Overview
EN ISO 21362:2026 - Nanotechnologies – Analysis of Nano-Objects using Asymmetrical Flow and Centrifugal Field-Flow Fractionation establishes international guidelines for characterizing nano-objects and their aggregates and agglomerates in aqueous media. Developed jointly by CEN and ISO, this standard describes the general principles of field-flow fractionation (FFF), including both asymmetrical flow (AF4) and centrifugal (CF3) methods. The document outlines essential parameters, operating conditions, validation protocols, and reporting requirements that support the reliable analysis of nano-objects in a wide range of scientific and industrial applications.
EN ISO 21362:2026 provides users with comprehensive procedures for developing and validating methods using FFF techniques, ensuring high levels of reproducibility and comparability in measurements across laboratories. The standard supports enhanced measurement reliability, regulatory compliance, and the ongoing advancement of nanotechnology research and industry.
Key Topics
The main areas addressed by EN ISO 21362:2026 include:
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General Principles of Field-Flow Fractionation (FFF):
- Detailed explanation of FFF theory, channel configuration, and the use of perpendicular force fields for nano-object separation.
- Overview of asymmetrical flow (AF4) and centrifugal (CF3) variants.
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Method Development and Validation:
- Parameters for selecting appropriate mobile phases, flow conditions, field strengths, and channel dimensions.
- Guidelines for developing and optimizing separation methods specific to AF4 and CF3.
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Measurement and Analysis Procedures:
- Standardized processes for sample introduction, focusing, relaxation, and elution.
- Use of online and offline detectors for assessing nano-object size, concentration, and composition.
- Calibration and quality control to ensure method accuracy and reproducibility.
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Reporting and Documentation:
- Clear minimum requirements for documenting experimental conditions, apparatus specifications, and measurement results.
- Test reporting protocols to enable transparent communication and data comparison.
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Performance Criteria:
- Qualification of systems and definition of performance metrics including recovery, selectivity, retention ratio, and resolution.
- Consideration of measurement uncertainty and test precision.
Applications
EN ISO 21362:2026 is a foundational document for organizations involved in the analytical characterization of nano-objects, particularly where reliable separations and detailed size distribution information are critical. Practical applications include:
- Materials Science and Nanotechnology: Characterization of engineered nanoparticles, nano-enabled composites, and advanced materials for research and manufacturing.
- Environmental Science: Analysis of nanoparticles and their behavior in environmental samples such as water, supporting risk assessment and monitoring.
- Quality Control and Regulatory Compliance: Meets increasing regulatory demands for nanomaterial detection, size distribution, and composition in industrial and consumer products.
- Pharmaceuticals and Biotechnology: Supports particle analysis for drug delivery systems and biomedical devices where precise characterization at the nanoscale is essential.
- Academic and Industrial Research: Enables reproducible, validated measurements for publications, patents, and interlaboratory comparison studies.
By providing robust protocols for the separation and analysis of nanoparticles in aqueous media, this standard fosters global harmonization in nano-object analysis and strengthens the foundation for scientific advances and product innovation.
Related Standards
To ensure comprehensive and consistent vocabulary, measurement procedures, and reporting, the following standards are closely related to EN ISO 21362:2026:
These references complement EN ISO 21362:2026 by providing clear terminology and additional guidance on the characterization of nanoparticles and nano-objects, supporting a unified approach across the nanotechnology sector.
Keywords: EN ISO 21362:2026, field-flow fractionation, nanotechnologies, asymmetrical flow FFF, centrifugal FFF, nano-object analysis, nanoparticle characterization, aqueous media, method validation, size distribution, CEN standards, ISO, nanomaterial measurement.
