DIN EN ISO 8362-2:2010-12

Closures made from elastic materials are used for injection vials and are considered to be primary packaging materials, as they might come into contact with the medicinal products. These closures must meet special requirements with regards to shape and dimensions as well as physical, biological and chemical characteristics. The standard DIN EN ISO 8362-2 specifies the shape, dimensions and performance requirements for closures made from elastomeric materials for injection vials; it also contains information for the labelling of these closures. This standard contains the standard ISO 8362-2:2008, which shall be adopted, without any modifications, under the Unique Acceptance Procedure (UAP). With respect to DIN ISO 8362-2:1989-12, the requirements for the materials (for example, resistance to ageing, hardness) and performance requirements (for example, fragmentation) have been revised. Here, partial reference was made to the ISO 8871 standard series, which contains special test methods for elastomeric parts. ISO 8362-2:2008, which forms the basis of this standard, has been prepared by ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use" with the substantial participation of German experts of NA 063-02-15 AA "Gummi" ("Rubber") of NAMed.