DIN Standards Committee Health Technologies
DIN EN ISO 8362-1
Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2009 + Amd 1:2015); German version EN ISO 8362-1:2009 + A1:2015
Injektionsbehältnisse und Zubehör - Teil 1: Injektionsflaschen aus Röhrenglas (ISO 8362-1:2009 + Amd 1:2015); Deutsche Fassung EN ISO 8362-1:2009 + A1:2015
Overview
Injection vials made of glass tubing are primary packaging materials, which are suitable for the packaging and storage of injectable preparations until they are administered for medicinal purposes. The injection vials may be made from different types of glass which can affect the chemical resistance properties. Amendment 1 amends Table 1 of the standard by adding injection vials of sizes 50R and 100R and revising the weights of all injection vials. The amendment has been prepared by CEN in collaboration with Technical Committee ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use" with the participation of German experts. Working Committee NA 063-02-03 AA "Primärpackmittel-Behältnisse" ("Primary packaging material containers") at DIN Standards Committee Medicine (NAMed) is responsible.
Document: references other documents
Responsible national committee
NA 176-04-04 AA - Packaging systems for loading and application of medical devices
Responsible european committee
Responsible international committee
ISO/TC 76/WG 2 - Rigid container systems and related accessories for parenterals and injectables
