DIN EN ISO 8362-1:2010

Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2009); German and English version EN ISO 8362-1:2009 (Foreign Standard)

This part of ISO 8362 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. This part of ISO 8362 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.*Injection vials made of glass tubing are primary packaging materials, which are suitable for the packaging and storage of injectable preparations until they are administered for medicinal purposes. The injection vials may be made from different types ofglass which can affect the chemical resistance properties. The standard specifies the dimensions, capacities, form, material and designation of glass the vials. With respect to the standard which was published in September 2004, injection vials made of glass tubing and containing neck finishes with blow back have been added. The standard has been prepared by CEN Management Centre (CMC) in collaboration with Technical Committee ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use" with the participation of German experts. At DIN, the German Institute for Standardization e. V., Medicine Standards Committee (NAMed), the responsible Working Committee is NA 063-02-03 AA "PrimΣrpackmittel-BehΣltnisse" ("Primary packaging material containers").