Biological evaluation of medical devices - Measurement of shed and released nanoparticles - Particle tracking analysis

This document describes the sample preparation method for particle detachment and release in medical devices, the particle size of nanoparticles in the detachment and release medium, and particle size distribution. Methods for particle tracking analysis of distribution and concentration. This document applies to the characterization of particle size distribution and number concentration of detached and released nanoparticles in medical devices (including nanomaterial medical devices). Analysis of the detachment or release of particles of other sizes in medical devices can also refer to this document.