SIST EN ISO 19238:2023 PDF

Overview

EN ISO 19238:2023 - Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics - Dicentric assay (ISO 19238:2023) defines performance, quality assurance and accreditation criteria for laboratories that perform biological dosimetry using the dicentric assay with manual scoring. The standard addresses practical requirements for dose estimation from unstable chromosome aberrations, laboratory safety, data confidentiality, reporting and inter-laboratory performance checks. EN ISO 19238:2023 supersedes the 2017 edition and is intended for service laboratories working in radiological protection and emergency response.

Key topics and technical requirements

• Scope and responsibilities: Roles of the requestor and the service laboratory, including setup and sustainment of a QA program.
• Confidentiality: Protection of personal information, anonymization, secure transmission and storage of sample and result data.
• Laboratory safety: Microbiological, chemical and optical safety measures for cytogenetic processing.
• Sample processing & scoring: Standardized culturing, coding, scoring techniques and procedures for first-division metaphases with emphasis on manual scoring expertise.
• Calibration curves: Requirements for calibration sources and dose ranges to establish reference dose–response curves for unstable aberrations.
• Dose estimation: Criteria to convert aberration frequency into absorbed dose, testing aberration distribution, detection limits, confidence limits and uncertainty estimation.
• Special cases: Guidance on acute/non‑acute, partial‑body, prior exposure and other exposure scenarios.
• Reporting: Minimum content for reports (Annex C sample report) and interpretation of results.
• Quality assurance & QC: Inter-comparisons, scorer qualification checks, transport and sample integrity checks, instrumentation and protocol validation.
• Informative annexes: Practical tools such as requestor instructions, sample questionnaire, data sheets, statistical fitting (maximum likelihood for low‑LET curves), odds-ratio methods for low-dose suspicion, decision threshold/detection limit methods.

Applications and users

• Service laboratories providing biological dosimetry for occupational monitoring, emergency response, public health and radiation incident investigations.
• Accreditation bodies and regulatory agencies assessing laboratory competence and conformity for cytogenetic dosimetry.
• Radiation protection professionals, hospital labs, and emergency planners seeking standardized procedures for dicentric assay dose estimation and reporting.
• Use cases include triage after radiological incidents, dose reconstruction, and routine verification of occupational exposures.

Related standards

• EN ISO 19238:2023 is the endorsed European version of ISO 19238:2023 and supersedes the 2017 edition. Laboratories should align QA programs with this standard alongside applicable national accreditation and radiation protection regulations.

Keywords: biological dosimetry, dicentric assay, cytogenetics, radiological protection, dose estimation, calibration curve, quality assurance, EN ISO 19238:2023.