DIN ISO 4802-2:2024-08

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). specifies: a) a method for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at (121 ± 1) °C for (60 ± 1) min; the resistance is measured by determining the amount of sodium and other alkali metal or alkaline earth oxides in the extraction solution using flame atomic emission or absorption spectrometry (flame spectrometry); b) a classification of glass containers according to the hydrolytic resistance of the interior surfaces determined by the methods specified in this document. The test method specified in this document might not be applicable to containers whose surfaces have been treated for functional modifications, e.g. silicone (for example, containers that are ready for direct filling).