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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.
This document replaces DIN EN ISO 8362-4:2004-11 .