ISO 21243:2022 PDF

Radiation protection — Performance criteria for laboratories performing initial cytogenetic dose assessment of mass casualties in radiological or nuclear emergencies — General principles and application to dicentric assay

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Title (English):

ISO 21243:2022

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 18
Publication date:: November 7, 2022
Edition:: ISO IS 21243 edition 2 version 1
ICS:: 13.280

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Description (English):

The purpose of this document is to give an overview of the minimum requirements for performing the dicentric assay with quality control measures using mitogen stimulated peripheral blood lymphocytes for initial assessment of individuals involved in a mass casualty scenario. The dicentric assay is the use of chromosome damage to quickly estimate approximate radiation doses received by individuals in order to supplement the early clinical categorization of casualties. This document focuses on the organizational and operational aspects of applying the dicentric assay in an initial assessment mode. The technical aspects of the dicentric assay can be found in ISO 19238. This document is applicable either to an experienced biological dosimetry laboratory working alone or to a network of collaborating laboratories (as defined in Clause 7).

Technical details

Technical committee: ISO/TC 85/SC 2 - Radiological protection
SKU: ISO 21243:2022

Abstract

Overview

ISO 21243:2022 - Radiation protection - Performance criteria for laboratories performing initial cytogenetic dose assessment of mass casualties in radiological or nuclear emergencies - General principles and application to dicentric assay - provides minimum organizational and operational requirements for performing an expedited dicentric assay for initial dose assessment in mass-casualty radiological or nuclear events. The standard focuses on rapid, quality‑assured cytogenetic categorization of exposed individuals using mitogen-stimulated peripheral blood lymphocytes to support early clinical decision-making and triage.

Key topics and requirements

Scope & purpose: Guidance for initial (rapid) dicentric assay use in mass-casualty incidents to estimate approximate absorbed dose and support clinical triage.
Organizational responsibilities: Laboratory preparedness, pre‑planning, confidentiality, handling of biological dosimetry requests and reporting.
Laboratory network design: Roles and responsibilities of lead and associate laboratories; procedures for coordinated surge capacity and network operation.
Biological dosimetry process: Sample collection, transport integrity, simplified/expedited processing and validated scoring strategies for initial assessment.
Quality assurance and quality control (QA/QC): Defined performance checks covering sample integrity, instrumentation, scoring, dose estimation and confidence intervals, report generation and data security.
Performance checks: Regular verification of protocols, scoring thresholds (including manual scoring guidance), and network performance to ensure reproducible, defensible dose estimates.
Interpretation guidance: Consideration of whole‑body vs. inhomogeneous exposures, uncertainty communication and when acute exposure assumptions may not apply (note: for low LET radiation below ~0.3 Gy linearity is generally assumed).
Automation and validation: Semi‑ or fully automated methods may be used if validated and documented by the laboratory.

Applications and users

ISO 21243:2022 is intended for:

National and regional biological dosimetry laboratories and cytogenetic labs involved in emergency response
Lead laboratories coordinating multi‑laboratory networks for surge capacity
Emergency planners, public health authorities, medical responders and hospital laboratories seeking validated procedures for rapid dose categorization
Organizations developing training, drills and stockpiling strategies for radiological/nuclear mass-casualty preparedness

Practical uses include rapid triage support to identify non-exposed individuals, low/moderately exposed persons who need monitoring, and highly exposed patients requiring urgent treatment.

Related standards

ISO 19238 (technical aspects of dicentric assay)
ISO 17099 (cytokinesis-block micronucleus assay guidance)
ISO/IEC 17025 (laboratory competence)
ISO Guide 98 and ISO 5725 (uncertainty and accuracy guidance)

Keywords: ISO 21243:2022, dicentric assay, biological dosimetry, radiation protection, cytogenetic dose assessment, mass casualty, laboratory network, quality assurance, radiological emergency.

Related standards

Standards mentioned in the description

Abstract

Overview

Key topics and requirements

Scope & purpose: Guidance for initial (rapid) dicentric assay use in mass-casualty incidents to estimate approximate absorbed dose and support clinical triage.
Organizational responsibilities: Laboratory preparedness, pre‑planning, confidentiality, handling of biological dosimetry requests and reporting.
Laboratory network design: Roles and responsibilities of lead and associate laboratories; procedures for coordinated surge capacity and network operation.
Biological dosimetry process: Sample collection, transport integrity, simplified/expedited processing and validated scoring strategies for initial assessment.
Quality assurance and quality control (QA/QC): Defined performance checks covering sample integrity, instrumentation, scoring, dose estimation and confidence intervals, report generation and data security.
Performance checks: Regular verification of protocols, scoring thresholds (including manual scoring guidance), and network performance to ensure reproducible, defensible dose estimates.
Interpretation guidance: Consideration of whole‑body vs. inhomogeneous exposures, uncertainty communication and when acute exposure assumptions may not apply (note: for low LET radiation below ~0.3 Gy linearity is generally assumed).
Automation and validation: Semi‑ or fully automated methods may be used if validated and documented by the laboratory.

Applications and users

ISO 21243:2022 is intended for:

National and regional biological dosimetry laboratories and cytogenetic labs involved in emergency response
Lead laboratories coordinating multi‑laboratory networks for surge capacity
Emergency planners, public health authorities, medical responders and hospital laboratories seeking validated procedures for rapid dose categorization
Organizations developing training, drills and stockpiling strategies for radiological/nuclear mass-casualty preparedness

Practical uses include rapid triage support to identify non-exposed individuals, low/moderately exposed persons who need monitoring, and highly exposed patients requiring urgent treatment.

Related standards

ISO 19238 (technical aspects of dicentric assay)
ISO 17099 (cytokinesis-block micronucleus assay guidance)
ISO/IEC 17025 (laboratory competence)
ISO Guide 98 and ISO 5725 (uncertainty and accuracy guidance)

Keywords: ISO 21243:2022, dicentric assay, biological dosimetry, radiation protection, cytogenetic dose assessment, mass casualty, laboratory network, quality assurance, radiological emergency.

ISO 21243:2022 PDF

Technical details

Abstract

Overview

Key topics and requirements

Applications and users

Related standards

Related standards

Abstract

Overview

Key topics and requirements

Applications and users

Related standards

Related standards

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