Nanomaterials in Medical Devices: Considerations and Challenges

Nanomaterials gain increasing focus within the regulatory context of Medical Devices. ISO/TR 10993 22:2017 addresses the biological safety assessment of medical devices that are composed of or contain nanomaterials as well as the evaluation of nanomaterials generated within the clinical application (e.g. due to degradation, wear or from mechanical treatment processes).

Nevertheless, a clear strategy in terms of experimental set-up and adjustment of ISO 10993 series endpoint testing is not implemented yet. Within this webinar an overview of the regulatory background as well as possible testing strategies will be presented. Additionally experimental feasibility of different biological testing procedures and consideration of their practical approach will be described and discussed.