Overview

Infusion bottles are suitable primary packaging materials for the storage of infusion solutions until they are administered to the patient. Due to the direct contact between infusion solution and the primary container components and in view of the extended storage periods, it is essential to avoid possible interactions in order to guarantee the patient's safety. Adequate means to achieve this goal include the proper selection of the primary packaging materials, the choice of suitable package design and the availability of specific criteria and methods for testing of individual container systems. This standard specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bottles for single use. This standard has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use" (secretariat: DIN, Germany). It has been adopted without any modifications as a European Standard. At DIN, the German Institute for Standardization e. V., Working Committee NA 063-02-03 AA "Verpackungssysteme für die Befüllung und Applikation von medizinischen Produkten" ("Packaging systems for filling and application of medical products") is responsible at the Medical Standards Committee (NAMed). The new edition of DIN EN ISO 8536-1 takes into account updates of the normative references and further editorial revisions.

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