EN ISO 8362-1:2009
(Main)Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2009)
Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2009)
ISO 8362-1:2009 specifies the form, 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 of those containers.
ISO 8362-1:2009 applies to colourless or amber glass containers made from borosilicate or soda-lime glass, made from glass tubing, whether internally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection.
Injektionsbehältnisse und Zubehör - Teil 1: Injektionsflaschen aus Röhrenglas (ISO 8362-1:2009)
Dieser Teil von ISO 8362 legt die Formen, Maße und Inhaltsmengen für Glasbehältnisse für Injektions-präparate 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 8362-1:2009)
L'ISO 8362-1:2009 spécifie la forme, les dimensions et les capacités des flacons en verre pour des préparations injectables. Elle spécifie également le matériau constitutif et les exigences auxquelles ces flacons doivent répondre.
L'ISO 8362-1:2009 est applicable aux flacons en verre blanc ou ambré, en verre borosilicaté ou en verre de silicate sodocalcique, obtenus à partir de verre étiré, 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 - 1. del: Viale iz cevnega stekla (ISO 8362-1:2009)
Ta del ISO 8362 določa obliko, mere in prostornino steklenih vial za pripravke za injiciranje. Določa tudi material, iz katerega morajo biti ti vsebniki narejeni, in zahteve za zmogljivost teh vsebnikov. Ta del ISO 8362 velja za brezbarvne ali rumenkasto rjave steklene vsebnike, narejene iz borosilikatnega ali natrij-kalcijevega stekla iz cevnega stekla, z obdelano notranjo površino ali brez, ki se uporabljajo pri pakiranju, shranjevanju ali prevozu proizvodov, namenjenih injiciranju.
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 1. del: Viale iz cevnega stekla (ISO 8362-1:2009)Injektionsbehältnisse und Zubehör - Teil 1: Injektionsflaschen aus
Röhrenglas (ISO 8362-1:2009)Récipients et accessoires pour produits injectables - Partie 1: Flacons en verre étiré (ISO 8362-1:2009)Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2009)11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:Ta slovenski standard je istoveten z:EN ISO 8362-1:2009SIST EN ISO 8362-1:2010en01-marec-2010SIST EN ISO 8362-1:2010SLOVENSKI
STANDARDSIST EN ISO 8362-1:20051DGRPHãþD
SIST EN ISO 8362-1:2010
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 8362-1
December 2009 ICS 11.040.20 Supersedes EN ISO 8362-1:2004English Version
Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2009)
Récipients et accessoires pour produits injectables - Partie 1: Flacons en verre étiré (ISO 8362-1:2009)
Injektionsbehältnisse und Zubehör - Teil 1: Injektionsflaschen aus
Röhrenglas (ISO 8362-1:2009) This European Standard was approved by CEN on 21 December 2009.
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 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 Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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 © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8362-1:2009: ESIST EN ISO 8362-1:2010
EN ISO 8362-1:2009 (E) 2 Contents Page Foreword .3 SIST EN ISO 8362-1:2010
EN ISO 8362-1:2009 (E) 3 Foreword This document (EN ISO 8362-1:2009) 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 June 2010, and conflicting national standards shall be withdrawn at the latest by June 2010. 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 8362-1:2004. 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, 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 8362-1:2009 has been approved by CEN as a EN ISO 8362-1:2009 without any modification.
SIST EN ISO 8362-1:2010
SIST EN ISO 8362-1:2010
Reference numberISO 8362-1:2009(E)© ISO 2009
INTERNATIONAL STANDARD ISO8362-1Third edition2009-12-15Injection containers and accessories — Part 1: Injection vials made of glass tubing Récipients et accessoires pour produits injectables — Partie 1: Flacons en verre étiré
SIST EN ISO 8362-1:2010
ISO 8362-1:2009(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a
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