Overview

This standard specifies the shape, dimensions, material, performance requirements and labelling of plunger stoppers for glass barrels (single chamber design) for injection preparations. The performance requirements include freedom from leakage as well as gliding characteristics. This standard includes ISO 11040-5:2012-01. In comparison with DIN ISO 11040-5:2001-12, the standard has been brought in line with the ISO 8871 series, "Elastomeric parts for parenterals and for devices for pharmaceutical use" and the title has been adapted to the ISO standard. The requirements for the material and the hardness of the plunger stoppers have been revised and the height of the spacers has been partially changed. Requirements for the resistance to ageing have been incorporated. Table 1 has been supplemented by a missing value and the German translation of PSL has been adjusted to the new English designation. The standard ISO 11040-5 which forms the basis of this document 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 German experts. The responsible committee is Working Committee NA 063-02-15 AA "Elastomere Pharmapackmittel und zugehörige Komponenten" ("Elastomeric pharmaceutical packaging and related components") of the DIN Standards Committee Medicine (NaMed).

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