DIN ISO 13926-3
Pen systems - Part 3: Seals for pen-injectors for medical use (ISO 13926-3:2012)
Pen-Systeme - Teil 3: Dichtungen für Pen-Injektoren zur medizinischen Verwendung (ISO 13926-3:2012)
Overview
The standard specifies the shape, dimensions, materials, performance requirements and labelling of seals for pen-injectors for medical use. This includes requirements for hardness of the discs, fragmentation characteristics, freedom from leakage, resistance to ageing as well as chemical and biological requirements. The International Standard ISO 13926-3:2012-05 has been prepared by ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use" with collaboration of German experts. The body responsible for the standard is Working Committee NA 063-02-15 AA "Elastomere Pharmapackmittel und zugehörige Komponenten" ("Elastomeric pharmaceutical packaging and related components").
Document: references other documents
Responsible national committee
NA 176-04-05 AA - Elastomeric pharmaceutical packaging and related components
Responsible international committee
ISO/TC 76/WG 4 - Elastomeric parts and components and related secondary packaging components