EN ISO 8362-2:2024

Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)

This document 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 document 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 8362-2:2024)

Dieses Dokument legt die Form, die Maße, die Werkstoffe, die Leistungsanforderungen und die Kennzeichnung von Stopfen für Injektionsflaschen nach ISO8362-1 und ISO8362-4 fest.
Die maßlichen Anforderungen sind nicht anwendbar auf beschichtete Stopfen.
Die Stopfen nach diesem Dokument sind nur zum einmaligen Gebrauch bestimmt.
ANMERKUNG Die Wirksamkeit, Reinheit, Beständigkeit und Sicherheit eines Arzneimittels während seiner Herstellung 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 8362-2:2024)

Le présent document spécifie la forme, les dimensions, le matériau, les exigences de performances 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 du présent document sont à usage unique seulement.
NOTE            La nature et les performances de l’emballage primaire peuvent influer considérablement sur l’efficacité, la pureté, la stabilité et la sécurité d’un produit pharmaceutique au cours de sa fabrication et de son stockage.

Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala za viale (ISO 8362-2:2024)

General Information

• Status: Published
• Publication Date: 02-Apr-2024
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/SS S02 - Transfusion equipment
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 03-Apr-2024
• Completion Date: 03-Apr-2024
• Ref Project: SIST EN ISO 8362-2:2024 - Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)

Relations

• Replaces: EN ISO 8362-2:2015/A1:2022 - Injection containers and accessories - Part 2: Closures for injection vials - Amendment 1 (ISO 8362-2:2015/Amd 1:2022)
• Effective Date: 21-Jun-2023
• Replaces: EN ISO 8362-2:2015 - Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015)
• Effective Date: 21-Jun-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 8362-2:2023
01-november-2023
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala
za viale (ISO/DIS 8362-2:2023)
Injection containers and accessories - Part 2: Closures for injection vials (ISO/DIS 8362-
2:2023)
Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO/DIS 8362-
2:2023)
Récipients et accessoires pour produits injectables - Partie 2 : Bouchons pour flacons
(ISO/DIS 8362-2:2023)
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 8362-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 8362-2:2023

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oSIST prEN ISO 8362-2:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8362-2
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2023-08-28 2023-11-20
Injection containers and accessories —
Part 2:
Closures for injection vials
Récipients et accessoires pour produits injectables —
Partie 2: Bouchons pour flacons
ICS: 11.040.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
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 8362-2:2023(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 2023

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oSIST prEN ISO 8362-2:2023
ISO/DIS 8362-2:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8362-2
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:

Injection containers and accessories —
Part 2:
Closures for injection vials
Récipients et accessoires pour produits injectables —
Partie 2: Bouchons pour flacons
ICS: 11.040.20
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 8362-2:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

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oSIST prEN ISO 8362-2:2023
ISO/DIS 8362-2:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references .
...