SIST EN ISO 8362-2:2016
(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)
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.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage
can strongly be affected by the nature and performance of the primary packaging.
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
SIST EN ISO 8362-2:2016
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
SIST EN ISO 8362-2:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8362-2:2016
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SIST EN ISO 8362-2:2016
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.
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SIST EN ISO 8362-2:2016
EN ISO 8362-2:2015 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 8362-2:2016
EN ISO 8362-2:2015 (E)
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.
3
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SIST EN ISO 8362-2:2016
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SIST EN ISO 8362-2:2016
INTERNATIONAL ISO
STANDARD 8362-2
Third edition
2015-10-01
Injection containers and
accessories —
Part 2:
Closures for injection vials
Récipients et accessoires pour produit
...
SLOVENSKI STANDARD
oSIST prEN ISO 8362-2:2014
01-september-2014
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala
za viale (ISO/DIS 8362-2:2014)
Injection containers and accessories - Part 2: Closures for injection (ISO/DIS 8362-
2:2014)
Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO/DIS 8362-
2:2014)
Récipients et accessoires pour produits injectables - Partie 2: Bouchons pour flacons
(ISO/DIS 8362-2:2014)
Ta slovenski standard je istoveten z: prEN ISO 8362-2
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 8362-2:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 8362-2:2014
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oSIST prEN ISO 8362-2:2014
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8362-2
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2014-07-03 2014-12-03
Injection containers and accessories —
Part 2:
Closures for injection
Récipients et accessoires pour produits injectables —
Partie 2: Bouchons pour flacons
ICS: 11.040.20
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 8362-2:2014(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2014
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oSIST prEN ISO 8362-2:2014
ISO/DIS 8362-2:2014(E)
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as
permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,
electronic, photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
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Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2014 – All rights reserved
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oSIST prEN ISO 8362-2:2014
ISO/DIS 8362-2
Contents Page
Foreword . iv
Introduction . iv
1 Scope . 1
2 Normative references . 1
3 Classification . 1
4 Shape and dimensions . 2
5 Designation . 3
6 Material .
...
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