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Standards [CURRENT]

DIN EN ISO 8362-4
Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:2011); German version EN ISO 8362-4:2011

Title (German)

Injektionsbehältnisse und Zubehör - Teil 4: Injektionsflaschen aus Hüttenglas (ISO 8362-4:2011); Deutsche Fassung EN ISO 8362-4:2011

Overview

The materials, shapes, dimensions, capacities as well as performance requirements for injection vials made of moulded glass are specified. The standard considers colourless and amber glass containers moulded from borosilicate or soda-lime-silica glass, with or without an internal surface treatment. The injection vials are used in the packaging, storage or transportation of products intended for injection. This standard has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use" (secretariat: DIN, Germany) and has been adopted without any modifications as EN ISO 8362-4:2011. At DIN, the German Institute for Standardization, e. V., the Medical Standards Committee (NAMed), Working Committee NA 063-02-03 AA "Verpackungssysteme für die Befüllung und Applikation von medizinischen Produkten" ("Packaging systems for the filling and application of medical products") is responsible. The new edition of DIN EN ISO 8362-4 contains updates of the normative references and modifications of the dimensions of the injection vials.

Document: references other documents

Responsible national committee

NA 176-04-04 AA - Packaging systems for loading and application of medical devices  

Responsible european committee

CEN/BT - BT Technical Board  

Edition 2011-12
Original language German
Translation English
Price from 70.50 €
Table of contents

Contact

Dipl.-Ing.

Margarethe Boresch

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