Hamburg, 15.01.2020, Dr. Silvia Georges

ISO published second edition of the ISO 10993-18 on chemical characterization of medical device materials

The ISO / TC 194 released the revised ISO 10993-18:2020 which cancels and replaces the first edition ISO 10993-18:2005. The standard is essential for the evaluation of biological safety of medical devices. It specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents. The main changes compared to the previous edition include

– a greater integration and harmonization with ISO 10993-1, ISO 10993-12 and ISO 10993-17;
– a revised and expanded chemical characterization process flowchart;
– a strengthened explanation that analytical testing is not necessarily required;
– clarified testing approaches unique to chemical characterization (i.e. digestion and dissolution for hazard identification);

In addition, a number of definitions was added as well as informative annexes on general principles, vehicle extraction considerations and the analytical evaluation threshold (AET). Furthermore, considerations related to analytical method qualification are discussed.