Assessing particle count in electron microscopy measurements of nanomaterials to support regulatory guidance.

ABSTRACT: In the European Union, nanomaterials are regulated through different pieces of sectoral legislation. This legislation often requires risk assessments and thus reliable characterization data, for which regulatory guidance generally recommend electron microscopy. The guidance provides best practices for measurements but lacks requirements on how many particles to measure. Using transmission electron microscopy data of nanomaterials, a strategy based on repeated subsampling is proposed to establish, for different particle size and shape measurands, mathematical relationships between particle count and precision, and subsequently to determine the minimum particle count. Our results confirm that the minimum particle count generally depends on the width of the size and shape distributions and th

SUBMITTER: Wouters C 

PROVIDER: S-EPMC11973222 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature