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

Overview

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

ISO 21362:2026 PDF

Technical details

Abstract

Overview

Key Topics

Abstract

Overview

Key Topics

Applications

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