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