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 pr...
Saved in:
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2025-04-01
|
| Series: | Scientific Reports |
| Subjects: | |
| Online Access: | https://doi.org/10.1038/s41598-025-92266-4 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850145510548045824 |
|---|---|
| author | Charlotte Wouters Vikram Kestens Eveline Verleysen Jan Mast |
| author_facet | Charlotte Wouters Vikram Kestens Eveline Verleysen Jan Mast |
| author_sort | Charlotte Wouters |
| collection | DOAJ |
| description | 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 that the median of the distribution can be determined with the highest precision compared to other percentiles. Upon combining the precision uncertainty related to particle number with uncertainties from other sources, such as sample preparation, calibration and trueness, we reach an optimal particle count above which additional particle measurements only yield negligible improvements to the combined measurement uncertainty. Our findings offer an experimental approach for determining the minimum particle count to measure particle size and shape by electron microscopy. It enables efficient analyses and facilitates compliance with legislation addressing nanomaterials across various application domains. |
| format | Article |
| id | doaj-art-4f32208f8e3c4adbb18c3b8b7d1dbb2c |
| institution | OA Journals |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj-art-4f32208f8e3c4adbb18c3b8b7d1dbb2c2025-08-20T02:28:05ZengNature PortfolioScientific Reports2045-23222025-04-0115111310.1038/s41598-025-92266-4Assessing particle count in electron microscopy measurements of nanomaterials to support regulatory guidanceCharlotte Wouters0Vikram Kestens1Eveline Verleysen2Jan Mast3Trace Elements and NanomaterialsEuropean Commission, Joint Research Centre (JRC)Trace Elements and NanomaterialsTrace Elements and NanomaterialsAbstract 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 that the median of the distribution can be determined with the highest precision compared to other percentiles. Upon combining the precision uncertainty related to particle number with uncertainties from other sources, such as sample preparation, calibration and trueness, we reach an optimal particle count above which additional particle measurements only yield negligible improvements to the combined measurement uncertainty. Our findings offer an experimental approach for determining the minimum particle count to measure particle size and shape by electron microscopy. It enables efficient analyses and facilitates compliance with legislation addressing nanomaterials across various application domains.https://doi.org/10.1038/s41598-025-92266-4Electron microscopyNanomaterialPrecisionParticle countRegulatory guidanceParticle size |
| spellingShingle | Charlotte Wouters Vikram Kestens Eveline Verleysen Jan Mast Assessing particle count in electron microscopy measurements of nanomaterials to support regulatory guidance Scientific Reports Electron microscopy Nanomaterial Precision Particle count Regulatory guidance Particle size |
| title | Assessing particle count in electron microscopy measurements of nanomaterials to support regulatory guidance |
| title_full | Assessing particle count in electron microscopy measurements of nanomaterials to support regulatory guidance |
| title_fullStr | Assessing particle count in electron microscopy measurements of nanomaterials to support regulatory guidance |
| title_full_unstemmed | Assessing particle count in electron microscopy measurements of nanomaterials to support regulatory guidance |
| title_short | Assessing particle count in electron microscopy measurements of nanomaterials to support regulatory guidance |
| title_sort | assessing particle count in electron microscopy measurements of nanomaterials to support regulatory guidance |
| topic | Electron microscopy Nanomaterial Precision Particle count Regulatory guidance Particle size |
| url | https://doi.org/10.1038/s41598-025-92266-4 |
| work_keys_str_mv | AT charlottewouters assessingparticlecountinelectronmicroscopymeasurementsofnanomaterialstosupportregulatoryguidance AT vikramkestens assessingparticlecountinelectronmicroscopymeasurementsofnanomaterialstosupportregulatoryguidance AT evelineverleysen assessingparticlecountinelectronmicroscopymeasurementsofnanomaterialstosupportregulatoryguidance AT janmast assessingparticlecountinelectronmicroscopymeasurementsofnanomaterialstosupportregulatoryguidance |