Overview
EN ISO 17099:2024 - Radiological protection - Performance criteria for laboratories using the cytokinesis-block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry - provides performance guidance for laboratories that use the CBMN assay to estimate absorbed radiation dose from micronucleus yields in peripheral blood lymphocytes. Endorsed by CEN in 2024, this standard replaces EN ISO 17099:2017 and defines technical, quality and reporting expectations for biological dosimetry using the CBMN method. Note: methods for automated scoring of CBMN are excluded.
Key topics and requirements
- Confidentiality and data protection: handling and storage of personal information, anonymity of samples, transmission and reporting of confidential results.
- Laboratory safety: microbiological, chemical and optical safety measures and an overarching safety plan.
- Calibration and sensitivity: recommended calibration sources, calibration dose ranges to establish reference dose–response curves, background micronucleus (MN) frequency, and methods to characterise the minimum detectable dose.
- Sample processing and scoring: procedures for blood collection, culturing, harvesting, staining, microscopy and clear scoring criteria for micronuclei in binucleated cells (BNCs).
- Dose estimation: converting MN frequency in BNCs to an absorbed dose estimate, including calculations, uncertainty, comparison with controls and handling acute vs non‑acute exposures.
- Quality assurance / quality control (QA/QC): requirements for setting up and sustaining QA programs and routine QC measures.
- Reporting: content and format of result reports, interpretation guidance and practical annex material.
- Annexes: informative examples such as customer instructions, sample questionnaires, a microscope scoring data sheet and a sample report.
Practical applications
- Rapid biological dose assessment after accidental or suspected radiation exposure (individual or population triage).
- Support for emergency response teams, occupational health, radiation protection services and public health agencies assessing exposed individuals.
- Standardization of inter-laboratory comparisons and networks for large-scale event response.
- Ensuring consistent QA/QC and traceable dose estimation for medico-legal, clinical and regulatory reporting.
Who should use this standard
- Diagnostic and service laboratories performing CBMN biodosimetry
- Radiation protection specialists and emergency response labs
- Public health authorities, occupational health providers and research groups working on biological dosimetry
Related standards (applicable)
- ISO 17099:2024 is complementary to laboratory competence and quality standards (e.g., ISO/IEC 17025 for testing laboratories) for establishing validated, auditable biodosimetry services.
Keywords: EN ISO 17099:2024, CBMN assay, cytokinesis-block micronucleus, biological dosimetry, radiological protection, peripheral blood lymphocytes, calibration curve, minimum detectable dose, micronucleus frequency, binucleated cells, laboratory QA/QC.
