Overview
ISO 21362:2026 - Nanotechnologies - Analysis of nano-objects using asymmetrical flow and centrifugal field-flow fractionation is an international standard developed by ISO. This document provides comprehensive guidelines for analyzing nano-objects, including their aggregates and agglomerates, in aqueous media utilizing field-flow fractionation (FFF) techniques. Specifically, it addresses the use of asymmetrical flow field-flow fractionation (AF4) and centrifugal field-flow fractionation (CF3), detailing their general principles, method development, operational parameters, and minimal reporting requirements.
The standard is designed to support the development and validation of analytical methods for precise nano-object characterization, making it highly relevant to research, quality control, and regulatory compliance within the nanotechnology sector.
Key Topics
1. Field-Flow Fractionation Principles
- Outlines core concepts of field-flow fractionation, involving the application of an external field perpendicular to the flow direction in a narrow channel, resulting in the differential separation of nano-objects based on size, diffusion coefficient, or density.
2. AF4 and CF3 Techniques
- Details specific operational modes:
- Asymmetrical Flow Field-Flow Fractionation (AF4): Uses a cross flow field for size-based separation, covering a wide particle size range from approximately 1 nm to 50 µm.
- Centrifugal Field-Flow Fractionation (CF3): Utilizes a centrifugal field to separate particles based on both size and density, applicable from approximately 10 nm up to 50 µm.
3. Method Development
- Provides guidance on:
- Selection of sample and mobile phase specifications
- Channel and membrane selection
- Injection methods, flow conditions, and elution program design
- Calibration, validation, and optimization steps
4. Measurement and Reporting
- Defines minimal reporting requirements for measurement parameters and test results to ensure method transparency and reproducibility.
5. Data Analysis and Quality Control
- Covers procedures for online and offline size and concentration analysis, material identification, system qualification, performance criteria, and uncertainty estimates.
Applications
ISO 21362:2026 supports a broad spectrum of nanotechnology applications by enabling accurate and reproducible analysis of nano-objects and their associated structures. Key practical uses include:
- Advanced Materials Research: Facilitates the characterization and identification of nanoparticles and their aggregates, supporting material innovation and process optimization.
- Quality Control in Nanomanufacturing: Ensures robust quality assurance for nanomaterials, providing essential data for product consistency and specification compliance.
- Environmental and Health Safety Assessments: Assists in the detection, classification, and quantification of nanoparticles in environmental samples or biological matrices, aiding regulatory evaluations.
- Regulatory Compliance: Helps organizations meet global regulatory requirements for nanomaterial characterization by following standardized analytical protocols.
- Instrument Calibration and Validation: Guides laboratories in method development, system qualification, and interlaboratory comparisons for consistent results.
Related Standards
For comprehensive implementation and harmonization, ISO 21362:2026 references and aligns with foundational documents, including:
Other related standards and measurement guidelines may further complement the practices established in ISO 21362:2026, especially within nano-object sizing, sample preparation, data analysis, and equipment calibration.
Implementing ISO 21362:2026 supports high-confidence nano-object analysis, contributing to innovation, safety, and compliance in nanotechnology industries. For laboratories, manufacturers, and regulators, this standard provides essential practices to ensure reproducibility, accuracy, and clarity in nano-object assessment using AF4 and CF3 field-flow fractionation techniques.