A Study on the Quality Assurance Procedures of Radioactive Certified Reference Materials from the U.S. National Institute of Standards and Technology

Abstract

Radioactive certified reference materials (CRMs) are crucial in various fields, such as the calibrationof radiation measuring instruments, environmental radiation monitoring, and applications within the medical andnuclear industries. The discharge of contaminated water into the ocean following the Fukushima nuclear accidenthas raised public concern about radiation safety in Korea. As a result, the demand for radioactive CRMs in Korea isexpected to continue increasing. However, the current supply system for radioactive CRMs in Korea relies solely ona single institution. This reliance raises concerns that the supply may not meet the anticipated demand in the future. Such limitations could lead to uncertainties regarding the reliability of radiation measurements at the national leveland overall public safety concerning radiation. To address these challenges, the introduction of a new producer ofradioactive CRMs is being proposed. Producing radioactive CRMs in Korea requires meeting specific legal andtechnical requirements. Among these, ISO 17034 outlines the general criteria for reference material producers, whichinclude assessing homogeneity, monitoring stability, assigning property values, characterizing materials, determiningthe uncertainties of the property values, and ensuring metrological traceability of certified values. Additionally, ISO33405 provides an approach to the requirements specified in ISO 17034. Therefore, to produce radioactive CRMs inKorea, compliance with the technical requirements set forth in ISO 17034 and ISO 33405 is essential. The NationalInstitute of Standards and Technology (NIST) performs functions similar to those of the Korea Research Instituteof Standards and Science (KRISS) and serves as a supplier of radioactive CRMs in the United States. This studyexamines the quality assurance procedures for radioactive CRMs developed by NIST. Their quality assuranceprocedures consist of 22 steps based on ISO 17034 and ISO 33405. This study analyzes these 22 steps by categorizingthem into pre-production, production, and post-production phases, presenting the overall process through a schematicdiagram. The findings of this study are intended to provide practical guidance for future radioactive CRM producersin Korea looking to comply with international technical standards.