Overview

The standard specifies the shape, dimensions, material, performance requirements and labelling of plunger stoppers for pen-injectors for medical use. The performance requirements include freedom from leakage as well as initiating and sustaining forces. The standard contains a test method for verification that there is no leakage between the cylinder and the plunger stopper. The standard contains the second edition of ISO 13926-2:2011-04 which shall be adopted without any modifications as a DIN ISO standard. With respect to DIN ISO 13926-2:2000-10, the requirements for plunger stoppers and seals have been divided. In the future, seals will be dealt with in a Part 3 of the standard series DIN ISO 13926 (publication in preparation). Other modifications include an adaptation to the standard series DIN EN ISO 8871, Elastomeric parts for parenterals and for devices for pharmaceutical use, modifications regarding the dimensions of plunger stoppers as well as revisions of the requirements for material, freedom from leakage, initiating and sustaining forces. Requirements for the resistance to ageing have been incorporated. Standard ISO 13926-2 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. The responsible committee is Working Committee NA 063-02-15 AA "Elastomere Pharmapackmittel und zugehörige Komponenten" ("Elastomeric pharmaceutical packagings and associated components") at the Medical Standards Committee (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