EN ISO 8362-2:2010

Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2008)

ISO 8362-2:2008 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 8362-2:2008 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

• Status: Withdrawn
• Publication Date: 31-Aug-2010
• Withdrawal Date: 27-Oct-2015
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/SS S02 - Transfusion equipment
• Drafting Committee: CEN/SS S02 - Transfusion equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 28-Oct-2015
• Ref Project: SIST EN ISO 8362-2:2010 - Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2008)

Relations

• Replaces: EN 28362-2:1993 - Injection containers for injectables and accessories - Part 2: Closures for injection vials (ISO 8362-2:1988)
• Effective Date: 21-Nov-2009
• Replaced By: EN ISO 8362-2:2015 - Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015)
• Effective Date: 11-Nov-2015

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.

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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: Bouchon
...