ISO 28218:2010

Overview

ISO 28218:2010 - "Radiation protection - Performance criteria for radiobioassay" defines performance, quality assurance and reporting criteria for radiobioassay service laboratories. The standard covers both in vivo and in vitro radiobioassay performance evaluation, including accuracy of measurements on test phantoms and test samples, minimal requirements for detection capability, and requirements for reporting and record retention. Clause 5 establishes the key statistical concepts (decision threshold and detection limit) used throughout the document; later clauses address laboratory responsibilities, quality assurance/control and a performance testing programme.

The standard is focused on performance criteria and testing protocols and explicitly does not prescribe detailed radiochemical methods, specific measurement procedures, biokinetic dose models, or procedures for preparing test samples and phantoms.

Key topics and requirements

• Performance measures: definition and application of decision threshold and detection limit, relative bias, and repeatability (Clause 5).
• In vivo radiobioassay criteria: accuracy assessment using phantoms, radionuclide identification, quantification and reporting expectations (Clause 6).
• In vitro radiobioassay criteria: minimum testing levels (MTL), analytical methodology considerations, and reporting obligations (Clause 7).
• Quality assurance (QA) and quality control (QC): requirements for QA plans, QC actions, records retention and documentation (Clause 8).
• Performance testing programme: criteria and procedures for testing laboratories and inter-laboratory testing (Clause 9).
• Reporting and documentation: standardized reporting of radiobioassay results, protocols for test evaluations and default procedures when customers do not specify criteria.
• Annex guidance: informative Annexes on detection limit models and application examples (Annex A and B).

Practical applications and who uses this standard

ISO 28218:2010 is used by:

• Radiobioassay service laboratories to establish and demonstrate measurement performance, detection capability and reporting consistency.
• Testing laboratories organizing inter-laboratory proficiency testing and performance evaluations.
• Radiation protection programme managers and occupational health professionals who rely on consistent, auditable radiobioassay results for internal contamination monitoring and record-keeping.
• Regulators and accreditation bodies assessing laboratory compliance with accepted performance criteria. Practical benefits include harmonized detection-limit definitions, clearer minimum testing levels (MTLs) for service providers, and standardized QA/QC expectations that improve comparability of results across laboratories.

Related standards and guidance

• ISO 12790-1 (superseded by ISO 28218)
• ISO 11929 (statistical concepts for detection)
• ISO 20553 and ISO 27048 (related radiological protection guidance)
• ISO/IEC Guide 99 and ISO 5725 series (metrology and measurement accuracy)

Keywords: ISO 28218:2010, radiobioassay, radiation protection, detection limit, decision threshold, in vivo, in vitro, quality assurance, quality control, minimum testing level, radiobioassay service laboratories.