Overview

This standard specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1. The closures are used in connection with the freeze drying of drugs and biological materials. The necessary test methods are also part of the standard. With respect to DIN ISO 8536-6:1996-07, technical modifications also have been made in addition to editorial modifications. This includes the incorporation of requirements for the integrity of the container closure, modifications regarding the requirements for the materials, hardness, resistance to ageing, residual moisture, self-sealing and container closure seal integrity as well as revision of the test for the determination of the fragments and the determination of spike penetration force. The underlying International Standard ISO 8536-6:2009 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

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