Overview

Ampoules are suitable primary packaging materials for storing pharmaceutical products until they are administered to the patient. Owing to the direct contact between injectables and the primary packaging materials, ampoules shall meet particular requirements in order to ensure patient safety. The DIN EN ISO 9187 standard series specifies materials, dimensions, capacities, performance and packaging requirements for three common forms of ampoules for injectables. Ampoules with and without a colour break-ring are described in part 1 of this standard series; part 2 applies to OPC (one-point-cut) ampoules. The ampoules are intended for single use only. With regard to the previous edition of DIN EN ISO 9187-1:2008-06, the base radius of the ampoules with the nominal volume of 10 ml, 20 ml, 25 ml and 30 ml has been modified; the previous edition DIN ISO 9187-2:1994-01 has only been editorially revised. The standards have been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use" (secretariat: DIN), in collaboration with Technical Committee CEN/TC S02 "Transfusionsgeräte" ("Transfusion equipment") (secretariat: CEN-CENELEC Management Centre). At DIN, the German Institute for Standardization, the responsible Working Committee is NA 063-02-03 AA "Primärpackmittel-Behältnisse" ("Primary packaging material containers") of the Medicine Standards Committee (NAMed).

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-04-04 AA - Packaging systems for loading and application of medical devices  

Responsible european committee

CEN/BT - BT Technical Board  

Responsible international committee

ISO/TC 76/WG 2 - Rigid container systems and related accessories for parenterals and injectables