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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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 - 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
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
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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
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
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ii © ISO 2009 – All rights reserved
ISO 8362-1:2009(E) © ISO 2009 – All rights reserved iii 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 established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. 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 rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 8362-1 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This third edition cancels and replaces the second edition (ISO 8362-1:2003), which has undergone minor revision by including further types of neck finishes for injection vials [model B – neck finish with blow back (European style) and model C – neck finish with blow back (American style)]. ISO 8362 consists of the following parts, under the general title Injection containers and accessories: ⎯ Part 1: Injection vials made of glass tubing ⎯ Part 2: Closures for injection vials ⎯ Part 3: Aluminium caps for injection vials ⎯ Part 4: Injection vials made of moulded glass ⎯ Part 5: Freeze drying closures for injection vials ⎯ Part 6: Caps made of aluminium-plastics combinations for injection vials ⎯ Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part
ISO 8362-1:2009(E) iv © ISO 2009 – All rights reserved Introduction The purpose of this part of ISO 8362 is to specify the dimensions, capacities, form and requirements of glass vials intended for medical use. Containers made from glass tubing are considered to be suitable for the packaging and storage of injectable preparations until they are administered for medicinal
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