Overview

This document has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use", the secretariat of which is held by DIN (Germany). The responsible German standardization committee is Working Committee NA 176-04-04 AA "Verpackungssysteme für die Befüllung und Applikation von medizinischen Produkten" ("Packaging systems for loading and application of medical devices") at DIN Standards Committee Health Technologies (NAGesuTech). This document specifies: a) a method for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at 121 °C ± 1 °C for 60 min ± 1 min ; the resistance is measured by titration of a known aliquot portion of the extraction solution produced with hydrochloric acid solution, in which case the resistance is inversely proportional to the volume of acid required; b) a classification of glass containers according to the hydrolytic resistance of the interior surfaces determined by the methods specified in this part of ISO 4802.

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