ISO 10933 Biocompatibility Requirements for Medical Devices

In this white paper by UL Solutions, we’ll provide an overview of the structure and requirements presented in the latest version of ISO 10993-1 and provide details on the biological safety evaluation process set forth in Annex B of the standard.

ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, provides detailed guidance on the assessment of potential biological hazards associated with all types of medical devices, including active, nonactive, implantable and non-implantable. Most recently updated in 2018, the current version of the standard also places a greater emphasis on the use of chemical characterization and in vitro modeling in situations where these methods provide information as valid or as relevant as that generated by in vivo testing.