DIN Standards Committee Health Technologies
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
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
