Overview

This standard specifies the shape, dimensions, materials, performance requirements and labelling of seals for dental local anesthetic cartridges intended for single use only. This includes requirements for hardness of the discs, fragmentation characteristics, freedom from leakage, resistance to ageing as well as chemical and biological requirements. With respect to the standard DIN ISO 11040-3:1993-11 the scope has been extended by considering seals as a unit of aluminium caps and discs. 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