Overview
CEN ISO/TS 12025:2021 - "Nanomaterials - Quantification of nano-object release from powders by generation of aerosols" - is a Technical Specification from ISO/CEN that defines methods to quantify the release of nano-objects from powder materials by generating and measuring aerosols. The standard covers the full measurement chain - generation, transport and measurement - and specifies minimum requirements for sample preparation, test protocol development, measurement of particle release, and reporting. Measured outputs include particle number concentration, particle size distribution, and derived mass concentration for nano-objects as well as their agglomerates and aggregates.
Key topics and requirements
- Scope and exclusions
- Applies to release of nano-objects from powders via aerosolization (handling → high-energy dispersion).
- Does not cover particle size characterization within the bulk powder.
- Tribological methods (direct mechanical grinding/abrasion) are excluded.
- Measurement stages
- Three core stages: generation (aerosolization), transport (minimizing losses and agglomeration), and measurement (instrument sampling).
- Test design and minimum requirements
- Guidance on selecting powder sampling and sample treatment procedures (dustiness generation and dispersing methods).
- Sample preparation, safety assessment, and documentation requirements.
- Selection criteria for measuring methods according to generation system characteristics (time-dependence, transport losses).
- Measurement outputs
- Particle number concentration and size distribution across the nanoscale and larger agglomerates/aggregates; mass concentration derived from number and size data.
- Protocol and reporting
- Minimum criteria for test setups, protocol reproducibility, and comprehensive test reports describing methods, parameters, and results.
- Annexes provide informative guidance (e.g., dynamic methods, dispersing methods, choosing measuring instruments).
Applications and users
- Practical for:
- Nanomaterial manufacturers and formulators assessing potential release during handling and processing.
- Occupational hygiene and safety teams developing exposure mitigation strategies.
- Research laboratories validating dispersion and aerosolization behavior of powders.
- Test houses creating standardized protocols for comparative testing.
- Use cases:
- Comparing nano-object release between different powder formulations.
- Evaluating process changes (handling, milling, packaging) that influence aerosol release.
- Supporting safer-by-design decisions and engineering controls (though the standard is not a health risk assessment or a replacement for dustiness testing).
Related standards
- ISO/TS 80004-1:2015 - Nanotechnologies - Vocabulary (core terms)
- ISO/TS 80004-2:2015 - Nanotechnologies - Vocabulary (nano-objects)
- Refer to the standard’s informative annexes and bibliography for additional methodological guidance and linked test methods.
Keywords: nanomaterials, nano-object release, aerosols, powders, aerosolization, particle number concentration, size distribution, dustiness, dispersion, agglomerates, test protocols.