DIN Standards Committee Health Technologies
DIN ISO 11418-1
Containers and accessories for pharmaceutical preparations - Part 1: Drop-dispensing glass bottles (ISO 11418-1:2016)
Behältnisse und Zubehör für Arzneimittel - Teil 1: Tropfflaschen aus Glas (ISO 11418-1:2016)
Overview
This part of ISO 11418 specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug. This part of ISO 11418 is applicable to drop-dispensing glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use. This document is the German translation of the International Standard ISO 11418-1:2016 which has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use" with the 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).
Document: references other documents
Responsible national committee
NA 176-04-04 AA - Packaging systems for loading and application of medical devices
Responsible international committee
ISO/TC 76/WG 2 - Rigid container systems and related accessories for parenterals and injectables
