Biological evaluation of medical devices - Part 22 : guidance on nanomaterials

Biological evaluation of medical devices - Part 22 : guidance on nanomaterials

Standard Number FD ISO/TR 10993-22 2017
Organization French national organization for standardization France
Level National
Category Test Method | Characterization | Measurement
Status
  • JAN 2017 Published
ABSTRACT
This document describes the aspects to be taken into account for the biological evaluation of medical devices which contain or are composed of nanomaterials. These guidelines can also be applied for the assessment of nano-elements generated as degradation or wear products, or as a result of mechanical processing (e.g. in situ grinding or polishing of medical devices) of devices. products or their components, made without nanomaterials.