealing and aqueous solution tightness test . 4
7.2.5 Dye solution tightness test . 4
7.2.6 Resistance to ageing . 4
7.3 Chemical requirements. 4
7.4 Biological requirements . 4
7.5 Particulate contamination requirements . 5
8 Labelling . 5
Bibliography . 6
ISO 8362-2:2015(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.
The procedures used to develop this document and those intended for its further maintenance are
described in
...