Overview

This part of ISO 8362 specifies caps made of aluminium-plastics combinations for injection vials as specified in ISO 8362-1 and ISO 8362-4. In addition to the dimensions, requirements for the design and the force required for lifting the seal and for the packaging and marking are specified. With respect to DIN ISO 8362-6:1993-06, editorial amendments, in particular an update of the normative references have been made. The International Standard on which this standard is based has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use" (secretariat: DIN, Germany), in collaboration with CEN/TC 205 "Non-active medical devices" (secretariat: DIN, Germany). The responsible national Committee is Working Committee NA 063-02-15 AA "Elastomere Pharmapackmittel und zugehörige Komponenten" ("Elastomeric pharmaceutical packagings and associated components") of the Medical 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