The purpose of the medical device is to provide a benefit to the patient, directly or indirectly, by allowing the diagnosis, prognosis, treatment or mitigation (etc.) of a disease. Nevertheless, because of its design, manufacture, or intended use, it can also pose safety problems, in particular biological risks in humans during use, if no evaluation is performed. Therefore, the biological evaluation of a medical device must be conducted as soon as there is direct or indirect contact with the human body (patient and/or user) in order to assess the biological safety of the medical device during its clinical use.
Among the various steps in this process, physical and chemical characterization is the critical first step in the biological evaluation process. It is to be carried out after the categorization of the medical device, i.e. after establishing the nature and duration of contact with the body.
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