EN ISO 8362-2:2015
(Main)Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015)
Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015)
ISO 8362-2:2015 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362‑1 and ISO 8362‑4.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in ISO 8362-2:2015 are intended for single use only.
Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO 8362-2:2015)
Dieser Teil von ISO 8362 legt die Form, die Maße, die Werkstoffe, die Leistungsanforderungen und die Kennzeichnung von Stopfen für Injektionsflaschen nach ISO 8362-1 und ISO 8362-4 fest.
Die maßlichen Anforderungen sind nicht anwendbar auf beschichtete Stopfen.
Die Stopfen nach diesem Teil von ISO 8362 sind nur zum einmaligen Gebrauch bestimmt.
ANMERKUNG Die Wirksamkeit, Reinheit, Beständigkeit und Sicherheit eines Arzneimittels während seiner Herstel-lung und Lagerung können erheblich durch die Art und Ausführung des Primärpackmittels beeinträchtigt werden.
Récipients et accessoires pour produits injectables - Partie 2 : Bouchons pour flacons (ISO 8362-2:2015)
L'ISO 8362-2:2015 spécifie la forme, les dimensions, le matériau, les exigences de performance et l'étiquetage des bouchons de flacons pour produits injectables faisant l'objet de l'ISO 8362‑1 et de l'ISO 8362‑4.
Les exigences dimensionnelles ne s'appliquent pas aux bouchons avec revêtement protecteur.
Les bouchons faisant l'objet de l'ISO 8362-2:2015 sont à usage unique.
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala za viale (ISO 8362-2:2015)
Ta del standarda ISO 8362 določa obliko, dimenzije, material, delovne zahteve in etiketiranje zapiral za viale, obravnavanih v standardih ISO 8362-1 in ISO 8362-4. Zahteve glede dimenzij ne veljajo za zapirala s pregrado. Zapirala, ki jih določa ta del standarda ISO 8362, so namenjena le enkratni uporabi.
OPOMBA: Na jakost, čistost, stabilnost in varnost zdravila med med proizvodnjo in skladiščenjem lahko močno vplivata tip in zmogljivost primarne embalaže.
General Information
Relations
Standards Content (Sample)
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
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
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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 the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is 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 8362-2:2008), which has been technically
revised in order to include a new 7.5 particulate contamination requirements.
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
iv © ISO 2015 – All rights reserved
ISO 8362-2:2015(E)
Introduction
The purpose of this part of ISO 8362 is to specify the shape and dimensions of, and the requirements
for, elastomeric closures intended for pharmaceutical use. Closures made from elastomeric materials
are suitable primary packaging materials for parenteral preparations. In order to provide seal integrity
of the container closure systems, the dimensions of the elastomeric closures have to be compatible with
the dimensions of the glass vials and the caps as specified in corresponding parts of ISO 8362.
Primary packaging components made of elastomeric materials are an integral part of medicinal
products and thus the principles of current Good Manufacturing Practices (cGMP) apply to the
manufacturing of these components.
Principles of cGMP are described in, for example, ISO 15378 or GMP Guidelines as published by the
European Community and the United States of America.
INTERNATIONAL STANDARD ISO 8362-2:2015(E)
Injection containers and accessories —
Part 2:
Closures for injection vials
1 Scope
This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and
labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this part of ISO 8362 are inten
...
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