EN ISO 8362-4:2004

Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:2003)

ISO 8362-4:2003 specifies the shape, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers shall be made and the performance requirements for the containers.
It 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 8362-4:2003)

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 Alkali-Kalkglas 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 8362-4:2003)

L'ISO 8362-4:2003 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.
Elle est applicable aux flacons en verre blanc ou ambré, moulés en verre borosilicate ou sodocalcique, avec une surface interne traitée ou non, conçus pour l'emballage, le stockage ou le transport des produits injectables.

Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 4. del: Viale iz litega stekla (ISO 8362-4:2003)

General Information

• Status: Withdrawn
• Publication Date: 29-Jun-2004
• Withdrawal Date: 31-Aug-2011
• 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
• Start Date: 01-Sep-2011
• Completion Date: 01-Sep-2011
• Ref Project: SIST EN ISO 8362-4:2005 - Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:2003)

Relations

• Replaces: EN 28362-4:1993 - Injection containers for injectables and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:1989)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 8362-4:2011 - Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO/FDIS 8362-4:2011)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 4. del: Viale iz litega stekla (ISO 8362-4:2003)Injektionsbehältnisse und Zubehör - Teil 4: Injektionsflaschen aus Hüttenglas (ISO 8362-4:2003)Récipients et accessoires pour produits injectables - Partie 4: Flacons en verre moulé (ISO 8362-4:2003)Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:2003)11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:Ta slovenski standard je istoveten z:EN ISO 8362-4:2004SIST EN ISO 8362-4:2005en,fr,de01-januar-2005SIST EN ISO 8362-4:2005SLOVENSKI
STANDARDSIST EN 28362-4:20001DGRPHãþD



SIST EN ISO 8362-4:2005



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 8362-4June 2004ICS 11.040.20Supersedes EN 28362-4:1993English versionInjection containers and accessories - Part 4: Injection vialsmade of moulded glass (ISO 8362-4:2003)Récipients et accessoires pour produits injectables - Partie4: Flacons en verre moulé (ISO 8362-4:2003)Injektionsbehältnisse und Zubehör - Teil 4:Injektionsflaschen aus Hüttenglas (ISO 8362-4:2003)This European Standard was approved by CEN on 1 April 2004.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2004 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 8362-4:2004: ESIST EN ISO 8362-4:2005



EN ISO 8362-4:2004 (E)
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Foreword
The text of ISO 8362-4:2003 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 8362-4:2004 by CMC.
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 December 2004, and conflicting national standards shall be withdrawn at the latest by December 2004.
This document supersedes EN 28362-4:1993.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 8362-4:2003 has been approved by CEN as EN ISO 8362-4:2004 without any modifications. SIST EN ISO 8362-4:2005



EN ISO 8362-4:2004 (E)
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Annex ZA (informative)
A-deviations
A-deviation: National deviation due to regulations, the alteration of which is for the time being outside the competence of CEN/CENELEC member:
NOTE: Where standards fall under EC Directives it is the view of the Commission of the European Communities (OJ No G 59, 9.3, 1982) that the effect of the decision of the Court of Justice in case 815/79 Cremonini/Vrankovitch (European Court Reports 1980, p.3583) is that compliance with A-deviations is no longer mandatory and that the free movement of products complying with such a standard should not be restricted except under the safeguard procedure provided for in the relevant Directive.
A-deviations in an EFTA country are valid instead of the relevant provisions of the European Standard in that country until they have been removed.
The European standard is not in agreement with the European Pharmacopoeia, 4th Edition,
§ 3.2.1 "Glass containers for pharmaceutical use", which is mandatory in Sweden by "Svensk Läkemedelsstandard 2004:1, page 25" and "Regulation LVFS 2004:1. SIST EN ISO 8362-4:2005



SIST EN ISO 8362-4:2005



Reference numberISO 8362-4:2003(E)© ISO 2003
INTERNATIONAL STANDARD ISO8362-4Se
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