Biological evaluation according to ISO 10993
A biological evaluation is indispensable for assessing the biological safety and biocompatibility of any medical device. The starting point of a biological evaluation is the chemical, biological and physical characterization of the device. Based on this, the toxicological risk is assessed in relation to the biological endpoints, which are determined by the duration and nature of contact with the body in accordance with ISO 10993-1. This may require biocompatibility testing.
Data from literature, material databases, tests and clinical application can be used for the assessment of biological safety. Through careful planning and research, some biocompatibility tests can be replaced by data from literature and material search, thus saving you time and money.
The biocompatibility of a medical device is included in the clinical evaluation as an important component of its safety.
Chemical, biological and physical characterization, identification and assessment of biological risks, toxicological and biological assessment. In short: we offer all the services you will need – from plan to final report and all according to your needs and wishes.
Contact your novineon specialist.
Phone: +49 7071 98979 – 127