DIN Standards Committee Elastomer Technology
DIN ISO 8536-6
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles (ISO 8536-6:2016)
Infusionsgeräte zur medizinischen Verwendung - Teil 6: Gefriertrocknungsstopfen für Infusionsflaschen (ISO 8536-6:2016)
Overview
This document is the German translation of the International Standard ISO 8536-6:2016, which has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use", the secretariat of which is held by DIN (Germany), with significant participation of German experts. The responsible national standardization committee is Working Committee NA 063-02-15 AA "Elastomere Pharmapackmittel und zugehörige Komponenten" ("Elastomeric pharmaceutical packagings and associated components") at DIN Standards Committee Medicine (NAMed). This document specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this document are intended for single use only.
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
