ISO 24479:2024 PDF

Overview

ISO 24479:2024 - Biotechnology - Cellular morphological analysis - General requirements and considerations for cell morphometry to quantify cell morphological features - sets out general requirements and guidance for measuring cell morphology from optical microscopy images. The standard defines terms and cell morphological descriptors (shape, size, texture), provides example formulae, and addresses key aspects of image capture and image processing for reliable morphometric analysis. It primarily targets cultured mammalian cells and is not intended for clinical diagnostic imaging. Statistical analysis of morphometry results is explicitly outside its scope.

Key topics and technical requirements

• Definitions and descriptors: Unified terminology for cell morphology, morphometric concepts, and descriptors (shape, size, texture) with example formulae to promote consistent reporting.
• Image capture: Guidance on optical microscopy methods, sample preparation, microscope system components and settings (light source, objective and condenser lenses, optical path), image capture devices, bit depth and image data handling, environmental and observing conditions, and single vs multiple image capture strategies.
• Pre-processing and segmentation: Considerations for image pre-processing, segmentation of the Target of Interest (TOI) and preparing images suitable for quantitative analysis.
• Quantification and measurement: Procedures for extracting morphological features from segmented objects and considerations for qualifying measurements (measurement reliability and traceability).
• Reporting requirements: Detailed reporting of sample properties, microscopy conditions, image data and processing steps, and quantified morphological features to enable reproducibility and data comparability.
• Informative annexes: Practical check sheets (e.g., contrast-enhancing technique selection, microscope selection), lists of morphological descriptors with definitions and formulae (shape/size/texture), and guidance for acquiring phase-contrast images suitable for analysis.

Practical applications and users

ISO 24479:2024 is designed for:

• Researchers in academia performing cellular phenotype and morphology studies.
• Industry users in drug discovery, cell therapy development, cell manufacturing quality control, and cell bank characterization.
• Suppliers of microscopes, image acquisition hardware, image analysis software, and databases that store morphometric data.
• Authors preparing scientific publications who need standardized descriptor definitions and reporting templates.

Practical benefits include improved reproducibility, standardized descriptor calculation, clearer reporting, and better comparability of morphometric datasets across labs and vendors.

Related standards

Relevant referenced documents and related ISO work include standards cited in definitions (e.g., ISO 22493, ISO/TR 13014, ISO/IEC 30137-4) and the work of ISO/TC 276 Biotechnology (Subcommittee SC 1). Users should consult these and national guidance for complementary requirements.