Overview

The shape, dimensions, material, performance requirements and labelling for freeze drying closures made of elastomeric materials for injection vials according to ISO 8362-1 and ISO 8362-4. The closures are intended for single use only. Performance requirements included in this standard are, for example, resistance to ageing and residual moisture. With respect to the edition DIN ISO 8362-5:1996-07, requirements for the materials, resistance to ageing, residual moisture and determination of the hardness have been revised. For requirements relating to penetrability, fragmentation, self-sealing and container closure seal integrity and for biological and chemical requirements, reference is made to DIN EN ISO 8871-1, DIN EN ISO 8871-4 and DIN ISO 8871-5. The standard contains the German translation of the International Standard ISO 8362-5:2008, which has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use" with the participation of German experts. At DIN, the German Institute for Standardization e. V., the responsible 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

Document: referenced in other documents

Responsible national committee

NA 176-04-05 AA - Elastomeric pharmaceutical packaging and related components