DIN Standards Committee Health Technologies
DIN EN ISO 8362-2
Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015); German version EN ISO 8362-2:2015
Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO 8362-2:2015); Deutsche Fassung EN ISO 8362-2:2015
Overview
This standard has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use" in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices", the secretariat of which is held by DIN (Germany). The responsible national standardization committee is Working Committee NA 063-02-15 AA "Gummi" ("Rubber") at DIN Standards Committee Medicine (NAMed). This part of ISO 8362-2 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this part of ISO 8362-2 are intended for single use only.
Document: references other documents
Responsible national committee
NA 176-04-05 AA - Elastomeric pharmaceutical packaging and related components
Responsible european committee
Responsible international committee
ISO/TC 76/WG 4 - Elastomeric parts and components and related secondary packaging components
