SIST EN ISO 8362-4:2005

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 ISO8362-4Second edition2003-08-01Injection containers and accessories — Part 4: Injection vials made of moulded glass Récipients et accessoires pour produits injectables — Partie 4: Flacons en verre moulé
SIST EN ISO 8362-4:2005



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SIST EN ISO 8362-4:2005



ISO 8362-4:2003(E) © ISO 2003 — All rights reserved iii Contents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.1 4 Dimensions and designation.2 4.1 Injection vials for insulin.2 4.2 Injection vials for antibiotics.3 5 Material.5 6 Defects, sealing surfaces.5 7 Performance requirements.6 7.1 Hydrolytic resistance.6 7.2 Internal pressure resistance.6 7.3 Thermal shock resistance.6 7.4 Annealing quality.6 8 Marking.6
SIST EN ISO 8362-4:2005



ISO 8362-4:2003(E) iv © ISO 2003 — All rights reserved 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 8362-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This second edition cancels and replaces the first edition (ISO 8362-4:1989), which has been technically revised. 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
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