EN ISO 10993-10 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. EN ISO 10993-10 includes essential tools for the development of safe products. It is intended to be used by professionals, appropriately qualified by training and experience, who can interpret its requirements and judge the outcomes of the evaluation for each medical device.
It is crucial to consider all the factors relevant to the device, its intended use and the current knowledge of the medical device provided by the review of the scientific literature and previous clinical experience. EN ISO 10993-10 includes:
— details of in vivo skin sensitization test procedures,
— key factors for the interpretation of the results.
The text of ISO 10993-10:2021 has been approved in Europe as EN ISO 10993-10:2023 without any changes.