SIST EN ISO 8362-1:2005
(Main)Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2003)
Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2003)
Injektionsbehältnisse und Zubehör - Teil 1: Injektionsflaschen aus Röhrenglas (ISO 8362-1:2003)
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.
Dieser Teil von ISO 8362 gilt für farblose oder braune Röhrenglasbehältnisse 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 1: Flacons en verre étiré (ISO 8362-1:2003)
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 1. del: Viale iz cevnega stekla (ISO 8362-1:2003)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8362-1:2005
01-januar-2005
1DGRPHãþD
SIST EN 28362-1:2000
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 1. del: Viale iz
cevnega stekla (ISO 8362-1:2003)
Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO
8362-1:2003)
Injektionsbehältnisse und Zubehör - Teil 1: Injektionsflaschen aus Röhrenglas (ISO 8362
-1:2003)
Récipients et accessoires pour produits injectables - Partie 1: Flacons en verre étiré (ISO
8362-1:2003)
Ta slovenski standard je istoveten z: EN ISO 8362-1:2004
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8362-1:2005 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8362-1:2005
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SIST EN ISO 8362-1:2005
EUROPEAN STANDARD
EN ISO 8362-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2004
ICS 11.040.20 Supersedes EN 28362-1:1993
English version
Injection containers and accessories - Part 1: Injection vials
made of glass tubing (ISO 8362-1:2003)
Récipients et accessoires pour produits injectables - Partie Injektionsbehältnisse und Zubehör - Teil 1:
1: Flacons en verre étiré (ISO 8362-1:2003) Injektionsflaschen aus Röhrenglas (ISO 8362-1:2003)
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 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 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 translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
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 STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8362-1:2004: E
worldwide for CEN national Members.
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SIST EN ISO 8362-1:2005
EN ISO 8362-1:2004 (E)
Foreword
The text of ISO 8362-1:2003 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-
1:2004 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 28362-1:1993.
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 8362-1:2003 has been approved by CEN as EN ISO 8362-1:2004 without any
modifications.
2
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SIST EN ISO 8362-1:2005
EN ISO 8362-1:2004 (E)
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.
3
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SIST EN ISO 8362-1:2005
INTERNATIONAL ISO
STANDARD 8362-1
Second edition
2003-09-01
Injection containers and accessories —
Part 1:
Injection vials made of glass tubing
Récipients et accessoires pour produits injectables —
Partie 1: Flacons en verre étiré
Reference number
ISO 8362-1:2003(E)
©
ISO 2003
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SIST EN ISO 8362-1:2005
ISO 8362-1:2003(E)
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ii © ISO 2003 — All rights reserved
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SIST EN ISO 8362-1:2005
ISO 8362-1:2003(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
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International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
ri
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