Legal and Technical Requirements for Radioactive Certified Reference Materials in Korea

Abstract

Following the recent discharge of treated radioactive water from the Fukushima Daiichi nuclear powerplants into the ocean, public interest in radiation safety has significantly increased in Korea. As a result, ensuring theaccuracy and reliability of radiation measurements for imported seafood and goods distributed in Korea has becomea key societal concern. Accurate and traceable measurements of radioactivity require the calibration of instrumentsusing certified reference materials (CRMs). Consequently, there is a growing demand for radioactive CRMs acrossvarious sectors in Korea, including environmental monitoring, nuclear power, and medical applications. However, theKorea Research Institute of Standards and Science (KRISS) is currently the sole institution responsible for developingand producing radioactive CRMs in the country. This study aims to identify and analyze the legal and technicalrequirements that institutions must fulfill to be recognized as producers of radioactive CRMs. The legal frameworkincludes the Framework Act on National Standards, the Conformity Assessment Management Act, and the KoreaLaboratory Accreditation Scheme (KOLAS) accreditation operational guidelines. On the technical side, the studyexamines the essential implementation of KS A ISO 17034 (General requirements for the competence of referencematerial producers) and KS A ISO Guide 35 (Reference materials – Guidance for characterization and assessmentof homogeneity and stability), which provide internationally accepted guidelines for CRM production. Additionally,quality system documentation from the National Institute of Standards and Technology (NIST) in the United Statesis reviewed to offer comparative insights. The findings of this study aim to support the development of a nationallycoordinated CRM production system that meets both Korea’s needs and international standards.