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

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

Standard Number KS P ISO TR 10993-22
Organization Korean Agency for Technology and Standards South Korea
Level National
Category Guide | Practice
Status
  • DEC 2020 Published
ABSTRACT
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. .