SIST EN ISO 8362-2:2010
(Main)Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2008)
Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2008)
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 intended for single use only.
Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO 8362-2:2008)
Dieser Teil von ISO 8362-2 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 8362-2:2008)
L'ISO 8362-2:2008 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 8362-2:2008 sont à usage unique.
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala za viale (ISO 8362-2:2008)
Ta del ISO 8362 določa obliko, dimenzije, material, delovne zahteve in etiketiranje zapiral za viale, zajete z ISO 8362-1 in ISO 8362-4. Zahteve glede dimenzij ne veljajo za zapirala s pregrado. Zapirala, ki jih določa ta del ISO 8362, so namenjena le enkratni uporabi.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8362-2:2010
01-november-2010
1DGRPHãþD
SIST EN 28362-2:2000
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala
za viale (ISO 8362-2:2008)
Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-
2:2008)
Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO 8362-
2:2008)
Récipients et accessoires pour produits injectables - Partie 2: Bouchons pour flacons
(ISO 8362-2:2008)
Ta slovenski standard je istoveten z: EN ISO 8362-2:2010
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8362-2:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8362-2:2010
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SIST EN ISO 8362-2:2010
EUROPEAN STANDARD
EN ISO 8362-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2010
ICS 11.040.20 Supersedes EN 28362-2:1993
English Version
Injection containers and accessories - Part 2: Closures for
injection vials (ISO 8362-2:2008)
Récipients et accessoires pour produits injectables - Partie Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für
2: Bouchons pour flacons (ISO 8362-2:2008) Injektionsflaschen (ISO 8362-2:2008)
This European Standard was approved by CEN on 5 August 2010.
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 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 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
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8362-2:2010: E
worldwide for CEN national Members.
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SIST EN ISO 8362-2:2010
EN ISO 8362-2:2010 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 8362-2:2010
EN ISO 8362-2:2010 (E)
Foreword
The text of ISO 8362-2:2008 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion
and injection equipment for medical and pharmaceutical use” of the International Organization for
Standardization (ISO) and has been taken over as EN ISO 8362-2:2010.
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 March 2011, and conflicting national standards shall be withdrawn at the
latest by March 2011.
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 28362-2:1993.
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 8362-2:2008 has been approved by CEN as a EN ISO 8362-2:2010 without any modification.
3
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SIST EN ISO 8362-2:2010
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SIST EN ISO 8362-2:2010
INTERNATIONAL ISO
STANDARD 8362-2
Second edition
2008-10-15
Injection containers and accessories —
Part 2:
Closures for injection vials
Récipients et accessoires pour produits injectables —
Partie 2: Bouchons pour flacons
Reference number
ISO 8362-2:2008(E)
©
ISO 2008
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SIST EN ISO 8362-2:2010
ISO 8362-2:2008(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2008
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 2008 – All rights reserved
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SIST EN ISO 8362-2:2010
ISO 8362-2:2008(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 8362-2 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 8362-2:1988) which has been technically
revised in order to align this part with ISO 8871-1, ISO 8871-4 and ISO 8871-5.
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 combin
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala za viale (ISO 8362-2:2008)Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO 8362-2:2008)Récipients et accessoires pour produits injectables - Partie 2: Bouchons pour flacons (ISO 8362-2:2008)Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2008)11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:Ta slovenski standard je istoveten z:FprEN ISO 8362-2kSIST FprEN ISO 8362-2:2010en01-april-2010kSIST FprEN ISO 8362-2:2010SLOVENSKI
STANDARD
kSIST FprEN ISO 8362-2:2010
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
FINAL DRAFT
FprEN ISO 8362-2
February 2010 ICS 11.040.20 Will supersede EN 28362-2:1993English Version
Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2008)
Récipients et accessoires pour produits injectables -Partie 2: Bouchons pour flacons (ISO 8362-2:2008)
Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO 8362-2:2008) This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee CEN/SS S02.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. FprEN ISO 8362-2:2010: EkSIST FprEN ISO 8362-2:2010
FprEN ISO 8362-2:2010 (E) 2 Contents Page Foreword .3 kSIST FprEN ISO 8362-2:2010
FprEN ISO 8362-2:2010 (E) 3 Foreword The text of ISO 8362-2:2008 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use” of the International Organization for Standardization (ISO) and has been taken over as FprEN ISO 8362-2:2010. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN 28362-2:1993. Endorsement notice The text of ISO 8362-2:2008 has been approved by CEN as a FprEN ISO 8362-2:2010 without any modification.
kSIST FprEN ISO 8362-2:2010
kSIST FprEN ISO 8362-2:2010
Reference numberISO 8362-2:2008(E)© ISO 2008
INTERNATIONAL STANDARD ISO8362-2Second edition2008-10-15Injection containers and accessories —
Part 2: Closures for injection vials Récipients et accessoires pour produits injectables —
Partie 2: Bouchons pour flacons
kSIST FprEN ISO 8362-2:2010
ISO 8362-2:2008(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
©
ISO 2008 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 2008 – All rights reserved
kSIST FprEN ISO 8362-2:2010
ISO 8362-2:2008(E) © ISO 2008 – All rights reserved
iiiForeword 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 8362-2 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This second edition cancels and replaces the first edition (ISO 8362-2:1988) which has been technically revised in order to align this part with ISO 8871-1, ISO 8871-4 and ISO 8871-5. 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 kSIST FprEN ISO 8362-2:2010
ISO 8362-2:2008(E) iv
© ISO 2008 – All rights reserved 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 primar
...
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