EN ISO 8362-4:2011

Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO/FDIS 8362-4:2011)

ISO 8362-4:2011 specifies the shape, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements for the containers.
ISO 8362-4:2011 applies to colourless or amber glass containers moulded from borosilicate or soda-lime glass, with or without an internal surface treatment, and intended to be used in the packaging, storage or transportation of products intended for injection.

Injektionsbehältnisse und Zubehör - Teil 4: Injektionsflaschen aus Hüttenglas (ISO/FDIS 8362-4:2011)

Dieser Teil von ISO 8362 legt die Formen, Maße und Inhaltsmengen für Glasbehältnisse für Injektionspräparate
fest. Er legt auch die Werkstoffe fest, aus denen diese Behältnisse hergestellt werden müssen, sowie die
Leistungsanforderungen für diese.
Er gilt für farblose oder braune Hüttenglasbehältnisse aus Borosilicatglas oder Kalk-Natron-Silicatglas mit
oder ohne Behandlung der Innenoberfläche, die für die Verpackung, Aufbewahrung oder den Transport von
Injektionspräparaten verwendet werden sollen.

Récipients et accessoires pour produits injectables - Partie 4: Flacons en verre moulé (ISO/FDIS 8362-4:2011)

L'ISO 8362-4:2011 spécifie la forme, les dimensions et les capacités des flacons en verre pour préparation injectable. Elle spécifie également le matériau constitutif et les exigences auxquelles ces flacons doivent répondre.
L'ISO 8362-4:2011 s'applique aux flacons en verre blanc ou ambré, moulés en verre borosilicaté ou sodocalcique, avec une surface interne traitée ou non, conçus pour l'emballage, le stockage ou le transport de produits injectables.

Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 4. del: Viale iz litega stekla (ISO 8362-4:2011)

Ta del ISO 8362 določa obliko, mere in prostornino steklenih vial za pripravke za injiciranje. Določa tudi material, iz katerega so ti vsebniki narejeni, in zahteve za zmogljivost teh vsebnikov. Velja za brezbarvne ali rjave steklene vsebnike, narejene iz borosilikatnega ali natrij-kalcijevega stekla, z obdelano notranjo površino ali brez obdelave, ki se uporabljajo pri pakiranju, shranjevanju ali prevozu proizvodov, namenjenih injiciranju.

General Information

• Status: Published
• Publication Date: 31-Aug-2011
• Withdrawal Date: 30-Mar-2012
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Sep-2011
• Completion Date: 01-Sep-2011
• Ref Project: SIST EN ISO 8362-4:2011 - Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:2011)

Relations

• Replaces: EN ISO 8362-4:2004 - Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:2003)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8362-4:2011
01-december-2011
1DGRPHãþD
SIST EN ISO 8362-4:2005
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 4. del: Viale iz
litega stekla (ISO 8362-4:2011)
Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO
8362-4:2011)
Injektionsbehältnisse und Zubehör - Teil 4: Injektionsflaschen aus Hüttenglas (ISO 8362-
4:2011)
Récipients et accessoires pour produits injectables - Partie 4: Flacons en verre moulé
(ISO 8362-4:2011)
Ta slovenski standard je istoveten z: EN ISO 8362-4:2011
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8362-4:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8362-4:2011

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SIST EN ISO 8362-4:2011


EUROPEAN STANDARD
EN ISO 8362-4

NORME EUROPÉENNE

EUROPÄISCHE NORM
September 2011
ICS 11.040.20 Supersedes EN ISO 8362-4:2004
English Version
Injection containers and accessories - Part 4: Injection vials
made of moulded glass (ISO 8362-4:2011)
Récipients et accessoires pour produits injectables - Partie Injektionsbehältnisse und Zubehör - Teil 4:
4: Flacons en verre moulé (ISO 8362-4:2011) Injektionsflaschen aus Hüttenglas (ISO 8362-4:2011)
This European Standard was approved by CEN on 31 August 2011.

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, 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
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8362-4:2011: E
worldwide for CEN national Members.

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SIST EN ISO 8362-4:2011
EN ISO 8362-4:2011 (E)
Contents Page
Foreword .3

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SIST EN ISO 8362-4:2011
EN ISO 8362-4:2011 (E)
Foreword
This document (EN ISO 8362-4:2011) has been prepared by Technical Committee ISO/TC 76 "Transfusion,
infusion and injection, and blood processing 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 March 2012, and conflicting national standards shall be withdrawn at
the latest by March 2012.
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 8362-4:2004.
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 8362-4:2011 has been approved by CEN as a EN ISO 8362-4:2011 without any modification.

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SIST EN ISO 8362-4:2011

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SIST EN ISO 8362-4:2011

INTERNATIONAL ISO
STANDARD 8362-4
Third edition
2011-09-01

Injection containers and accessories —
Part 4:
Injection vials made of moulded glass
Récipients et accessoires pour produits injectables —
Partie 4: Flacons en verre mou
...