DIN Standards Committee Health Technologies
DIN EN ISO 8362-7
Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006); German version EN ISO 8362-7:2010
Injektionsbehältnisse und Zubehör - Teil 7: Bördelkappen aus Aluminium-Kunststoffkombinationen für Injektionsflaschen ohne überstehendes Kunststoffteil (ISO 8362-7:2006); Deutsche Fassung EN ISO 8362-7:2010
Overview
This part of ISO 8362 specifies aluminium-plastic combinations for injection caps of injection vials, as specified in ISO 8362-1 and ISO 8362-4, where the plastics part does not overlap the diameter of the vial body. In addition to the dimensions, requirements are specified for the force required to remove the plastic component and tear off tab completely and packaging and marking.
The underlying International Standard has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use" (secretariat: DIN, Germany) and has been adopted as a European Standard by CEN/TC 205 "Non-active medical devices" (secretariat: DIN, Germany). With regard to the previous standard DIN ISO 8362-7:2007-06, only the European foreword has been supplemented. The responsible national Committee is Working Committee NA 063-02-15 AA "Gummi" ("Rubber") of the Medicine Standards Committee (NAMed).
Document: references other documents
Responsible national committee
NA 176-04-05 AA - Elastomeric pharmaceutical packaging and related components
Responsible european committee
CEN/TC 205 - Non-active medical devices
Responsible international committee
ISO/TC 76/WG 4 - Elastomeric parts and components and related secondary packaging components
