Biological evaluation of medical devices —Part 22: Guidance on nanomaterials

This standard describes considerations that should be taken into account in the biological evaluation of medical devices consisting of or containing nanomaterials. These guidelines may also be used to evaluate nanomaterials produced by disassembly, wear, or mechanical processing (e.g., in situ grinding, polishing of medical devices) of (parts of) medical devices manufactured without the use of nanomaterials. .