ISO 17099:2024

Overview - ISO 17099:2024 (CBMN assay for biological dosimetry)

ISO 17099:2024 specifies performance criteria and practical guidance for laboratories using the cytokinesis‑block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry. The standard supports radiological protection by defining how micronucleus (MN) yields in binucleated cells (BNCs) are collected, scored, converted into absorbed dose estimates, and reported. It covers laboratory responsibilities, confidentiality, safety, calibration, sample processing, scoring criteria, dose conversion, quality assurance, and informative annexes with sample forms. The document explicitly excludes methods for automated scoring of CBMN.

Key topics and technical requirements

• Confidentiality and data security: Principles for protecting personal information of both the customer and laboratory, sample anonymity, transmission and storage of results.
• Laboratory safety: Microbiological, chemical and optical safety requirements and a safety plan for CBMN operations.
• Calibration and detection limits: Guidance on calibration sources, calibration dose ranges, background MN frequency, calibration curves and characterization of the minimum detectable dose.
• Sample processing and scoring: Requirements for blood collection, culture, harvesting, staining, microscopy and manual scoring criteria for micronuclei in BNCs; includes scoring data sheets.
• Dose estimation: Methods to convert MN frequency into absorbed dose, calculation of uncertainties, comparison with controls, and considerations for acute and non‑acute exposures.
• Accident response and triage: Procedures for scoring and reporting results in single‑case assessments and large‑scale population triage, including networked laboratory approaches.
• Quality assurance/quality control (QA/QC): Lab QA program setup, inter‑comparisons, scorer qualification checks, sample integrity checks and performance checks for instrumentation and reporting.
• Informative annexes: Sample instructions for requestors, questionnaires, microscope scoring sheets and sample single/group reports.

Applications and who should use ISO 17099

ISO 17099 is intended for:

• Clinical and reference laboratories performing biological dosimetry with the CBMN assay
• Emergency response and public health agencies planning radiological incident triage
• Nuclear industry and occupational health services conducting post‑exposure assessment
• Laboratory quality managers implementing QA/QC and reporting practices
• Regulators and accreditation bodies evaluating biodosimetry competence

Using ISO 17099 improves consistency in dose estimation, supports credible reporting in radiological incidents, and aids interoperability between biodosimetry networks.

Related standards (if applicable)

• ISO/IEC 17025 (general requirements for the competence of testing and calibration laboratories) - often used in conjunction with ISO 17099 for laboratory accreditation and quality management.