Overview
ISO/ASTM 52628:2020 - Standard practice for dosimetry in radiation processing provides general requirements and guidance for making absorbed dose measurements in radiation processing. Published as the second edition in 2020, this practice is a common reference for the ASTM E61 series of dosimetry standards. It covers dosimetry using electrons and photons (gamma or X‑radiation), gives direction on selecting dosimetry systems, and points users to system‑specific standards for calibration, uncertainty estimation, and application‑specific guidance. The standard addresses minimum requirements of a measurement management system but does not cover personnel or medical dosimetry nor primary standard dosimetry.
Key topics and technical requirements
- Absorbed dose measurement fundamentals - definitions, units (gray, Gy), and measurement intent for radiation processing.
- Dosimetry system requirements and classification - characteristics of dosimeters and dosimetry systems used for high absorbed doses typical in processing (≈10 Gy to >100 kGy).
- Calibration and traceability - requirements that dose measurements be traceable to national/international standards and calibrated per referenced practices.
- Uncertainty estimation - guidance on identifying and quantifying measurement uncertainties, including influence quantities (radiation type/energy, temperature, dose rate, post‑irradiation time).
- Dose mapping and mathematical methods - principles for absorbed‑dose mapping in facilities and product dose distribution calculations.
- Measurement management - minimum elements of a measurement management system to ensure consistent, repeatable dosimetry results (not a full quality management system).
- Scope limitations - excludes personnel/medical dosimetry and primary standard systems; users must establish appropriate safety and regulatory compliance.
Practical applications
ISO/ASTM 52628:2020 is applied where accurate dose measurement and process validation are required:
- Sterilization of healthcare products (device sterilization qualification and routine monitoring)
- Food and agricultural irradiation (microbial reduction, phytosanitary treatment)
- Polymer modification and material processing (crosslinking, property modification)
- Facility qualification and routine control - installation (IQ), operational (OQ), and performance qualification (PQ) dose mapping and monitoring
Who should use this standard
- Dosimetrists and radiation processing engineers
- QA/QC managers in irradiation facilities
- Calibration and testing laboratories (ISO/IEC 17025)
- Regulatory bodies and auditors assessing process validation
- Manufacturers of dosimetry systems and service providers
Related standards (select)
- ASTM E61 series (dosimetry practices and guides)
- ISO 11137 (healthcare product sterilization - dosimetric aspects)
- ISO 10012 (measurement management systems)
- ICRU Reports 80 & 85; JCGM (GUM) guidance on uncertainty
Keywords: ISO/ASTM 52628:2020, dosimetry, radiation processing, absorbed dose, dosimetry systems, calibration, uncertainty estimation, dose mapping, gamma radiation, electron beam, X‑ray.