DIN Standards Committee Health Technologies
DIN EN ISO 8362-5
Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016); German version EN ISO 8362-5:2016
Injektionsbehältnisse und Zubehör - Teil 5: Gefriertrocknungsstopfen für Injektionsflaschen (ISO 8362-5:2016); Deutsche Fassung EN ISO 8362-5:2016
Overview
This document (EN ISO 8362-5:2016) 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 Technical Committee CEN/TC 205 "Non-active medical devices" (secretariat: DIN, Germany) with substantial participation of German experts. The responsible nation 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 part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which 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 part of ISO 8362 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 european committee
CEN/TC 205 - Non-active medical devices
Responsible international committee
ISO/TC 76/WG 4 - Elastomeric parts and components and related secondary packaging components
