Human body

Biocompatibility evaluation therefore covers contact with users as well as patients. A device that only touches the clinician's skin still needs a biological evaluation for that contact.

For the purposes of this document, the term “human body” refers to either patient tissues or the clinical practitioner.

FDA guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (September 2023), Footnote 1